Decree No. 96/2023/ND-CP dated December 30, 2023 on elaboration of Law on Medical Examination and Treatment

• Official number: 96/2023/ND-CP
• Legislation Type: Decree of Government
• Organization: The Government
• Signer: Tran Hong Ha
• Issued Date: 30/12/2023

THE GOVERNMENT OF VIETNAM ------------	THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ------------
No. 96/2023/ND-CP	Hanoi, December 30, 2023

DECREE

ELABORATION OF LAW ON MEDICAL EXAMINATION AND TREATMENT

Pursuant to the Law on Government Organization dated June 19, 2015; the Law on Amendments to the Law on Government Organization and the Law on Local Government Organization dated November 22, 2019;

Pursuant to the Law on Medical Examination and Treatment dated January 09, 2023;

At the request of the Minister of Health of Vietnam;

The Government of Vietnam promulgates a Decree elaborating the Law on Medical Examination and Treatment.

Chapter I

GENERAL PROVISIONS

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1. This Decree provides detailed regulations on some Articles of the Law on Medical Examination and Treatment in respect of:

a) Issuance of license to practice medicine (hereinafter referred to as “practicing license”);

b) Issuance of license to provide medical services (hereinafter referred to as “operating license”);

c) Application of new techniques and methods, and clinical trials in healthcare;

d) Management of medical devices at health facilities;

dd) Mobilization or dispatch of health facilities to delivery medical services in case of occurrence of natural disasters, catastrophes, group-A infectious diseases or state of emergency;

e) Preconditions for healthcare operations;

g) Guidance on implementation roadmap; transition provisions on practicing license and operating license.

2. This Decree does not apply to the following operations of medical practitioners and health facilities under People's armed forces, including:

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b) Cases, conditions, application requirements and procedures of issuance, re-issuance, modification, suspension or revocation of operating license of health facilities, and templates of operating license;

c) Healthcare quality assessment and certification;

d) Classification of professional and technical expertise in healthcare.

3. Health facilities that are public administrative units shall exercise autonomy in accordance with regulations of law on autonomy.

Article 2. Definitions

1. “full-time medical practitioner” means an employee who has been granted a practicing license and has obtained registration for practice medicine for the full administrative working hours of a health facility.

2. “administrative hours” of a health facility means the length of time available for performing administrative tasks, defined and publicly announced by that health facility on the condition that it is appropriate to normal working hours prescribed by the Labor Code.

3. “opening hours” of a health facility means the length of time used for performing medical examination and treatment activities, defined and registered by that health facility, and specified in its operating license issued by a competent authority. Opening hours include administrative working hours.

4. “change in professional title” is a medical practitioner’s applying for change from a professional title to another one upon his/her satisfaction of relevant conditions, and terminating practicing of medicine under the professional title previously awarded by a competent authority.

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6. “not-for-profit health facility” means a health facility whose revenues earned during its operation shall not be distributed to its employees, shareholders, members or capital contributors but be used for maintaining its main operations.

7. “head of health facility” means the person who holds the position of general director or director of a health facility (including those that are public administrative units having management boards) or who is appointed to act as the head of a private health facility under the relevant enterprise's charter on operation.

A health facility’s head may not be the person in charge of professional practices of that health facility.

8. “specialty qualification" means a document certifying its holder's completion of a specialized postgraduate training course in healthcare sector in corresponding to one of the titles specified in points a, c, d, dd, e, g, h clause 1 Article 26 of the Law on Medical Examination and Treatment.

9. “scope of practice” means a range of activities which can be performed by a medical practitioner, and is specified in:

a) his/her practicing license;

b) the decision to adjust scope of practice issued by a competent authority defined in Article 28 of the Law on Medical Examination and Treatment; or

c) written permission to implement techniques given by the person in charge of professional practices of the health facility as prescribed in clause 3 Article 10 or clause 3 Article 125 of this Decree.

10. “professional department” of a health facility means a body that takes charge of performing medical examination and treatment tasks and is included in the organizational structure of that health facility. A professional department may be an institute, center, division or ward, or unit.

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12. “test equipment” means medical devices, including reagents, calibrators, control materials, instruments and other products, whether used alone or in combination, intended by the product owner, to be used in tests for the examination of specimens derived from the human body.

13. “risk management” means a competent health authority’s application of methods and professional processes to identify, evaluate and classify risks as the basis for allocating or arranging reasonable resources for inspecting, monitoring and assisting effective management of medical examination and treatment activities.

Chapter II

ISSUANCE OF LICENSE TO PRACTICE MEDICINE

Section 1. PRACTICING AS MEDICAL INTERNS

Article 3. Duration and contents of medical internship required for issuance of practicing license

1. The required duration of practicing as a medical intern for a doctor is 12 months, including:

a) The duration for practicing medical examination and treatment is 09 months; and

b) The duration for practicing resuscitation in emergency care medicine is 03 months.

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a) The duration for practicing medical examination and treatment is 06 months; and

b) The duration for practicing resuscitation in emergency care medicine is 03 months.

3. The required duration of practicing as a medical intern for a nurse, midwife or medical technician is 06 months, including:

a) The duration for practicing medical examination and treatment is 05 months; and

b) The duration for practicing resuscitation in emergency care medicine is 01 month.

4. The required duration of practicing as a medical intern for a clinical nutritionist is 06 months.

5. The required duration of practicing as a medical intern for an out-of-hospital paramedic is 06 months, including:

a) The duration for practicing out-of-hospital emergency care is 03 months; and

b) The duration for practicing resuscitation in emergency care medicine is 03 months.

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7. Instructions about regulations of law on medical examination and treatment, professional regulations, code of ethics, patient safety, communication skills and behavior of medical practitioners shall be also given during the internship.

8. Based on the scope of practice prescribed by the Minister of Health of Vietnam and in clause 1 through 7 of this Article, the health facility accepting medical interns (hereinafter referred to as “instructing facility”) shall compile specific contents of medical internship appropriate to each professional title for which it accepts medical interns.

Article 4. Leave of absence from medical internship

1. Medical interns will work according to working regimes of the instructing facility. Due to health conditions of the medical intern or in the event of force majeure, a medical internship may be suspended for a maximum period of 12 months while results of completed internship contents of the medical intern will be kept unchanged.

2. Leave of absence procedures:

a) The medical intern will submit an application for leave of absence and support documents indicating his/her reasons for such leave;

b) The head of the instructing facility will consider the received application and decide whether or not to approve the application. If the application is refused, written reasons for refusal shall be given;

c) Within 30 days upon the expiry of the leave of absence period, if the medical intern submits neither a written request for permission to resume internship nor an application for extension of leave of absence period, his/her internship results will be invalidated. Total leave of absence period shall not exceed 12 months.

Article 5. Instructing facilities

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a) For medical doctors and preventive medicine doctors: health facilities that have been granted operating license in the form of hospitals;

b) For traditional medicine doctors: health facilities that have been granted operating license in the form of hospitals and whose scope of operation includes traditional medicine;

c) For odonto-stomatology doctors: health facilities that have been granted operating license in the form of hospitals and whose scope of operation includes odonto-stomatology specialty.

2. Instructing facilities for physician assistants:

a) For general physician assistants: health facilities that have been granted operating license in the form of hospitals; polyclinics; health stations of communes, wards or commune-level towns (hereinafter referred to as “commune health stations”);

b) For traditional medicine physician assistants: health facilities that have been granted operating license in the form of hospitals or polyclinics or commune health stations. Traditional medicine must fall within the scope of operation of these facilities.

3. Instructing facilities for nurses: health facilities that have been granted operating license in the form of hospitals.

4. Instructing facilities for midwives: health facilities that have been granted operating license in the form of hospitals or maternity wards or commune health stations. If instructing facilities are hospitals or commune health stations, obstetrics must fall within their scope of operation.

5. Instructing facilities for medical technicians:

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b) For medical technicians in medical imaging: health facilities that have been granted operating license in the form of hospitals or clinics or medical imaging facilities. The scope of operation of these facilities must be appropriate to the medical imaging technique;

b) For medical technicians in dental technology: health facilities that have been granted operating license in the form of hospitals or clinics or dental technology facilities. The scope of operation of these facilities must be appropriate to the dental technology;

d) For medical technicians in ophthalmic refraction: health facilities that have been granted operating license in the form of hospitals or clinics or corrective spectacle stores performing refraction tests. The scope of operation of these facilities must be appropriate to the ophthalmic refraction techniques;

dd) For medical technicians in rehabilitation: health facilities that have been granted operating license in the form of hospitals or clinics or rehabilitation facilities. The scope of operation of these facilities must be appropriate to the rehabilitation technique.

6. Instructing facilities for clinical nutritionists: health facilities that have been granted operating license in the form of hospitals, and have nutrition departments.

7. Instructing facilities for out-of-hospital paramedics: health facilities that have been granted operating license in the form of hospitals or out-of-hospital emergency care facilities.

8. Instructing facilities for clinical psychologists: health facilities that have been granted operating license in the form of hospitals or clinical psychology centers. If instructing facilities are hospitals, their scope of operation must include psychiatry or clinical psychology departments must be established.

Article 6. Eligibility requirements and responsibilities of instructing facilities

1. An instructing facility is required to meet the following eligibility requirements:

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b) Its scope of operation is suitable for the internship contents specified in Article 3 of this Decree. In case the instructing facility does not have sufficient specialties for the internship contents as prescribed in Article 3 of this Decree, it may enter into contracts with other health facilities whose specialties meet internship contents.

2. Before accepting medical interns, the health facility is required to send its declaration of eligibility to provide medical internship, which is made using Form No. 01 in Appendix I enclosed herewith, and its specific internship program to:

a) The Ministry of Health of Vietnam, for health facilities under this Ministry's management; or

b) Health authority affiliated to the People's Committee of province or city where such health facility is located (including a private health facility), except health facilities under management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam or the Ministry of Public Security of Vietnam.

3. Upon receipt of the declaration of eligibility to provide medical internship, the receiving authority shall give a receipt note using the Form No. 02 in Appendix I enclosed herewith to the sending health facility.

4. Within 15 days from the date specified on the receipt note which is given according to clause 3 of this Article, the receiving authority shall publish information on the instructing facility on its website or web portal and on the healthcare management information system.

If the received documents are not yet satisfactory, the receiving authority shall send a written response indicating reasons therefor to the sending health facility.

Information to be published, as a minimum, includes: name and address of the instructing facility, scope of internship (in case of cooperation in providing medical internship, contents of cooperation and name of the cooperating facility must be also published), and costs of the internship program).

5. Within 15 days from the date specified in the receipt note, if the receiving authority does not send any document notifying that the health facility fails to meet eligibility requirements to provide medical internship or fails to publish information as prescribed in clause 4 of this Article, the health facility may start organizing its medical internship program.

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1. Receiving medical interns:

a) A candidate for a medical internship program shall submit an application form which is made using Form No. 03 in Appendix I enclosed herewith and a legitimate copy of one of the professional qualifications specified in Article 8 of this Decree to the instructing facility.

b) Upon receipt of the application form, if approved, the head or the person in charge of professional practices of the health facility that is the instructing facility shall:

- Enter into a medical internship contract with the approved candidate using Form No. 04 in Appendix I enclosed herewith;

- Send an application for registration of list of medical interns, which is made using Form No. 05 in Appendix I enclosed herewith, to the authority receiving its declaration as prescribed in clause 2 Article 6 of this Decree. Such an application must indicate the start date and planned completion date of the internship; and

- Publish the list of medical interns on its website and the healthcare management information system.

2. Assigning instructors:

a) Assignment of instructors will be made using Form No. 06 in Appendix I enclosed herewith;

b) An instructor shall concurrently take charge of no more than 05 interns.

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a) He/she has obtained a practicing license on which his/her title and scope of practice must be appropriate to the internship contents and the intern to be instructed;

b) His/her training qualification is equivalent or higher than that of the intern; and

c) He/she has been practicing medicine for a consecutive period of at least 03 years.

4. Required title and scope of practice of instructors in some specific cases:

a) If the intern holds a degree of medical doctor, the instructor must be a doctor whose scope of practice involves medicine or a specific specialty, except traditional medicine doctors, preventive medicine doctors and odonto-stomatology doctors.

b) If the intern holds a degree of preventive medicine doctor, the instructor must be a doctor whose scope of practice involves preventive medicine, or medicine, or a specific specialty, except traditional medicine doctors and odonto-stomatology doctors;

c) If the intern holds a degree of general physician assistant, the instructor must be a physician assistant whose scope of practice involves general medicine, or a doctor whose scope of practice involves medicine or a specific specialty, except traditional medicine doctors, preventive medicine doctors and odonto-stomatology doctors;

d) If the intern holds a degree of traditional medicine physician assistant, the instructor must be a physician assistant or doctor whose scope of practice involves traditional medicine;

dd) If the intern holds a nursing degree, the instructor must be a nurse;

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g) If the intern holds a degree of medical imaging technician, the instructor must be a medical imaging technician or a doctor whose scope of practice involves medical imaging;

h) If the intern holds a degree of medical laboratory technician, the instructor must be a medical laboratory technician or a doctor whose scope of practice involves medical laboratory technology;

i) If the intern holds a degree of rehabilitation technician, the instructor must be a rehabilitation technician or a doctor whose scope of practice involves rehabilitation specialty;

k) If the intern holds a degree of dental technician, the instructor must be a dental technician or a doctor whose scope of practice involves odonto-stomatology specialty;

l) If the intern holds a degree of refractive ophthalmic technician, the instructor must be a refractive ophthalmic technician or a doctor whose scope of practice involves ophthalmology specialty;

m) If the intern holds a degree in nutrition, the instructor must be a clinical nutritionist or a doctor whose scope of practice involves nutrition specialty;

n) If the intern holds a degree of out-of-hospital paramedic, the instructor must be an out-of-hospital paramedic or a doctor whose scope of practice involves intensive care medicine;

o) If the intern holds a degree of clinical psychologist, the instructor must be a clinical psychologist or a doctor who has his/her scope of practice involving psychiatry and possesses a certificate of completion of basic training course in clinical psychology as prescribed in clause 2 Article 128 of this Decree.

5. Instructors must be responsible for ensuring patients’ safety during their provision of instructions for interns and will be burdened with responsibility for any medical errors which are committed by their interns during internship and thus cause harm to patients, unless such medical errors are intentionally committed by the intern.

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a) issue a certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith to the intern;

b) publish the list of medical interns who have successfully completed the internship program on its website and the healthcare management information system.

7. The instructor’s assessment and comments, and certificate of completion of internship program must be objective and accurate.

Section 2. ASSESSMENT OF QUALIFICATION FOR PRACTICE OF MEDICINE (HEREINAFTER REFERRED TO AS “QUALIFICATION TEST”)

Article 8. Academic qualification requirements for taking qualification test to be satisfied by professional title holders

1. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for doctor title:

a) For a doctor whose scope of practice involves medicine:

- Degree of medical doctor, including a graduation diploma in healthcare sector issued by a foreign training institution, provided such diploma holder has been accredited as medical doctor by the Minister of Education and Training of Vietnam;

- Bachelor of medicine issued by a foreign training institution and certified by the Minister of Education and Training of Vietnam to be equivalent to bachelor's degree in Vietnam, provided such degree holder has successfully completed a refresher training course for medical doctor as prescribed by the Minister of Health of Vietnam.

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- Degree of traditional medicine doctor, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as traditional medicine doctor by the Minister of Education and Training of Vietnam;

- Bachelor of traditional medicine issued by a foreign training institution and certified by the Minister of Education and Training of Vietnam to be equivalent to bachelor's degree in Vietnam, provided such degree holder has successfully completed a refresher training course for traditional medicine doctor as prescribed by the Minister of Health of Vietnam.

c) For a doctor whose scope of practice involves preventive medicine:

Degree of preventive medicine doctor, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as preventive medicine doctor by the Minister of Education and Training of Vietnam.

d) For a doctor whose scope of practice involves odonto-stomatology:

- Degree of odonto-stomatology doctor, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as odonto-stomatology doctor by the Minister of Education and Training of Vietnam;

- Bachelor of medicine issued by a foreign training institution and certified by the Minister of Education and Training of Vietnam to be equivalent to bachelor's degree in Vietnam, provided such degree holder has successfully completed a refresher training course for odonto-stomatology doctor as prescribed by the Minister of Health of Vietnam.

dd) For a doctor whose scope of practice involves a specific specialty: Degree of specialist doctor as prescribed in clause 1 Article 12 of this Decree.

2. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for physician assistant title:

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- Associate degree for general medicine physician assistant, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree for general medicine physician assistant;

- Bachelor of medicine issued by a foreign training institution and certified by the Minister of Education and Training of Vietnam to be equivalent to bachelor’s degree in Vietnam.

b) For a physician assistant whose scope of practice involves traditional medicine:

Associate degree for traditional medicine physician assistant or associate degree in traditional medicine, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree for traditional medicine physician assistant or associate degree in traditional medicine.

3. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for nurse title:

a) For a nurse whose scope of practice involves nursing:

- Intermediate professional education diploma in nursing, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in nursing;

- Associate degree in nursing, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in nursing;

- Bachelor of nursing, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of nursing by the Minister of Education and Training of Vietnam.

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4. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for midwife title:

a) For a midwife whose scope of practice involves midwifery:

- Intermediate professional education diploma in midwifery, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in midwifery;

- Intermediate professional education diploma in midwifery, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in midwifery;

- Bachelor of midwifery, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of midwifery by the Minister of Education and Training of Vietnam.

b) For a midwife whose scope of practice involves specialty midwifery: degree of specialist midwife as prescribed in clause 1 Article 12 of this Decree.

5. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for medical technician title:

a) For a medical technician whose scope of practice involves medical laboratory:

- Intermediate professional education diploma in medical laboratory technology, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in medical laboratory technology;

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- Bachelor of medical laboratory technology, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of medical laboratory technology by the Minister of Education and Training of Vietnam.

b) For a medical technician whose scope of practice involves specialty medical laboratory technology: degree of specialist medical laboratory technician as prescribed in clause 1 Article 12 of this Decree.

c) For a medical technician whose scope of practice involves medical imaging:

- Intermediate professional education diploma in medical imaging technique, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in medical imaging technique;

- Associate degree in medical imaging technique, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in medical imaging technique;

- Bachelor of medical imaging technique, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of medical imaging technique by the Minister of Education and Training of Vietnam.

d) For a medical technician whose scope of practice involves specialty medical imaging: degree of specialist medical imaging technician as prescribed in clause 1 Article 12 of this Decree.

dd) For a medical technician whose scope of practice involves dental technology:

- Intermediate professional education diploma in dental technology, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in dental technology;

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- Bachelor of dental technology, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of dental technology by the Minister of Education and Training of Vietnam.

e) For a medical technician whose scope of practice involves specialty dental technology: degree of specialist dental technician as prescribed in clause 1 Article 12 of this Decree.

g) For a medical technician whose scope of practice involves ophthalmic refraction:

- Associate degree in ophthalmic refraction technique, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in ophthalmic refraction technique;

- Bachelor of ophthalmic refraction technique, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of ophthalmic refraction technique by the Minister of Education and Training of Vietnam.

h) For a medical technician whose scope of practice involves specialty ophthalmic refraction: degree of specialist refractive ophthalmic technician as prescribed in clause 1 Article 12 of this Decree.

i) For a medical technician whose scope of practice involves rehabilitation:

- Intermediate professional education diploma in one of the following majors: rehabilitation technique, physical therapy or physical therapy and rehabilitation technique, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in one of the mentioned majors;

- Associate degree in one of the following majors: rehabilitation technique, physical therapy or physical therapy and rehabilitation technique, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in one of the mentioned majors;

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k) For a medical technician whose scope of practice involves specialty rehabilitation: degree of specialist rehabilitation technician as prescribed in clause 1 Article 12 of this Decree.

6. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for clinical nutritionist title:

a) For a clinical nutritionist whose scope of practice involves clinical nutrition:

- Associate degree in nutrition, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in nutrition;

- Bachelor of nutrition, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of nutrition by the Minister of Education and Training of Vietnam.

b) For a clinical nutritionist whose scope of practice involves specialty clinical nutrition: degree of specialist clinical nutritionist as prescribed in clause 1 Article 12 of this Decree.

7. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for out-of-hospital paramedic title:

a) Degree or diploma specified in clause 1, 2, 3, 4 or 5 of this Article;

b) Associate degree in out-of-hospital emergency care, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in out-of-hospital emergency care;

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d) A specialty qualification as prescribed in clause 1 Article 12 of this Decree.

8. A candidate is required to hold one of the following qualifications as a prerequisite for taking qualification test for clinical psychologist title:

a) For a clinical psychologist whose scope of practice involves clinical psychology:

- Degree of doctor specified in clause 1 of this Article, provided such degree holder has successfully completed the basic training course in clinical psychology as prescribed in clause 2 Article 128 of this Decree;

- Bachelor of psychology, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of psychology by the Minister of Education and Training of Vietnam and has successfully completed the basic training course in clinical psychology as prescribed in clause 2 Article 128 of this Decree.

b) For a clinical psychologist whose scope of practice involves specialty clinical psychology:

- Master’s degree in clinical psychology, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a Master by the Minister of Education and Training of Vietnam.

- Degree of doctor of clinical psychology, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a doctor of philosophy by the Minister of Education and Training of Vietnam.

- degree of specialist clinical psychologist as prescribed in clause 1 Article 12 of this Decree.

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Article 9. Organization of qualification test

1. Contents of qualification tests for the titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic or clinical psychologist shall be compiled based on corresponding professional qualification standards for such a title and benchmarking toolkit for assessment and measurement of qualification for the practice of medicine.

2. Vietnam’s National Medical Council (VNMC) shall take charge of developing qualification test regulations; eligibility criteria of qualification test location, and submit them to the Minister of Health of Vietnam for approval.

3. VNMC shall:

a) play the leading role in organizing qualification tests according to qualification test regulations laid down in clause 2 of this Article;

b) Select qualified facilities as qualification test locations meeting approved criteria.

4. VNMC shall develop regulations on qualification test fees, collection, transfer, management and use thereof, and submit them to the Minister of Health of Vietnam for approval.

Section 3. ISSUANCE OF LICENSE TO PRACTICE MEDICINE

Article 10. Procedures for issuance of practicing license for titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

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a) Follow procedures for issuance of practicing license. Before applying for the practicing license, the applicant is required to successfully complete the medical internship as prescribed in Section 1 Chapter II of this Decree, and pass the qualification test as prescribed in Article 9 of this Decree;

b) Attend a specialty training course and, upon completion of such course, apply for practicing license on which the scope of practice involves a specific specialty.

Before applying for the practicing license, the applicant shall not be required to attend a medical internship as prescribed in Section 1 Chapter II of this Decree, but must pass the qualification test as prescribed in Article 9 of this Decree.

2. Upon the issuance of the practicing license according to point a clause 1 of this Article, if the license holder attends a specialty training course and then obtains a specialty qualification, he/she may apply for modification of practicing license in respect of the scope of practice involving such specialty without attending medical internship and taking qualification test.

3. In case a medical practitioner attends a training course in a professional technique which is not yet included in his/her licensed scope of practice, and is issued with a professional technique certificate as prescribed in clause 2 Article 12 of this Decree, he/she must not follow procedures for modification of the licensed scope of practice but the person in charge of professional practices of the relevant health facility shall, based on such professional technique certificate as prescribed in clause 2 Article 12 of this Decree, decide to give written permission to him/her to implement his/her trained technique.

In case a medical practitioner receives a transferred technique which is not included in his/her licensed scope of practice, he/she must not follow procedures for modification of the licensed scope of practice but the person in charge of professional practices of the relevant health facility shall, based on certificate of competence to implement such technique issued according to point c clause 4 Article 85 of this Decree, decide to give written permission to him/her to implemented such transferred technique.

4. If a person who has successfully completed a specialty training course as prescribed in point b clause 1 of this Article fails to file an application for qualification test within 24 months from the issue date of his/her specialty qualification, he/she shall be required to attend a medical internship in such specialty for the period specified in Article 3 of this Decree before applying for the qualification test.

5. If a person who has been granted a specialty qualification as prescribed in clause 2 of this Article fails to apply for modification of his/her practicing license within 24 months from the issue date of his/her specialty qualification, he/she shall be required to attend a medical internship in such specialty for the period specified in Article 3 of this Decree before applying for modification of his/her practicing license.

6. If a person currently holds a graduation diploma in healthcare and one or some of the following certificates: herbalist certificate, folk remedy certificate or folk therapy certificate, he/she may apply for practicing license for one of the titles specified in Article 26 of the Law on Medical Examination and Treatment and follow the procedures set out in either clause 1 or clause 2 of this Article. The scope of practice shall be written on the practicing license issued according to provisions of this clause as follows:

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b) The scope of practice specified in the practicing license for the title of herbalist, folk remedy holder or folk therapy holder includes the scope of practice of the licensed title and the scope of practice shown in his/her certificate of qualification test results.

Article 11. Procedures for issuance of practicing license for titles of herbalists, folk remedy holders and folk therapy holders

1. Holders of herbalist certificates, folk remedy certificates or folk therapy certificates shall follow procedures for issuance, re-issuance or renewal of practicing license as prescribed in Section 5 Chapter II of this Decree.

2. If a person who has been granted a practicing license for the title of herbalist, folk remedy certificate holder or folk therapy certificate holder obtains a graduation diploma in healthcare and applies for practicing license for the title of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic or clinical psychologist, he/she shall follow procedures laid down in Article 10 of this Decree.

The licensing authority shall issue a new practicing license and revoke the former one. The scope of practice specified on the issued practicing license includes the scope of practice for the new licensed title and that for the former one.

Article 12. Requirements attached to specialty qualifications and professional technique certificates in healthcare and clinical psychology

1. Requirements attached to a specialty qualification in healthcare issued by a training institution:

a) It must be issued by a lawful training institution as prescribed by laws; and

b) The training duration is not shorter than 18 months.

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a) It is issued by a training institution that has run at least 01 training course in the same profession at the same qualification level after which the graduate has been granted practicing license with the same title or by a health facility that has implemented the corresponding professional technique for at least 06 months under a competent authority’s permission;

b) The training institution may use training curriculum and materials for professional technique certificate that itself compile, appraise and issue, or use such training program and materials of another training institution with written consent of the latter; contents of the training curriculum, training volume and lecturers must be appropriate to the list of professional techniques issued by the Ministry of Health of Vietnam.

3. In case a specialty qualification is used for modifying the scope of practice as prescribed in point a, b or c clause 1 Article 19 of this Decree, the start date of the training course must fall after the issue date of the practicing license or the modified practicing license.

4. Training for qualifications and certificates specified in clauses 1, 2 of this Article must be published on websites of training institutions.

Section 4. ISSUANCE OF PRACTICING LICENSE FOR PROFESSIONAL TITLES OF DOCTOR, PHYSICIAN ASSISTANT, NURSE, MIDWIFE, MEDICAL TECHNICIAN, CLINICAL NUTRITIONIST, OUT-OF-HOSPITAL PARAMEDIC AND CLINICAL PSYCHOLOGIST

Sub-section 1. ISSUANCE OF PRACTICING LICENSE FOR PROFESSIONAL TITLES OF DOCTOR, PHYSICIAN ASSISTANT, NURSE, MIDWIFE, MEDICAL TECHNICIAN, CLINICAL NUTRITIONIST, OUT-OF-HOSPITAL PARAMEDIC AND CLINICAL PSYCHOLOGIST

Article 13. Eligible applicants and conditions for issuance of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

1. A practicing license may be issued to:

a) a person who first applies for the practicing license as prescribed in point a clause 1 Article 30 of the Law on Medical Examination and Treatment.

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c) a person mentioned in:

- Point c clause 1 Article 33 of this Decree;

- Clause 2 Article 33 of this Decree;

- Point c clause 3 Article 33 of this Decree;

- Point b clause 4 Article 33 of this Decree;

- Point c clause 5 Article 33 of this Decree;

- Clause 6 Article 33 of this Decree;

- Clause 7 Article 33 of this Decree;

- Clause 8 Article 33 of this Decree; or

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d) a medical practitioner who fails to follow renewal procedures as prescribed in point a clause 2 Article 18 of this Decree.

dd) a medical practitioner who has been granted a practicing license by a licensing authority in people’s armed forces but stops using the issued practicing license for working in people’s armed forces, and wishes to practice at a health facility other than that under people’s armed forces. In this case, the period after the medical practitioner stops working for a health facility in people’s armed forces until his/her submission of application for practicing license is longer than 60 months.

2. Conditions for issuance of practicing license shall comply with the provisions of clause 2 Article 30 of the Law on Medical Examination and Treatment.

Article 14. Application package and procedures for issuance of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

1. An application package for issuance of practicing license submitted by the person who first applies for the practicing license as prescribed in point a clause 1 Article 30 of the Law on Medical Examination and Treatment or the person mentioned in point dd clause 1 Article 13 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith).

b) The original or legitimate copy of any of the following documents:

- Qualification test pass certificate (not required if such qualification test results have been shared or published on the healthcare management information system or national healthcare database);

- Practicing license which has been accredited as prescribed in Article 37 of this Decree (not required if such accreditation has been shared or published on the healthcare management information system or national healthcare database).

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d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database).

dd) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

e) for the applicant mentioned in point a clause 6 Article 10 of this Decree, legitimate copy(ies) of the following document(s) (not required if these documents have been shared or published on the healthcare management information system or national healthcare database):

- Herbalist certificate;

- Fork remedy certificate;

- Folk therapy certificate.

2. An application package for issuance of practicing license submitted by a medical practitioner making change in professional title specified in his/her practicing license as prescribed in point b clause 1 Article 30 of the Law on Medical Examination and Treatment is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The original or legitimate copy of qualification test pass certificate or practicing license which has been accredited as prescribed in Article 37 of this Decree in case the applicant has been granted a practicing license and wishes to change his/her professional title into the title of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic or clinical psychologist (not required if such qualification test results or accreditation has been shared or published on the healthcare management information system or national healthcare database);

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d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database);

dd) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

3. An application package for issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point c clause 1, clause 2, point c clause 3, point b clause 4, clause 6, clause 7, clause 8 or point c clause 9 Article 33 of this Decree due to forging of documents included in the submitted application package for such practicing license (point b clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in section 1 of this Article;

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

4. An application package for issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point c clause 5 Article 33 of this Decree in the case specified in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in section 1 of this Article.

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

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- The original or legitimate copy of certificate of completion of probation period or certificate that the medical practitioner has successfully served the court’s decision or sentence (clause 2, 3, or 4 Article 20 of the Law on Medical Examination and Treatment);

- The original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

5. An application package for issuance of practicing license submitted by a person who fails to apply for renewal of his/her practicing license as prescribed in point a clause 2 Article 18 of this Decree within 24 months is composed of:

a) The documents specified in section 1 of this Article;

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

6. Procedures for issuance of practicing license:

a) The applicant submits an application package for the corresponding case specified in clauses 1 through 5 of this Article and application fee to the authority competent to issue practicing license as prescribed in Article 28 of the Law on Medical Examination and Treatment (hereinafter referred to as “licensing authority”);

b) The licensing authority is required to issue the requested practicing license within 30 days of receipt of an adequate application package. In case of refusal, a written response, clearly indicating reasons for such refusal, shall be sent to the applicant.

Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to issue a practicing license shall be 30 days from the day on which verification results are available.

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Article 15. Eligible cases and conditions for re-issuance of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

1. A practicing license may be re-issued if:

a) It is lost or damaged.

b) There is any change in the information specified in point a clause 3 Article 27 of the Law on Medical Examination and Treatment, or any error in the information specified in clause 3 Article 27 of the Law on Medical Examination and Treatment.

c) The applicant falls in the case specified in:

- Point a or b clause 1 Article 33 of this Decree;

- Point a or b clause 3 Article 33 of this Decree;

- Point a clause 4 Article 33 of this Decree;

- Point a or b clause 5 Article 33 of this Decree;

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d) The practicing license is issued ultra vires as prescribed in clause 1 Article 28 of the Law on Medical Examination and Treatment.

dd) A medical practitioner who has been granted a practicing license by a licensing authority in people’s armed forces stops using the issued practicing license for working in people’s armed forces, and wishes to practice at a health facility other than that under people’s armed forces in case the period after he/she stops working for the health facility in people’s armed forces until his/her submission of application for practicing license is not longer than 24 months.

e) A medical practitioner who has been granted a practicing license by a licensing authority in people’s armed forces stops using the issued practicing license for working in people’s armed forces, and wishes to practice at a health facility other than that under people’s armed forces in case the period after he/she stops working for the health facility in people’s armed forces until his/her submission of application for practicing license is longer than 24 months but shorter than 60 months.

2. Conditions for re-issuance of practicing license shall comply with the provisions of clause 2 Article 31 of the Law on Medical Examination and Treatment.

Article 16. Application package and procedures for re-issuance of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

1. An application package for re-issuance of practicing license in case it is lost or damaged as prescribed in point a clause 1 Article 15 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The original or legitimate copy of the issued practicing license (if available) (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

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a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The original of the issued practicing license;

c) The original(s) or legitimate copy(ies) of the document(s) proving such a change or erroneous information (not required if such information can be found or verified on the healthcare management information system or national healthcare database);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

3. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 1 Article 33 of this Decree in case the application package for award of the practicing license fails to meet regulations (point a clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

4. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point b clause 1 Article 33 of this Decree in case the application package for issuance of the practicing license fails to meet regulations (point a clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

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c) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database).

5. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 3 Article 33 of this Decree in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license (point c clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

6. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point b clause 3 Article 33 of this Decree in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license (point c clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database).

7. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 4 Article 33 of this Decree in case he/she has not practiced medicine for 24 consecutive months (point d clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

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b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database).

8. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 5 Article 33 of this Decree in case he/she is subject to prohibition of practice of medicine as defined in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree.

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- The original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

- The original or legitimate copy of certificate of completion of probation period or certificate that the medical practitioner has successfully served the court’s decision or sentence (clause 2, 3, or 4 Article 20 of the Law on Medical Examination and Treatment);

- The original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

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a) The documents specified in Clause 1 Article 14 of this Decree.

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- The original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

- The original or legitimate copy of certificate of completion of probation period or certificate that the medical practitioner has successfully served the court’s decision or sentence (clause 2, 3, or 4 Article 20 of the Law on Medical Examination and Treatment);

- The original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

d) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database).

10. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 9 Article 33 of this Decree in case such revocation is made at the request of the medical practitioner (point i clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

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11. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point b clause 9 Article 33 of this Decree in case such revocation is made at the request of the medical practitioner (point i clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database).

12. An application package for re-issuance of practicing license in case the practicing license has been issued ultra vires as prescribed in point d clause 1 Article 31 of the Law on Medical Examination and Treatment is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The original of the issued practicing license;

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

13. An application package for re-issuance of practicing license in the case prescribed in point dd clause 1 Article 15 of this Decree is composed of:

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b) The original or legitimate copy of a written certification that the practicing license has been issued by a licensing authority in people’s armed forces, clearly indicating the number, issue date, issuing authority, personal information of the license holder, professional title and scope of practice;

c) The original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code;

d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database);

dd) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

14. An application package for re-issuance of practicing license in the case prescribed in point e clause 1 Article 15 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The original or legitimate copy of a written certification that the practicing license has been issued by a licensing authority in people’s armed forces, clearly indicating the number, issue date, issuing authority, personal information of the license holder, professional title and scope of practice;

c) The original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code;

d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database);

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e) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

15. Procedures for re-issuance of practicing license:

a) The applicant submits an application package for re-issuance of practicing license for the corresponding case specified in clauses 1 through 14 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority;

b) The licensing authority is required to re-issue the requested practicing license within 15 days of receipt of adequate required documents. In case of refusal, a written response, clearly stating reasons for such refusal, shall be sent to the applicant;

c) Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to re-issue a practicing license shall be 15 days from the day on which verification results are available.

Sub-section 3. RENEWAL OF PRACTICING LICENSE FOR PROFESSIONAL TITLES OF DOCTOR, PHYSICIAN ASSISTANT, NURSE, MIDWIFE, MEDICAL TECHNICIAN, CLINICAL NUTRITIONIST, OUT-OF-HOSPITAL PARAMEDIC AND CLINICAL PSYCHOLOGIST

Article 17. Eligible cases and conditions for renewal of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

1. A practicing license may be renewed if it expires as prescribed in clause 2 Article 27 of the Law on Medical Examination and Treatment.

2. Conditions for renewal of practicing license shall comply with the provisions of clause 2 Article 32 of the Law on Medical Examination and Treatment.

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1. An application package for renewal of practicing license for the professional title of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic or clinical psychologist is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database);

c) Documentary evidence that the applicant has continuously updated medical knowledge in accordance with the Minister of Health of Vietnam’s regulations (not required if continuous medical knowledge updating results have been shared or published on the healthcare management information system or national healthcare database);

d) The original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code.

2. Procedures for renewal of practicing license:

a) The applicant submits an application package prescribed in clause 1 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority at least 60 days before the practicing license expires.

In case of sickness, accident or a force majeure event occurring at the application submission date, the applicant shall notify the licensing authority in order to extend the submission deadline.

A medical practitioner may request permission for extension of the submission deadline multiple times, provided that an application package for renewal of practicing license must be submitted within 22 months after it expires;

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c) Where it is necessary to verify whether the applicant participates in medical knowledge updating programs run by a qualified foreign entity or organization, the duration of decision to renew the practicing license shall be 15 days from the day on which verification results are available.

Sub-section 4. MODIFICATION OF PRACTICING LICENSE FOR PROFESSIONAL TITLES OF DOCTOR, PHYSICIAN ASSISTANT, NURSE, MIDWIFE, MEDICAL TECHNICIAN, CLINICAL NUTRITIONIST, OUT-OF-HOSPITAL PARAMEDIC AND CLINICAL PSYCHOLOGIST

Article 19. Eligible cases and conditions for modification of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist

1. A practicing license may be modified in the following cases:

a) A person who has been issued with a practicing license on which the scope of practice does not include any specialty applies for addition of a specialty to the scope of practice on his/her issued practicing license;

b) A person who has been issued with a practicing license on which the scope of practice involves a particular specialty applies for addition of a specialty other than the licensed one to the scope of practice on his/her issued practicing license;

c) A person who has been issued with a practicing license on which the scope of practice involves a particular specialty stops practicing that licensed specialty and applies for replacement of that licensed specialty with another one;

d) A person who has been issued with a practicing license obtains a certificate of folk remedy holder or certificate of folk therapy holder.

2. Conditions for modification of a practicing license:

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b) In case a person who has been issued with a practicing license on which the scope of practice involves a particular specialty applies for addition of a specialty other than the licensed one to the scope of practice on his/her issued practicing license, he/she must hold a specialty qualification, as prescribed in clause 1 Article 12 of this Decree, for the title printed on his/her practicing license and the specialty to be added;

c) In case a person who has been issued with a practicing license on which the scope of practice involves a particular specialty applies for replacement of that licensed specialty with another one, he/she must hold a specialty qualification for the new title and specialty as prescribed in clause 1 Article 12 of this Decree.

Article 20. Application package and procedures for modification of practicing license

1. An application package for modification of a practicing license in case of addition of a specialty to the licensed scope of practice as prescribed in point a, b or c clause 1 Article 19 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database);

c) A legitimate copy of the specialty qualification as prescribed in clause 1 Article 12 of this Decree (not required if such specialty qualification has been shared or published on the healthcare management information system or national healthcare database):

d) An original or legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith in case the applicant is a medical practitioner defined in clause 4 Article 10 of this Decree (not required if internship results have been shared or published on the healthcare management information system or national healthcare database).

2. An application package for modification of a practicing license submitted by a person who has been issued with a practicing license but then obtains a certificate of folk remedy holder or certificate of folk therapy holder as prescribed in point d clause 1 Article 19 of this Decree is composed of:

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b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database);

c) A legitimate copy of certificate of folk remedy holder or certificate of folk therapy holder (not required if such certificates have been shared or published on the healthcare management information system or national healthcare database).

3. Procedures for modification of practicing license in any of the cases prescribed in clause 1 Article 19 of this Decree:

a) The applicant submits an application package for the corresponding case as prescribed in clause 1 or 2 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority;

b) The licensing authority is required to modify the foregoing practicing license within 15 days of receipt of adequate required documents. In case of refusal, a written response, clearly stating reasons for such refusal, shall be sent to the applicant.

The practicing license shall be modified by means of issuance of a decision to modify the scope of practice using Form No. 10 in Appendix I enclosed herewith. The issued decision to modify the scope of practice is an integral part of the issued practicing license;

c) Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to modify a practicing license shall be 15 days from the day on which verification results are available.

Section 5. ISSUANCE OF PRACTICING LICENSE FOR PROFESSIONAL TITLE OF HERBALIST, FOLK REMEDY HOLDER OR FOLK THERAPY HOLDER

Sub-section 1. ISSUANCE OF PRACTICING LICENSE FOR PROFESSIONAL TITLE OF HERBALIST, FOLK REMEDY HOLDER OR FOLK THERAPY HOLDER

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1. A practicing license may be issued to:

a) a person who first applies for the practicing license as prescribed in point a clause 1 Article 30 of the Law on Medical Examination and Treatment;

b) a medical practitioner making change in professional title specified in his/her practicing license as prescribed in point b clause 1 Article 30 of the Law on Medical Examination and Treatment;

c) a person whose practicing license is revoked in any of the cases prescribed in clauses 2, 4, 5, 6, 7 or 8 Article 34 of this Decree; or

d) a medical practitioner who fails to follow renewal procedures as prescribed in point a clause 2 Article 26 of this Decree.

2. Conditions for issuance of practicing license shall comply with the provisions of clause 3 Article 30 of the Law on Medical Examination and Treatment.

Article 22. Application package and procedures for issuance of practicing license for professional title of herbalist, folk remedy holder or folk therapy holder

1. An application package for issuance of practicing license submitted by a person who first applies for the practicing license as prescribed in point a clause 1 Article 30 of the Law on Medical Examination and Treatment is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith).

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- Herbalist certificate issued by a competent authority;

- Certificate of folk remedy holder issued by a competent authority; or

- Certificate of folk therapy holder issued by a competent authority.

c) An original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code.

d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database).

dd) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

e) For the case prescribed in point b clause 6 Article 10 of this Decree, a legitimate copy of any of the following documents:

- Qualification test pass certificate (not required if such qualification test results are shared or published on the healthcare management information system or national healthcare database);

- Practicing license which has been accredited as prescribed in Article 37 of this Decree (not required if such accreditation has been shared or published on the healthcare management information system or national healthcare database).

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a) An application form (made using Form 08 in Appendix I enclosed herewith).

b) A legitimate copy of any of the following documents (not required if such documents have been shared or published on the healthcare management information system or national healthcare database), including:

- Herbalist certificate, if the new title after change is herbalist;

- Certificate of folk remedy holder, if the new title after change is folk remedy holder;

- Certificate of folk therapy holder, if the new title after change is folk therapy holder.

c) An original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code.

d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database).

dd) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

3. An application package for issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 4 Article 34 of this Decree in case he/she has not practiced medicine for 24 consecutive months (point d clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

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b) The original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

4. An application package for issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 5 Article 34 of this Decree in case he/she is subject to prohibition of practice of medicine as defined in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in section 1 of this Article.

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- An original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

- An original or legitimate copy of certificate of completion of probation period or certificate that the medical practitioner has successfully served the court’s decision or sentence (clause 2, 3, or 4 Article 20 of the Law on Medical Examination and Treatment);

- An original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

5. An application package for issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 6, 7 or 8 Article 34 of this Decree (point e, g or h clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

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b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

6. An application package for issuance of practicing license submitted by a person who fails to apply for renewal of his/her practicing license as prescribed in point a clause 3 Article 24 of this Decree is composed of:

a) The documents specified in section 1 of this Article;

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

7. Procedures for issuance of practicing license:

a) The applicant submits an application package for the corresponding case specified in clauses 1 through 6 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the authority competent to issue practicing license as prescribed in Article 28 of the Law on Medical Examination and Treatment (hereinafter referred to as “licensing authority”);

b) The licensing authority is required to issue the requested practicing license within 30 days of receipt of an adequate application package. In case of refusal, a written response, clearly indicating reasons for such refusal, shall be sent to the applicant.

Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to issue a practicing license shall be 30 days from the day on which verification results are available.

Sub-section 2. RE-ISSUANCE OF PRACTICING LICENSE FOR PROFESSIONAL TITLE OF HERBALIST, FOLK REMEDY HOLDER OR FOLK THERAPY HOLDER

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1. A practicing license may be re-issued if:

a) It is lost or damaged;

b) There is any change in the information specified in point a clause 3 Article 27 of the Law on Medical Examination and Treatment, or any error in the information specified in clause 3 Article 27 of the Law on Medical Examination and Treatment;

c) A person has his/her practicing license revoked in any of the cases prescribed in clauses 1, 3 and 9 Article 34 of this Decree;

d) The practicing license is issued ultra vires as prescribed in clause 1 Article 28 of the Law on Medical Examination and Treatment.

2. Conditions for re-issuance of practicing license shall comply with the provisions of clause 2 Article 31 of the Law on Medical Examination and Treatment.

Article 24. Application package and procedures for re-issuance of practicing license for professional title of herbalist, folk remedy holder or folk therapy holder

1. An application package for re-issuance of practicing license in case it is lost or damaged as prescribed in point a clause 1 Article 21 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

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c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

2. An application package for re-issuance of practicing license in case there is any change in the information specified in point a clause 3 Article 27 of the Law on Medical Examination and Treatment or any error in the information specified in clause 3 Article 27 of the Law on Medical Examination and Treatment as prescribed in point b clause 1 Article 23 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The original of the issued practicing license;

c) The original(s) or legitimate copy(ies) of the document(s) proving such a change or erroneous information (not required if such information can be found or verified on the healthcare management information system or national healthcare database);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

3. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 1 Article 34 of this Decree in case the application package for issuance of the practicing license fails to meet regulations (point a clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 22 of this Decree;

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

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4. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 3 Article 34 of this Decree in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license (point c clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

5. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 4 Article 34 of this Decree in case he/she has not practiced medicine for 24 consecutive months (point d clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

6. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 5 Article 34 of this Decree in the case specified in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

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b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- An original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

- An original or legitimate copy of certificate of completion of probation period or certificate that the medical practitioner has successfully served the court’s decision or sentence (clause 2, 3, or 4 Article 20 of the Law on Medical Examination and Treatment);

- An original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

7. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in clause 9 Article 34 of this Decree in case such revocation is made at the request of the medical practitioner is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

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8. An application package for re-issuance of practicing license in case the practicing license has been issued ultra vires as prescribed in clause 1 Article 28 of the Law on Medical Examination and Treatment is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The issued practicing license;

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

9. Procedures for re-issuance of practicing license:

a) The applicant submits an application package for the corresponding case specified in clauses 1 through 8 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority prescribed in clause 1 Article 28 of the Law on Medical Examination and Treatment;

b) The licensing authority is required to re-issue the requested practicing license within 15 days of receipt of adequate required documents. In case of refusal, a written response, clearly stating reasons for such refusal, shall be sent to the applicant;

c) Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to re-issue a practicing license shall be 15 days from the day on which verification results are available.

Sub-section 3. RENEWAL OF PRACTICING LICENSE FOR PROFESSIONAL TITLE OF HERBALIST, FOLK REMEDY HOLDER OR FOLK THERAPY HOLDER

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1. A practicing license for the professional title of herbalist, folk remedy holder or folk therapy holder may be renewed if it expires as prescribed in clause 2 Article 27 of the Law on Medical Examination and Treatment.

2. Conditions for renewal of practicing license for the professional title of herbalist shall comply with the provisions of clause 2 Article 32 of the Law on Medical Examination and Treatment.

3. Conditions for renewal of practicing license for the professional title of folk remedy holder or folk therapy holder shall comply with the provisions of clause 3 Article 32 of the Law on Medical Examination and Treatment.

Article 26. Application package and procedures for renewal of practicing license for professional title of herbalist, folk remedy holder or folk therapy holder

1. An application package for renewal of practicing license for the professional title of herbalist, folk remedy holder or folk therapy holder is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database);

c) An original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code.

2. Procedures for renewal of practicing license:

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In case of sickness, accident or a force majeure event occurring at the application submission date, the applicant shall notify the licensing authority in order to extend the submission deadline.

A medical practitioner may request permission for extension of the submission deadline multiple times, provided that an application package for renewal of practicing license must be submitted within 22 months after it expires;

b) During the period from the date of receipt of all required application documents to the expiry date printed on a practicing license, the licensing authority shall be responsible for renewing it or replying in writing to the license holder with clear reasons for refusal of renewal; where there is no written reply till the expiry date printed on the foregoing practicing license, it still remains valid as prescribed.

Section 6. REGISTRATION FOR PRACTICE OF MEDICINE

Article 27. Instructions for registration for practice of medicine

In addition to the registration principles laid down in Article 36 of the Law on Medical Examination and Treatment, registration for practice of medicine shall comply with the following instructions:

1. A medical practitioner may hold multiple positions at a health facility as assigned by the person in charge of professional practices of that health facility, provided such positions must be appropriate to his/her scope of practice.

2. In case a medical practitioner has been working as a full-time medical practitioner, manager of a professional department, or person in charge of professional practices at a hospital, he/she may apply for registration for practice of medicine at another health facility in one of the following cases:

a) He/she may act as a medical practitioner for another health facility whose administrative hours are different from those of his/her current workplace;

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3. In case a medical practitioner has been practicing medicine at a health facility which is not a hospital, he/she may apply for registration for practice of medicine in one of the following cases:

a) He/she may act as a medical practitioner for another health facility with working hours and days other than his/her registered ones;

b) He/she may act as a person in charge of professional practices for another health facility with working hours and days other than his/her registered ones.

4. In case a medical practitioner has been working as a person in charge of professional practices for a health facility which is not a hospital, he/she may apply for registration for practice of medicine as a medical practitioner at another health facility with working hours and days other than his/her registered ones.

5. In case a medical practitioner has been working as a person in charge of professional practices for a health station, he/she may apply for registration for practice of medicine in one of the following cases:

a) He/she may act as a medical practitioner for another health facility whose administrative hours are different from those of his/her current workplace;

b) He/she may act as a person in charge of professional practices for another health facility whose administrative hours are different from those of his/her current workplace.

6. A medical practitioner may only take charge of a professional department of a hospital.

7. A medical practitioner who is a person in charge of professional practices of a hospital may concurrently take charge of a professional department of that hospital on the condition that it is appropriate to his/her scope of practice.

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9. When a medical practitioner provides healthcare under a contract signed between a health facility and his/her current workplace, he/she shall not be required to apply for registration for practice of medicine at that health facility.

10. Where a medical practitioner has obtained registration for practice of medicine at different health facilities, he/she must ensure appropriate time of travel between such registered health facilities.

11. In case a person in charge of professional practices of a health facility is absent from the health facility due to sickness, permitted leave, study or other causes, he/she shall:

a) give a written authorization to a person who is working at that health facility, has been issued with a practicing license on which the scope of practice is appropriate to one of registered specialties of the health facility, and has been practiced medicine for at least 36 months, if total absent days are fewer than 15 days;

b) give authorization as prescribed in point a of this clause and send a written notice to the authority that has issued the operating license, if total absent days are from 15 to under 90 days;

c) give authorization as prescribed in point a of this clause, send a written notice to the authority that has issued the operating license, and be required to obtain a written consent from this authority, if total absent days are from 90 to under 180 days;

d) If total absent days are longer than 180 days, the health facility is required to follow procedures for replacement of its person in charge of professional practices.

12. When there are any changes in its medical practitioners, the head of the health facility shall discharge the following responsibilities:

a) In case a medical practitioner quits his/her job:

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- Submit a report to a competent authority within 03 days after the medical practitioner terminates practice of medicine at the health facility.

b) In case of addition of a medical practitioner: follow procedures for registration for practice of medicine as prescribed in this Decree. The medical practitioner may start practicing medicine upon completion of such registration procedures.

Article 28. Contents of registration

1. Contents of registration:

a) Full name, number of practicing license of the medical practitioner;

b) Professional title or position if the medical practitioner is a person in charge of professional practices of a health facility or a manager of professional department of a hospital;

c) Information on the practice location, including name and address of the health facility granting registration to the medical practitioner;

dd) Working hours and days;

dd) Scope of practice;

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2. The list of medical practitioners shall be compiled by the health facility using Form No. 01 in Appendix II enclosed herewith and must bear certification and seal (if any) of the person in charge of professional practices of that health facility.

3. If a medical practitioner included in the list of medical practitioners of a health facility is working for another health facility, information on his/her practice of medicine at such another health facility must be also specified in the list.

Article 29. Registration procedures

1. A health facility shall act as follow to get registration for their medical practitioners:

a) Sending the list of medical practitioners applying for registration together with the application for issuance of an operating license to the authority having jurisdiction to grant operating licenses.

b) If any change of medical practitioners on the list occurs pending issuance of the operating license, a new list of medical practitioners which is made using Form No. 01 in Appendix II enclosed herewith must be sent to the authority having jurisdiction to grant operating licenses.

c) If any change of medical practitioners on the list occurs during its operation, an application form for registration shall be sent to the authority having jurisdiction to grant operating licenses as follows:

- In case a medical practitioner quits his/her job: a report shall be submitted to the competent authority within 03 working days after the medical practitioner terminates practice of medicine at the health facility;

- In case of addition of a medical practitioner: a list of additional medical practitioners which is made using Form No. 01 in Appendix II enclosed herewith will be sent to the authority that has issued the operating license within 10 days from the day on which such addition is made.

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a) at the same time as issuance of the operating license with respect to the cases specified in points a, b clause 1 of this Article;

b) within 05 working days of receipt of the application form for practice of medicine with respect to the case specified in point c clause 1 of this Article;

c) If an application is refused, a written response indicating reasons for such refusal shall be provided.

Section 7. SUSPENSION AND REVOCATION OF PRACTICING LICENSES, AND POST-REVOCATION ACTIONS

Article 30. Suspension procedures

1. In case a medical practitioner is suspended according to the conclusion given by the Expert Council mentioned in Article 101 of the Law on Medical Examination and Treatment (point a clause 1 Article 34 of the Law on Medical Examination and Treatment):

a) In case the Expert Council is founded by the health facility on its own account as prescribed in point a clause 4 Article 101 of the Law on Medical Examination and Treatment:

- Within 05 working days from the issue date of its conclusion, the Expert Council’s Chairperson shall sign written conclusion which shall be then sent to the subject health facility;

- Within 05 working days of receipt of the written conclusion sent from the Expert Council’s Chairperson, the health facility shall send a written request for suspension of the medical practitioner, clearly stating reasons for such suspension, to its supervisory health authority;

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b) In case the Expert Council is founded under the decision of the health authority in charge of managing the health facility as prescribed in point b clause 4 Article 101 of the Law on Medical Examination and Treatment:

- Within 05 working days from the issue date of its conclusion, the Expert Council’s Chairperson shall sign and send a written request for suspension of the medical practitioner, clearly stating reasons for such suspension, to the health authority in charge of managing the health facility;

- Within 05 working days of receipt of the written request from the Expert Council’s Chairperson as prescribed in point b of this clause, the health authority in charge of managing that health facility shall issue a suspension decision. Contents of this suspension decision must be based on the conclusions given by the Expert Council.

2. In case a medical practitioner is suspended according to the conclusion, given by a competent authority, establishing that he/she has committed a violation against professional ethics which is not so severe that the sanction of revocation of his/her practicing license is imposed (point b clause 1 Article 34 of the Law on Medical Examination and Treatment):

a) In case the competent authority concluding that the medical practitioner has committed a violation against professional ethics does not have the jurisdiction to suspend or revoke the practicing license:

- Its written conclusion on the violation against professional ethics, in which a request for suspension of the medical practitioner and reason therefor must be indicated, shall be sent to the health authority in charge of managing the subject medical practitioner;

- Within 05 working days of receipt of the written conclusion from the competent authority, the health authority in charge of managing the subject medical practitioner shall issue a suspension decision. Contents of this suspension decision must be based on the written conclusion given by the competent authority.

b) In case the competent authority concluding that the medical practitioner has committed a violation against professional ethics has the jurisdiction to suspend or revoke the practicing license:

Within 05 working days from the issue date of its written conclusion, the competent authority shall issue a suspension decision. Contents of this suspension decision must be based on its written conclusion.

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Within 05 working days of receipt of the written conclusion from a competent authority (including: courts, assessment authorities and health check service providers) establishing that the medical practitioner is not healthy enough to practice medicine, the health authority in charge of managing that medical practitioner shall issue a suspension decision. Contents of this suspension decision must be based on the written conclusion given by the competent authority.

4. A decision to suspend part or all of scope of practice of a medical practitioner shall, inter alia, include:

a) Suspension of part or all of scope of practice of the medical practitioner; if part of the scope of practice is suspended, it must be clearly indicated;

b) Suspension period;

c) Requirement for continuous medical knowledge updating, except the case where the medical practitioner is a herbalist, folk remedy holder or folk therapy holder;

d) Conditions for resuming practice of medicine.

5. Within 05 working days from the issue date of the decision to suspend part or all of scope of practice of the medical practitioner, the issuing authority shall:

a) send such suspension decision to the suspended medical practitioner and limit his/her scope of practice on the healthcare management information system, or send such decision to the health facility where the suspended medical practitioner is working for implementation and to the healthcare socio-professional organization for supervision; and

b) if the issuing authority is not the one that has issued the practicing license to the suspended medical practitioner, send such suspension decision to the latter.

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1. If a medical practitioner is not required to continuously update medical knowledge under the decision to suspend part or all of scope of practice of the medical practitioner (hereinafter referred to as “suspension decision”), he/she may carry on his/her practice of medicine upon the expiry of the suspension period stated in the suspension decision.

2. If a medical practitioner is required to continuously update medical knowledge under the suspension decision:

a) Within 12 months from the effective date of the suspension decision, the medical practitioner must complete the continuous medical knowledge updating according to conclusions given by the Expert Council;

b) Upon his/her completion of continuous medical knowledge updating, the medical practitioner shall send his/her continuous medical knowledge updating results to the authority that has issued his/her practicing license to apply for permission to resume practice of medicine;

c) Within 05 working days, the authority that has issued practicing license shall send a notice of permission to resume practice of medicine to the medical practitioner and publish information on such permission on its web portal or website or on the healthcare management information system;

d) If a medical practitioner fails to submit documentary evidence of his/her completion of continuous medical knowledge updating when the suspension decision has expired, within 15 days from the expiry date of the suspension decision, the authority that has issued practicing license to that medical practitioner shall issue another suspension decision. The suspended medical practitioner shall assume responsibility to comply with the provisions of points a, b of this clause.

If the sum of suspension periods exceeds 24 months, the authority that has issued practicing license shall revoke the issued practicing license within 15 working days and the medical practitioner shall be required to following procedures for issuance of practicing license.

3. Suspension period: not exceeding 24 months.

Article 32. Procedures for revocation of practicing license

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a) The authority, organization or individual that detects the medical practitioner subject to revocation of practicing license shall notify the authority competent to revoke practicing license;

b) The authority competent to revoke practicing license shall verify received documents and information, and, if such documents and information are satisfactory, issue a decision to revoke practicing license (hereinafter referred to as “revocation decision”).

2. For the case prescribed in point dd clause 1 Article 35 of the Law on Medical Examination and Treatment:

The health authority in charge of managing the medical practitioner shall issue a decision to revoke the practicing license of the medical practitioner within 05 working days after receipt of a competent authority’s notice of the fact that the medical practitioner is subject to prohibition of the practice of medicine as prescribed in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment.

3. For the cases prescribed in points e and g clause 1 Article 35 of the Law on Medical Examination and Treatment:

a) In case the Expert Council is founded by the health facility on its own account as prescribed in point a clause 4 Article 101 of the Law on Medical Examination and Treatment:

- Within 05 working days from the issue date of its conclusion, the Expert Council’s Chairperson shall sign written conclusion which shall be then sent to the subject health facility;

- Within 05 working days of receipt of the written conclusion sent from the Expert Council’s Chairperson, the health facility shall send a written request for revocation of the medical practitioner, clearly stating reasons for such revocation, to its supervisory health authority;

- Within 05 working days of receipt of the written request from the health facility, the health authority in charge of managing that health facility shall issue a revocation decision. Contents of this revocation decision must be based on the conclusions given by the Expert Council.

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- Within 05 working days from the issue date of its conclusion, the Expert Council’s Chairperson shall sign and send a written request for revocation of the medical practitioner, clearly stating reasons for such revocation, to the health authority in charge of managing the health facility;

- Within 05 working days of receipt of the written request from the Expert Council’s Chairperson as prescribed in point b of this clause, the health authority in charge of managing that health facility shall issue a revocation decision. Contents of this revocation decision must be based on the conclusions given by the Expert Council.

4. For the case prescribed in point h clause 1 Article 35 of the Law on Medical Examination and Treatment:

Within 05 working days of receipt of the written conclusion from the competent authority that the medical practitioner has committed a violation against professional ethics for the second time to the extent of incurring the sanction of suspension of his/her practice of medicine within the validity period of his/her practicing license, the health authority in charge of managing that medical practitioner shall issue a revocation decision. Contents of this revocation decision must be based on the written conclusion given by the competent authority.

5. For the case prescribed in point i clause 1 Article 35 of the Law on Medical Examination and Treatment: the licensing authority shall issue a revocation decision within 15 days of receipt of the written request for revocation, accompanied by the practicing license, from the medical practitioner.

6. A revocation decision shall, inter alia, include:

a) Full name of the medical practitioner and number of his/her practicing license;

b) Decision to revoke the practicing license and reasons therefor;

c) Conditions for resuming the practice of medicine.

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Article 33. Actions taken after revoking practicing license for professional title of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic or clinical psychologist

1. If a practicing license is revoked in case the application package for issuance of that practicing license fails to meet regulations as prescribed in point a clause 1 Article 35 of the Law on Medical Examination and Treatment: the medical practitioner whose practicing license is revoked (hereinafter referred to as “license holder”) is required to modify and re-submit the application package for issuance of practicing license.

a) If the license holder submits a complete application package for issuance of practicing license within 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

b) If the license holder submits a complete application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits a complete application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship and pass the qualification test before following procedures for issuance of practicing license.

2. If a practicing license is revoked in case there is any fraudulent document enclosed in the application package for issuance of the practicing license as prescribed in point b clause 1 Article 35 of the Law on Medical Examination and Treatment (including the case where the fraudulent document is graduation diploma or certificate of completion of internship program included in application package for a qualification test): an application package for issuance of practicing license shall only be submitted after

a) In case the graduation diploma or qualification test pass certificate included in the application package for issuance of practicing license is forged: at least 05 years from the issue date of the revocation decision;

b) In case any of other documents included in the application package for issuance of practicing license is forged: 03 years from the issue date of the revocation decision.

3. If a practicing license is revoked in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license as prescribed in point c clause 1 Article 35 of the Law on Medical Examination and Treatment: the license holder shall follow procedures for issuance of practicing license without incurring any fees.

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b) If the license holder submits an application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship and pass the qualification test before following procedures for issuance of practicing license.

4. If a practicing license is revoked in case the license holder has not practiced medicine for 24 consecutive months as prescribed in point d clause 1 Article 35 of the Law on Medical Examination and Treatment:

a) If the license holder completes a medical internship within 36 months from the issue date of the revocation decision, he/she may follow procedures for re-issuance of practicing license;

b) If the license holder fails to complete a medical internship within 36 months from the issue date of the revocation decision, he/she shall follow procedures for issuance of a new practicing license.

5. If a practicing license is revoked in the case prescribed in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment:

a) If the license holder submits an application package for issuance of practicing license within 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

b) If the license holder submits an application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship and pass the qualification test before following procedures for issuance of practicing license.

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7. If a practicing license is revoked in case the Expert Council defined in Article 101 of the Law on Medical Examination and Treatment establishes that the license holder has committed an error related to his/her professional and technical expertise in healthcare for the second time to the extent of incurring the sanction of revocation of his/her practicing license for the second time within the validity period of his/her practicing license (point g clause 1 Article 35 of the Law on Medical Examination and Treatment): an application package for issuance of practicing license shall only be submitted after 12 months counting from the issue date of the revocation decision.

8. If a practicing license is revoked in case the competent state agency establishes that the license holder has violated professional ethics for the second time to the extent of incurring the sanction of suspension of his/her practice of medicine within the validity period of that practicing license (point h clause 1 Article 35 of the Law on Medical Examination and Treatment): the license holder must complete a medical internship and pass the qualification test before following procedures for issuance of a new practicing license.

9. If a practicing license is revoked in case such revocation is made at the request of the medical practitioner as prescribed in point i clause 1 Article 35 of the Law on Medical Examination and Treatment:

a) If the license holder submits an application package for issuance of practicing license within a period of less than 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

b) If the license holder submits an application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship and pass the qualification test before following procedures for issuance of practicing license.

Article 34. Actions taken after revoking practicing license for professional title of herbalist, folk remedy holder or folk therapy holder

1. If a practicing license is revoked in case the application package for issuance of that practicing license fails to meet regulations as prescribed in point a clause 1 Article 35 of the Law on Medical Examination and Treatment: the license holder is required to modify and re-submit the application package following procedures for re-issuance of practicing license.

2. If a practicing license is revoked in case there is any fraudulent document enclosed in the application package for issuance of the practicing license as prescribed in point b clause 1 Article 35 of the Law on Medical Examination and Treatment: an application package for issuance of practicing license shall only be submitted after 05 years counting from the issue date of the revocation decision.

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4. If a practicing license is revoked in case the license holder has not practiced medicine for 24 consecutive months as prescribed in point d clause 1 Article 35 of the Law on Medical Examination and Treatment: the license holder is required to submit an application package following procedures for issuance of practicing license.

5. If a practicing license is revoked in the case prescribed in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment: the license holder is required to submit an application package following procedures for issuance of practicing license.

6. If a practicing license is revoked in case the Expert Council defined in Article 101 of the Law on Medical Examination and Treatment establishes that the license holder has committed an error related to his/her professional and technical expertise in healthcare to the extent of incurring the sanction of revocation of his/her practicing license (point e clause 1 Article 35 of the Law on Medical Examination and Treatment): the license holder may only follow procedures for issuance of practicing license after 12 months counting from the issue date of the revocation decision.

7. If a practicing license is revoked in case the Expert Council defined in Article 101 of the Law on Medical Examination and Treatment establishes that the license holder has committed an error related to his/her professional and technical expertise in healthcare for the second time to the extent of incurring the sanction of revocation of his/her practicing license for the second time within the validity period of his/her practicing license (point g clause 1 Article 35 of the Law on Medical Examination and Treatment): an application package for issuance of practicing license shall only be submitted after 12 months counting from the issue date of the revocation decision.

8. If a practicing license is revoked in case the competent state agency establishes that the license holder has violated professional ethics for the second time to the extent of incurring the sanction of suspension of his/her practice of medicine within the validity period of that practicing license (point h clause 1 Article 35 of the Law on Medical Examination and Treatment): the license holder may only follow procedures for issuance of practicing license after 12 months counting from the issue date of the revocation decision.

9. If a practicing license is revoked in case such revocation is made at the request of the medical practitioner as prescribed in point i clause 1 Article 35 of the Law on Medical Examination and Treatment: the license holder shall follow procedures for re-issuance of practicing license.

Section 8. USE OF LANGUAGES IN PRACTICE OF MEDICINE

Article 35. Standards of interpreters for foreign medical practitioners

1. An interpreter for a foreign medical practitioner who is delivering healthcare to a patient who does not use the same parent language as the medical practitioner or who is not proficient in the language that the medical practitioner has registered for use in his/her practice of medicine must be proficient in the languages that are used by the medical practitioner and the patient.

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a) be proficient in the language that is used by that foreign medical practitioner; and

b) hold a valid practicing license.

3. Prescription for treatment methods (or therapies) and medications must be given in Vietnamese. Prescription for treatment methods (or therapies) and medications given by a foreign medical practitioner must be written in the language that he/she has registered for use in his/her practice of medicine, and be translated into Vietnamese. Medication prescriptions must also bear his/her interpreter’s signature.

Article 36. Use of language in delivery of healthcare to patients who are foreigners, ethnic minorities incapable of using Vietnamese or people with language disorder or impairment in health facilities of Vietnam

1. In order to receive healthcare services from a health facility, a patient who is a foreigner living in Vietnam, ethnic minority incapable of using Vietnamese or a person with language disorder or impairment must follow registration procedures and indicate his/her preferred language in such registration so that the health facility may assign an appropriate medical practitioner or interpreter who is proficient in the language used by that patient.

If the health facility is incapable of doing so, the patient may provide his/her own interpreter and shall assume responsibility for this interpreter's performance.

2. Where a foreigner, ethnic minority incapable of using Vietnamese or a person with language disorder or impairment enters a health facility in a state of emergency without his/her representative but is still able to communicate:

a) In case a medical practitioner that is able to use the patient's language or an interpreter is not available when delivering emergency care to the patient, the health facility may assign its employee who is able to use the patient's language, if available, to assist during delivery of healthcare to the patient. In this case, the assigned employee assumes no responsibility for his/her interpretation;

b) In case none of the medical practitioner, interpreter and employee that is able to use the patient's language is available when delivering emergency care to the patient, the delivery of healthcare to the patient shall comply with the provisions of Article 15 of the Law on Medical Examination and Treatment.

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Section 9. RECOGNITION OF PRACTICING LICENSES

Article 37. Conditions, application package and procedures for recognition of practicing licenses issued by competent foreign bodies or organizations

1. An applicant for recognition of his/her practicing license issued by a competent foreign body or organization must meet the following conditions:

a) The applicant must be a Vietnamese or is working at a health facility in Vietnam or has been granted a work permit as prescribed by the Labor Code;

b) His/her practicing license must meet the conditions set out in clause 1 Article 29 of the Law on Medical Examination and Treatment.

2. An application package for recognition of a practicing license issued by a competent foreign body or organization is composed of:

a) An application form;

b) A legitimate copy of the issued practicing license.

3. Procedures for recognition of a practicing license:

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b) In case the applicant’s practicing license has been issued by a foreign body or organization competent to issue practicing licenses (hereinafter referred to as “foreign licensing body”) that has been assessed and accredited:

- Within 30 days of receipt of the application package, the Ministry of Health of Vietnam is obliged to send a response stating acceptance or refusal of grant of recognition;

- Where it is necessary to verify matters relating to the applicant’s training in foreign countries, the duration of decision to grant recognition shall be 30 days from the day on which verification results are available.

c) In case the applicant’s practicing license has been issued by a foreign licensing body that has not yet been assessed and accredited:

- The Ministry of Health of Vietnam shall carry out assessment for accreditation of that foreign licensing body as prescribed in Article 38 of this Decree;

- Within 30 days from the day on which assessment results are available, the Ministry of Health of Vietnam is obliged to send a response stating acceptance or refusal of grant of recognition;

- Where it is necessary to verify matters relating to the applicant’s training in foreign countries, the duration of decision to grant recognition shall be 30 days from the day on which verification results are available.

Article 38. Contents, principles and procedures for assessment for accreditation of foreign licensing bodies

1. The Ministry of Health of Vietnam shall carry out assessment for accreditation of foreign licensing bodies according to the contents prescribed in clause 3 Article 29 of the Law on Medical Examination and Treatment, which must be furnished by such foreign licensing bodies as the basis for consideration and recognition of practicing licenses.

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3. Upon completion of the assessment, the Ministry of Health of Vietnam shall give assessment and accreditation results to the foreign licensing body.

Chapter III

ISSUANCE OF OPERATING LICENSES

Section 1. FORMS OF ORGANIZATION AND LICENSING CONDITIONS FOR HEALTH FACILITIES

Article 39. Forms of organization of health facilities

1. Hospitals, including:

a) General hospitals;

b) Traditional medicine hospitals;

c) Odonto-stomatology hospitals;

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2. Clinics, including:

a) Polyclinics;

b) Specialty clinics;

c) Interspecialty clinics;

d) Medical doctor’s clinics;

dd) Traditional medicine clinics;

e) Odonto-stomatology clinics;

g) Nutrition clinics;

h) General physician assistant's clinics.

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4. Maternity wards.

5. Traditional medicine diagnosis and treatment centers.

6. Subclinical service facilities, including:

a) Testing facilities;

b) Medical imaging facilities;

c) Testing and medical imaging facilities.

7. Family medicine facilities.

8. Dental technology facilities.

9. Rehabilitation facilities.

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11. Nursing service facilities.

12. Maternity service facilities.

13. Palliative care facilities.

14. Out-of-hospital emergency care facilities.

15. Corrective spectacle stores performing refraction tests.

16. Blood purification facilities.

Article 40. General licensing conditions

Each health facility is required to meet the following general licensing conditions:
1. Scale: The health facility's scale must be appropriate to its form of organization.

2. Material facilities:

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b) It must have a signboard, patient flowchart and wayfinding signs to professional and administrative wards, departments and sections;

c) If the health facility establishes a venue outside its precinct, this venue must be also required to meet the specific conditions for the relevant form of organization as prescribed in Article 39 of this Decree.

3. Its medical devices must be appropriate to the list of professional techniques and its registered scope of operation.

4. Personnel:

a) The health facility must employ sufficient medical practitioners according to its scale and list of professional techniques, and ensure the medical practitioner ratio set by the Minister of Health of Vietnam (including medical practitioners who have been issued with practicing licenses by licensing authorities in people’s armed forces, stop working in people’s armed forces but still use their issued practicing licenses);

b) The person in charge of professional practices of the health facility must be its full-time medical practitioner whose scope of practice is appropriate to its scope of professional activities, and who has practiced within such scope of professional activities for at least 36 months, except a medical practitioner who is a herbalist, folk remedy holder or folk therapy holder.

In case the health facility has different specialties, the scope of practice on the practicing license of its person in charge of professional practices must be appropriate to one of its registered specialties;

c) The manager of a professional department or unit of the health facility must possess a practicing license appropriate to his/her in-charge specialty and must be its full-time medical practitioner;

d) Medical practitioners must be vested with tasks appropriate to their scope of practice approved by competent authorities;

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e) Medical technicians whose scope of practice involves medical imaging and who possess bachelor’s degrees may read and describe diagnostic images. In case the health facility does not have any medical practitioner who is granted a practicing license for the title of doctor specializing in medical imaging technique or medical technician possessing bachelor’s degree whose scope of practice involves medical laboratory, the doctor giving prescription for medical imaging technique shall read and sign such medical imaging report;

g) Other persons engaging in medical examination and treatment without holding practicing licenses as prescribed in point d clause 2 Article 19 of the Law on Medical Examination and Treatment (such as medical physics engineers, radiotherapy engineers, biotechnology engineers, biotechnology bachelors and other persons (hereinafter referred to as “employees”) may perform professional activities as assigned by the health facility’s person in charge of professional practices. This assignment must be appropriate to professional qualification and capacity of the assigned employee.

h) If a medical practitioner who is a lecturer of a training institution in healthcare sector is working at a health facility that acts as an instructing facility accepting medical interns from that training institution, he/she may hold the position of manager of a professional department, department or ward of that health facility.

5. A health facility that provides health checks must be a hospital or polyclinic, and meet the following conditions:

a) It must have sufficient clinical and subclinical departments, personnel and medical devices necessary for examination, screening and detection of health conditions according to health standards and templates of health check forms enclosed with guiding documents on health checks;

b) Data on health check forms for drivers must be connected with the healthcare management information system or national healthcare database or data receipt portal of health insurance assessment information system.

6. A health facility that provides HIV/AIDS diagnosis and treatment must be a hospital or clinic, and meet the following conditions:

a) Material facilities: It has a minimum area of at least 18m^2(excluding waiting area), which is divided into two rooms used for providing medical examination and consulting for patients;

b) Personnel: the person in charge of professional practices of the HIV/AIDS diagnosis and treatment department must be a medical practitioner who holds the professional title of doctor and possesses a certificate of completion of training course in HIV/AIDS diagnosis and treatment issued by a lawful training institution;

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7. A health facility that provides examination and treatment for occupational diseases must be a hospital, polyclinic, interspecialty clinic, specialty clinic or medical doctor’s clinic and meet the following conditions:

a) It is capable of performing biochemical testing techniques in conformity with diagnostic guidelines for occupational diseases it will adopt.

b) Its medical devices must be appropriate to the list of professional techniques and the list of occupational diseases registered.

c) The person that provides examination and treatment for occupational diseases must hold a practicing license for the title of doctor whose scope of practice involves medicine and possess a certificate of completion of training course in occupational diseases or doctor whose scope of practice involves preventive medicine and possess a certificate of completion of training course in occupational diseases.

d) In case it is an independent facility in charge of providing medical examination and treatment for occupational diseases, its person in charge of professional practices must meet the following conditions:

- He/she is a doctor holding a practicing license for occupational disease specialty or a doctor holding a practicing license on which the scope of practice involves either a particular specialty or medicine and possessing a certificate of completion of training courses in occupational diseases;

- He/she has practiced medicine for at least 36 months after obtaining a practicing certificate or practicing license.

8. A health facility that provides HIV/AIDS testing services must be a hospital, polyclinic, interspecialty clinic, specialty clinic, medical doctor’s clinic or subclinical service facility and meet the conditions set out in the Government’s Decree No. 75/2016/ND-CP dated July 01, 2016 prescribing eligibility conditions for conduct of HIV tests.

9. A health facility that provides in-vitro fertilization and altruistic surrogacy services must be a hospital and meet the conditions set out in the Government’s Decree No. 10/2015/ND-CP dated January 28, 2015 prescribing giving birth with in-vitro fertilization and conditions for altruistic surrogacy.

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11. A health facility that has been issued with an operating license for one of the forms of organization specified in Article 39 of this Decree may provide services in another form of organization or health checks or medical examination and treatment for HIV/AIDS or occupational diseases if it meets the conditions for operating in such another form of organization or for providing such services.

In case a health facility meets conditions for providing services in another form of organization or conditions for providing health checks or HIV/AIDS examination and treatment when it applies for an operating license, it may apply for appraisal of its satisfaction of such conditions together with its application for operating license.

It such conditions are met after a practicing license has been issued, procedures for modification of the practicing license shall be followed. Particularly, health checks or HIV/AIDS examination and treatment services may be provided without following such procedures for modification of the practicing license, provided that procedures for announcement of its eligibility must be followed as prescribed in Article 69 of this Decree.

If family medicine is delivered, there must be a medical practitioner holding the title of doctor and meeting the following conditions:

- The scope of practice on his/her practicing license involves family medicine;

- He/she must hold a certificate of completion of training or refresher course in family medicine whose duration is not shorter than 03 months;

- There is documentary evidence that the total duration of family medicine training in the training program is at least 03 months.

12. A health facility that provides the following cosmetic services or uses products with pharmacological effects must be a hospital, polyclinic or specialty clinic:

a) Cosmetic services that use drugs, substances and equipment to intervene in the human body (surgery, procedures, interventions involving injections, injections, pumps, irradiation, waves, burning or other invasive interventions) that:

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- correct defects or create desired shapes of body parts (skin, nose, eyes, lips, face, chest, abdomen, buttocks and other parts of the human body);

- regenerate or restore cells or parts or functions of body parts.

b) Tattooing, spraying and skin embroidery using injectable anesthetics.

13. Apart from the conditions set out in clauses 1 through 12 of this Article, a humanitarian or not-for-profit healthcare facility must also meet the following:

a) Other specific conditions corresponding to its form of organization.

b) Finance for its humanitarian healthcare is available.

c) The phrase “humanitarian healthcare facility” or “not-for-profit healthcare facility” must be shown on its signboard.

Article 41. Licensing conditions for hospitals

In addition to the general licensing conditions set out in Article 40 of this Decree, a hospital is also required to meet the following:

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a) For a general hospital: at least 30 hospital beds;

b) For a traditional medicine hospital or an odonto-stomatology hospital: at least 20 hospital beds;

c) For a specialty hospital: at least 20 hospital beds; particularly, an ophthalmology hospital must have at least 10 hospital beds.

2. Material facilities:

a) Professional departments are assigned according to their functions to facilitate medical examination and treatment activities;

b) Construction requirements must be met as prescribed by laws. To be specific: there must be a minimum construction floor area of 50 m^2 per hospital bed; the hospital façade must be at least 10 m; ambulances must be given way to emergency care unit; any clinics located within the hospital must meet minimum area requirements for corresponding types of clinics set out in Articles 42, 43, 45, 46, points b, c clause 1 Article 47, Article 53 of this Decree;

c) If the hospital establishes a professional department outside its precinct, it must ensure transport infrastructure connection between its departments to ensure the safety of patients, their families and health workers.

3. Mean of transport: there must be sufficient emergency vehicles for transporting patients in and out of the hospital. If emergency vehicles providing out-of-hospital treatment are not available, the hospital must enter into a contract with a local health facility that functions as emergency care/patient transport service provider.

4. Organization:

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b) Professional departments:

The hospital is composed of the following professional departments, including: outpatient department, clinical department, subclinical department, pharmaceutical department and auxiliary department. To be specific:

- The outpatient department must be composed of a reception area, emergency room, patient stay room, medical examination room, and technical/minor surgery rooms (if techniques/minor surgery operations are performed);

- Clinical departments of a general hospital include at least two of the following: internal medicine department, surgery, obstetrics and pediatrics; a specialty hospital, traditional medicine hospital or odonto-stomatology hospital must establish a clinical department appropriate to its scope of professional activities;

- The subclinical department is composed of at least a laboratory and a medical imaging room. If the ophthalmology hospital does not establish any medical imaging department, it must enter into a professional assistance agreement with a health facility that has been issued with an operating license and has a medical imaging department;

- Pharmaceutical department;

- A hospital that has a scale of at least 100 hospital beds must establish a nutrition department; there must be at least a person in charge of nutrition for each 100 hospital beds. A hospital that has a scale of less than 100 hospital beds shall establish a clinical nutrition section or appoint a person in charge of nutrition; the person in charge of nutrition must be a bachelor of nutrition or a medical practitioner who holds the title of doctor and possesses a certificate of completion of training course in clinical nutrition whose duration is 06 months or longer, or a nurse who holds a bachelor’s degree and possesses a certificate of completion of training course in clinical nutrition whose duration is 06 months or longer;

- A hospital that has a scale of at least 150 hospital beds must establish an infection control department; there must be at least a person in charge of infection control for each 150 hospital beds. A hospital that has a scale of less than 150 hospital beds shall establish an infection control section; the person in charge of infection control must hold a bachelor’s degree or higher in healthcare sector and possess a certification or certificate or diploma of graduation from a training course in infection control;

- Other professional departments of the hospital must be appropriate to its scale, tasks and functions.

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d) Depending on its material facilities and personnel, the head of the health facility may decide to establish professional departments in the form of inter-specialty departments; the person in charge of professional practices of a specialty must possess a practicing license on which the scope of practice is appropriate to at least one of such other specialties. In case the hospital is unable to establish separate departments, it may establish units affiliated to clinical departments; the person in charge of professional practices of a unit must possess a practicing license on which the scope of practice is appropriate to its specialty.

dd) Professional departments which are institutes or centers affiliated to and located within the precinct of a hospital are not eligible to operating licenses; persons in charge of professional practices of these institutes or centers and their professional units must meet relevant conditions set out in this Decree.

5. Personnel:

a) The number of full-time medical practitioners of a department must be accounted for at least 70% of total medical practitioners of such department;

b) The head of each professional department of the hospital must be a full-time medical practitioner of that hospital, possess a practicing license appropriate to the specialty of his/her in-charge professional department, and have practiced such specialty for at least 36 months. If a medical practitioner who is a lecturer of a training institution in healthcare sector is working at a health facility that acts as an instructing facility accepting medical interns from that training institution, he/she may hold the position of manager or head of a department or ward of that health facility;

c) The head of a professional department who is not eligible for a practicing license must possess a bachelor’s degree in a major appropriate to his/her assigned tasks and be a full-time employee of the hospital.

6. The hospital must provide inpatient treatment and adequate staff on duty at all times (i.e. 24 hours per day and 7 days per week) to provide professional care.

Article 42. Licensing conditions for polyclinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a polyclinic is also required to meet the following:

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a) It must have at least three specialties which include at least two of the following: internal medicine, surgery, obstetrics and pediatrics; establish subclinical departments (medical laboratory and medical imaging); and have emergency room, minor surgery room (if minor surgery operations are performed) and patient stay room;

b) In case a polyclinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scope of professional activities may include professional activities of such form of organization of health facility.

2. Material facilities and personnel:

a) Medical examination rooms of a polyclinic must meet the following minimum area requirements:

- The minimum area of the emergency room is 12 m^2;

- The patient stay room has a minimum area of 15 m^2, and has at least 02 hospital beds. If there are at least 03 hospital beds in the patient stay room, the minimum area of at least 05 m^2 per hospital bed must be ensured;

- The minimum area of each specialty-specific medical examination room is 10 m^2;

- If techniques and minor surgery operations are performed, in addition to specialty-specific medical examination rooms, a technical and minor surgery room with a minimum area of at least 10 m^2must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m^2.

b) A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the polyclinic has entered into a contract for sterilization of medical devices with another health facility.

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3. The polyclinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 43. Licensing conditions for specialty clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a specialty clinic is also required to meet the following:

1. Scale and organizational structure of the specialty clinic:

a) It has at least a specialty;

b) In case a specialty clinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scope of professional activities may include professional activities of such form of organization of health facility, provided that activities of no more than 03 forms of organization of health facility are added.

2. Material facilities:

a) The specialty clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m^2;

b) If techniques and minor surgery operations are performed, in addition to medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m^2 must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m^2.

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3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 44. Licensing conditions for interspecialty clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, an interspecialty clinic is also required to meet the following:

1. Scale and organizational structure of the interspecialty clinic:

a) It has at least two specialties (excluding internal medicine department, surgery, obstetrics and pediatrics);

b) In case an interspecialty clinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scale and scope of professional activities may include professional activities of such form of organization of health facility, provided that activities of no more than 03 forms of organization of health facility are added.

2. Material facilities:

Each specialty-specific medical examination department of the interspecialty clinic must meet the conditions set out in clause 2 Article 43 of this Decree.

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

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Article 45. Licensing conditions for medical doctor’s clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a medical doctor’s clinic is also required to meet the following:

1. Scale and organizational structure of the medical doctor’s clinic: A medical doctor’s clinic is a clinic owned by a person holding a practicing license for the title of doctor whose scope of practice involves medicine or a specific specialty.

2. Material facilities:

a) The medical doctor’s clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m^2;

b) A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the clinic has entered into a contract for sterilization of medical devices with another health facility;

c) If techniques and minor surgery operations are performed, in addition to its medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m^2 must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m^2.

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 46. Licensing conditions for traditional medicine clinics

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1. Material facilities:

a) The traditional medicine clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m^2.

b) Depending on its registered scope of professional activities, the traditional medicine clinic must also meet the following conditions:

- If techniques and minor surgery operations are performed, in addition to its medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m^2 must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m^2;

- In case of medical sauna, a closed but well-illuminated sauna room with a minimum area of at least 02 m^2 must be available.

- If traditional drugs are prepared or made up, standards for preparation of traditional drugs adopted by the Minister of Health of Vietnam must be met.

2. Equipment used for performing medical examination and treatment activities;

a) If medical examination, drug prescription and drug preparation are performed:

- Drug cabinets must be available; prepared traditional medicinal materials must be kept in drawers or in glass or white plastic bottles with caps, and have their names clearly written on such drawers or bottles;

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b) In case acupuncture, massage and acupressure are provided, the clinic must be equipped with the following:

- Beds for performing acupuncture, massage and acupressure activities;

- Adequate devices or tools for performing acupuncture, massage and acupressure activities;

- Adequate devices and instructions for dealing with needle shock (also known as vasovagal syncope, a common adverse event of acupuncture treatment).

c) In case of medical sauna, there must be a medicinal steam system that has control valves, sauna instructions and emergency alert system.

d) The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

3. Personnel:

The person in charge of professional practices of the traditional medicine clinic must be a medical practitioner holding the title of:

a) a doctor whose scope of practice involves traditional medicine; or

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Article 47. Licensing conditions for odonto-stomatology clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, an odonto-stomatology clinic is also required to meet the following:

1. Material facilities:

a) The odonto-stomatology clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m^2;

b) There must be at least 01 dental unit; the minimum area for each dental unit is 05 m^2;

c) In case dental implant technique is performed, a separate room for performing such implant technique with a minimum area of at least 10 m^2 must be provided.

2. Personnel:

The person in charge of professional practices of the odonto-stomatology clinic must be a medical practitioner holding the title of:

a) a doctor whose scope of practice involves odonto-stomatology; or

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3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 48. Licensing conditions for nutrition clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a nutrition clinic is also required to meet the following:

1. It is organized as an internal medicine clinic or medical doctor’s clinic.

2. The person in charge of professional practices of the clinic must be a medical practitioner holding the title of a doctor whose scope of practice involves clinical nutrition or the title of clinical nutritionist.

Article 49. Licensing conditions for general physician assistant's clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a general physician assistant's clinic is also required to meet the following:

1. It is located in an extremely socioeconomically disadvantaged area as defined by the Minister of Labour, War Invalids and Social Affairs of Vietnam.

2. The person in charge of professional practices of the clinic must be a medical practitioner holding the title of a physician assistant whose scope of practice involves general medicine.

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Article 50. Licensing conditions for health stations

In addition to the general licensing conditions set out in Article 40 of this Decree, a health station is also required to meet the following:

1. Personnel:

a) The person in charge of professional practices of the health station must be a medical practitioner holding the title of a doctor or physician assistant;

b) The number of medical practitioners working at the health station must comply with regulations of law on payroll of state-owned health facilities;

c) Village health workers shall provide primary healthcare according to assignment and professional directions given by the person in charge of professional practices of the health station.

2. The health station must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 51. Licensing conditions for maternity wards

In addition to the general licensing conditions set out in Article 40 of this Decree, a maternity ward is also required to meet the following:

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a) Departments, wards or rooms are assigned according to their functions to facilitate medical examination and treatment activities;

b) It must have antenatal care room, gynecological examination room, labour room, patient stay department with less than 20 beds where prenatal and postnatal monitoring and care are given, and nursery room.

2. There must be sufficient emergency vehicles for transporting patients in and out of the maternity ward. If emergency vehicles providing care and treatment out of the maternity ward are not available, the maternity ward must enter into a contract with a health facility that has been licensed to operate and provide emergency care/patient transport services.

3. The person in charge of professional practices of the maternity ward must be a medical practitioner holding the title of:

a) a doctor whose scope of practice involves obstetrics; or

b) a midwife possessing a bachelor’s degree or higher.

4. The maternity ward must provide adequate staff on duty at all times (i.e. 24 hours per day and 7 days per week) to provide professional care.

Article 52. Licensing conditions for traditional medicine diagnosis and treatment centers

In addition to the general licensing conditions set out in Article 40 and Article 46 of this Decree, a traditional medicine diagnosis and treatment center is also required to meet the following requirement regarding its person in charge of professional practices:

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1. Doctor whose scope of practice involves traditional medicine.

2. Doctor whose scope of practice specializes in traditional medicine.

3. Physician assistant whose scope of practice involves traditional medicine.

4. Herbalist.

5. Folk remedy holder.

6. Folk therapy holder.

Article 53. Licensing conditions for subclinical service facilities, dental technology facilities, and rehabilitation facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, a subclinical service facility, dental technology facility, or rehabilitation facility is also required to meet the following:

1. Testing facility:

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- Waiting area for specimen collection, and areas for receiving specimens and cleaning tools must be available;

- If any of the following testing types, including blood tests, biochemical tests, genetic tests and immunologic tests, is performed, the minimum area of the laboratory is 10 m^2;

- If 02 or 03 of the following testing types, including blood tests, biochemical tests, genetic tests and immunologic tests, are performed, the minimum area of the laboratory is 15 m^2;

- If all of the following testing types, including blood tests, biochemical tests, genetic tests and immunologic tests, are performed, the minimum area of the laboratory is 20 m^2;

- If anatomic pathology and cytological pathology are performed, the laboratory must have a minimum area of at least 20 m^2 and be separated from blood, biochemical, genetic and immunologic laboratories and other laboratories;

- If microbiological tests are performed, the laboratory must have a minimum area of at least 20 m^2 and be separated from blood, biochemical, genetic and immunologic laboratories and other laboratories;

- Wall surfaces in the laboratory must be covered with waterproof material from the floor to the ceiling;

- The floor surface of the laboratory must be waterproof, smooth and level without stagnant water;

- Laboratory workbench must be constructed of waterproof and anti-corrosive material, with sink and faucet installed thereon.

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The person in charge of professional practices of the testing facility must be a medical practitioner holding the title of:

- a doctor whose scope of practice specializes in medical laboratory; or

- a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves medical laboratory.

2. Medical imaging facility:

The person in charge of professional practices of the medical imaging facility must be a medical practitioner holding the title of:

a) a doctor whose scope of practice specializes in medical imaging technique; or

b) a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves medical imaging technique.

3. Dental technology facility:

The person in charge of professional practices of the dental technology facility must be a medical practitioner holding the title of a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves dental technology.

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The person in charge of professional practices of the rehabilitation facility must be a medical practitioner holding the title of:

a) a doctor whose scope of practice specializes in rehabilitation; or

b) a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves rehabilitation.

5. In addition to the conditions set out in this Decree, a health facility that performs HIV confirmatory tests must also meet the relevant conditions set out in the Government’s Decree No. 75/2016/ND-CP dated July 01, 2016.

6. In addition to the conditions set out in point a clause 1 of this Article, the person in charge of professional practices of a testing and medical imaging facility must meet the conditions in point b clause 1 or clause 2 of this Article.

Article 54. Licensing conditions for clinical psychology facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, the person in charge of professional practices of a clinical psychology facility must be a medical practitioner holding the title of:

1. a clinical psychologist; or

2. a doctor whose scope of practice specializes in psychiatry and who possesses a certificate of completion of basic training course in clinical psychology as prescribed in clause 2 Article 128 of this Decree.

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In addition to the general licensing conditions set out in Article 40 of this Decree, a nursing service facility, maternity service facility, or palliative care facility is also required to meet the following:

1. Material facilities: If techniques and minor surgery operations are performed, in addition to its medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m^2 must be available.

2. It must be equipped with anaphylaxis kits.

3. Personnel:

a) Nursing service facility:

The person in charge of professional practices of the nursing service facility must be a medical practitioner holding the title of:

- Doctor;

- Physician assistant;

- Nurse; or

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b) Maternity service facility:

The person in charge of professional practices of the maternity service facility must be a medical practitioner holding the title of a midwife.

c) Palliative care facility:

The person in charge of professional practices of the palliative care facility must be a medical practitioner holding the title of a doctor whose scope of practice involves:

- Medicine;

- Traditional medicine;

- Preventive medicine; or

- a specific specialty, except odonto-stomatology.

Article 56. Licensing conditions for out-of-hospital emergency care facilities

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1. Material facilities:

a) There must be an area for disinfection of ambulances with adequate decontamination devices and facilities, or the out-of-hospital emergency care facility must enter into a service contract with a qualified health facility to perform disinfection of its ambulances in accordance with regulations adopted by the Minister of Health of Vietnam.

b) 24/7 service room, personnel and hotline are available at its head office.

c) Its head office is exclusive of parking area for emergency vehicles.

d) Emergency vehicles:

- The out-of-hospital emergency care facility must be equipped with at least 02 ambulances;

- Its ambulances must meet relevant quality standards.

dd) It must be equipped with anaphylaxis kits and adequate emergency medicines to ensure safety and hygienic conditions for patients.

2. Personnel:

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a) a doctor; or

b) an out-of-hospital paramedic.

Article 57. Licensing conditions for corrective spectacle stores performing refraction tests

1. Material facilities: The minimum area of the refraction room is 10 m^2.

2. Refraction equipment is available.

3. The person in charge of professional practices must be a medical practitioner holding the title of:

a) a doctor specializing in ophthalmology; or

b) a medical technician whose scope of practice involves ophthalmic refraction.

Article 58. Licensing conditions for blood purification facilities

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1. Material facilities:

a) Area for receiving patients, waiting area, dry and wet storage areas, and dialyzer reprocessing room (if dialyzer reprocessing is performed) must be available;

b) The blood purification room must provide a minimum area of at least 4,5m^2 per dialysis machine; separate blood purification and dialyzer reprocessing areas must be provided for patients with infectious diseases;

c) There must be a system supplying R.O water for dialysis machine and dialyzer reprocessing (if dialyzer reprocessing is performed);

d) It must enter into a professional assistance contract with a local hospital whose scope of professional activities includes hemodialysis;

dd) Emergency vehicles must be available. If emergency vehicles are not available, it must enter into a contract for emergency transport.

2. Personnel:

a) The person in charge of professional practices of the blood purification facility must be a medical practitioner holding the title of a doctor whose scope of practice involves medicine, internal medicine, or intensive care, and possessing a certificate of completion of a professional training course in hemodialysis as prescribed in clause 3 Article 12 of this Decree;

b) The medical practitioner holding the title of nurse must possess a certificate of completion of a professional training course in hemodialysis as prescribed in clause 3 Article 12 of this Decree.

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Article 59. Cases of issuance of operating licenses

1. An operating license may be issued to:

a) a health facility that applies for operating license for the first time;

b) a health facility whose operating license is revoked, except as defined in point d clause 1 Article 56 of the Law on Medical Examination and Treatment;

c) a health facility that has been issued with an operating license if it changes its form of organization;

d) a health facility that has been issued with an operating license if it changes its operating location;

dd) a health facility that has been issued with an operating license if it undergoes a split-up, split-off, consolidation or merger process;

e) a health facility that has been issued with an operating license if its affiliated health facilities are established outside the precinct of the licensed one; or

g) a health facility that has been issued with an operating license if it applies for delivery of humanitarian healthcare or not-for-profit healthcare.

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Article 60. Application package for operating license

1. An application package for issuance of operating license in the case prescribed in point a, b, c, d, dd or e clause 1 Article 59 of this Decree is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) a legitimate copy of an establishment decision or a document containing name of the health facility (applicant) issued by a competent authority, if the applicant is a state-owned health facility, or enterprise registration certificate, if the applicant is a private health facility, or investment certificate, if the applicant is a foreign-invested health facility;

c) legitimate copies of the practicing license and certificate of practicing period, which is made using Form No. 11 in Appendix I enclosed herewith, of the person in charge of professional practices of the health facility (applicant) (not required if these documents have been shared or published on the healthcare management information system or national healthcare database);

d) legitimate copies of the practicing license and certificate of practicing period, which is made using Form No. 11 in Appendix I enclosed herewith, of the manager of professional department of the health facility (applicant) (not required if these documents have been shared or published on the healthcare management information system or national healthcare database);

dd) Declaration of material facilities, list of medical devices and list of personnel meeting licensing conditions for the corresponding form of organization, made using Form No. 08 in Appendix II enclosed herewith, and documents proving or certifying such declaration;

e) The list of medical practitioners who have registered for practice at the health facility (applicant), which is made using Form No. 01 in Appendix II enclosed herewith, and in which name and number of practicing license of each medical practitioner must be indicated;

g) A competent authority’s written approval of functions, tasks and organizational structure of the state-owned hospital or of the charter on organization and operation of a private hospital, which is made using Form No. 03 in Appendix II enclosed herewith;

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i) In case the health facility delivering humanitarian healthcare or not-for-profit healthcare applies for an operating license for the first time, documents proving the funding for humanitarian healthcare or not-for-profit healthcare must be submitted.

2. An application package for issuance of operating license submitted by a health facility that has been issued with an operating license but changes its operating location as prescribed in point d clause 1 Article 59 of this Decree is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) a legitimate copy of an establishment decision or a document containing name of the health facility (applicant) issued by a competent authority, if the applicant is a state-owned health facility, or enterprise registration certificate, if the applicant is a private health facility, or investment certificate, if the applicant is a foreign-invested health facility;

c) Declaration of material facilities meeting licensing conditions at the new location, and documents proving or certifying such declaration;

d) A legitimate copy of the issued operating license.

3. An application package for issuance of operating license submitted by a health facility that has been issued with an operating license but applies for delivery of humanitarian healthcare or not-for-profit healthcare without charging patients for medical costs as prescribed in point g clause 1 Article 59 of this Decree is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) Documents proving funding for humanitarian healthcare activities.

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1. The health facility (applicant) shall submit an application package and application fee, as defined by the Law on Fees and Charges, to the authority competent to issue operating license (hereinafter referred to as "licensing authority").

2. Upon receipt of the application package, the receiving authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant.

3. If the application is satisfactory:

a) The licensing authority shall carry out verification of operating conditions and list of professional techniques to be performed by the applicant, and issue a verification record within 60 days from the date specified in the receipt note;

b) If there are no matters that need to be modified, the licensing authority shall issue an operating license and a decision approving the list of professional techniques to be performed by the applicant within 10 working days from the date of the verification record;

c) Any matters that need to be modified must be clearly described in the verification record.

Within 10 working days from its receipt of a written notice and documents proving finished modification from the applicant, the licensing authority may conduct a physical inspection of items or matters modified by the applicant, where necessary, or issue an operating license. If an application is refused, a written response indicating reasons for refusal must be given.

4. If the modification of the application is required:

a) The licensing authority shall send a written request for modification of the application, which must clearly indicate the documents and/or contents that need to be modified, to the applicant within 10 days from the date of the receipt note.

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c) After receiving modified application documents, the licensing shall:

- follow procedures in clause 3 of this Article if the application is satisfactory; or

- follow procedures in points a, b of this clause if the application is still unsatisfactory.

5. Within 05 working days from the day on which an operating license is issued, the licensing authority shall publish the following information on its web portal and on the healthcare management information system, including: name and address of the licensed health facility; full name and number of practicing license of the person in charge of professional practices of the licensed health facility; number of the issued operating license; scope of professional activities and opening hours.

6. An operating license will be made using Form No. 06 in Appendix II enclosed herewith in 02 copies of which 01 copy is delivered to the applicant and the other is kept by the licensing authority, unless application processing results are returned electronically.

7. When issuing an operating license to a health facility in the form of a hospital, the licensing authority shall also issue a document to temporarily classify the hospital into the basic level. This document on temporary classification of the hospital shall be valid for 02 years from the date thereon. At least 60 days before the expiry date of this document, the hospital must submit an application for classification of its professional and technical expertise as prescribed in Article 90 of this Decree.

Article 62. Application package for re-issuance of operating license

1. An application form (made using Form 02 in Appendix II enclosed herewith).

2. In case the operating license is lost or damaged: a copy of the lost license or the original of the damaged license (if available).

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Article 63. Procedures for re-issuance of operating license

1. The health facility (applicant) shall submit an application package for re-issuance of operating license and application fee, as defined by the Law on Fees and Charges, to the licensing authority.

2. When receiving the application, the licensing authority shall give a receipt note to the applicant.

3. Within 20 days from the date of the receipt note, the licensing authority shall re-issue the requested operating license and update information on such re-issued license on its website or web portal and on the healthcare management information system.

Article 64. Application package for modification of an operating license

1. In case the name, address (without relocation) or opening hours of a health facility are changed, an application package for modification of its operating license is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) Documentary evidence of such a change.

2. In case the health facility changes its scale or scope of professional activities, or makes changes in its list of professional techniques, an application package for modification of its operating license is composed of:

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b) The original operating license;

c) Declaration of material facilities, medical devices and personnel corresponding to the new scale or scope of professional activities or the modified list of professional techniques and documentary evidence of such a change.

Article 65. Procedures for modification of an operating license in case of changes in health facility’s opening hours, name or address (without relocation)

1. The health facility (applicant) shall submit an application package for change in its name, address or opening hours as prescribed in clause 1 Article 64 of this Decree and application fee, as defined by the Law on Fees and Charges, to the licensing authority.

2. Upon receipt of the application package, the licensing authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant.

3. In case the application package is satisfactory, the licensing authority shall make changes to the requested operating license within 20 days from the date of the receipt note prescribed in clause 2 of this Article.

4. If the application package needs to be modified, within 05 working days from the date of the receipt note prescribed in clause 2 of this Article, the licensing authority shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, their submitted application documents will be invalidated.

5. Upon receipt of a modified application package, the licensing authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant, and take the following actions:

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Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, or after 12 months counting from the date of the initial submission of the application for modification of operating license, the modified application package is still unsatisfactory, the submitted application documents will be invalidated.

b) In case the modified application package is satisfactory, the licensing authority shall take actions as prescribed in clause 3 of this Article.

6. Within 05 working days after a modified operating license is issued, the licensing authority shall publish or update information on modified contents on its web portal and on the healthcare management information system.

7. A modified operating license will be issued in 02 copies of which 01 copy is delivered to the applicant and the other is kept by the licensing authority, unless application processing results are returned electronically.

Article 66. Procedures for modification of operating license in case of changes in health facility’s scale, scope of professional activities, or list of professional techniques

1. The health facility (applicant) shall submit an application package as prescribed in clause 2 Article 64 of this Decree and application fee, as defined by the Law on Fees and Charges, to the licensing authority.

2. Upon receipt of the application package, the licensing authority shall give a receipt note to the applicant.

3. If the application package needs to be modified, within 07 working days from the date of the receipt note, the licensing authority shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, their submitted application documents will be invalidated.

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In case the modified application package is still unsatisfactory, the licensing authority shall continue sending a written request for modification to the applicant as prescribed in clause 3 of this Article.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications.

If the applicant fails to make requested modifications by the aforementioned deadline, or after 12 months counting from the date of the initial submission of the application for modification of operating license, the modified application package is still unsatisfactory, the submitted application documents will be invalidated.

5. In case the application package is satisfactory or modifications to the submitted application package are satisfactory as prescribed in clauses 3, 4 of this Article, the licensing authority shall:

a) issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques within 20 days from the date of the receipt note, if the physical inspection to the applicant’s premises is deemed unnecessary; or

b) conduct a physical inspection to the applicant’s premises and issue an inspection record within 60 days from the date of the receipt note, if such a physical inspection is deemed necessary. Any matters that need to be modified must be indicated in the inspection record.

6. Upon completion of the physical inspection, the licensing authority shall:

a) issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques within 10 working days from the date of the inspection record, if no matters need to be modified;

b) issue a notice of contents that need to be modified within 05 working days from the date of the inspection record, if there are matters that need to be modified.

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7. Within 10 working days from the receipt of written notice of finished modifications and documentary evidence thereof from the applicant, the licensing authority shall:

a) issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques, if a physical inspection to the applicant’s premises is deemed unnecessary.

b) conduct a physical inspection to the applicant’s premises, if such physical inspection is deemed necessary, and:

- issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques, in case the applicant has completely made modifications; or

- give a written response indicating reasons for its refusal to approve changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques, if the applicant has completely made modifications.

8. Within 05 working days after giving approval of the health facility’s addition of its professional techniques, the licensing authority shall publish or update information on modified contents on its web portal or website and on the healthcare management information system.

9. A written approval of addition of professional techniques is given in 02 copies of which 01 copy is delivered to the applicant and the other is kept by the licensing authority, unless application processing results are returned electronically.

10. Regarding addition of a technique included in the list of special-type techniques:

a) The health facility shall submit an application package as prescribed in clause 2 Article 64 of this Decree to the Ministry of Health of Vietnam for consideration of its capacity to perform such special-type technique.

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c) In case an experiment on the special-type technique should be conducted, procedures in Article 97 of this Decree will be followed.

d) In case the health facility has completed the experiment on the special-type technique and made a report on experimental results which includes proposal for official application of that special-type technique, the following procedures shall be followed:

- The health facility shall submit an application package which includes the report on results of the experiment conducted as prescribed in point c of this clause and procedures for performing that special-type technique proposed by the health facility;

- Within 15 days from its receipt of adequate application documents, the Ministry of Health of Vietnam shall carry out an appraisal of experimental results and technical procedures proposed by the health facility;

- Within 05 working days from the day on which an appraisal record is issued, the Ministry of Health of Vietnam shall issue a decision to allow the health facility to officially apply that special-type technique. If an application is refused, a written response indicating reasons for such refusal shall be given;

- The health facility shall follow procedures prescribed in clause 1 through 9 of this Article for adding the special-type technique which it is allowed to officially apply to its scope of professional activities.

dd) In case an experiment on the special-type technique is deemed unnecessary, the following procedures will be followed:

- Within 05 working days, the Ministry of Health of Vietnam shall issue a decision to allow the health facility to officially apply that special-type technique without conducting experiment thereon. If an application is refused, a written response indicating reasons for such refusal shall be given;

- The health facility shall follow procedures prescribed in clauses 1 through 9 of this Article for adding the special-type technique which it is allowed to officially apply to its scope of professional activities.

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1. The Minister of Health shall have authority to:

a) issue and re-issue operating licenses to health facilities under its management;

c) modify operating licenses of health facilities under its management if their scope of professional activities are changed: addition or removal of techniques to or from their scope of professional activities.

c) modify operating licenses of health facilities under its management if their scale is changed. To be specific:

- There is an increase or decrease in number of professional departments or wards of the health facility, including the case specified in point dd clause 1 Article 54 of the Law on Medical Examination and Treatment;

- The number of hospital beds of the health facility is increased or decreased by at least 10% or by less than 10% but more than 30 hospital beds;

- The number of hospital beds of the health facility is changed as prescribed in clause 4 of this Article.

d) modify operating licenses of health facilities under its management if their opening hours are changed.

dd) modify operating licenses of health facilities under its management if there are changes in their names or addresses (without relocation).

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a) issue or re-issue operating licenses to health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam.

b) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if their scope of professional activities are changed: addition or removal of techniques to or from their scope of professional activities.

c) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if their scale is changed. To be specific:

- There is an increase or decrease in number of professional departments or wards of the health facility, including the case specified in point dd clause 1 Article 54 of the Law on Medical Examination and Treatment;

- The number of hospital beds of the health facility is increased or decreased by at least 10% or by less than 10% but more than 30 hospital beds;

- The number of hospital beds of the health facility is changed as prescribed in clause 4 of this Article.

d) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if their opening hours are changed.

dd) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if there are changes in their names or addresses (without relocation).

3. A hospital may increase or decrease the number of hospital beds of its departments or wards by less than 10% of its total number of hospital beds specified in its operating license but not more than 30 hospital beds, and must send a written report on such change to its supervisory authority. Such report must indicate:

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b) Declaration of its material facilities, medical devices and personnel proving its satisfaction of conditions for making change in number of its hospital beds.

4. If a hospital wishes to change the number of its hospital beds after it has completed procedures for increase or decrease of the number of its hospital beds by less than 10%, it shall be required to follow procedures for modification of its operating license as prescribed in Article 66 of this Decree. The hospital shall send an application package for modification of its operating license to:

a) The Ministry of Health of Vietnam, if it is affiliated to the Ministry of Health of Vietnam; or

b) The health authority affiliated to the People’s Committee of province or city where it is located, unless it is affiliated to the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam.

5. If a hospital wishes to change the number of its hospital beds after it has completed procedures for modification of its operating license as prescribed in clause 4 of this Article, it shall follow corresponding guidelines in clause 3 and clause 4 of this Article.

Article 68. Documentation for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment

1. Written declaration of eligibility to provide health checks or HIV/AIDS examination and treatment (which is made using Form No. 04 in Appendix II enclosed herewith).

2. A legitimate copy of the health facility’s operating license accompanied with its list of professional techniques.

3. List of personnel and medical devices meeting conditions for providing health checks or HIV/AIDS examination and treatment, which is made using Form No. 05 in Appendix II enclosed herewith.

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Article 69. Procedures for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment

1. Before its provision of initial health check, the health facility must submit 01 set of required documents for declaration of its eligibility to provide health checks or HIV/AIDS examination and treatment as prescribed in Article 68 of this Decree to the competent health authority. To be specific:

a) For health facilities affiliated to the Ministry of Health of Vietnam and other ministries and central-government authorities (except the Ministry of National Defence of Vietnam and the Ministry of Public Security of Vietnam): required documents shall be sent to the Ministry of Health of Vietnam;

b) For health facilities under the management of the Ministry of National Defence of Vietnam: required documents shall be sent to the Ministry of National Defence of Vietnam;

c) For health facilities under the management of the Ministry of Public Security of Vietnam: required documents shall be sent to the Ministry of Public Security of Vietnam;

d) For health facilities under the management of health authorities affiliated to provincial People's Committees (health facilities do not fall in the cases specified in points a, b, c of this clause): required documents shall be sent to the health authority affiliated to the People's Committee of province where the health facility is headquartered.

2. Procedures for considering a document package for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment:

a) Upon receipt of a document package for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment, the health authority as defined in clause 1 of this Article (hereinafter referred to “receiving authority”) shall give a receipt note, which is made using Form No. 02 in Appendix I enclosed herewith, to the health facility that declares its eligibility to provide health checks or HIV/AIDS examination and treatment (hereinafter referred to “declaring facility”).

In case the received documents are inadequate or invalid as prescribed in Article 68 of this Decree, the receiving authority shall send a written request for modification to the declaring facility. Upon receipt of modified documents from the declaring facility, the receiving authority shall also give a receipt note, which is made using Form No. 02 in Appendix I enclosed herewith, to the declaring facility;

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c) In case a health facility that has successfully completed procedures for declaration of its eligibility to provide health checks or HIV/AIDS examination and treatment changes its name, address, material facilities, personnel and declared scope of professional activities, it shall send a written notice of such a change to the authority that has received its document package for eligibility declaration.

Article 70. Signboards of health facilities

A health facility that has been issued with an operating license must have a signboard which is designed in accordance with regulations of law on signboards, does not bear the red cross symbol, and must adequately contain the following basic information:

1. Full name of the health facility.

2. Form of organization.

3. Number of operating license.

4. Address of the health facility as written in its operating license; telephone number.

5. Opening hours.

Section 3. HEALTHCARE QUALITY ASSESSMENT AND CERTIFICATION

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1. Every year, health facilities shall carry out quality self-assessment as prescribed in clause 3 Article 58 of the Law on Medical Examination and Treatment, and send assessment results to regulatory authorities.

2. Quality assessment results must openly be posted on web portals of health authorities and on the healthcare management information system.

3. Based on the assessment results published by health facilities, regulatory authorities shall randomly select the health facilities whose quality will be re-assessed according to risk management principles.

Article 72. Assessment of advanced quality standards of health facilities, quality standards of a particular specialty or technical services

1. Quality assessment and certification which are based on advanced quality standards, or quality standards of a particular specialty or technical services promulgated by the Ministry of Health of Vietnam shall be carried out as follows:

a) Healthcare quality certification bodies shall carry out assessment of quality of health facilities according to advanced quality standards, or quality standards of a particular specialty or technical services promulgated by the Ministry of Health of Vietnam, and their internal procedures;

b) Quality assessment results must be reported to competent health authorities, and openly be posted on web portals of health authorities and on the healthcare management information system;

c) Competent health authorities may randomly select health facilities for re-assessment according to risk management principles.

2. Quality assessment and certification which are based on advanced quality standards, or quality standards of a particular specialty or technical services recognized by the Ministry of Health of Vietnam shall be carried out as follows:

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b) Quality assessment results must be reported to competent health authorities, and openly be posted on web portals of health authorities and on the healthcare management information system.

Article 73. Operating rules of healthcare quality certification bodies

1. Ensure compliance with provisions of clauses 1 and 2 Article 58 of the Law on Medical Examination and Treatment.

2. Carry out quality assessment and certification in conformity with quality standards promulgated or recognized by the Ministry of Health of Vietnam.

3. Voluntarily carry out quality assessment and certification on the basis of service contracts signed with health facilities.

4. Keep confidentiality of information collected or obtained during quality assessment and certification.

Article 74. Functions and tasks of healthcare quality certification bodies

1. Give advice and instructions to health facilities to apply quality standards to improve their healthcare quality.

2. Issue fixed-term quality certificates to health facilities that satisfy quality standards or give notices of refusal to issue new quality certificates to health facilities that fail to maintain their satisfaction of quality standards as certified.

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4. Submit periodical reports or ad hoc reports at the request of competent health authorities, and bear inspection of such competent health authorities.

Article 75. Eligibility requirements for healthcare quality certification bodies

In order to provide healthcare quality assessment and certification services, an entity or organization must meet the following requirements:
1. It is lawfully established.

2. It runs an appropriate organizational structure according to quality standards in order to perform:

a) Professional techniques; and

b) Data management.

3. There are at least 05 assessment specialists who are its full-time employees and meet the following conditions:

a) The person in charge of professional practices must:

- hold a bachelor’s degree or higher;

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- have attended and been issued with a certificate of completion of training course in healthcare quality assessment skills by a training institution announced or accredited by the Ministry of Health of Vietnam in accordance with regulations of law.

b) Each assessor must:

- hold a bachelor’s degree or higher;

- have attended and been issued with a certificate of completion of training course in healthcare quality assessment skills by a training institution announced or accredited by the Ministry of Health of Vietnam in accordance with regulations of law; and

- have at least 03 years of working experience in providing healthcare at health facilities or health authorities that directly manage health facilities;

Article 76. Application package for certificate of registration for provision of healthcare quality assessment and certification services

In addition to the required documents included in an application package for certificate of registration for provision of certification services for products and management systems as prescribed in the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016, as amended by the Decree No. 154/2018/ND-CP dated November 09, 2018, an application package for certificate of registration for provision of healthcare quality assessment and certification services must also include:

1. A personnel list.

2. Legitimate copies of certificates of completion of training course in healthcare quality assessment skills of the applicant’s assessors.

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Article 77. Procedures for issuance, suspension and revocation of certificate of registration for provision of healthcare quality assessment and certification services

Procedures for issuance, suspension and revocation of certificate of registration for provision of healthcare quality assessment and certification services shall be followed in accordance with regulations of law on conformity assessment.

Section 4. SUSPENSION AND REVOCATION OF OPERATING LICENSES

Article 78. Procedures for revocation of operating licenses and suspension of operation of health facilities

1. Suspension of part or all of professional activities of a health facility:

a) Within 05 working days from the day on which by the Expert Council as defined in Article 101 of the Law on Medical Examination and Treatment or a competent authority draws their conclusion or inspection record asserting that the health facility has committed a violation to an extent that it is subject to suspension of part or all of its operation as prescribed in clause 1 Article 55 of the Law on Medical Examination and Treatment, the competent authority defined in Article 51 of the Law on Medical Examination and Treatment shall issue a decision to suspend operation of that health facility.

b) A suspension decision shall, inter alia, include:

- Name of the health facility;

- Reasons for suspension;

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- Suspension period;

- Conditions for restoring operation.

c) Within 03 working days from the day on which a decision to suspend part or all of operation of the health facility is issued, the issuing authority shall:

- publish information on the suspension and make limitations on scope of professional activities of the suspended health facility on the healthcare management information system, if that health facility is under its management;

- send the suspension decision to the authority that has issued operating license to that health facility.

d) Within 03 working days from its receipt of the suspension decision as prescribed in point d of this clause, the authority that has issued operating license to the health facility shall publish information on the suspension and make limitations on scope of professional activities of the suspended health facility on the healthcare management information system.

dd) Suspension of operating license of a health facility that is found to have committed an administrative violation shall be carried out in accordance with regulations of law on penalties for administrative violations.

2. Revocation of an operating license:

a) Within 05 working days from the day on which by the Expert Council as defined in Article 101 of the Law on Medical Examination and Treatment or a competent authority draws their conclusion or inspection record asserting that the health facility has committed a violation to an extent that its operating license is revoked as prescribed in clause 1 Article 56 of the Law on Medical Examination and Treatment, or the health facility applies for revocation at its discretion, the authority that has issued operating license to the health facility shall issue a decision to revoke operating license of that health facility.

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- Name of the health facility;

- Reasons for revocation of operating license;

- Post-revocation actions and legal liabilities.

c) Within 03 working days from the issue date of the revocation decision, the licensing authority shall publish information on the revocation on its web portal or website.

Article 79. Actions taken after revocation of operating license or suspension of part or all of professional activities of a health facility

1. In case an operating license is revoked according to clause 1 Article 56 of the Law on Medical Examination and Treatment: the health facility whose operating license is revoked shall follow procedures for issuance of a new operating license in accordance with provisions of this Decree.

2. In case a health facility has part or all of its professional activities suspended as prescribed in clause 1 Article 55 of the Law on Medical Examination and Treatment, the authority issuing the suspension decision must clearly specify contents and period of suspension in its issued decision.

3. Upon its fulfillment of remedial obligations, the health facility subject to suspension decision shall submit a report on remedial measures to its licensing authority.

4. Upon receipt of the report, the licensing authority shall give a receipt note to the health facility.

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a) issue a decision to terminate suspension period within 15 days from the date of the receipt note, if the report on remedial measures is satisfactory; or

b) carry out a physical inspection at the health facility’s premises within 30 days from the date of the receipt note, if necessary.

6. If the report on remedial measures needs to be modified, within 10 working days from the date of the receipt note, the licensing authority shall send a written request for modification, which must clearly indicate documents and/or contents that need to be modified, to the health facility.

Within 06 months from the date of the written request for modification given by the licensing authority, the health facility must submit a modified report as requested. If the health facility fails to make the requested modifications, its submitted report will be invalidated.

7. Upon receipt of the modified report, the licensing authority shall give a receipt note to the health facility, and take the following actions:

a) In case the modified report is still unsatisfactory, the licensing authority shall continue sending a written request for modification to the health facility as prescribed in clause 6 of this Article.

Within 06 months from the date of the written request for modification given by the licensing authority, the health facility must submit a modified report as requested. If the health facility fails to make the requested modifications by the aforementioned deadline, or after 12 months counting from the date of the initial submission of the report, the modified report is still unsatisfactory, the submitted reports will be invalidated.

b) In case the modified report is satisfactory, the licensing authority shall follow the procedures in clause 5 of this Article.

8. Upon completion of the physical inspection to the health facility’s premises, the licensing authority shall:

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b) give a written notice of contents that need to be remedied or modified within 05 working days after completion of the physical inspection, if there are still contents that need to be remedied or modified.

If the health facility fails to fulfill its remedial obligations within 06 months from the date of the licensing authority’s written notice of contents that need to be remedied or modified, its submitted documents will be invalidated.

9. Within 20 days from its receipt of a written notice and documents proving the health facility’s fulfillment of remedial obligations, the licensing authority shall follow the procedures in clause 5 of this Article.

Section 5. HUMANITARIAN HEALTHCARE AND MOBILE HEALTHCARE

Article 80. Humanitarian healthcare activities

1. Forms of humanitarian healthcare:

a) Humanitarian healthcare facilities, that are organized in any of the forms of organization defined in Article 48 of the Law on Medical Examination and Treatment and in Article 39 of this Decree;

b) Humanitarian healthcare delegations;

c) Humanitarian healthcare individuals.

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Article 81. Conditions, application package and procedures for issuance, re-issuance, modification, suspension and revocation of operating license of humanitarian healthcare facilities

Conditions, application package and procedures for issuance, re-issuance, modification, suspension and revocation of operating license of humanitarian healthcare facilities shall comply with the provisions of Chapter III of this Decree.

Article 82. Conditions for provision of humanitarian outreach healthcare campaigns at intervals, provision of humanitarian healthcare by individuals, and mobile healthcare (including health checks)

1. Humanitarian outreach healthcare campaigns at intervals must be organized by health facilities holding operating licenses.

2. Humanitarian healthcare activities of individuals must be performed by medical practitioners who have been issued with practicing licenses on which the scope of practice must be appropriate to humanitarian healthcare activities to be performed.

3. Mobile healthcare must be delivered by health facilities that have been issued with operating licenses and whose scope of professional activities must be appropriate to mobile healthcare activities.

4. In case an intervals-based humanitarian outreach healthcare campaign or mobile healthcare is organized at a location other than that specified in the operating license, material facilities at this location must meet the following conditions:

a) There are areas for receiving patients and performing medical examination and treatment activities meeting the following conditions:

- Regulations of law on contamination control, radiation safety, biomedical waste management, and fire fighting and prevention must be observed;

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b) There are adequate medical practitioners, medical devices and other conditions in conformity with the scale and scope of healthcare services to be provided.

5. When organizing humanitarian outreach healthcare campaigns at intervals or mobile healthcare activities or providing health checks in the form of healthcare delegations, the following personnel conditions must be satisfied:

a) The person in charge of professional practices of the humanitarian healthcare delegation or mobile healthcare delegation must have an unexpired practicing license at the time of application for permission to provide humanitarian or mobile healthcare, on which the scope of practice must be appropriate to the list of professional techniques registered by the delegation, and have at least 36 months, up to the date of application for permission to provide humanitarian or mobile healthcare, of experience in providing healthcare;

b) Other persons directly engaging in healthcare process must possess practicing licenses. If a person directly engaging in healthcare process is exempt from practicing license as prescribed by the Law on Medical Examination and Treatment, he/she must possess qualifications or certificates appropriate to his/her assigned activities;

c) In case drugs are dispensed, the person in charge of dispensing activities must possess a diploma of pharmacist assistant or hold a practicing license for the title of a doctor;

d) If a person delivering humanitarian healthcare is a foreigner, a language interpreter shall be required, unless such foreigner is proficient in Vietnamese.

6. A medical practitioner who delivers humanitarian healthcare as an independent individual shall be required to meet personnel conditions set out in clause 2 of this Article. He/she may make up drug prescriptions but shall not be allowed to dispense drugs.

7. Medical devices and drugs:

a) Medical devices, anaphylaxis kits, emergency drugs and drugs for medical treatment must be adequately equipped in conformity with the registered scope of healthcare activities;

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Article 83. Application package and procedures for granting permission for humanitarian outreach healthcare campaigns at intervals, mobile healthcare as prescribed in clause 1 Article 79 of Law on Medical Examination and Treatment or humanitarian healthcare delivered by individuals

1. An application package for permission for humanitarian outreach healthcare campaigns at intervals or mobile healthcare as prescribed in clause 1 Article 79 of Law on Medical Examination and Treatment is composed of:

a) An application form which is made using Form No. 01 in Appendix IV enclosed herewith;

b) List of persons engaging in humanitarian or mobile healthcare process which is made using Form No. 02 in Appendix IV enclosed herewith, and must clearly state the person in charge of professional practices of the healthcare delegation; a legitimate copy of the practicing license of this person must be also accompanied with the list;

c) Legitimate copies of professional qualifications/certificates of persons who directly deliver healthcare but are exempt from practicing licenses as prescribed by the Law on Medical Examination and Treatment (if any);

d) A humanitarian or mobile healthcare plan which is made using Form No. 03 in Appendix IV enclosed herewith;

dd) Written approval given by the health facility or the head of the location where healthcare activities are to be performed.

2. An application package for permission for humanitarian healthcare delivered by an individual is composed of:

a) An application form which is made using Form No. 01 in Appendix IV enclosed herewith;

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c) A humanitarian healthcare plan which is made using Form No. 03 in Appendix IV enclosed herewith;

d) Written approval given by the health facility or the head of the location where humanitarian healthcare activities are to be performed.

3. An application package for permission for a humanitarian outreach healthcare campaign at intervals or mobile healthcare shall be submitted to:

a) the Ministry of Health of Vietnam, if:

- a foreign organization or individual organizes a humanitarian outreach healthcare campaign at intervals or mobile healthcare in 02 provinces or central-affiliated cities or more; or

- the humanitarian outreach healthcare campaign at intervals or mobile healthcare is organized at a health facility affiliated to the Ministry of Health of Vietnam or another Ministry, except the Ministry of National Defence of Vietnam and the Ministry of Public Security of Vietnam.

b) the Ministry of National Defence of Vietnam, if the humanitarian outreach healthcare campaign at intervals or mobile healthcare is organized at a health facility, agency or unit affiliated to this Ministry.

c) the Ministry of Public Security of Vietnam, if the humanitarian outreach healthcare campaign at intervals or mobile healthcare is organized at a health facility, agency or unit affiliated to this Ministry.

d) a health authority affiliated to the relevant provincial People's Committee, for humanitarian outreach healthcare campaign at intervals or mobile healthcare activities other than those specified in points a, b and c of this clause.

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Within 10 days from its receipt of an adequate application package, the receiving authority as defined in clause 3 of this Article shall give its written permission for the humanitarian outreach healthcare campaign at intervals or mobile healthcare. If an application is refused, a written response which clearly states reasons for refusal shall be given.

Section 6. TRANSFER OF PROFESSIONAL TECHNIQUES IN HEALTHCARE OR COOPERATION IN PROVISION OF TRAINING COURSES ON MEDICINE INVOLVING MEDICAL INTERNSHIP

Article 84. Cases and conditions for transfer and receipt of transfer of professional techniques between health facilities

1. Only techniques included in the list of techniques promulgated by the Ministry of Health of Vietnam may be transferred between domestic health facilities. In case a technique is transferred to a foreign country, it must not be subject to prohibition from transfer to foreign countries as prescribed by the Law on Technology Transfer.

2. Conditions to be satisfied by the health facility that transfers a professional technique (hereinafter referred to as “transferring facility”):

a) The technique to be transferred must fall within its scope of professional activities approved by a competent authority;

b) The person in charge of technique transfer must have experience in performing the technique to be transferred and have been assigned in writing by the person in charge of professional practices of the transferring facility to carry out such technique transfer.

3. Conditions to be satisfied by the health facility that receives transfer of a professional technique (hereinafter referred to as “receiving facility”):

a) Its scope of professional activities must be appropriate to the technique received;

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Article 85. Technique transfer process

1. Do surveys for determining the demand for technique transfer.

2. Formulate a technique transfer protocol.

3. Enter into a technique transfer contract, in which the transferring facility and the person in charge of technique transfer must assume responsibility for medical examination and treatment results.

Where a technique included in the list of special-type techniques is transferred, the receiving facility must also follow the procedures in clause 10 Article 66 of this Decree before entering into a technique transfer contract.

4. Carry out the transfer of technique, including the following steps:

a) Provide theoretical and practical training for the person in charge of technique receipt. Upon completion of the training, the transferring facility shall issue a written certification of completion of technical training to the trainee.

Where the transferring facility is a continuous training provider, the written certification of completion of technical training mentioned in this point shall be also used as certification of continuous training;

b) Carry out transfer of technique at the receiving facility;

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5. Upon completion of the technique transfer process, relevant health facilities shall follow procedures for modification of their scope of professional activities in accordance with provisions of this Decree.

Article 86. Conditions, application package and procedures for granting permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship

1. Conditions for granting permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship (hereinafter referred to as “provision of healthcare at intervals”):

a) The foreigner must possess a practicing license issued by a competent authority of a foreign country which is still valid at the application date;

b) The foreigner meets conditions for foreigners entering Vietnam for study or working set out in laws;

c) Language interpreter(s) must be employed as prescribed in clause 2 Article 35 of this Decree, unless a foreigner is proficient in Vietnamese;

d) Drugs and medical devices used must be conformable with the scope of professional activities of the applicant; must have clearly known origin and been granted marketing authorization by competent authorities of foreign countries or a competent authority of Vietnam; must be unexpired and usable;

dd) A consent given by an authority, organization or health facility of Vietnam to receive foreigners is available.

2. An application package for permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship is composed of:

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b) List of foreigners that will enter Vietnam for provision of healthcare which must bear the seal of the Vietnamese authority or organization receiving such foreigners and contain the following information: full name; passport’s number; professional title; tasks performed in Vietnam and commitment to assume responsibility for quality of healthcare services provided by foreigners of the Vietnamese authority or organization receiving such foreigners, and be enclosed with legitimate copy of practicing license of each foreigner;

c) List of interpreters of foreigners entering Vietnam for provision of healthcare at intervals which must bear certification of the Vietnamese authority or organization receiving such foreigners and contain the following information: full name; ID number, passport’s number, citizen identity card’s number or personal identification number; professional qualifications and commitment to assume responsibility for interpretation quality of the Vietnamese authority or organization receiving such foreigners, and be enclosed with legitimate copy of professional qualification of each interpreter;

d) List of medical devices which must bear certification of the Vietnamese authority or organization receiving such foreigners (if any), and contain the following information: name and origin of the device, and commitment that the device is still in good use.

If medical devices of a Vietnamese health facility are used, the written agreement to provide medical devices of the authority or organization where healthcare services will be provided shall be required.

If foreigners who enter Vietnam for provision of healthcare at intervals donate medical devices to the Vietnamese authority or organization upon completion of their healthcare provision, the Vietnamese authority or organization must follow procedures for receiving such medical devices in accordance with the Government’s regulations.

dd) List of drugs (if any) which must contain the following information: name of drug, active ingredient, expiry date, marketing authorization number and commitment that the drug is lawfully placed on the market of at least a foreign country;

e) The written agreement on provision of healthcare at intervals between the Vietnamese authority or organization and the foreigner or the foreign authority or organization.

3. An application package for permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship shall be sent to:

a) The Ministry of Health of Vietnam, if foreigners will work at a health facility affiliated to the Ministry of Health of Vietnam or another ministry, except the Ministry of National Defence of Vietnam and the Ministry of Public Security;

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c) The Ministry of Public Security of Vietnam, if foreigners will work at a health facility affiliated to this Ministry;

d) The health authority affiliated to a provincial People's Committee, if foreigners will work at a health facility affiliated to this health authority or within this province.

4. Procedures for granting permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship:

Within 15 days from its receipt of an adequate application package, the receiving authority as defined in clause 3 of this Article shall give its written permission to foreigners entering Vietnam for provision of healthcare. If an application is refused, a written response indicating reasons for such refusal shall be given.

Section 7. TELEHEALTH AND TELEHEALTH SUPPORT

Article 87. Telehealth

1. Conditions for carrying out telehealth:

a) Telehealth must be provided by medical practitioners of any of the health facilities defined in Article 39 of this Decree;

b) The health facility’s scope of professional activities must be appropriate to the telehealth contents;

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d) Technical infrastructure, IT equipment, specialized equipment and IT software programs must be suitable for the type of services to be provided and be capable of transmitting, displaying, processing and storing data in a safe and confidential manner. Data storage and backup periods must comply with regulations of law.

2. Application for declaration of eligibility to carry out telehealth:

a) An application form for approval of telehealth, which must clearly state the start date of telehealth;

b) A legitimate copy of the operating license of the health facility (not required if such operating license has been shared or published on the healthcare management information system or national healthcare database);

c) List of registered medical practitioners in which their practicing license numbers must be indicated (in case the health facility's operating license has been shared or published on the healthcare management information system or national healthcare database). If the health facility’s operating license has not yet been shared or published on the healthcare management information system or national healthcare database, a legitimate copy of the practicing license of each medical practitioner who will provide telehealth shall be required.

d) List of telehealth services to be provided;

dd) Documentary evidence of satisfaction of the conditions set out in Point d Clause 1 of this Article.

3. Procedures for declaring eligibility to carry out telehealth:

a) The health facility shall send an application package for declaration of eligibility to carry out telehealth as prescribed in clause 2 of this Article to:

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- The health authority affiliated to the People's Committee of province or city where this health facility is located (event if it is a private health facility), except health facilities under management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam or the Ministry of Public Security of Vietnam.

b) Upon receipt of the application package for declaration of eligibility to carry out telehealth, the receiving authority shall give a receipt note using the Form No. 02 in Appendix I enclosed herewith to the applicant.

c) Within 10 days from the date specified on the receipt note which is given according to clause 2 of this Article, the receiving authority shall publish information on the health facility that is eligible to carry out telehealth on its website or web portal and on the healthcare management information system.

If the received application is not satisfactory, the receiving authority shall send a written response indicating reasons therefor to the applicant.

Information to be published shall, inter alia, include: name and address of the health facility providing telehealth, and list of telehealth services to be provided.

d) After 10 days from the date specified in the receipt note, if the receiving authority neither sends a document to the health facility on its eligibility to carry out telehealth nor publishes information as prescribed in point c of this clause, the health facility may start providing telehealth.

dd) During its provision of telehealth, if any changes in the information published as prescribed in clause 2 of this Article occur, the health facility shall repeat procedures for declaring its eligibility to carry out telehealth as prescribed in this clause.

4. The scope of telehealth shall comply with point a clause 1 Article 80 of the Law on Medical Examination and Treatment.

5. If a health facility's scope of telehealth includes the diseases or health conditions which are not included in this list specified in clause 4 of this Article, the health facility must meet the conditions set out in clause 1 of this Article and send an application for permission to pilot telehealth as prescribed in clause 6 of this Article to the authority that has issued the operating license for approval.

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a) The health facility that applies for approval of its pilot provision of telehealth shall submit an application which includes the following documents to the authority that has issued its operating license (hereinafter referred to as “licensing authority”):

- An application form which must clearly state the start date of telehealth;

- The operating license of the health facility (not required if such operating license has been shared or published on the healthcare management information system or national healthcare database);

- List of telehealth services to be provided;

- Documentary evidence of satisfaction of the conditions set out in Point d Clause 1 of this Article;

- List of medical practitioners who will engage in pilot provision of telehealth, in which full name and number of practicing license of each medical practitioner must be indicated;

- Other documentary evidences of its satisfaction of conditions.

b) Upon receipt of the application, the licensing authority shall give a receipt note to the applicant.

c) In case the application package is satisfactory, the licensing authority shall carry out an appraisal within 30 days from the date specified in the receipt note. A physical inspection may be conducted at the applicant’s premises if it is deemed necessary.

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dd) If an application package needs to be modified, within 15 working days from the date specified in the receipt note, the licensing authority shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

e) After receiving the modified application, the licensing authority shall provide a receipt note for the applicant and follow the procedures specified in Point c and Point d co this Clause.

g) In case the modified application package is still unsatisfactory, the licensing authority shall send a written notification to the applicant in accordance with Point dd of this Clause.

h) Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, or after 12 months from the day on which the application is submitted for the first time, the modified application package is still unsatisfactory, the submitted application documents will be invalidated.

7. Upon the end of the pilot period, the health facility shall send a report on pilot results to the licensing authority for reporting to the Ministry of Health of Vietnam.

8. Prices of telehealth services, which shall also be applied during pilot period:

a) Prices of medical examination shall be the prices of medical examination services provided by the health facility that carries out telehealth as approved by a competent authority, including the prices of on-demand healthcare services (if any);

b) The price of hospital bed services per day and prices of technical services provided shall be the prices, approved by competent authorities, of the health facility that receives the patient (hereinafter referred to as “receiving health facility”), including the prices of on-demand services (if any);

c) Prices of drugs, medical devices, whole blood and blood products to be used for the patient shall be reasonable costs incurred during provision of the service (if any) as prescribed.

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If a patient holds a health insurance card, costs of covered medical services shall be paid by the health insurance fund in accordance with regulations of law on health insurance. The patient shall themself make the prescribed co-payment and payment of other costs and expenses greater than the maximum coverage percentages (if any).

Costs shall not be covered by the health insurance fund in case of pilot provision of telehealth as prescribed in clause 5 of this Article.

The patient that does not hold a valid health insurance care shall themself pay costs of telehealth services according to the prices of healthcare services approved by competent authorities.

10. If a patient receives telehealth services not through any other health facility, costs of healthcare services shall be paid as agreed upon between the parties.

11. A contract for provision of telehealth services shall, inter alia, include the following contents:

a) Responsibilities, rights and benefits of the health facility providing telehealth towards the receiving health facility;

b) Technical infrastructure, IT equipment, specialized equipment and IT software programs for ensuring safety and security of information which must be suitable for telehealth services;

c) Data storage and backup which must meet information safety and security requirements as laid down in laws;

d) Costs of telehealth services;

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Article 88. Telehealth support

1. Conditions for providing telehealth support:

a) Telehealth support provided must be appropriate to the licensed scope of professional activities of the supporting health facility.

b) A contract for provision of telehealth support must be available. This contract shall, inter alia, include the following contents:

- Responsibilities, rights and benefits of the supporting health facility and the supported health facility;

- Technical infrastructure, IT equipment, specialized equipment and IT software programs for ensuring safety and security of information which must be suitable for telehealth support services;

- Data storage and backup which must meet information safety and security requirements as laid down in laws;

- Costs of telehealth support services;

- Costs of telehealth support services agreed upon between health facilities.

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3. Health facilities providing telehealth support assume responsibility to strictly comply with the signed contracts for provision of telehealth support, and submit annual reports thereon to supervisory authorities.

4. Rules for payment of costs of telehealth support services:

a) Prices of healthcare services are those at the supported health facility with approval of a competent authority;

b) The supported heath facility must pay costs of telehealth support services to the supporting health facility at the rates agreed upon between them and under terms and conditions of the signed contract for provision of telehealth support services.

Section 8. LEVELS OF PROFESSIONAL TECHNIQUES IN HEALTHCARE

Article 89. Classification of health facilities by levels of professional techniques

1. Primary healthcare level includes health facilities that do not provide inpatient treatment, commune health stations and regional polyclinics that have hospital beds.

2. Basic and intensive healthcare levels include hospital (health centers that have hospital beds).

3. Classification of a health facility into a basic or intensive healthcare level shall comply with provisions of Appendix V enclosed herewith.

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1. An application for classification of a health facility by professional technique level includes:

a) An application form;

b) The scoring results according to the assessment criteria and contents specified in Appendix V enclosed herewith;

c) Documents and statistical figures proving the given score;

d) Other relevant documents.

2. Procedures for classification of a health facility by professional technique levels:

a) The hospital (applicant) shall submit an application as prescribed in clause 1 of this Article to the authority defined in clause 3 of this Article.

b) Upon receipt of the application, the receiving authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant.

c) In case the application is satisfactory, the authority defined in clause 3 of this Article shall issue a document to classify the health facility by professional technique level within 60 days from the date specified in the receipt note.

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dd) Upon its completion of modifications, the applicant shall give a written notice, accompanied with documents proving its completion of modifications.

e) Upon receipt of modified application, the authority defined in clause 3 of this Article shall:

- follow procedures in point c of this clause if the application is satisfactory; or

- follow procedures in points d, dd of this clause if the application is still unsatisfactory.

g) Within 05 working days from the day on which the health facility is classified, the authority defined in clause 3 of this Article shall publish the name and address of the classified health facility and its professional technique level on its web portal and on the healthcare management information system.

3. Authority to classify health facilities by professional technique levels:

a) The Ministry of Health shall classify hospitals affiliated to this Ministry;

b) The health authority affiliated to a provincial People’s Committee shall classify hospitals located in that province or city and private hospitals that have been issued with operating licenses by the Ministry of Health of Vietnam, except hospitals affiliated to the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam.

Section 9. INVOLUNTARY TREATMENT

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1. Patient cases subject to the involuntary treatment requirements in accordance with this Decree shall be defined as follows:

a) Persons suffering from group-A infectious diseases that are defined in laws on prevention and control of infectious diseases (hereinafter referred to as “group-A infectious disease patients”);

b) Persons with depression susceptible to suicidal thoughts and behaviors; persons with mental illness in an agitated state that is likely to harm himself or with behaviors harming other persons, or destroying property (hereinafter referred to as “mental patients”).

2. The involuntary treatment for a person who violates the law or is suspected of violating the criminal law and suffers from mental illness as prescribed in point b clause 1 of this Article shall comply with provisions of the criminal code, the criminal procedure code, and regulations of law on judgment enforcement.

3. In consideration of actual status, the Ministry of Health of Vietnam shall request the Government to consider and decide other patient cases subject to involuntary treatment as prescribed in point c clause 1 Article 82 of the Law on Medical Examination and Treatment.

Article 92. Involuntary treatment for group-A infectious disease patients

1. In case a person with a confirmed diagnosis is undergoing home quarantine or quarantine at a non-healthcare setting (hereinafter referred to as “at home”):

a) If the patient's condition can be treated at home or according to guidelines on home care treatment given by the Steering Committee for epidemic prevention, the Chairperson of the People’s Committee of commune where the patient is residing shall issue a decision on involuntary treatment at home which must clearly state the health facility that is responsible for instructing and supporting the patient during his/her treatment at home as proposed by the at the health authority of the same level;

b) If the patient’s condition cannot be treated at home, the Chairperson of the People’s Committee of commune where the patient is residing shall issue a decision on involuntary treatment and organize the transfer of the patient from his/her home to a suitable health facility for getting involuntary treatment;

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2. In case a person with a confirmed diagnosis is undergoing quarantine at a quarantine setting with healthcare services:

a) If the patient’s condition can be treated at the quarantine setting with healthcare services, the head of this quarantine setting shall issue a decision on involuntary treatment at the quarantine setting and provide treatment for the patient;

b) If the patient’s condition cannot be treated at the quarantine setting, the head of this quarantine setting shall issue a decision on involuntary treatment and organize the transfer of the patient from the quarantine setting to a suitable health facility for getting involuntary treatment;

c) If the patient’s condition cannot be treated at the quarantine setting but the patient cannot be transferred to any health facility, the head of the quarantine setting shall issue a decision on involuntary treatment which must clearly state the reasons for failure to transfer the patient to a health facility, and contact and ask another health facility for guidance and support in treatment for the patient.

3. In case a person is diagnosed with a group-A infectious disease when he/she is receiving medical examination and treatment at a health facility:

a) If the patient's condition can be treated at the health facility where the patient is receiving medical examination and treatment, the head of this health facility or his/her authorized person (hereinafter referred to as “the health facility’s head”) shall issue a decision on involuntary treatment and provide treatment for the patient;

b) If the patient’s condition cannot be treated at the health facility, the health facility’s head shall issue a decision on involuntary treatment and organize the transfer of the patient to another health facility capable of treating the patient’s condition for getting involuntary treatment;

c) If the patient’s condition cannot be treated at the health facility but the patient cannot be transferred to another health facility, the health facility's head shall issue a decision on involuntary treatment which must clearly state the reasons for failure to transfer the patient to another health facility, and contact and ask another health facility for guidance and support in treatment for the patient.

Article 93. Involuntary treatment for mental patients

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a) The People’s Committee of commune where that person is found shall adopt measures for transferring him/her to a health facility for carrying out confirmatory diagnosis;

b) In case that person is diagnosed with mental illness and requires involuntary treatment, the health facility shall provide involuntary treatment or transfer him/her to a mental health facility for getting involuntary treatment, and inform his/her family for cooperating in managing and caring for him/her.

c) In case the patient’s family cannot be identified or refuses to accept the patient, a request for management, caring and provision of benefits for the patient shall be prepared and sent to a competent authority in charge of labour, war invalids and social affairs in accordance with regulations of law on social protection.

2. If any person is found to have the signs mentioned in point b clause 1 Article 91 of this Decree during delivery of medical examination and treatment:

a) The health facility shall provide involuntary treatment or transfer the patient to a suitable mental health facility for getting treatment. The patient’s family must also be informed for cooperation in managing and caring for the patient;

b) In case the patient’s family cannot be identified or refuses to accept the patient, a request for management, caring and provision of benefits for the patient shall be prepared and sent to a competent authority in charge of labour, war invalids and social affairs in accordance with regulations of law on social protection.

Section 10. HANDLING PROCEDURES FOR FOREIGN PATIENTS WITHOUT FAMILIES AND DECEASED PATIENTS WHO ARE FOREIGNERS WITHOUT FAMILIES

Article 94. Foreign patients without families

1. Provision of medical examination and treatment for patients who are foreigners without families shall comply with the provisions of Article 15 of the Law on Medical Examination and Treatment.

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Article 95. Deceased patients who are foreigners without families

1. Health facilities shall manage death of patients who are foreigners without families and whose nationality cannot be defined in accordance with the provisions of Article 73 of the Law on Medical Examination and Treatment.

2. If the deceased patient is a foreigner without family but has his/her nationality defined, the health facility shall notify the death case to the People’s Committee of district where it is headquartered for management in accordance with regulations of the law on civil status.

The health facility shall directly embalm or employ another facility to embalm the body of the deceased patient pending response from the People’s Committee.

Chapter IV

APPLICATION OF NEW TECHNIQUES, NEW METHODS AND CLINICAL TRIALS IN MEDICAL EXAMINATION AND TREATMENT

Article 96. Procedures for obtaining permission for application of new techniques and new methods

1. When there is a new technique that is not on the list of professional techniques promulgated by the Minister of Health, the health facility shall send an application for identification of the new technique or new method to the Ministry of Health, including the following documents:

a) Application form No. 01 in Appendix VI hereto appended;

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c) If application of the new technique or new method is permitted by a competent authority of the foreign country: technical procedures and documentary evidence that the new technique or method is permitted by a competent authority of the foreign country, in addition to the documents specified in Point b of this Clause.

2. Upon receipt of an application, the Ministry of Health of Vietnam shall give a receipt note which is made using Form 02 in Appendix I enclosed herewith to the applicant.

3. If the application package is satisfactory, the receiving authority shall provide a written response within 30 days from the date or receipt written on the receipt note. The response shall specify one of the following cases:

a) The new technique/method has to undergo clinical trial;

b) The new technique/method does not have to undergo clinical trial but have to undergo experimental application;

c) The new technique/method does not have to undergo clinical trial and experimental application.

4. After receiving the written response from the Ministry of Health, the applicant shall have the following responsibility:

a) If the new technique/method has to undergo clinical trial: carry out the clinical trial in accordance with Decree. After the clinical trial result is approved in writing, prepare the documents specified in Point c of this Clause and follow the procedures specified in Clause 6 of this Article.

b) If the new technique/method does not have to undergo clinical trial but has to undergo experimental application: carry out the experimental application in accordance with Article 97 of this Decree. After the experimental application is complete, prepare the documents specified in Point c of this Clause and complete form No. 03 in Appendix VI hereof, the report on results of the experimental application, and follow the procedures specified in Clause 6 of this Article;

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5. Within 60 days from the receipt of the documents specified in Point c Clause 4 of this Article, the Ministry of Health shall:

a) Approve the technical procedures of the new technique/method;

b) Approve the economic – technical norms of the new technique/method;

c) Approve the price of the new technique/method;

d) Classify the new technique/method;

dd) Issue a written permission for the health facility to apply the new technique/method.

6. After the written permission mentioned in Clause 5 of this Article is received:

a) If the health facility is under the management of the Ministry of Health, the written permission for the health facility to apply the new technique/method is also the written permission for operating scope expansion of the health facility;

b) If the health facility is not under the management of the Ministry of Health: the health facility shall follow procedures for adjustment of its operating scope in accordance with the written permission issued by the Ministry of Health;

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7. After the Ministry of Health has approved the technical procedures and classification, the other health facilities that wish to apply the same new technique/method shall follow these procedures:

a) If the new technique is included in the list of special-type techniques:

- Prepare the application for permission for experimental application;

- After the experimental application is completed, prepare an application for official approval.

b) If the new technique is not included in the list of special-type techniques: follow the procedures for adjustment of the health facility's operating scope in accordance with this Decree.

Article 97. Procedures for experimental application of new techniques and new methods to medical examination and treatment

1. The health facility requesting permission for experimental application of a new technique/method shall:

a) Have technical procedures for application of the new technique/method approved by the head of the health facility.

The procedures shall have at least the following contents: outlines and definitions; indications; contraindications; instructions for preparation and execution of the procedures (personnel, equipment, drugs, medical devices, and other conditions); steps to execute; monitoring; how to handle complications, and other notes (if any).

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- Have practicing license that covers the new technique/method;

- Have one of the following documents: certificate of completion of training in the new technique/method issued by a licensed training facility, or the certificate of completion of transfer training in the new technique/method issued by a Vietnamese or foreign health facility;

- Be a registered medical practitioner at the health facility.

2. The application package for permission to apply the new technique/method shall include:

a) Application form No. 02 in Appendix VI hereto appended.

b) the technical procedures for application of the new technique/method.

d) Documents proving adequacy of manpower, equipment, medical devices and other conditions required for application of the new technique/method, including:

- A list of full names and practicing license numbers of medical practitioners expected to participate in the application of the new technique/method;

- Floor plan of the place where the new technique/method is applied;

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- Documents proving fulfillment of other conditions.

d) List of prices of technical services and economic – technical norms for pricing.

3. The application for permission for experimental application of the new technique/method shall include:

a) The health facility that wishes to carry out experimental application of the new technique/method shall send an application package specified in Clause 2 of this Article to the Ministry of Health;

b) After receiving the application package, the Ministry of Health shall provide a receipt note for the applicant;

c) If the application package is satisfactory, the receiving authority shall organize a verification within 30 days from the date or receipt written on the receipt note. If necessary, the verification can be carried out at the applying facility;

d) Within 15 days from the day on which the verification record is available, the Ministry of Health shall issue a written permission for experimental application, which shall specify the number of experimented cases. If the application is rejected, a written response with explanation shall be provided;

If the application package has to be modified, within 15 days from the date written on the receipt note, the receiving authority shall send a document to the applicant specifying the documents and/or contents that need to be modified or added;

e) After receiving the modified application, the receiving authority shall provide a receipt note for the applicant and follow the procedures specified in Point c and Point d co this Clause;

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h) Within 06 months from the day on which the receiving authority issues the request for notification, the applicant shall submit the modified application package. If the applicant fails to submit the modified application package within this 6-month period or the modified application package is still unsatisfactory after 12 months from the date of submission of the initial application package, the application package will be invalid.

Article 98. Phases of clinical trial serving medical examination and treatment

Phases of clinical trial of a new technique/method for medical examination or treatment:

1. Phase 1: The first phase of human experimentation in order to evaluate safety and initially evaluate effectiveness of the new technique/method for medical examination or treatment.

2. Phase 2: The phase for determination of effectiveness and safety of the new technique/method for recognition and application to medical examination or treatment.

3. Phase 3: carried out after the new technique/method has been permitted for application in Vietnam in order to collect more evidence of its safety and effectiveness when requested by regulatory bodies.

Article 99. Cases of exemption of clinical trial or certain phases of clinical trial of a new technique/method for medical examination or treatment

1. Clinical trial of new techniques/methods shall be exempted in the cases specified in Point b Clause 2 Article 92 of the Law on Medical Examination and Treatment and for the new techniques/methods with low risks, including new techniques/methods that are non-invasive, minimally invasive and not likely to affect the patients' health.

2. Cases of exemption of certain phases of clinical trial of a new technique/method:

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b) New techniques/methods that are researched overseas and applied in Vietnam for the first time:

- Any new technique/method that satisfies the following requirements: the previous phase has been completed in a foreign country with a result report; the next phase if being carried out in the same foreign country; the Ministry of Health permits simultaneous research in Vietnam;

- Any new technique/method that satisfies the following requirements will be exempted from phase 1 trial: all phases of clinical trial has been completed under regulations of the foreign country; the result has been accepted or published on a prestigious journal but has not been applied in the foreign country and in Vietnam.

Article 100. Requirements for new techniques and new methods

Requirements for a technique/method for which clinical trial is mandatory:

1. The nonclinical phase has been completed with documentary evidence of safety for next phases of trial.

2. There are results of previous phases of clinical trials if the next phase is proposed.

Article 101. Requirements for the facility carrying out clinical trial of the new technique/method

The facility that carries out clinical trial of the new technique/method (hereinafter referred to as "testing facility") shall:

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2. Be a health facility whose operating scope is appropriate for the new technique/method undergoing clinical trial.

Article 102. Documentation for clinical trial of a new technique/method for medical examination or treatment

1. Documentation for clinical trial of a new technique/method include the application package for approval for clinical trial, application package for approval for changes to the clinical trial; application package for approval for clinical trial result.

2. The application package for approval for clinical trial of the new technique/method shall include:

a) Application form No. 04 in Appendix VI hereto appended prepared by the organization/individual having the new technique/method (hereinafter referred to as "new technique/method owner").

b) Application form No. 05 in Appendix VI hereto appended prepared by the testing facility.

c) Documents about the new technique/method being tested:

- Documents about the product (if the new technique/method uses the product): Name of products, composition, indications, origin, properties, manufacturing process, quality standards, certificate of analysis issued by a unit assigned by the Ministry of Health, and other relevant information.

- Documents about nonclinical study of the new technique/method, including reports on safety, efficacy, proposed uses, dosage (if any), and approval from the Expert Council of the testing facility.

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- Documents about previous phases of clinical trial before the proposed phase.

d) Legal documents:

- A written permission issued by a competent authority for application of the new technique/method to medical examination and treatment if the new technique/method has to undergo phase 3 trial;

- Written confirmations of participation from organizations participating in the trial;

- The clinical trial council between the new technique/method owner and the testing facility (if any); the contract for assistance in trial between the new technique/method owner and the assisting organization (if any).

dd) Scientific documents:

- Trial protocol according to form No. 06 in Appendix VI hereto appended.

- Case Report Form;

- Information sheet and consent form of participants in the clinical trial.

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- Academic profile and copy of the certificate of completion of training in Good Clinical Practice (GCP) of the main researcher issued by the Ministry of Health or a licensed GCP training facility;

- The research science and ethics appraisal record issued by the facility's Biomedical Ethics Committee;

- Product label (if the product is used for the new technique/method).

3. The application package for approval for changes to the clinical trial of the new technique/method shall include:

a) For administrative changes: the testing facility shall submit a report to the Ministry of Health.

b) In case the main researcher or testing facility is changed, the application package shall include:

- b) Application form No. 07 in Appendix VI hereto appended;

- Documents proving the changes.

c) For the changes other than those mentioned in the cases specified in Point a and Point b of this Clause, the application package shall include:

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- Updates of corresponding documents mentioned in Clause 1 of this Article;

- The appraisal record issued by the facility's Biomedical Ethics Committee.

4. The application package for approval for result of clinical trial of the new technique/method shall include:

a) Application form No. 08 in Appendix VI hereto appended;

b) Copy of the approved protocol;

c) Copy of the decision on approval for the trial;

d) Record on appraisal of the clinical trial result issued by the facility's Biomedical Ethics Committee;

dd) Report on clinical trial result prepared according to form No. 09 in Appendix VI hereto appended;

e) Technical procedures of the new technique/method according to Point a Clause 1 Article 97 of this Decree.

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a) Documents about clinical trial of the new technique/method must be written in Vietnamese. Otherwise, a notarized Vietnamese translations of these documents are required;

b) Documents issued by foreign regulatory bodies shall bear consular legalization in accordance with regulations of law on consular legalization, unless consular legalization is exempted as prescribed by law.

Article 103. Procedures for permitting clinical trial of a new technique/method for medical examination or treatment

1. Procedures for permitting clinical trial of a new technique/method include: approving the clinical trial; approving changes to the clinical trial; approving the clinical trial result.

2. Procedures for approving the clinical trial

a) The testing facility shall send 01 application package to the Ministry of Health in person, online or by post;

b) The Ministry of Health shall inspect the validity of the application package within 05 working days from the day on which it is received. If the application package is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for appraisal of ethical issues. If the application package is invalid, a written notice and instructions to supplement the application package shall be issued within 02 working days.

The testing facility shall complete the application package within 60 days from the receipt of the written notice. After this 60-day period, the procedures for approving the clinical trial must be carried out from the beginning;

c) National Research Ethics Committee shall carry out appraisal of ethical issues of the trial on a monthly basis;

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3. Procedures for approving changes to the clinical trial

a) The testing facility shall send 01 application package to the Ministry of Health in person, online or by post;

b) The Ministry of Health shall inspect the validity of the application package within 05 working days from the day on which it is received. If the application package is invalid, within 02 working days, the Ministry of Health shall issue a written notification and instructions to supplement the application package. The testing facility shall complete the application package within 60 days from the receipt of the written notice. After this 60-day period, the procedures for approving changes to the clinical trial must be carried out from the beginning.

c) Regarding the changes mentioned in Point c Clause 3 Article 102 of this Decree:

- If the application package is valid, within 02 working days, the Ministry of Health shall transfer it to National Research Ethics Committee for appraisal;

- National Research Ethics Committee shall carry out appraisal of ethical issues of the trial on a monthly basis;

- Within 05 working days from the receipt of the certificate of approval for changes to the clinical trial from National Research Ethics Committee and enclosed documents, the Ministry of Health shall issue a decision to approve the changes to the clinical trial.

d) Regarding the changes mentioned in Point b Clause 3 Article 102 of this Decree: Within 07 working days from the receipt of the valid application package, the Ministry of Health shall issue a decision to approve changes to the clinical trial.

4. Procedures for approving the clinical trial result

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b) The Ministry of Health shall inspect the validity of the application package within 05 working days from the day on which it is received. If the application package is valid, within 02 working days, the Ministry of Health shall transfer it to the National Research Ethics Committee for appraisal. If the application package is invalid, a written notice and instructions to supplement the application package shall be issued within 02 working days.

The testing facility shall complete the application package within 60 days from the receipt of the written notice. After this 60-day period, the procedures for approving the clinical trial result must be carried out from the beginning;

c) National Research Ethics Committee shall evaluate ethical issues of the trial on a monthly basis;

d) Within 05 working days from the receipt of the certificate of approval for the clinical trial result from National Research Ethics Committee and enclosed documents, the Ministry of Health shall issue a decision to approve the clinical trial result.

Article 104. Biomedical Ethics Committees.

1. Biomedical Ethics Committees include a National Biomedical Ethics Committee and internal Biomedical Ethics Committees.

2. The Minister of Health shall promulgate specific regulations on establishment, organization and operation of Biomedical Ethics Committees.

Chapter V

MANAGEMENT AND USE OF MEDICAL DEVICES AT HEALTH FACILITIES

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1. Medical devices used at health facilities must have marketing authorization, permitted for sale and received in accordance with regulations of law on medical device management and relevant regulations of law.

2. Health facilities shall strictly comply with regulations of law on medical device management and relevant regulations of law.

3. Health facilities shall have adequate funds for maintenance, repair, inspection, calibration of medical device, provision of training and knowledge updating for employees about medical devices used therein in accordance with law.

4. Every hospital shall have a department and personnel dedicated to management, inspection, maintenance, repair and calibration of medical devices.

5. The personnel mentioned in Clause 4 of this Article shall have certificates of training and knowledge update in medical device management according to regulations of the Ministry of Health.

Article 106. Requirements for management, inspection, maintenance, repair, part replacement and calibration of medical devices

1. Inventory, use, inspection, maintenance, repair, part replacement and calibration of medical devices used at health facilities must be documented and monitored.

2. The head of each health facility shall issue the Regulation on management, use, inspection, maintenance, repair, part replacement and calibration of medical devices therein on the basis of instruction manuals of manufacturers and their uses at the health facility. Medical devices that are public property shall comply with regulations of law on management and use of public property.

Chapter VI

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Article 107. Mobilization of health facilities in case of natural disasters, Group A infectious diseases or emergencies

1. Presidents of the People’s Committees of provinces shall issue decisions to establish, mobilize health facilities under their jurisdiction to participate in provision of medical examination and treatment in their provinces or other provinces in case of natural disasters, Group A infectious diseases or emergencies (hereinafter referred to as "mobilized facilities").

2. The Minister of Health shall establish, mobilize health facilities under their jurisdiction to assist local governments and healthcare units in case of natural disasters, Group A infectious diseases or emergencies at their request.

3. The Minister of National Defense and the Minister of Public Security shall establish, mobilize health facilities under their jurisdiction to assist local governments and healthcare units in case of natural disasters, Group A infectious diseases or emergencies at their request.

4. On the basis of the establishment or mobilization decision, mobilized facilities shall participate in medical examination and treatment in case of natural disasters, Group A infectious diseases or emergencies.

Article 108. Funding for recurrent expenditures of state-owned health facilities mobilized under Article 116 of the Law on Medical Examination and Treatment

1. The sources of funding for recurrent expenditures of mobilized state-owned health facilities shall comply with Article 117 of the Law on Medical Examination and Treatment.

2. Recurrent expenditures of state-owned health facilities that are established under Clause 1 Article 116 of the Law on Medical Examination and Treatment shall comply with regulations of the Government on Group 3 public service providers (those that cover part of their own recurrent expenditures) and include the following amounts:

a) Expenditures on payment of salaries, remunerations, allowances, contributions and other benefits (if any) of the people mobilized to participate in medical examination and treatment in case of natural disasters, Group A infectious diseases or emergencies (hereinafter referred to as "mobilized people") from other facilities;

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c) Costs of medical examination and treatment, benefits for patients undergoing treatment during natural disasters, Group A infectious diseases or emergencies, including concurrent disorders (if any);

d) Subsidies on meals (if any), rents or housing according to regulations on business trip expenses; travel costs for mobilized people during work at the health facility;

dd) Business trip allowances according to regulations for mobilized people;

e) Other costs related to medical examination and treatment during natural disasters, Group A infectious diseases or emergencies.

3. Recurrent expenditures of state-owned health facilities that are mobilized under Clause 1 Article 116 of the Law on Medical Examination and Treatment shall comply with regulations of the Government on public service providers, including the expenditures specified in Clause 2 of this Article.

If the total revenue of a health facility in a year is smaller than total recurrent expenditures, it will receive assistance in recurrent expenditures from state budget.

Article 109. Responsibility for payment

1. Employers of mobilized people shall:

a) Provide business trip allowances for the days of travel from their workplace to the receiving health facility;

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2. The receiving health facility shall:

a) Pay the amounts specified in Clause 2 Article 108 of this Decree from the receipt of the mobilized people;

b) Reimburse the employers of the mobilized people according to the list of payments mentioned in Point b Clause 1 of this Article.

Article 110. Payment of costs of medical examination and treatment provided for patients during natural disasters, Group A infectious diseases or emergencies

1. State budget shall pay the costs of medical examination and treatment during natural disasters, Group A infectious diseases or emergencies, including:

a) Cost of medical examination services, daily hospital bed services, technical services and tests that have been used for patients. The payment shall be made according to the quantity of medical services provided for the patients and the prices for medical examination and treatment services covered by health insurance;

b) The costs of medicines, chemicals, medical devices, whole blood and blood products that are not included in medical examination and treatment service prices, have been used for technical services provided for the patients whose prices are not regulated or that are not covered by health insurance. The payment shall be made according to the actual quality used and the buying prices in accordance with bidding laws. The costs of whole blood and blood products shall be paid in accordance with instructions of the Minister of Health;

c) Technical services that are not covered by health insurance. The payment shall be made according to the quantity of medical services provided for the patients and the prices for medical examination and treatment that have been approved by competent authorities for such facility or the supervisory facility.

2. Regarding the costs of medical examination and treatment for other diseases during treatment of Group A infectious disease diseases: Health insurance fund shall pay the costs of medical examination and treatment covered by health insurance for the beginning to the end of treatment of the Group A infectious disease. Patients who have the Group A infectious disease and have health insurance shall co-pay certain costs and uncovered costs (if any) in accordance with health insurance laws.

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4. Prices for medical examination and treatment services and medicines covered by health insurance shall be those imposed by the mobilized health facilities or their supervisory hospitals.

5. Rules for payment of the costs of medical examination and treatment at private health facilities assigned by provincial authorities to admit and treat patients during natural disasters, Group A infectious diseases or emergencies:

a) The costs of medical examination and treatment at private health facilities shall be paid by state budget and the health insurance fund in accordance with Clause 1 and Clause 2 of this Article;

b) The prices for medical services, medicines, medical devices and prices for medical services covered by health insurance shall be the prices imposed by such health facilities but not exceeding the highest prices for medical services provided by local state-owned health facilities.

c) Health authorities affiliated to the People’s Committees of provinces shall sign contracts with private health facilities assigned by provincial authorities to admit and treat patients during natural disasters, Group A infectious diseases or emergencies.

6. Payment of cots of medical examination and treatment at a health facility in case the number of patients admitted exceed its number of hospital beds or personnel (including personnel for calculation of costs and technical services provided for the patients):

a) State budget shall pay the costs of medical examination and treatment according to the actual quantity and buying prices in accordance with bidding laws.

In case the health facility is not capable of providing certain technical services, it may sign contracts with other local health facilities that are capable, and will have the prices for medical services provided by the latter covered by health insurance paid by state budget under approval by competent authorities.

b) The health insurance fund shall pay the costs of medical examination and treatment for other diseases during treatment of the Group A infectious disease within the health insurance coverage; patients who have the Group A infectious disease and have health insurance shall co-pay certain costs and uncovered costs (if any) in accordance with health insurance laws.

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7. Force majeure events mentioned in this Article include:

a) The patient dies during treatment but the health facility fails to contact his/her family;

b) The patient does not have family and identification document upon admission to the health facility.

8. Health facilities that are established or mobilized under Article 116 of the Law on Medical Examination and Treatment and their supervisory hospitals shall be responsible for the accuracy and legality of their reports, ensuring no losses, wastefulness and corruption.

Article 111. Guidance on payment from state budget to health facilities established under Article 116 of the Law on Medical Examination and Treatment

1. Estimating costs: the established/mobilized health facilities and their supervisory hospitals shall prepare and send estimates of their recurrent expenditures to their superior authorities, which will report to finance authorities as per regulations.

2. On the basis of budget allocated by competent authorities, the superior authorities shall allocate budget to the established/mobilized health facilities and their supervisory hospitals under their management in accordance with state budget laws.

3. The management, use and settlement of budget shall be carried out in accordance with state budget laws. The units are responsible for the accuracy of the costs of medical examination and treatment as prescribed by law.

4. Recurrent expenditures of health facilities and documentation thereof shall be controlled as follows:

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The supervisory health facility shall compile a statement of medical examination and treatment costs using the form in Appendix VII hereof and send it to State Treasury for transfer of money to the deposit accounts of the established/mobilized health facility and the supervisory hospital opened at State Treasury.

The statement shall be prepared in accordance with the principles specified in Clause 1, Clause 3 and Clause 4 Article 110 of this Decree. The health facilities shall be responsible for the accuracy of medical examination and treatment costs specified in the statement; manage, use and settle the budget as prescribed by law;

b) Other payments shall be controlled in accordance with Article 7 of the Government’s Decree No. 11/2020/ND-CP on State Treasury-related administrative procedures and other relevant regulations of law;

c) State Treasury shall pay private health facilities assigned by local authorities to admit and treat patients during natural disasters, Group A infectious diseases or emergencies on the basis of the contracts, acceptance and contract finalization records between them and health affiliated to the People’s Committees of provinces.

5. In case the revenue of the health facility established/mobilized under Article 116 of the Law on Medical Examination and Treatment in the year is not sufficient to cover its recurrent expenditures, the deficit will be covered by state budget in accordance with regulations of law on financial autonomy.

Article 112. transfer of medicines and medical devices purchased using state budget or donations serving preparation, response and recovery of natural disasters, Group A infectious diseases or emergencies

Health facilities may use the remainder of medicines and medical devices that are purchased using state budget or donations serving preparation, response and recovery of natural disasters, Group A infectious diseases or emergencies for their own medical examination and treatment in order to avoid wastefulness.

1. Rules for payment for medical examination and treatment

a) Regarding medicines and medical devices that are purchased using state budget to serve preparation, response and recovery of natural disasters, Group A infectious diseases or emergencies and covered by health insurance:

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- For patients who do not have health insurance: the health facilities may only collect payments from the patients that are equal to the buying prices according to bidding laws but not exceeding the highest prices paid by social insurance authorities to local state-owned health facilities;

In case the health facilities do not have the prices covered by health insurance, the prices paid by the health insurance fund to other health facilities in the same province shall apply. If the prices paid by the health insurance fund to other health facilities in the same province are also unavailable, the payments shall be equal to the buying prices according to bidding laws;

b) Regarding medicines and medical devices that have been paid for by state budget to serve preparation, response and recovery of natural disasters, Group A infectious diseases or emergencies and are not covered by health insurance, the health facilities may only collect payments from the patients that are equal to the buying prices according to bidding laws.

c) Regarding medicines and medical devices that are donated to serve preparation, response and recovery of natural disasters, Group A infectious diseases or emergencies: health facilities must not collect payments from the patients and health insurance fund shall not paid for them.

2. The payments collected by health facilities shall be transferred to state budget in accordance with regulations of law on state budget.

Chapter VII

PRECONDITIONS FOR HEALTHCARE OPERATIONS

Section 1. FUNDING FOR TRAINING, SCHOLARSHIPS AND LIVING EXPENSES

Article 113. Policies for grating support and scholarships to students majoring in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine

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a) Tuitions and living expenses of students who are attending postgraduate courses for master’s degree, doctorate degree, level-I or level-II specialty qualification, and specialty resident physicians majoring in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine (hereinafter referred to as “students”) at health training institutions shall be funded by the State;

b) Students at public health training institutions who are displaying good learning and training results, or better, and are not disciplined by reprimand or any severer form during the scholarship awarding period shall be eligible to incentive scholarships granted by the State.

Incentive scholarships granted to students of private health training institutions shall comply with regulations of law in force;

c) Students who are working for health facilities located in poor or extremely poor local areas shall be eligible to social service grants offered by the State;

d) The State solicits organizations and individuals to offer grants or scholarships or financial aid to students.

2. Procedures for considering and awarding scholarships; principles for supporting and awarding scholarships shall comply with regulations of law in force.

3. Rates of support and scholarships:

a) Support for tuitions:

- Financial support for tuitions shall be granted in accordance with the Government’s Decree No. 81/2021/ND-CP dated August 27, 2021 prescribing collection and management of tuitions by training institutions included in the national educational network and policies for tuition exemption and reduction, and funding for learning expenses, and service prices in education and training sector (hereinafter referred to as “Decree No. 81/2021/ND-CP”);

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b) Financial support for living expenses shall be granted in accordance with the Government’s Decree No. 116/2020/ND-CP dated September 25, 2020 introducing policies for granting financial support for tuitions and living expenses of pedagogy students (hereinafter referred to as “Decree No. 116/2020/ND-CP”).

c) Values of incentive scholarships shall comply with the provisions of the Government’s Decree No. 84/2020/ND-CP dated July 17, 2020 elaborating the Law on Higher Education (hereinafter referred to as “Decree No. 84/2020/ND-CP”).

d) Values of social service scholarships:

- For students who are working for health facilities located in poor local areas: the scholarship shall equal 80% of the statutory pay rate per month;

- For students who are working for health facilities located in extremely poor local areas: the scholarship shall equal 100% of the statutory pay rate per month.

4. Funding sources, preparation of cost estimates, allocation of funding for granting financial support and scholarships, management, use and statement of funding, reimbursement of funding, procedures for application for financial support for tuitions, living expenses and scholarships shall comply with provisions of the Decree No. 84/2020/ND-CP, Decree No. 116/2020/ND-CP, and Decree No. 81/2021/ND-CP.

Article 114. Determination of training, task assignment, order placement or bidding demands

1. Every year, each provincial People's Committee shall review the calculation and determination of demands for recruitment and training of postgraduate students for master’s degree, doctorate degree, and specialty qualifications in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine for the enrolment year, and send review results to licensed training institutions by January 31 every year, and also publish the same on mass media.

2. Based on the enrolment target determined annually as prescribed, training institutions shall publicly inform such enrolment target to local areas, organizations and individuals in need of training teachers, and publish the same on the web portal of the Ministry of Education and Training of Vietnam and websites of teacher training institutions.

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a) Assign tasks of postgraduate training for master’s degree, doctorate degree, and specialty qualifications in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine to its affiliated training institutions;

b) Place orders for postgraduate training for master’s degree, doctorate degree, and specialty qualifications in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine to licensed training institutions;

c) Organize bidding for selecting qualified training institutions to provide postgraduate training for master’s degree, doctorate degree, and specialty qualifications in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine.

4. Task assignment decisions or training contracts between authorities that assign tasks, place orders or conduct bidding and training institutions must be established or made on the basis of annual demands and plan for postgraduate training in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine, and in conformity with the educational development plan, and local annual and long-term health personnel training plans.

5. Task assignment, order placement or bidding for postgraduate training for master’s degree, doctorate degree, and specialty qualifications in psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, infectious diseases or resuscitation in emergency care medicine shall comply with provisions of the Government’s Decree No. 32/2019/ND-CP dated April 10, 2019 prescribing task assignment, order placement or bidding for provision of public services and products funded by state budget-derived funding for covering recurrent expenditures.

Section 2. WAYS TO CALL FOR SOCIAL INVESTMENTS IN HEALTHCARE

Article 115. Borrowing funds for investment in infrastructure and medical devices

1. Health facilities that are classified as group-1, 2 or 3 units according to regulations on financial autonomy of public administrative units may borrow funds for making investments in infrastructure and medical devices which are used to serve their operations.

2. Health facilities shall submit reports to get opinions from their supervisory authorities on borrowing funds for making investments. Where management board, school board or university board is available, reports shall be submitted to these boards for getting their opinions on borrowing funds for making investments. A report submitted to a supervisory authority shall, inter alia, include:

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b) Objectives;

c) Scale and location of the project funded by borrowed funds;

d) Form of operation;

dd) Personnel plan for performing activities using medical devices or facilities invested using borrowed funds;

e) Project duration: investment and construction duration, and operating duration of the project;

g) Feasibility of the borrowing plan;

h) Socio-economic effectiveness of the project.

3. Borrowing procedures shall be followed in accordance with regulations of law on credit institutions and relevant documents.

4. Assets established from borrowed funds may be provided as collateral in accordance with provisions of the Civil Code and relevant laws.

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Article 116. Private sector involvement in healthcare

1. Public health facilities may lease or let out assets that are infrastructure facilities or medical devices to serve professional activities within the ambit of their assigned functions and tasks or to provide on-demand healthcare services. Leasing or letting out assets shall comply with regulations of law on management and use of public property; selection of lessees and lessors shall comply with regulations of law on bidding. Lease period shall not be longer than the depreciation period of assets as prescribed by law or shall not be longer than the life cycle of assets.

2. Leasing or letting out clinical services, sub-clinical services, non-medical services, pharmacy services or hospital management and operation services shall comply with provisions of the law on bidding and the law on management and use of public property.

Article 117. Buying under deferred or installment payment terms, and borrowing medical devices

1. Buying under deferred or installment payment terms:

a) Public health facilities shall, based on standards and norms on medical devices and their funding sources, decide to buy medical devices under deferred or installment payment terms;

b) Purchase of medical devices shall comply with regulations of the law on bidding, in which the payment method that is deferred or installment payment must be specified in bidding documents for purchase of medical devices.

2. Borrowing medical devices shall comply with regulations of the Civil Code.

3. Costs of use of medical devices in the forms specified in clauses 1 and 2 of this Article for providing healthcare services may be included in costs of healthcare services to be paid by patients or the health insurance fund in accordance with regulations of law on health insurance.

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1. Health facilities may receive financial aid, technical assistance and in-kind aid from international authorities and organizations and foreigners to serve their provision of healthcare services in accordance with regulations of law on management and use of official development assistance (ODA) and concessional loans from foreign sponsors, non-refundable aid which is not considered as ODA granted by foreign authorities, organizations and individuals to Vietnam.

2. Health facilities may receive grants or donations in cash, assets, materials and in kind from domestic and foreign authorities, organizations and individuals to service their provision of healthcare services in accordance with regulations of the law on anti-corruption, the law on management and use of public property and relevant laws.

3. Health facilities are allowed to receive grants, aid and support in property from domestic and foreign organizations and individuals to serve their epidemic prevention and control regardless of standards and norms for use of property. After announcing the end of the epidemic, such property shall be handled in accordance with regulations of law on management and use of public property.

4. Assets, materials and goods (hereinafter referred to as “assets”) which are received as grants but for which procedures for establishing all-people ownership are yet to be completed shall be used for provision of healthcare services. Costs of healthcare services provided with use of these assets shall be paid by patients or the health insurance fund in accordance with regulations of law on health insurance. Health facilities shall assume responsibility for quality of their healthcare services provided with use of these assets and may use their own funding for maintaining and repairing these assets during their use.

Section 3. Prices of healthcare services and funding for other activities in healthcare sector

Article 119. Prices of healthcare services

1. Price of healthcare services means total amount payable for each healthcare services, including:

a) Price of medical examination;

b) Price of hospital bed per day;

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2. Prices of healthcare services classified by service users include:

a) Prices of healthcare services paid by the health insurance fund;

b) Prices of healthcare services paid by state budget;

c) Prices of healthcare services which are not included in list of healthcare services covered by the health insurance fund and are not on-demand healthcare services;

d) Prices of on-demand healthcare services.

3. Total prices of healthcare services shall be composed of the factors specified in clause 2 Article 110 of the Law on Medical Examination and Treatment. To be specific:

a) Personnel costs:

- Personnel costs included in prices of healthcare services paid by the health insurance fund, prices of healthcare services paid by state budget, and prices of healthcare services which are not included in list of healthcare services covered by the health insurance fund and are not on-demand healthcare services include: salaries, wages, allowances and compulsory contributions of public employees, workers and outsourced personnel (if any), including direct and indirect personnel; specific costs which shall not exceed 50% of salaries and salary-based allowances to be paid to experts and outstanding physicians working at health facilities;

- Personnel costs included in prices of on-demand healthcare services shall equal wages paid to employees/ workers. The head of the health facility shall decide specific wages paid for specific tasks according to its internal spending regulations or collective bargaining agreement or adopting comparison method.

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Expenses incurred during the provision of healthcare services and those incurred by departments/wards providing such healthcare services may be considered as direct costs (except depreciation costs and personnel costs), including:

- Costs of drugs, chemicals, blood, blood products, and costs of raw materials, supplies, tools, instruments directly used (including costs of maintenance and losses thereof) for performing technical services;

- Costs of fuels and energy used, including electricity, water, fuels, waste treatment, environmental sanitation, and infection control;

- Other direct costs, including: costs of maintenance, repair, inspection and calibration of medical devices; costs of maintenance and repair of fixed assets; costs of replacement of tools, instruments and equipment directly used for performing technical services; costs of application or leasing of IT services; and other direct costs.

c) Depreciation costs of medical devices and fixed assets as prescribed. Only medical devices qualified as fixed assets may be depreciated.

d) General and administrative costs are those costs of indirect management units serving the provision of healthcare services and costs of general activities of a health facility, including:

- Costs of maintenance and repair of medical devices and fixed assets; costs of inspection and calibration of assets, purchase of devices, tools, instruments, materials, supplies and office stationery serving operation of management departments, indirect and general activities of the health facility;

- Costs of environmental protection, infection control, quality control; costs of uniforms, clothing, labor protective equipment, assurance of occupational safety and health, protection of workers’ health, prevention of HIV infection, and vaccination for officials, public employees and workers;

- Costs of training, scientific research; receipt of transfer of techniques, training for improvement of professional capacity;

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- Costs of hiring interpreters and translators; costs of purchasing, printing and photocopying of documents and publications used in professional activities; costs of mass media and promotion of the health facility’s image and brand as prescribed;

- Fees, charges and taxes (including land use levies), costs of renting land used in business and service provision (if any); liability insurance in medical examination and treatment, asset insurance costs; costs of fire prevention and fighting; costs of quality management; costs of storage, loss and destruction of drugs and materials; risk prevention costs; costs associated with liquidation or disposal of assets as prescribed;

- Loan interests (if any) and other management expenses.

4. Prices of healthcare services exclude specific allowances, including allowances for health workers funded by state budget as prescribed by law.

5. Methods for pricing of healthcare services shall comply with regulations of the Ministry of Health of Vietnam. If cost method is employed, costs composing the price of a healthcare service shall be determined on the basis of technical-economic norms (if any), and appropriate costs of medical examination and treatment activities.

6. Pricing of healthcare services shall be based on the grounds specified in clause 4 Article 110 of the Law on Medical Examination and Treatment:

a) Prices of on-demand healthcare services shall include adequate cost factors specified in clause 3 of this Article;

b) Prices of healthcare services paid by the health insurance fund; prices of healthcare services paid by state budget; prices of healthcare services which are not included in the list of healthcare services covered by the health insurance fund and are not on-demand healthcare services: The Ministry of Health of Vietnam shall play the leading role and cooperate with the Ministry of Finance of Vietnam and the Ministry of Planning and Investment of Vietnam in requesting competent authorities to make consideration and decision.

7. Payment of healthcare costs:

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b) Technical economic norms and cost rates used in the compilation of prices of healthcare services shall not be used as the basis for making payment for each specific healthcare service;

c) Payment for on-demand healthcare services: The health insurance fund shall be liable for costs of healthcare services within the coverage scope (if any) as prescribed by the law on health insurance. Patients shall pay the difference between costs of on-demand healthcare services and amounts covered by the health insurance fund to health facilities.

8. Private health facilities that provide healthcare services covered by the health insurance fund shall be eligible to payment of costs of healthcare services according to the prices of healthcare services included in the list of healthcare services covered by the health insurance fund to be applied in local public health facilities with approval of provincial People’s Councils. Patients shall pay the difference between the cost of healthcare service charged by the private health facility and the price of that healthcare service specified in the list of healthcare services covered by the health insurance fund.

9. Provincial People’s Councils shall set specific prices of healthcare services as prescribed in clause 6 Article 110 of the Law on Medical Examination and Treatment and prices of the following healthcare services:

a) Services which are provided by public health facilities located within the areas under their authority and whose prices are yet to be set by the Ministry of Health of Vietnam;

b) Services which are not provided by health facilities affiliated to the Ministry of Health or other ministries but are provided by local health facilities.

Article 120. Funding for out-of-hospital emergency care

1. The funding for out-of-hospital emergency care is subject to the following provisions:

a) State budget's funding shall be provided for making investment in constructing facilities and equipment of the state-owned out-of-hospital emergency care facilities, and the system of receiving information and coordinating emergency services provided by these facilities in accordance with provisions of the Law on Public Investment;

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c) State budget's funding for paying general and administrative expenses for management and operation of state-owned out-of-hospital emergency facilities shall be allocated in accordance with the Government’s regulations on financial sources of public administrative units.

2. Provincial People’s Committees shall:

a) organize the system of state-owned out-of-hospital emergency care facilities in local areas falling within their remit, and the system of receiving information and coordinating emergency services provided by these facilities in a manner that is suitable for the organizational model of these service providers in local areas;

b) allocate funding according to applicable regulations on hierarchical management of state budget for implementing the provisions in clause 1 of this Article;

c) mobilize social resources and adopt measures for encouraging organizations and individuals to make investment in or establish out-of-hospital emergency care facilities.

3. Preparation, allocation and implementation of estimates of costs covered by state budget’s funding, and statement thereof shall comply with regulations of the Law on public investment, the Law on state budget, the Law on accounting and their guiding documents.

Article 121. Costs of care, nursing, medical examination and treatment for patients without families in health facilities

1. Regimes for medical examination and treatment, care and nursing services provided for patients without families include:

a) Costs of healthcare services: comply with regulations on prices of healthcare services provided by health facilities promulgated by competent authorities;

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c) Patients without families will be provided with tools and instruments serving their daily life such as blankets, curtains, sleeping mats, summer and winter clothes, underwear, sandals, toothbrush, monthly hygiene products for females and other costs as prescribed;

d) Costs of transfer of patients from health facilities to social assistance centers. Costs of patient transfer shall be determined according to costs of fuels actually consumed by vehicles used for transferring patients.

2. Funding shall be provided in the following order:

a) The health insurance fund shall cover costs of healthcare services within the maximum coverage percentages in accordance with regulations of the Law on health insurance, if patients hold valid health insurance cards;

b) Medical support funds as prescribed in clause 2 Article 111 of the Law on Medical Examination and Treatment;

c) Grants, mobilized funding and other lawful funding sources;

d) Funding derived from state budget according to regulations on hierarchical management of state budget.

3. Cost estimation and method for payment of state budget’s funding:

Preparation, allocation and implementation of estimates of costs covered by state budget’s funding, and statement thereof shall comply with regulations of the Law on state budget, relevant laws and the following provisions:

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- Every year, at the time of preparation of the state budget estimates, public health facilities shall make consolidated reports on their funding used for making payment of costs prescribed in clause 1 of this Article in the previous year, after deducting funding sources mentioned in points a, b, c clause 2 of this Article, and send them to their supervisory authorities;

- These supervisory authorities shall consider and aggregate such payments in their annual state budget estimates which shall be sent to finance authorities of the same level for consolidation and submission to competent authorities for making reimbursement to health facilities;

- Based on state budget estimates allocated to make reimbursement, public health facilities shall withdraw estimated funding at state treasuries for transferring to their deposit accounts on public service charges opened at state treasuries.

b) For private health facilities:

- Private health facilities that provide care, nursing, medical examination and treatment services for patients without families shall send written request to health authorities affiliated to provincial People’s Committees for reimbursement of funding used for making payments as prescribed in clause 1 of this Article in the previous year, after deducting funding sources in points a, b, c clause 2 of this Article;

- Health authorities affiliated to provincial People’s Committees shall prepare consolidated reports on funding used for making prescribed payments of private health facilities within their management, and send them to finance authorities. Finance authorities shall consider and request provincial People’s Committees to make consideration as prescribed.

c) Health facilities shall assume responsibility for the accuracy of the funding amount allocated by state budget at their request, management, use and statement thereof in accordance with regulations of law.

Article 122. Costs of burial services for death cases specified in point b clause 1, point b clause 2 Article 73 of Law on Medical Examination and Treatment and clause 2 Article 95 of this Decree

1. Costs of burial services incurred by authorities, organizations and individuals providing burial services for the death cases specified in point b clause 1, point b clause 2 Article 73 of the Law on Medical Examination and Treatment and clause 2 Article 95 of this Decree may be reimbursed at the rates prescribed in clause 3 Article 25 of the Decree No. 20/2021/ND-CP.

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Section 4. PROFESSIONAL LIABILITY INSURANCE IN HEALTHCARE

Article 123. Principles for professional liability insurance in healthcare

1. Professional liability insurance in healthcare is a type of insurance used to pay indemnities for damage caused by medical accidents occurring during the course of delivery of healthcare within the insurance policy period, and legal costs related to these medical accidents, except as specified in point d clause 2 Article 100 of the Law on Medical Examination and Treatment.

2. Insurers or branches of foreign non-life insurers and health facilities may proactively reach agreements on insurance conditions, limit on insurance liability, and premiums on the basis of assessment of risks to health facilities and relevant factors as prescribed by law.

Article 124. Funding for purchasing professional liability insurance in healthcare

1. Private health facilities shall use their own funding for purchasing professional liability insurance in healthcare.

2. For public health facilities: funding for purchasing professional liability insurance in healthcare is derived from financial sources of public administrative units according to the Government’s regulations on financial autonomy of public administrative units.

Chapter VIII

GUIDANCE ON IMPLEMENTATION ROADMAP; TRANSITION PROVISIONS ON PRACTICING LICENSE AND OPERATING LICENSE

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Article 125. Procedures for issuance of practicing licenses

1. Upon completion of the training program, a holder of graduation diploma in healthcare may adopt one of the following three methods for applying for practicing license:

a) Follow procedures for issuance of practicing license.

Before applying for the practicing license, the applicant is required to successfully complete the medical internship as prescribed in Article 129 of this Decree.

b) Attend a specialty training course and, upon completion of such course, apply for practicing license on which the scope of practice involves a specific specialty.

Before applying for the practicing license, the applicant is not required to successfully complete the medical internship as prescribed in Article 129 of this Decree.

c) Continue attending postgraduate training course for master's degree or doctorate degree in healthcare sector at a foreign training institution, and upon completion of such course, apply for practicing license on which the scope of practice involves a specific specialty.

Before applying for the practicing license, the applicant is required to successfully complete the medical internship as prescribed in Article 129 of this Decree.

2. If a holder of practicing license issued as prescribed in point a clause 1 of this Article or a holder of practicing certificate issued before January 01, 2024 continues attending a specialty training course:

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b) The holder of basic specialty certificate is required to complete an internship in the specialty written in his/her basic specialty certificate until the sum of the basic specialty training period and the internship period is enough 18 months (determined from the start date of the basic specialty training). Upon completing the internship, he/she may apply for modification of practicing license on which the scope of practice involves a specific specialty;

c) He/she may continue attending postgraduate training course for master's degree or doctorate degree in healthcare sector at a foreign training institution, and upon completion of such course, apply for modification of practicing license on which the scope of practice involves a specific specialty after having successfully completed the medical internship as prescribed in Article 129 of this Decree.

3. In case a medical practitioner attends a training course and is issued with a professional technique certificate as prescribed in clause 3 Article 128 of this Decree or a certificate or certification (including those issued before January 01, 2024) which is not yet included in his/her licensed scope of practice, he/she must not follow procedures for modification of the licensed scope of practice but the person in charge of professional practices of the relevant health facility shall, based on such professional technique certificate issued by a lawful training institution and the medical practitioner’s capacity to perform professional technique, decide to give written permission to him/her to implement his/her trained technique.

In case a medical practitioner receives a transferred technique which is not included in his/her licensed scope of practice, he/she must not follow procedures for modification of the licensed scope of practice but the person in charge of professional practices of the relevant health facility shall, based on certificate of competence to implement such technique issued according to point c clause 4 Article 85 of this Decree, decide to give written permission to him/her to implemented such transferred technique.

4. If a person who has successfully completed a specialty training program as prescribed in point b clause 1 of this Article fails to apply for issuance of practicing license within 24 months from the issue date of his/her specialty qualification, he/she shall be required to attend a medical internship in such specialty for the period specified in Article 129 of this Decree before applying for issuance of practicing license.

5. If a person who has been granted a specialty qualification as prescribed in point a clause 2 of this Article fails to apply for modification of his/her practicing license within 24 months from the issue date of his/her specialty qualification, he/she shall be required to attend a medical internship in such specialty for the period specified in Article 129 of this Decree before applying for modification of his/her practicing license.

6. If a person who has been granted a basic specialty certificate as prescribed in point b clause 2 of this Article fails to apply for modification of his/her practicing license within 24 months after completing a medical internship as prescribed in point b clause 2 of this Article, he/she shall be required to attend another medical internship in such specialty for the period specified in Article 129 of this Decree before applying for modification of his/her practicing license.

7. If a person currently holds a graduation diploma in healthcare and one or some of the following certificates: herbalist certificate, folk remedy certificate or folk therapy certificate, he/she may apply for practicing license for one of the titles specified in Article 26 of the Law on Medical Examination and Treatment and follow the procedures set out in either clause 1 or clause 2 of this Article. The scope of practice shall be written on the practicing license issued according to provisions of this clause as follows:

a) The scope of practice specified in the practicing license for the title of doctor, nurse, medical technician, midwife, clinical nutritionist, clinical psychologist or out-of-hospital paramedic includes the scope of practice of the licensed title and the corresponding scope of practice on one or some of the following certificates: herbalist certificate, certificate of folk remedy or certificate of folk therapy;

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8. If an applicant for practicing license has completed a medical internship at a health facility of the armed forces and wishes to obtain a practicing license issued by the Ministry of Health of Vietnam or a health authority affiliated to a provincial People's Committee, his/her medical internship must meet the requirements set forth in Section 1 Chapter II of this Decree.

Article 126. Cases and conditions for issuance of practicing license

1. A practicing license may be issued to:

a) A person who first applies for the practicing license as prescribed in point a clause 1 Article 30 of the Law on Medical Examination and Treatment.

b) A medical practitioner making change in professional title specified in his/her practicing license as prescribed in point b clause 1 Article 30 of the Law on Medical Examination and Treatment.

c) The applicant falls in the case specified in:

- Point c clause 2 Article 137 of this Decree;

- Clause 3 Article 137 of this Decree;

- Point c clause 4 Article 137 of this Decree;

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- Point c clause 6 Article 137 of this Decree;

- Clause 7 Article 137 of this Decree;

- Clause 8 Article 137 of this Decree;

- Clause 9 Article 137 of this Decree;

- Point c clause 10 Article 137 of this Decree.

d) A medical practitioner who fails to follow renewal procedures as prescribed in point a clause 2 Article 134 of this Decree.

dd) A medical practitioner who has been granted a practicing license by a licensing authority in people’s armed forces stops using the issued practicing license for working in people’s armed forces, and wishes to practice in a health facility other than that under people’s armed forces in case the period after he/she stops working for the health facility in people’s armed forces until his/her submission of application for practicing license is longer than 60 months.

2. Conditions for issuance of practicing license for professional titles of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, out-of-hospital paramedic and clinical psychologist:

a) The applicant must hold a professional qualification as prescribed in Article 127 of this Decree or a practicing license recognized as prescribed in Article 37 of this Decree in conformity with the title for which he/she is applying for the practicing license;

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c) He/she is proficient in Vietnamese as prescribed in Article 138 of this Decree or is supported by an interpreter meeting the requirements in Article 139 of this Decree in case the applicant is a foreigner who is not proficient in Vietnamese;

d) He/she does not fall into the cases specified in Article 20 of the Law on Medical Examination and Treatment or is punished for an administrative offence involving the unlicensed practice of medicine within the time limit assigned for deeming that he/she has not yet been punished for administrative offences;

dd) He/she has successfully completed a medical internship as prescribed in Article 129 of this Decree, except the case specified in point b clause 1 Article 125 of this Decree.

Article 127. Qualifications required for issuance of practicing license

1. For the titles of doctor, nurse, midwife, medical technician (except the title of medical technician whose scope of practice involves medical laboratory), clinical nutritionist (except the title of clinical nutritionist with basic scope of practice), out-of-hospital paramedic and clinical psychologist:

a) Qualification required as a precondition for issuance of practicing license as prescribed in Article 8 of this Decree;

b) Degree of resident physician as prescribed in clause 1 Article 128 of this Decree;

c) Level-I specialty qualification as prescribed in clause 1 Article 128 of this Decree;

d) Level-II specialty qualification as prescribed in clause 1 Article 128 of this Decree;

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e) Doctorate degree in healthcare sector.

2. For the title of physician assistant:

a) For a physician assistant whose scope of practice involves general medicine:

- Intermediate professional education diploma of physician assistant, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma of physician assistant. These diplomas must be issued before January 01, 2027;

- Associate degree for general medicine physician assistant, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree for general medicine physician assistant;

- Bachelor of medicine issued by a foreign training institution and certified by the Minister of Education and Training of Vietnam to be equivalent to bachelor’s degree in Vietnam.

b) For a physician assistant whose scope of practice involves traditional medicine:

- Intermediate professional education diploma of physician assistant in traditional medicine or intermediate professional education diploma in traditional medicine, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma of physician assistant in traditional medicine. These diplomas must be issued before January 01, 2027;

- Associate degree for traditional medicine physician assistant or associate degree in traditional medicine, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree for traditional medicine physician assistant or associate degree in traditional medicine.

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a) Intermediate professional education diploma in medical laboratory technology, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the intermediate professional education diploma in medical laboratory technology;

b) Associate degree in medical laboratory technology, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in medical laboratory technology;

c) Bachelor of medical laboratory technology, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of medical laboratory technology by the Minister of Education and Training of Vietnam;

d) Bachelor’s degree in chemistry, biology or pharmacy (including graduation diploma issued by a foreign training institution and certified by the Minister of Education and Training of Vietnam to be equivalent to a bachelor’s degree) which must be accompanied with certificate or certification of completion of training course in medical laboratory technology with a minimum training duration of at least 03 months, issued by a training institution providing training courses in medical laboratory technology or a postgraduate qualification in testing.

4. For a clinical nutritionist whose scope of practice involves clinical nutrition:

a) Associate degree in nutrition, including graduation diploma issued by a foreign training institution and certified by the Minister of Labour, War Invalids and Social Affairs of Vietnam to be equivalent to the associate degree in nutrition;

b) Bachelor of nutrition, including a graduation diploma issued by a foreign training institution, provided such diploma holder has been accredited as a bachelor of nutrition by the Minister of Education and Training of Vietnam;

c) Degree of doctor as prescribed in clause 1 of this Article which is accompanied with a basic specialty certificate in nutrition.

Article 128. Requirements attached to specialty qualifications, basic specialty certificates, and professional technique certificates in healthcare, clinical psychology

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a) It must be issued by a lawful training institution as prescribed by laws; and

b) The training duration is not shorter than 18 months.

2. Requirements attached to basic specialty certificates issued by domestic training institutions:

a) The basic specialty certificate is issued by a training institution that has run at least 01 training course in the corresponding specialty certificate or by a health facility that is eligible to provide medical internship as prescribed in clause 2 Article 10 of the Government's Decree No. 111/2017/ND-CP dated October 05, 2017 prescribing organization of medical internship programs in healthcare sector (hereinafter referred to as " Decree No. 111/2017/ND-CP”) and is providing medical internship in the major or discipline of the same specialty level corresponding to training contents of the issued basic specialty certificate;

b) The training institution may use training curriculum and materials for the basic specialty certificate that itself compiles, appraises and issues, or use such training program and materials of another training institution with written consent of the latter; contents of the training curriculum, training volume and lecturers must be appropriate to the training curriculum for specialty qualification in corresponding major or discipline, and may be connected with the training curriculum for specialty level;

c) The training duration is not shorter than 09 months.

3. Requirements attached to a professional technique certificate in healthcare:

a) It is issued by an educational institution that has run at least 01 training course in the same profession at the same qualification level after which the graduate has been granted practicing license with the same title or by a health facility that has implemented the corresponding professional technique for at least 06 months under a competent authority’s permission;

b) The training institution may use training curriculum and materials for professional technique certificate that itself compile, appraise and issue, or use such training program and materials of another training institution with written consent of the latter; contents of the training curriculum, training volume and lecturers must be appropriate to the list of professional techniques issued by the Ministry of Health of Vietnam.

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5. If a medical practitioner who holds a basic specialty certificate wishes to apply for modification of his/her scope of practice as prescribed in point a or b clause 1 Article 135 of this Decree, the following conditions must be satisfied:

a) The start date of the training course for the basic specialty certificate falls after the issue date of the practicing license or practicing certificate or the modified practicing license;

b) A medical internship in the specialty written in the basic specialty certificate must be successfully completed as a basis for modification of the practicing license. The sum of the basic specialty training period and the internship period is not shorter than 18 months.

6. Training for qualifications and certificates specified in clauses 1, 2, 3 of this Article must be published by training institutions on their websites.

Article 129. Medical internship required for issuance of practicing license

1. Any persons who start practicing as medical interns from January 01, 2024 shall comply with the provisions of Section 1 Chapter II of this Decree and the following provisions on the medical internship for the titles of clinical nutritionist, out-of-hospital paramedic or clinical psychologist:

a) The practicing duration, location and contents shall comply with provisions of Section 1 Chapter II of this Decree.

b) Instructors must meet the following conditions:

- From January 01, 2024 to December 31, 2026: instructors must be medical practitioners whose scope of practice is suitable for the instruction on the medical interns’ practice of medicine or must be medical practitioners who have at least 36 months of working experience suitable for the instruction on the medical interns’ practice of medicine;

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2. Provisions on certificate of completion of internship program for the title of clinical nutritionist:

a) The certificate of completion of internship program is issued according to the provisions of Section 1 Chapter II of this Decree;

b) There must be a written certification of working period in clinical nutrition of at least 09 months up to the date of submission of an application for practicing license at a health facility whose scope of professional activities includes clinical nutrition.

3. Provisions on certificate of completion of internship program for the title of out-of-hospital paramedic:

a) The certificate of completion of internship program is issued according to the provisions of Section 1 Chapter II of this Decree.

b) There must be a written certification of working period in emergency care of at least 09 months up to the date of submission of an application for practicing license at any of the following health facilities:

- A hospital’s emergency care department;

- An out-of-hospital emergency care facility;

- A facility providing emergency medical transportation service that is established before January 01, 2024 and whose scope of professional activities includes emergency care.

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a) The certificate of completion of internship program is issued according to the provisions of Section 1 Chapter II of this Decree.

b) There must be a written certification of working period in clinical psychology of at least 09 months up to the date of submission of an application for practicing license at any of the following health facilities:

- A clinical psychology facility;

- A hospital whose scope of professional activities includes psychiatry or that has a clinical psychology department.

5. A person who starts practicing as a medical intern before January 01, 2024 as prescribed in the Law on Medical Examination and Treatment No. 40/2009/QH12 may:

a) apply the duration of practicing as a medical intern as prescribed in Article 3 of this Decree; and

b) include the duration of practicing as a medical intern before January 01, 2024 in total duration of practicing as a medical intern, provided the required duration of practicing as prescribed in Article 3 of this Decree must be achieved before December 31, 2024.

Article 130. Application package and procedures for issuance of practicing license

1. An application package for issuance of practicing license submitted by a person who first applies for the practicing license as prescribed in point a or b clause 1 Article 30 of the Law on Medical Examination and Treatment is composed of:

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b) A legitimate copy of any of the following documents:

- Professional qualification (not required if such professional qualification has been shared or published on the healthcare management information system or national healthcare database);

- Practicing license which has been accredited as prescribed in Article 37 of this Decree (not required if such accreditation has been shared or published on the healthcare management information system or national healthcare database).

c) In addition to the documents prescribed in point b of this clause, an application package for issuance of practicing license on which the scope of practice involves a specific specialty must also include a legitimate copy of one of the specialty qualifications specified in points b, c, d, dd or e clause 1 Article 127 of this Decree (not required if such specialty qualification has been shared or published on the healthcare management information system or national healthcare database).

d) An original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code.

dd) A legitimate copy of any of the following documents:

- Certificate of proficiency in Vietnamese as prescribed in Article 138 of this Decree (not required if such certificate has been shared or published on the healthcare management information system or national healthcare database);

- Interpreter’s eligibility certificate as prescribed in Article 139 of this Decree in case a foreigner is not proficient in Vietnamese (not required if such certificate has been shared or published on the healthcare management information system or national healthcare database), enclosed with the employment contract signed between the interpreter with the health facility where such foreigner will come to work.

e) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database).

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h) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

2. An application package for issuance of practicing license in the cases specified in points d, dd clause 1 Article 126 and where a practicing license has been revoked as prescribed in point c clause 2 Article 137, point c clause 3 Article 137, point b clause 4 Article 137, clause 7 Article 137, clause 8 Article 137, clause 9 Article 137, point c clause 10 Article 137 of this Decree includes:

a) The documents specified in section 1 of this Article;

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

3. An application package for issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point c clause 6 Article 137 of this Decree in the case specified in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in section 1 of this Article.

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- An original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

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- An original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

4. An application package for issuance of practicing license in the case prescribed in point a clause 7 Article 125 of this Decree is composed of:

a) The documents specified in section 1 of this Article.

b) Legitimate copy(ies) of one or some of the following documents (not required if such documents have been shared or published on the healthcare management information system or national healthcare database), including:

- Herbalist certificate;

- Fork remedy certificate;

- Folk therapy certificate.

5. Procedures for issuance of practicing license:

a) The applicant submits an application package for the corresponding case specified in clauses 1 through 4 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the authority competent to issue practicing license as prescribed in Article 28 of the Law on Medical Examination and Treatment (hereinafter referred to as “licensing authority”);

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Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to issue a practicing license shall be 30 days from the day on which verification results are available.

Article 131. Cases and conditions for re-issuance of practicing license

1. A practicing license may be re-issued if:

a) The practicing certificate has been issued before January 01, 2024 and the practicing license has been lost or damaged;

b) The practicing certificate has been issued before January 01, 2024 and there is any change in the following information on the practicing license: full name, date of birth or personal identification number of a Vietnamese practitioner; Passport number and nationality for foreign practitioner;

c) A person’s practicing certificate of practicing license has been revoked and he/she is eligible for re-issuance of practicing license as prescribed in Article 137 of this Decree.

d) The practicing license is issued ultra vires as prescribed in point d clause 1 Article 31 of the Law on Medical Examination and Treatment;

dd) A medical practitioner who has been granted a practicing license by a licensing authority in people’s armed forces stops using the issued practicing license for working in people’s armed forces, and wishes to practice in a health facility other than that under people’s armed forces in case the period after he/she stops working for the health facility in people’s armed forces until his/her submission of application for practicing license is not longer than 24 months;

e) A medical practitioner who has been granted a practicing license by a licensing authority in people’s armed forces stops using the issued practicing license for working in people’s armed forces, and wishes to practice in a health facility other than that under people’s armed forces in case the period after he/she stops working for the health facility in people’s armed forces until his/her submission of application for practicing license is longer than 24 months but shorter than 60 months.

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a) Conditions for re-issuance of practicing license shall comply with the provisions of clause 2 Article 31 of the Law on Medical Examination and Treatment;

b) Practicing certificates issued before January 01, 2024 as prescribed by the Law on Medical Examination and Treatment No. 40/2009/QH12 falling in re-issuance cases prescribed in points a, b, d clause 1 of this Article may be changed into practicing licenses in accordance with the Law on Medical Examination and Treatment No. 15/2023/QH15 and this Decree.

Article 132. Application package and procedures for re-issuance of practicing license

1. An application package for re-issuance of practicing license in case it is lost or damaged as prescribed in point a clause 1 Article 131 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the issued practicing license (if available) (not required if such practicing license has been shared on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

2. An application package for re-issuance of practicing certificate in case there is any change in the following information on the practicing license: full name, date of birth or personal identification number of a Vietnamese practitioner; passport number and nationality for foreign practitioner as prescribed in point b clause 1 Article 131 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

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c) The original(s) or legitimate copy(ies) of the document(s) proving such a change (not required if such information can be found or verified on the healthcare management information system or national healthcare database);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

3. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 2 Article 137 of this Decree in case the application package for award of the practicing license fails to meet regulations (point a clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

4. An application package for re-issuance of practicing license in case the practicing license is revoked as prescribed in point b clause 2 Article 137 of this Decree because the application package for award of the practicing license fails to meet regulations (point a clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) The documents specified in Clause 1 Article 14 of this Decree;

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

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5. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 4 Article 137 of this Decree in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license (point c clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

6. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point b clause 4 Article 137 of this Decree in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license (point c clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database);

c) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

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a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) An original or legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

8. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 6 Article 137 of this Decree in case he/she is subject to prohibition of practice of medicine as defined in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith).

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- An original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

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- An original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

9. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point b clause 6 Article 137 of this Decree in case he/she is subject to prohibition of practice of medicine as defined in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment (point dd clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith).

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database).

c) One of the following documents:

- An original or legitimate copy of a competent authority’s written conclusion that the medical practitioner is found innocent or not subject to prohibition of practice of medicine in case he/she had been criminally prosecuted but then acquitted in writing and thus not banned from practicing medicine (clause 1 Article 20 of the Law on Medical Examination and Treatment);

- An original or legitimate copy of certificate of completion of probation period or certificate that the medical practitioner has successfully served the court’s decision or sentence (clause 2, 3, or 4 Article 20 of the Law on Medical Examination and Treatment);

- An original or legitimate copy of a competent authority’s written certification that the medical practitioner has full capacity to perform civil acts or does no longer face impaired cognition or difficulties in behavior control, or restricted capacity to perform civil acts (clause 6 Article 20 of the Law on Medical Examination and Treatment).

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dd) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

10. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point a clause 10 Article 137 of this Decree in case such revocation is made at the request of the medical practitioner (point i clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

11. An application package for re-issuance of practicing license submitted by a person whose practicing license is revoked as prescribed in point b clause 10 Article 137 of this Decree in case such revocation is made at the request of the medical practitioner (point i clause 1 Article 35 of the Law on Medical Examination and Treatment) is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

c) The legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database);

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12. An application package for re-issuance of practicing license in case the practicing license has been issued ultra vires as prescribed in point d clause 1 Article 31 of the Law on Medical Examination and Treatment is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) The issued practicing license;

c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

13. An application package for re-issuance of practicing license in the case prescribed in point dd clause 1 Article 131 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of a written certification that the practicing license has been issued by a licensing authority in people’s armed forces, clearly indicating the number, issue date, issuing authority, personal information of the license holder, professional title and scope of practice;

c) An original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code;

d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database);

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14. An application package for re-issuance of practicing license in the case prescribed in point e clause 1 Article 131 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of a written certification that the practicing license has been issued by a licensing authority in people’s armed forces, clearly indicating the number, issue date, issuing authority, personal information of the license holder, professional title and scope of practice;

c) An original or legitimate copy of health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or the legitimate copy of the work permit which is required as prescribed by the Labor Code;

d) The medical practitioner’s CV which is made using Form 09 in Appendix I enclosed herewith (not required if the medical practitioner’s CV has been shared or published on the healthcare management information system or national healthcare database);

dd) A legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database);

e) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

15. An application package for issuance of practicing license submitted by a medical practitioner who is issued with a practicing certificate before January 01, 2024 in case this certificate has been lost or damaged is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

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c) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

16. An application package for issuance of practicing certificate submitted by a medical practitioner who has been issued with a practicing certificate before January 01, 2024 in case there is any change in the following information: full name, date of birth or personal identification number of a Vietnamese practitioner, or passport number and nationality for foreign practitioner, is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original of the issued practicing certificate;

c) The original(s) or legitimate copy(ies) of the document(s) proving such a change (not required if such information can be found or verified on the healthcare management information system or national healthcare database);

d) 02 pictures of 04 x 06 cm size, taken against a white background within 06 months of submitting the application (not required if the applicant's picture has been published when following online administrative procedures).

17. An application package for issuance of practicing license submitted by a medical practitioner whose practicing certificate has been revoked before January 01, 2024 as prescribed in Point a or b clause 1 Article 29 of the Law on Medical Examination and Treatment No. 40/2009/QH12 in case the period from after the practicing certificate has been revoked to the date of submission of application for practicing license shall not exceed 24 months is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) An original or legitimate copy of the decision to revoke practicing license (not required if such decision has been shared or published on the healthcare management information system or national healthcare database);

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18. Procedures for re-issuance of practicing license or practicing certificate issued before January 01, 2024:

a) The applicant for re-issuance of practicing license or practicing certificate which is issued before January 01, 2024 shall submit an application package for issuance or re-issuance of practicing license for the corresponding case specified in clauses 1 through 17 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority;

b) The licensing authority is required to re-issue the requested practicing license within 15 days of receipt of adequate required documents. In case of refusal, a written response, clearly stating reasons for such refusal, shall be sent to the applicant;

c) Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to re-issue a practicing license shall be 15 days from the day on which verification results are available.

Article 133. Cases and conditions for renewal of practicing license

1. A practicing license may be renewed if it expires as prescribed in clause 2 Article 27 of the Law on Medical Examination and Treatment.

2. Conditions for renewal of practicing license shall comply with the provisions of clause 2 Article 32 of the Law on Medical Examination and Treatment.

Article 134. Application package and procedures for renewal of practicing license

1. An application package for renewal of practicing license for the professional title of doctor, physician assistant, nurse, midwife, medical technician, clinical nutritionist, clinical psychologist, or out-of-hospital paramedic, is composed of:

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b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database);

c) Documentary evidence that the applicant has continuously updated medical knowledge in accordance with the Minister of Health of Vietnam’s regulations (not required if such continuous updating of medical knowledge has been shared or published on the healthcare management information system or national healthcare database);

d) A health check report issued by a qualified health facility (not required if such health check results have been shared or published on the healthcare management information system or national healthcare database) or a legitimate copy of the work permit which is required as prescribed by the Labor Code.

2. Procedures for renewal of practicing license:

a) The applicant submits an application package as prescribed in clause 1 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority at least 60 days before his/her practicing license expires.

In case of sickness, accident or a force majeure event occurring at the application submission date, the applicant shall notify the licensing authority in order to extend the submission deadline.

A medical practitioner may request permission for extension of the submission deadline multiple times, provided that an application package for renewal of practicing license must be submitted within 22 months after it expires;

b) During the period from the date of receipt of all required application documents to the expiry date printed on a practicing license, the licensing authority shall be responsible for renewing it or replying in writing to the license holder with clear reasons for refusal of renewal; where there is no written reply till the expiry date printed on the foregoing practicing license, it still remains valid as prescribed;

c) Where it is necessary to verify whether the applicant participates in medical knowledge updating programs run by qualified foreign entities or organizations, the duration of decision to renew the practicing license shall be 15 days from the day on which verification results are available.

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1. A practicing license may be modified in the following cases:

a) A person who has been issued with a practicing license or practicing certificate before January 01, 2024 on which the scope of practice does not include any specialty applies for addition of a specialty to his/her scope of practice;

b) A person who has been issued with a practicing license or practicing certificate before January 01, 2024 on which the scope of practice involves a particular specialty applies for addition of a specialty other than the licensed one to his/her scope of practice;

c) A person who has been issued with a practicing license or practicing certificate before January 01, 2024 on which the scope of practice involves a particular specialty stops practicing that licensed specialty and applies for replacement of that licensed specialty with another one;

d) A person who has been issued with a practicing license or practicing certificate before January 01, 2024 obtains a certificate of folk remedy holder or certificate of folk therapy holder.

2. Conditions for modification of a practicing license:

a) In case a person who has been issued with a practicing license or practicing certificate before January 01, 2024 on which the scope of practice does not include any specialty applies for addition of a specialty to his/her scope of practice, he/she must:

- hold one of the training qualifications specified in points b, c, d, dd or e clause 1 Article 127 of this Decree or the basic specialty certificate as prescribed in clause 2 Article 128 of this Decree corresponding to the title written in his/her practicing license and the specialty to be added;

- has successfully completed a medical internship, for the case prescribed in point b or c clause 2 Article 125 of this Decree.

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- hold one of the training qualifications specified in points b, c, d, dd or e clause 1 Article 127 of this Decree or the basic specialty certificate as prescribed in clause 2 Article 128 of this Decree corresponding to the title written in his/her practicing license and the specialty to be added;

- has successfully completed a medical internship, for the case prescribed in point b or c clause 2 Article 125 of this Decree.

c) In case a person who has been issued with a practicing license or practicing certificate before January 01, 2024 on which the scope of practice involves a particular specialty applies for replacement of that licensed specialty with another one, he/she must:

- hold one of the training qualifications specified in points b, c, d, dd or e clause 1 Article 127 of this Decree corresponding to the title written in his/her practicing license and the new specialty;

- has successfully completed a medical internship, for the case prescribed in point c clause 2 Article 125 of this Decree.

Article 136. Application package and procedures for modification of practicing license

1. An application package for modification of a practicing license in case of addition of a specialty to the licensed scope of practice as prescribed in point a, b or c clause 1 Article 135 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith).

b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database) or the practicing certificate issued before January 01, 2024.

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- The training qualification as prescribed in Points b, c, d, dd or e Clause 1 Article 127 of this Decree;

- The basic specialty certificate as prescribed in clause 2 Article 128 of this Decree.

d) An original or legitimate copy of certificate of completion of internship program made using Form No. 07 in Appendix I enclosed herewith (not required if internship results have been shared or published on the healthcare management information system or national healthcare database), if the applicant is:

- a medical practitioner prescribed in Point b or c Clause 2 Article 125 of this Decree; or

- a medical practitioner prescribed in Clause 5 or 6 Article 125 of this Decree.

2. An application package for modification of practicing license submitted by a person who has been issued with a practicing license on which the scope of practice involves a particular specialty but stops practicing that licensed specialty and applies for replacement of that licensed specialty with another one as prescribed in point c clause 1 Article 135 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith).

b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database) or the practicing certificate issued before January 01, 2024.

c) A legitimate copy of the training qualification prescribed in point b, c, d, dd or e clause 1 Article 127 of this Decree (not required if such training qualification has been shared or published on the healthcare management information system or national healthcare database).

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- a medical practitioner prescribed in Point c Clause 2 Article 125 of this Decree; or

- a medical practitioner prescribed in Clause 5 Article 125 of this Decree.

3. An application package for modification of a practicing license submitted by a person who has been issued with a practicing license but then obtains a certificate of folk remedy holder or certificate of folk therapy holder as prescribed in point d clause 1 Article 135 of this Decree is composed of:

a) An application form (made using Form 08 in Appendix I enclosed herewith);

b) A legitimate copy of the issued practicing license (not required if such practicing license has been shared or published on the healthcare management information system or national healthcare database) or the practicing certificate issued before January 01, 2024;

c) A legitimate copy of certificate of folk remedy holder or certificate of folk therapy holder (not required if such certificates have been shared on the healthcare management information system or national healthcare database).

4. Procedures for modification of practicing license in any of the cases prescribed in clause 1 Article 136 of this Decree:

a) The applicant submits an application package for the corresponding case as prescribed in clause 1 through 4 of this Article and application fee, as prescribed by the Law on Fees and Charges, to the licensing authority;

b) The licensing authority is required to modify the foregoing practicing license within 15 days of receipt of adequate required documents. In case of refusal, a written response, clearly stating reasons for such refusal, shall be sent to the applicant;

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c) Where it is necessary to verify documents of foreign origin enclosed in the application package, the duration of decision to modify a practicing license shall be 15 days from the day on which verification results are available.

Article 137. Procedures for suspension of medical practice, post-suspension actions; procedures for revocation of practicing license and post-revocation actions

1. Procedures for suspension of medical practice, post-suspension actions, and procedures for revocation of practicing license shall comply with the provisions of Articles 30, 31 and 32 of this Decree.

2. If a practicing license is revoked in case the application package for issuance of that practicing license fails to meet regulations as prescribed in point a clause 1 Article 35 of the Law on Medical Examination and Treatment: the medical practitioner whose practicing license is revoked (hereinafter referred to as “license holder”) is required to modify and re-submit the application package for issuance of practicing license.

a) If the license holder submits an application package for issuance of practicing license within 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

b) If the license holder submits an application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for issuance of practicing license.

3. If a practicing license is revoked in case there is any fraudulent document enclosed in the application package for issuance of the practicing license as prescribed in point b clause 1 Article 35 of the Law on Medical Examination and Treatment: an application package for issuance of practicing license may be submitted after the following time limit:

a) In case the qualification or certificate of completion of internship program included in the application package for issuance of practicing license is forged: at least 05 years from the issue date of the revocation decision;

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4. If a practicing license is revoked in case the professional title or the scope of practice printed in that practicing license is different from those stated in the application package for issuance of the practicing license as prescribed in point c clause 1 Article 35 of the Law on Medical Examination and Treatment: the license holder shall follow procedures for issuance of practicing license without incurring any fees.

a) If the license holder submits an application package for issuance of practicing license within 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

b) If the license holder submits an application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for issuance of practicing license.

5. If a practicing license is revoked in case the license holder has not practiced medicine for 24 consecutive months as prescribed in point d clause 1 Article 35 of the Law on Medical Examination and Treatment:

a) If the license holder completes a medical internship within 36 months from the issue date of the revocation decision, he/she may follow procedures for re-issuance of practicing license;

b) If the license holder fails to complete a medical internship within 36 months from the issue date of the revocation decision, he/she shall follow procedures for issuance of a new practicing license.

6. If a practicing license is revoked in the case prescribed in clause 1, 2, 3, 4 or 6 Article 20 of the Law on Medical Examination and Treatment:

a) If the license holder submits an application package for issuance of practicing license within 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

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c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for issuance of practicing license.

7. If a practicing license is revoked in case the Expert Council defined in Article 101 of the Law on Medical Examination and Treatment establishes that the license holder has committed an error related to his/her professional and technical expertise in healthcare to the extent of incurring the sanction of revocation of his/her practicing license (point e clause 1 Article 35 of the Law on Medical Examination and Treatment): the license holder must complete a medical internship before following procedures for issuance of a new practicing license.

8. If a practicing license is revoked in case the Expert Council defined in Article 101 of the Law on Medical Examination and Treatment establishes that the license holder has committed an error related to his/her professional and technical expertise in healthcare for the second time to the extent of incurring the sanction of revocation of his/her practicing license for the second time within the validity period of his/her practicing license (point g clause 1 Article 35 of the Law on Medical Examination and Treatment): an application package for issuance of practicing license shall only be submitted after 12 months counting from the issue date of the revocation decision.

9. If a practicing license is revoked in case the competent state agency establishes that the license holder has violated professional ethics for the second time to the extent of incurring the sanction of suspension of his/her practice of medicine within the validity period of that practicing license (point h clause 1 Article 35 of the Law on Medical Examination and Treatment): the license holder must complete a medical internship before following procedures for issuance of a new practicing license.

10. If a practicing license is revoked in case such revocation is made at the request of the medical practitioner as prescribed in point i clause 1 Article 35 of the Law on Medical Examination and Treatment:

a) If the license holder submits an application package for issuance of practicing license within 24 months from the issue date of the revocation decision, he/she shall be re-issued with the practicing license without re-practicing as a medical intern;

b) If the license holder submits an application package for issuance of practicing license within the period from 24 to 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for re-issuance of practicing license;

c) If the license holder submits an application package for issuance of practicing license after 60 months from the issue date of the revocation decision, he/she shall be required to complete a medical internship before following procedures for issuance of practicing license.

Article 138. Criteria for recognition of medical practitioners’ proficiency in Vietnamese or in another language in healthcare

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2. In case a medical practitioner registers for use of a language other than his/her native language or Vietnamese when delivering healthcare services, he/she must be tested and recognized by a training institution prescribed in Article 140 of this Decree to be proficient in the language that he/she has registered for use in healthcare, except the cases prescribed in clause 3 of this Article.

3. A medical practitioner shall be recognized to be proficient in Vietnamese or another language in healthcare without passing a language test if he/she meets any of the following criteria:

a) He/she holds an intermediate professional education diploma, or higher, in healthcare sector issued by a Vietnamese or foreign lawful training institution after having successfully completed this institution’s training program delivered in Vietnamese or the language that he/she registers for use during delivery of healthcare services.

b) He/she holds certificate of completion of a training course in healthcare sector which lasts at least 12 months and is delivered in Vietnamese or the language that he/she registers for use during delivery of healthcare services;

c) He/she holds a bachelor’s degree in Vietnamese or the language that he/she registers for use during delivery of healthcare services, which is issued by a Vietnamese or foreign lawful training institution.

The diploma or certificate prescribed in point a or b of this clause must have been issued within 05 years of submitting an application.

Article 139. Criteria for recognition of eligibility of interpreters in healthcare sector

1. A person’s eligibility to make language interpretation in healthcare sector shall be recognized if he/she has been tested and recognized by a training institution prescribed in Article 140 of this Decree, except the cases prescribed in clause 2 of this Article.

2. An interpreter in healthcare sector may be recognized to be eligible without passing any language test if he/she:

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b) hold a certificate of completion of a training course in healthcare sector which lasts at least 12 months and is delivered in the language that he/she registers for acting as an interpreter;

c) hold an intermediate professional education diploma, or higher, in healthcare sector, or herbalist certificate and a bachelor's degree in the language that he/she registers for acting as an interpreter.

The diploma or certificate prescribed in point a or b clause 2 of this Article must have been issued within 05 years of submitting an application.

3. An interpreter may only interpret for a medical practitioner at the same time he/she is giving medical examination and treatment to a patient.

Article 140. Eligibility requirements to be satisfied by training institutions testing and recognizing ones’ proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector

A training institution shall be eligible to test and recognize ones’ proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector if it meets the following requirements:

1. It is a Vietnamese higher education institution providing training courses in healthcare sector.

2. It has a foreign language department teaching the language being tested.

3. It has a question bank for testing ones’ proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector.

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1. An application package includes:

a) Legitimate copies of documents proving the establishment and operation of the training institution;

b) Documentary evidences of the existence of the foreign language department as prescribed in clause 2 Article 140 of this Decree and the list of full-time lecturers working at this department;

c) The question bank used for testing ones’ proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector in respect of the language to be tested.

2. In case a training institution that has been issued with a certificate of eligibility to test and recognize ones’ proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector applies for addition of a language being tested, the application package shall include the documents in points b and c clause 1 of this Article.

3. Procedures:

a) The training institution shall send an application package for certificate of eligibility to test and recognize ones’ proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector (hereinafter referred to as “test language”) as prescribed in clause 1 of this Article to the Ministry of Health of Vietnam;

b) Upon its receipt of the application package, the Ministry of Health of Vietnam shall give a receipt note made using Form 02 in Appendix I enclosed herewith to the training institution;

c) Within 15 days from the receipt of the application package, if the application package is satisfactory, the Ministry of Health of Vietnam shall issue a certificate of eligibility to test language in healthcare sector to the training institution using Form 02 in Appendix III enclosed herewith. If an application is refused, a written response clearly indicating reasons for refusal shall be given;

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dd) Within 15 days from the receipt of the modified application, the Ministry of Health of Vietnam shall issue a certificate of eligibility to test language to the training institution using Form 02 in Appendix III enclosed herewith; If an application is refused, a written response clearly indicating reasons for refusal shall be given;

e) Within 10 days from the issue date of the certificate of eligibility to test language, the Ministry of Health of Vietnam shall publish the name of the certificate holder on its web portal and on the healthcare management information system.

Article 142. Application package and procedures for recognition of proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector

1. An application package for testing and recognition of language proficiency in healthcare sector includes:

a) An application form (made using Form 01 in Appendix III enclosed herewith);

b) A legitimate copy of ID card, citizen identity card or unexpired passport;

c) Two color photos of 04 x 06 cm size, taken against a white background within 06 months of submitting the application.

2. An application package for recognition of proficiency in Vietnamese or other languages or eligibility of interpreters in healthcare sector includes:

a) An application form (made using Form 01 in Appendix III enclosed herewith);

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c) Legitimate copies of the qualifications/certificates prescribed in clause 3 Article 138 of this Decree, in case of application for recognition of proficiency in Vietnamese or other languages in healthcare sectors; legitimate copies of the qualifications/certificates prescribed in clause 2 Article 139 of this Decree, in case of application for recognition of interpreter’s eligibility in healthcare sector.

3. Procedures for testing and recognition:

a) The applicant shall submit an application package as prescribed in clause 1 of this Article to the training institution mentioned in Article 140 of this Decree;

b) Within 30 days from the receipt of adequate and valid application package, the training institution shall organize testing and issue a certificate using Form 03 in Appendix III enclosed herewith to the applicant mentioned in clauses 1 and 2 Article 138, and clause 1 Article 139 of this Decree. Testing results must be openly published.

4. Procedures for recognition:

a) The applicant shall submit an application package as prescribed in clause 2 of this Article to the training institution mentioned in Article 140 of this Decree;

b) Within 10 working days from the receipt of adequate and valid application package, the training institution shall issue a certificate using Form 03 in Appendix III enclosed herewith to the applicant mentioned in clause 3 Article 138, and clause 2 Article 139 of this Decree. If an application is refused, a written response clearly indicating reasons for such refusal shall be given.

5. The list of persons granted certificates as prescribed in point b clause 3 and point b clause 4 of this Article shall be published on the website of the training institution and on the healthcare management information system.

Section 2. ROADMAP FOR CONVERSION TO PRACTICING LICENSE AND TRANSITION ON OPERATING LICENSE

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1. A person who has started their internship before January 01, 2024 but not yet completed the internship duration may:

a) continue their internship according to provisions of the Law on Medical Examination and Treatment No. 40/2009/QH12 and its guiding documents. Internship results shall be used as the basis for issuance of a practicing license on which the scope of practice shall comply with the provisions of the Law on Medical Examination and Treatment No. 40/2009/QH12; or

b) comply with provisions on medical internship in this Decree.

2. From January 01, 2024, the practicing certificates issued under the Law on Medical Examination and Treatment No. 40/2009/QH12 and its guiding documents shall be deemed valid as practicing licenses until they are converted as prescribed in clause 3 of this Article while the scope of practice approved by competent authorities remain unchanged.

3. Conversion of practicing certificates into practicing licenses shall be made when following renewal procedures. To be specific:

a) Since 2030, a practicing certificate issued under the Law on Medical Examination and Treatment No. 40/2009/QH12 and its guiding documents shall be valid for 05 years;

b) The practicing certificate prescribed in point a of this clause shall expire in 2035. The expiry date shall be determined according to the date written on the issued practicing certificate;

c) A medical practitioner shall follow renewal procedures as prescribed in clause 2 Article 134 of this Decree to continue practicing medicine. If a medical practitioner who holds a practicing certificate issued by the Ministry of Health of Vietnam stops working for health facilities affiliated to this Ministry, he/she shall follow renewal procedures with a health authority affiliated to the relevant provincial People’s Committee.

4. Modification, re-issuance, suspension, revocation and post-suspension and post-revocation actions against holders of practicing certificates issued under the Law on Medical Examination and Treatment No. 40/2009/QH12 shall comply with provisions of the Law on Medical Examination and Treatment No. 15/2023/QH15 and the provisions of Section 1 Chapter VIII of this Decree. The validity period of a practicing license shall start from the day on which that practicing license is re-issued.

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6. If a holder of a practicing certificate issued under the Law on Medical Examination and Treatment No. 40/2009/QH12 wishes to apply for conversion of his/her practicing certificate into practicing license before the time prescribed in clause 3 of this Article, he/she shall be required to submit an application package and follow procedures for issuance of a new practicing license as prescribed in Article 130 of this Decree and return the issued practicing certificate.

7. Where an application package for practicing certificate has been shared and published on the healthcare management information system, the application package for re-issuance or modification or that practicing certificate under the Law on Medical Examination and Treatment No. 40/2009/QH12 shall be sent to the competent authority defined in Article 28 of the Law on Medical Examination and Treatment No. 15/2023/QH15.

8. Where an application package for practicing certificate has not yet been shared and published on the healthcare management information system, the application package for re-issuance or modification or that practicing certificate under the Law on Medical Examination and Treatment No. 40/2009/QH12 shall be sent to the authority issuing that practicing certificate.

Article 144. Transition on operating license

1. Health facilities that have been operating under operating licenses issued under the Law on Medical Examination and Treatment No. 40/2009/QH12 and its guiding documents shall be allowed to continue their operating under such issued operating licenses without converting into forms of organization prescribed in the Law on Medical Examination and Treatment No. 15/2023/QH15 and Article 39 of this Decree.

Any health facility that wishes to convert into a form of organization prescribed in this Decree must follow procedures for modification of its operating license as prescribed in Articles 64, 65 and 66 of this Decree.

2. A health facility that is a regional polyclinic and is issued with an operating license before the effective date of this Decree shall be allowed to provide inpatient treatment but must provide adequate staff on duty at all times (i.e. 24 hours per day and 7 days per week) to provide professional care.

3. A health facility that is an emergency care and patient transport service provider and is issued with an operating license before the effective date of this Decree may continue their operation but must meet the following requirements:

a) Material facilities:

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- Electricity and water systems and other conditions for caring patients are available.

b) Equipment and vehicles for transporting patients;

- Emergency vehicles with adequate medical devices are sufficient;

- It must be equipped with anaphylaxis kits and adequate emergency medicines to ensure safety and hygienic conditions for patients.

c) Personnel:

- Any employee that provides medical examination and treatment shall be required to possess a valid practicing certificate or practicing license and perform assigned tasks suitable to his/her scope of practice;

- Its person in charge of professional practices must be a doctor possessing a valid practicing certificate or person holding a practicing license for the title of doctor, holding professional qualification or certificate or certification of completion of training course in resuscitation in emergency care; have at least 36 months of practicing period; is its full-time medical practitioner.

d) A contract for emergency transport services signed with an air service company must be available, if it registers for transport of patients to foreign countries.

Article 145. Authority to issue, re-issue and modify operating license within period from January 01, 2024 to December 31, 2026

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a) issue and re-issue operating licenses to health facilities under its management and private hospitals.

b) modify operating licenses of health facilities under its management and private hospitals if their scope of professional activities are changed: addition or removal of techniques to or from their scope of professional activities.

c) modify operating licenses of health facilities under its management and private hospitals if their scale is changed. To be specific:

- There is an increase or decrease in number of professional departments or wards of the health facility, including the case specified in point dd clause 1 Article 54 of the Law on Medical Examination and Treatment;

- The number of hospital beds of the health facility is increased or decreased by at least 10% or by less than 10% but more than 30 hospital beds;

- The number of hospital beds of the health facility is changed as prescribed in clause 4 of this Article.

d) modify operating licenses of health facilities under its management and private hospitals if their opening hours are changed.

dd) modify operating licenses of health facilities under its management and private hospitals if there are changes in their names or addresses (without relocation).

2. Health authorities affiliated to provincial People's Committees shall have authority to:

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b) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, and private hospitals, if their scope of professional activities are changed: addition or removal of techniques to or from their scope of professional activities.

c) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, and private hospitals, if their scale is changed. To be specific:

- There is an increase or decrease in number of professional departments or wards of the health facility, including the case specified in point dd clause 1 Article 54 of the Law on Medical Examination and Treatment;

- The number of hospital beds of the health facility is increased or decreased by at least 10% or by less than 10% but more than 30 hospital beds;

- The number of hospital beds of the health facility is changed as prescribed in clause 4 of this Article.

d) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, and private hospitals, if their opening hours are changed.

dd) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, and private hospitals, if there are changes in their names or addresses (without relocation).

3. A hospital may increase or decrease the number of hospital beds of its departments or wards by less than 10% of its total number of hospital beds specified in its operating license but not more than 30 hospital beds, and must send a written report on such change to its supervisory authority. Such report must indicate:

a) The number of hospital beds of its departments or wards to be increased or decreased;

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4. If a hospital wishes to change the number of its hospital beds after it has completed procedures for increase or decrease of the number of its hospital beds by less than 10%, it shall be required to follow procedures for modification of its operating license as prescribed in Article 66 of this Decree. The hospital shall send an application package for modification of its operating license to:

a) The Ministry of Health of Vietnam, if it is affiliated to the Ministry of Health of Vietnam or a private hospital; or

b) The health authority affiliated to the People’s Committee of province or city where it is located, unless it is affiliated to the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, and private hospitals.

5. If a hospital wishes to change the number of its hospital beds after it has completed procedures for modification of its operating license as prescribed in clause 4 of this Article, it shall follow corresponding guidelines in clause 3 and clause 4 of this Article.

6. Application packages for issuance, re-issuance and modification of operating licenses submitted before December 31, 2026 shall be considered by the corresponding authority prescribed in clauses 1, 2 and 4 of this Article.

Article 146. Classification of health facilities by levels of professional techniques

Hospitals that have been issued with operating licenses before January 01, 2024 must follow procedures for being classified before January 01, 2025. Classification of these hospitals by levels of professional techniques shall be carried out as follows:

1. If the period from the issue date of the operating license to the day on which procedures are followed is shorter than 02 years, only an application form for classification as prescribed in point a clause 1 Article 90 of this Decree is submitted. Within 15 working days from the receipt of the application form submitted by the hospital, the licensing authority shall issue a document to temporarily classify the hospital into the basic healthcare level. This document on temporary classification of the hospital shall be valid for 02 years from the date thereon. At least 60 days before the expiry date of this document, the hospital must submit an application for classification of its professional and technical expertise as prescribed in Article 90 of this Decree.

2. If the period from the issue date of the operating license to the day on which procedures are followed is enough 02 years or longer, the hospital must submit an application package and follow procedures as prescribed in Article 90 of this Decree. Classification results shall be applied from January 01, 2025.

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IMPLEMENTATION

Article 147. Effect

1. This Decree comes into force from January 01, 2024.

2. Provisions on updating and publishing of information on the healthcare management information system in this Decree shall apply from January 01, 2027.

3. The Government’s Decree No. 109/2016/ND-CP dated July 01, 2016 prescribing issuance of practicing certificates to medical practitioners and issuance of operating licenses to health facilities and Article 11 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam shall cease to have effect from the effective date of this Decree.

4. Health facilities may make payment of healthcare costs according to regulations promulgated or approved by competent authorities until new regulations are promulgated but not later than December 31, 2024.

Health facilities that are issued with operating licenses within the period specified in clause 4 of this Article may apply regulations on classification to payment of healthcare services covered by the health insurance fund in accordance with regulations of law on health insurance.

5. Administrative procedures prescribed in this Decree shall be followed directly, by post or online in accordance with regulations of law on online completion of administrative procedures when relevant conditions are met.

6. Hospitals must complete the implementation of provisions of clause 4 Article 105 and Article 106 of this Decree before January 01, 2026.

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8. Heading of Chapter IV of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is changed as follows:

“Chapter IV. CLINICAL TRIALS FOR MEDICAL DEVICES”.

9. Article 12 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 12. Clinical trial phases for medical devices

1. A clinical trial for medical devices other than in vitro diagnostic (IVD) medical devices has the following phases:

a) Phase 1: preliminary study on the safety of medical device for patients and its usability for medical practitioners and healthcare workers.

b) Phase 2: confirmatory study to ascertain and establish evidence for the safety and efficacy of medical device;

c) Phase 3: post-market study which is conducted after the medical device has been placed on market to collect additional evidences on the safety and efficacy of the medical device when used at the request of competent authorities.

2. A clinical trial for IVD medical devices has the following phases:

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b) Phase 2: post-market study which is conducted after the IVD medical device has been placed on market to collect additional evidences on the safety and efficacy of the IVD medical device when used at the request of a competent authority.”.

10. Article 13 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 13. Exemption from clinical trials or some clinical trial phases before applying for marketing authorization for medical devices

1. The following medical devices will be exempt from clinical trials:

a) Class-A or Class-B medical devices;

b) Class-C or Class-D medical devices for which marketing authorization has been granted by the Ministry of Health of Vietnam or competent authorities of foreign countries.

2. Class-C or Class-D medical devices which are domestically manufactured and are not IVD medical devices will be exempt from the clinical trial Phase 1 if the following requirements are met:

a) The medical device has been manufactured employing a transferred technology which has been used in the manufacturing of a medical device granted marketing authorization by a competent authority, unless such marketing authorization has been revoked;

b) The subject medical device has the same indications for use as the one which has been granted marketing authorization by a competent authority as prescribed in point a of this clause.

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11. Article 14 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 14. Requirements for medical devices undergoing clinical trial

1. All legal and technical requirements set out in documentation requirements for marketing authorization for a medical device are met.

2. The investigational medical device must be labeled as “for clinical trial only - not for any other purposes”. The labeling of the investigational medical device shall comply with regulations of law on labeling of goods.”.

12. Article 15 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 15. Eligibility requirements for institutions conducting medical device clinical trials

1. It must meet good clinical practices (GCP) for medical devices in accordance with regulations of the Minister of Health of Vietnam.

2. It is capable of performing scientific research function and has its scope of operation conformable with the medical device subject to the clinical trial.

3. It must be a juridical person whose organizational structure, personnel and finance are independent from the organization or individual whose medical device is subject to the clinical trial.”.

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“Article 16. Clinical trial dossier for medical devices

1. A clinical trial dossier for medical device includes: an application for approval of clinical trial, application for approval of changes in clinical trial, and application for approval of clinical trial results. Components of each application will comply with the provisions of Article 17 of this Decree.

2. Documentation requirements:

a) Documents included in the clinical trial dossier for a medical device must be made in Vietnamese. Documents in a language other than Vietnamese must be accompanied by their certified Vietnamese translations.

b) Documents issued by foreign regulatory authorities must bear consular legalization made in accordance with regulations of law on consular legalization, unless such consular legalization procedures are exempted in accordance with regulations of law.”.

14. Article 17 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 17. Components of a clinical trial dossier for medical device

1. An application for approval of clinical trial includes:

a) An application form made by the organization or individual whose medical device is subject to the clinical trial.

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c) A competent authority’s written request in respect of the medical device which must undergo the clinical trial phase 3 or the IVD medical device which must undergo the clinical trial phase 2.

d) Documents on the medical device subject to the clinical trial, including:

- Description of the product (general information about the medical device subject to the clinical trial, including: name, characteristics, uses, indications, contraindications, technical specifications and other relevant information);

- Documents on preclinical study on the investigational medical device, including: study report on the safety and efficacy of the medical device, recommendations for use and storage of the medical device, and study reports on the stability and analytical performance (of IVD medical device) which have been appraised and certified to be satisfactory by the Expert Council of the institution conducting the clinical trial or the institution conducting preclinical study vested with certification task by the Ministry of Health of Vietnam;

- Documents on the clinical trial phases before the requested phase.

dd) Legal documents, including:

- Information on the owner and manufacturer of the medical device, manufacturing process;

- Technical file of the medical device;

- Technical standards applicable to the medical device as announced by its owner;

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- The approved user manual, if the medical device undergoes the clinical trial phase 3;

- Certificates of consent given by institutions participating in the trial;

- The clinical trial agreement signed by and between the authority, organization or individual whose medical device is subject to the clinical trial and the institution conducting the clinical trial; the research support agreement signed by and between the organization or individual whose medical device is subject to the clinical trial and the sponsor (if any).

e) Scientific documents, including:

- Description of the medical device clinical trial;

- Case Report Form (CRF);

- Informed consent forms given by the clinical trial participants.

g) Administrative documents:

- Academic resume and copy of certificate of completion of a training course in GCP, issued by the Ministry of Health of Vietnam or a qualified GCP training institution, of the principal investigator;

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- Label of the investigational medical device as prescribed in clause 2 Article 14 of this Decree and its user manual.

2. An application for approval of changes in clinical trial includes:

a) For changes in administrative documents or contact information of the institution conducting the clinical trial: this institution shall take charge of reporting such changes to the Ministry of Health of Vietnam for information consolidation.

b) For replacement of the principal investigator or the institution conducting the clinical trial, the application shall include:

- An application form for approval of changes in clinical trial;

- Documents proving corresponding changes.

c) For changes other than those specified in points a and b of this Clause, the application shall include: 

- An application form for approval of changes in clinical trial;

- Updated versions of the corresponding documents specified in clause 1 of this Article, as changed.

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a) An application form for approval of clinical trial results;

b) The copy of the approved clinical study protocol;

c) A copy of the decision to approve the clinical trial;

d) The record of appraisal of clinical trial results made by the internal Research Ethics Committee;

dd) Report on clinical trial results.”.

15. Article 18 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 18. Procedures for approving clinical trial

1. The clinical institution shall send an application for approval of clinical trial directly, online or by post to the Ministry of Health of Vietnam.

2. The Ministry of Health of Vietnam shall check the validity of the application within 05 working days from its receipt. If the application is valid, within 02 working days, the Ministry of Health of Vietnam shall transfer the application to the National Research Ethics Committee for appraisal and ethical considerations. If the application is invalid, within 02 working days, a written notice providing specific instructions for application modification shall be given to the applicant.

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3. The National Research Ethics Committee shall conduct review and ethical consideration of the trial on a periodical basis of every month.

4. Within 05 working days from the receipt of the certificate of approval of clinical trial given by the National Research Ethics Committee and the accompanied application, the Ministry of Health of Vietnam shall issue a decision to approve clinical trial.”.

16. Article 19 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 19. Procedures for approving changes in clinical trial

1. The clinical institution shall send an application for approval of changes in clinical trial directly, online or by post to the Ministry of Health of Vietnam.

2. The Ministry of Health of Vietnam shall check the validity of the application within 05 working days from its receipt. If the application is invalid, within 02 working days, the Ministry of Health of Vietnam shall give a written notice providing specific instructions for modification until the application is considered valid.

The clinical institution shall complete the application within 60 days from the receipt of the notice. After this period, procedures for approving changes in clinical trial must be restarted.

3. For changes specified in point b clause 2 Article 17 of this Decree: within 07 working days from the receipt of adequate and valid application, the Ministry of Health of Vietnam shall issue a decision to approve changes in clinical trial.

4. For changes specified in point c clause 2 Article 17 of this Decree:

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b) The National Research Ethics Committee shall conduct review and ethical consideration of the trial on a periodical basis of every month;

c) Within 05 working days from the receipt of the certificate of approval of changes in clinical trial given by the National Research Ethics Committee and the accompanied application, the Ministry of Health of Vietnam shall issue a decision to approve changes in clinical trial.”.

17. Article 20 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

“Article 20. Procedures for approving clinical trial results

1. The clinical institution shall send an application for approval of clinical trial results, which must be made in Vietnamese, directly, online or by post to the Ministry of Health of Vietnam.

2. The Ministry of Health of Vietnam shall check the validity of the application within 05 working days from its receipt. If the application is valid, within 02 working days, the Ministry of Health of Vietnam shall transfer it to the National Research Ethics Committee for review. If the application is invalid, within 02 working days, the Ministry of Health of Vietnam shall give a written notice providing specific instructions for modification to the clinical institution.

The clinical institution shall complete the application within 60 days from the receipt of the notice. After this period, procedures for approving clinical trial results must be restarted.

3. The National Research Ethics Committee shall conduct review and ethical consideration of the trial on a periodical basis of every month.

4. Within 05 working days from the receipt of the certificate of approval of clinical trial results given by the National Research Ethics Committee and the accompanied application, the Ministry of Health of Vietnam shall issue a decision to approve clinical trial results.”.

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a) The application form for approval of clinical trial made by an organization or individual whose medical device is subject to the clinical trial included in the application for approval of clinical trial as prescribed in clause 14 of this Article shall be made using Form 10 in Appendix VI enclosed herewith;

b) The application form for approval of clinical trial made by a clinical institution included in the application for approval of clinical trial as prescribed in clause 14 of this Article shall be made using Form 11 in Appendix VI enclosed herewith;

c) Description of the clinical trial protocol included in the application for approval of clinical trial as prescribed in clause 14 of this Article shall be made using Form 12 in Appendix VI enclosed herewith;

d) The application form for approval of changes in clinical trial included in the application for approval of changes in clinical trial as prescribed in clause 14 of this Article shall be made using Form 13 in Appendix VI enclosed herewith;

dd) The application form for approval of clinical trial results included in the application for approval of clinical trial results as prescribed in clause 14 of this Article shall be made using Form 14 in Appendix VI enclosed herewith;

e) The report on clinical trial results included in the application for approval of clinical trial results as prescribed in clause 14 of this Article shall be made using Form 15 in Appendix VI enclosed herewith.

19. Article 30 of the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices is amended as follows:

a) Point h is added following point g clause 1 Article 30 as follows:

“h) Certificate of results of clinical trial for medical device issued by a competent authority, if the medical device is subject to a clinical trial as prescribed in clause 2 Article 94 of the Law on Medical Examination and Treatment.”.

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“c) The documents specified in Points b, c, d, dd, e and h clause 1 of this Article.”.

c) Point h is added following point g clause 4 Article 30 as follows:

“h) Certificate of results of clinical trial for medical device issued by a competent authority, if the medical device is subject to a clinical trial as prescribed by law.”.

d) Point e is added following point dd clause 5 Article 30 as follows:

“e) Certificate of results of clinical trial for medical device issued by a competent authority, if the medical device is subject to a clinical trial as prescribed in clause 2 Article 94 of the Law on Medical Examination and Treatment.”.

20. Provisions of clause 5 Article 105 of this Decree and clause 19 of this Article shall apply from January 01, 2026.

21. Article 32a is added to the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices as follows:

“Article 32a. Priority in processing applications for marketing authorization for medical devices

1. Processing of applications for marketing authorization for medical devices shall be prioritized in the following cases:

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b) Imported medical devices for which applications for import license have been submitted to the Ministry of Health of Vietnam before January 01, 2022 but not yet been processed, and for which applications for marketing authorization have also been submitted;

c) Chemicals and preparations which are only used for decontamination of medical devices;

d) Medical devices which are employed for performing new techniques or methods in medical examination and treatment under official approvals given by the Ministry of Health of Vietnam but for which marketing authorization numbers have not yet been granted in Vietnam;

dd) Medical devices for which there is no change in information on type and HS code on the unexpired import license or decision to grant marketing authorization number or marketing authorization but which is subject to one of the following cases:

- There are changes in the importer or the applicant for marketing authorization;

- The name of the manufacturer is changed but its address;

- The name of the medical device’s owner is changed but its address;

e) A medical device for which there is no information on its type on the unexpired import license or decision to grant marketing authorization number or marketing authorization but information on product code on the same document is changed due to terminated manufacturing of products of the previous code;

g) The Ministry of Health of Vietnam has given a document rejecting, or requesting modification of, the submitted application for marketing authorization due to validity of one of the following documents: letter of authorization of the marketing authorization holder, certificate of conformity with ISO 13485 quality standards, or marketing authorization for the medical device;

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2. Procedures for priority processing of an application for marketing authorization:

a) The applicant shall submit the following documents to the Ministry of Health of Vietnam:

- An application form for priority processing of the application which must indicate adequate information on the code of the submitted application for marketing authorization on the website of the Ministry of Health of Vietnam;

- Corresponding support documents for the cases specified in clause 1 of this Article;

b) The Ministry of Health of Vietnam shall consider permitting the priority processing of application for marketing authorization for medical device within 10 working days from its receipt of the application form for priority processing and accompanied documents. If an application is refused, a written response indicating reasons for such refusal shall be provided.

3. Applications for license to import medical devices prescribed in point b clause 1 of this Article for which marketing authorization has been issued shall not be rejected.".

22. The Government’s Decree No. 102/2011/ND-CP dated November 14, 2011 on liability insurance in healthcare sector shall cease to have effect from the effective date of this Decree.

23. Authorities issuing practicing licenses and operating licenses shall:

a) establish secretarial boards in charge of appraising applications for issuance, re-issuance and modification of practicing licenses falling within their jurisdiction;

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c) establish appraisal teams to serve the issuance, re-issuance, modification or renewal of operating licenses falling within their jurisdiction.

Article 148. Responsibility for implementation

Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of Provincial People’s Committees and relevant authorities, organizations and individuals are responsible for the implementation of this Decree.

ON BEHALF OF THE GOVERNMENT
 PP. PRIME MINISTER
DEPUTY PRIME MINISTER




Tran Hong Ha