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THE
GOVERNMENT
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
148/2025/ND-CP
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Hanoi,
June 12, 2025
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DECREE
ON DEVOLUTION AND DELEGATION IN THE HEALTH SECTOR
Pursuant to the Law on Organization
of the Government 2025;
Pursuant to the Law on
Organization of Local Government 2025;
Pursuant to Resolution No.
190/2025/QH15 dated February 19, 2025 of the National Assembly on addressing
certain issues related to the reorganization of the State administrative
apparatus;
At the request of the Minister
of Health;
The Government hereby
promulgates the Decree on devolution and delegation in the health sector.
Chapter I
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Article 1.
Scope
This Decree stipulates the
competence, procedures for performing the tasks and exercising the powers of
competent authorities and persons in the health sector as provided in laws,
resolutions of the National Assembly, ordinances, resolutions of the Standing
Committee of the National Assembly, decrees of the Government, and decisions of
the Prime Minister which need to be adjusted for the purposes of devolution and
delegation.
Article 2.
Principles of competence allocation
1. Ensure compliance with the Constitution;
conformity with the principles and regulations on devolution and delegation as
prescribed in the Law on Organization of the Government 2025 and the Law on
Organization of Local Government 2025.
2. Ensure thorough delegation of
tasks between central state agencies and local authorities, while guaranteeing
unified management authority of the Government, executive power of the Prime
Minister over state management in the field of the Ministry of Justice, and
promoting autonomy, creativity, and accountability of local governments in
state management in the field of justice.
3. Ensure that the Government, the
Prime Minister, Ministries, and ministerial-level agencies focus on macro-level
state management tasks; formulate institutions, strategies, master plans, and
plans in a synchronous and unified manner; play a facilitating role; and
strengthen inspection, supervision, and oversight.
4. To promote devolution and
delegation and clearly define the competence of the People’s Council, the
People’s Committee, and the head of the specialized health authority under the
People’s Committee; clearly distinguish the general competence of the People’s
Committee and the separate competence of the head of the specialized health
authority under the People’s Committee; ensure such distribution is appropriate
to the assigned tasks, powers, and capacity of the competent authorities and
persons.
5. To implement devolution and
delegation among relevant sectors and areas in a consistent, holistic, and
interconnected manner, avoiding omission, overlap, or duplication of tasks; to
ensure a legal basis for the uninterrupted, seamless, and continuous operations
of agencies; and to prevent disruption, overlapping, redundancy, or omission of
functions, tasks, fields, or jurisdictions.
6. To ensure human rights and
citizens’ rights; ensure transparency and openness; facilitate individuals and
organizations in accessing information, exercising rights and obligations, and
performing procedures in accordance with the law; and avoid disruption to the
normal operations of society, people, and enterprises.
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Article 3. Fees
and charges
For administrative procedures requiring
fees and charges in accordance with the law on fees and charges, individuals
and organizations must pay such fees and charges at the time of submitting
applications to the receiving authority. The fee and charge rates, as well as
the management and use thereof, shall comply with the regulations of the
Government, the Minister of Finance, or the Province-level People’s Council for
the corresponding fees and charges.
Chapter II
DEVOLUTION IN THE HEALTH
SECTOR
Article 4.
Appointment of forensic examiners and forensic psychiatric examiners
1. The appointment of forensic
examiners and forensic psychiatric examiners as stipulated in Clauses 1 and 2
Article 9 of the Law on Judicial Expertise 2012 as amended in 2020 shall fall
under the competence of the head of the specialized health authority under the
Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 1 of Appendix I enclosed with this Decree.
Article 5.
Dismissal of forensic examiners and forensic psychiatric examiners
1. The dismissal of forensic
examiners and forensic psychiatric examiners as stipulated in Article 10 of the
Law on Judicial Expertise 2012 as amended in 2020 shall fall under the
competence of the head of the specialized health authority under the Province-level
People’s Committee.
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Article 6.
Adjustment of medical operation license
1. The adjustment of the medical
operation license in cases of changes to operational scale, scope of medical
services, or addition/removal of medical techniques (excluding special-category
techniques) for private hospitals as prescribed in Clause 13 Article 121 of the
Law on Medical Examination and Treatment shall fall under the competence of the
head of the specialized health authority under the Province-level People’s
Committee.
2. Applications, procedures shall
comply with Section 1 of Appendix II enclosed with this Decree.
Article 7.
Issuance, reissuance, extension, modification, suspension, and revocation of
medical practice certificates
1. The issuance, reissuance,
extension, modification, suspension, and revocation of medical practice
certificates for entities specified at Point a, Clause 1, Article 28 of the Law
on Medical Examination and Treatment shall fall under the competence of the
head of the specialized health authority under the Province-level People’s
Committee.
2. Applications, procedures:
a) Issuance of medical practice
certificates shall comply with Section 2 of Appendix II enclosed with this
Decree;
b) Reissuance of medical practice
certificates shall comply with Section 3 of Appendix II enclosed with this
Decree;
c) Extension of medical practice
certificates shall comply with Section 4 of Appendix II enclosed with this
Decree;
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dd) Suspension of medical practice
shall comply with Section 6 of Appendix II enclosed with this Decree;
e) Revocation of medical practice
certificates shall comply with Section 7 of Appendix II enclosed with this
Decree.
Chapter III
DELEGATION IN THE HEALTH
SECTOR
Section 1.
DELEGATION IN THE FIELD OF DISEASE PREVENTION
Article 8.
Issuance of certificates of occupational HIV exposure and certificates of
occupational HIV infection
1. The issuance of the certificate
of occupational HIV exposure and the certificate of occupational HIV infection
as prescribed in Clause 1, Article 4 of the Prime Minister’s Decision No.
24/2023/QD-TTg dated September 22, 2023, on conditions for identifying persons
exposed to HIV and persons infected with HIV due to occupational accidents, for
those working in health facilities affiliated to the Ministry of Health located
in a province, shall fall under the competence of the head of the specialized
health authority under the Province-level People’s Committee.
2. Applications, procedures:
a) Issuance of the certificate of
occupational HIV exposure shall comply with Section 1 of Appendix III enclosed
with this Decree;
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Article 9.
Issuance of the certificate of compliance with biosafety level III standards
for testing facilities
1. The issuance and reissuance of
the certificate of compliance with biosafety level III standards for testing
facilities as prescribed in Clause 1, Article 10 of Decree No. 103/2016/ND-CP
dated July 01, 2016 of the Government on biosafety assurance in laboratories
shall fall under the competence of the head of the specialized health authority
under the Province-level People’s Committee.
2. Applications, procedures:
a) Issuance of the certificate of
compliance with biosafety level III standards shall comply with Section 3 of
Appendix III enclosed with this Decree;
b) Reissuance of the certificate of
compliance with biosafety level III standards due to expiration shall comply
with Section 4 of Appendix III enclosed with this Decree;
c) Reissuance of the certificate of
compliance with biosafety level III standards due to damage or loss shall
comply with Section 5 of Appendix III enclosed with this Decree;
d) Reissuance of the certificate of
compliance with biosafety level III standards due to change of the testing
facility's name shall comply with Section 6 of Appendix III enclosed with this
Decree.
Article 10.
Issuance of certificate of eligibility for confirmatory HIV testing facilities
1. The issuance, reissuance,
modification, and revocation of certificates of eligibility for confirmatory
HIV testing facilities as prescribed in Clause 1, Article 42 of Decree No.
141/2024/ND-CP dated October 28, 2024 of the Government on elaboration of the
Law on Prevention and Control of Human Immunodeficiency Virus (HIV/AIDS), shall
fall under the competence of the head of the specialized health authority under
the Province-level People’s Committee.
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a) Issuance of the certificate of
eligibility for confirmatory HIV testing facilities shall comply with Section 7
of Appendix III enclosed with this Decree;
b) Reissuance of the certificate of
eligibility for confirmatory HIV testing facilities shall comply with Section 8
of Appendix III enclosed with this Decree;
c) Modification of the certificate
of eligibility for confirmatory HIV testing facilities shall comply with
Section 9 of Appendix III enclosed with this Decree.
Article 11.
Applications, procedures for declaration of eligibility for occupational
environment monitoring
1. The receipt of applications for
declaration of eligibility for occupational environment monitoring as
prescribed at Point a, Clause 2, Article 34 of Decree No. 44/2016/ND-CP dated
May 15, 2016 of the Government on elaboration of the Law on Occupational Safety
and Hygiene regarding technical inspection of occupational safety, training on
occupational safety and hygiene, and occupational environment monitoring, for
organizations headquartered in the province, shall fall under the competence of
the head of the specialized health authority under the Province-level People’s
Committee.
2. Applications, procedures shall
comply with Section 10 of Appendix III enclosed with this Decree.
Article 12.
Applications, procedures for registration of circulation of insecticidal and
germicidal products used in household and healthcare sectors
1. The issuance, reissuance,
extension, supplementation, revocation of circulation registration, and
issuance of import licenses for insecticidal and germicidal products used in
household and healthcare sectors as prescribed in Decree No. 91/2016/ND-CP
dated July 01, 2016 of the Government on management of chemicals and
insecticidal and germicidal products used in household and healthcare sectors,
as amended in 2024, shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee.
2. Applications, procedures:
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b) Extension of circulation
registration of insecticidal and germicidal products used in household and
healthcare sectors shall comply with Section 12 of Appendix III enclosed with
this Decree;
c) Supplementation of circulation
registration of insecticidal and germicidal products used in household and
healthcare sectors due to change of ownership shall comply with Section 13 of
Appendix III enclosed with this Decree;
d) Supplementation of circulation
registration of insecticidal and germicidal products used in household and
healthcare sectors due to change of product name shall comply with Section 14
of Appendix III enclosed with this Decree;
dd) Supplementation of circulation
registration of insecticidal and germicidal products used in household and
healthcare sectors due to change of production site or production facility
shall comply with Section 15 of Appendix III enclosed with this Decree;
e) Supplementation of circulation
registration of insecticidal and germicidal products used in household and
healthcare sectors due to change of name or contact address of the registrant
or manufacturer shall comply with Section 16 of Appendix III enclosed with this
Decree
g) Supplementation of circulation
registration due to change in efficacy, dosage, method of use, concentration of
active ingredient, co-formulant content, product form, shelf life, or source of
active ingredient shall comply with Section 17 of Appendix III enclosed with this
Decree;
h) Reissuance of circulation
certificate of insecticidal and germicidal products used in household and
healthcare sectors shall comply with Section 18 of Appendix III enclosed with
this Decree;
i) Notification of changes in label
content or format of insecticidal and germicidal products used in household and
healthcare sectorsshall comply with Section 19 of Appendix III enclosed with
this Decree;
k) Issuance of import license of
insecticidal and germicidal products used in household and healthcare sectors
for research purposes shall comply with Section 20 of Appendix III enclosed
with this Decree;
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m) Issuance of import license for
insecticidal and germicidal products used in household and healthcare sectors
as gifts or donations shall comply with Section 22 of Appendix III enclosed
with this Decree;
n) Issuance of import license for
insecticidal and germicidal products used in household and healthcare sectors
due to the unavailability of suitable products or methods of use on the market
shall comply with Section 23 of Appendix III enclosed with this Decree;
o) Issuance of certificate of free
sale (CFS) for export of insecticidal and germicidal products used in household
and healthcare sectors under the management of the Ministry of Health shall
comply with Section 24 of Appendix III enclosed with this Decree;
p) Amendment, supplementation, or
reissuance of certificate of free sale (CFS) for export of insecticidal and
germicidal products used in household and healthcare sectors under the
management of the Ministry of Health shall comply with Section 25 of Appendix
III enclosed with this Decree;
q) Suspension of circulation or
revocation of circulation registration number of insecticidal and germicidal
products used in household and healthcare sectors shall comply with Section 26
of Appendix III enclosed with this Decree.
Section 2.
DELEGATION IN THE FIELD OF MEDICAL EXAMINATION AND TREATMENT
Article 13.
Receipt of declaration of eligibility for health examination and HIV/AIDS
diagnosis and treatment
1. The receipt of declaration of
eligibility for health examination and HIV/AIDS diagnosis and treatment as
prescribed at Point a, Clause 1, Article 69 of Decree No. 96/2023/ND-CP dated
December 30, 2023 of the Government on elaboration of the Law on Medical
Examination and Treatment, shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 8 of Appendix II enclosed with this Decree.
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1. The permission for foreign
nationals to enter Vietnam to transfer medical techniques or collaborate in
clinical medical training as prescribed at Point a, Clause 3, Article 86 of Decree
No. 96/2023/ND-CP shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 9 of Appendix II enclosed with this Decree.
Article 15.
Permission to organize periodic humanitarian medical missions or mobile medical
services
1. Permission to organize periodic
humanitarian medical missions or mobile medical services as prescribed in
Clause 1, Article 79 of the Law on Medical Examination and Treatment, or for
individual humanitarian practitioners as prescribed at Point a, Clause 3,
Article 83 of Decree No. 96/2023/ND-CP (excluding cases involving two or more
centrally-affiliated provinces or cities) shall fall under the competence of the
head of the specialized health authority under the Province-level People’s
Committee.
2. Applications, procedures shall
comply with Section 10 of Appendix II enclosed with this Decree.
Article 16.
Receipt of declaration of health facility qualified as a practice-based
training facility
1. The receipt of declaration of a
health facility that meets the requirements to serve as a practice-based
training facility as prescribed at Point a, Clause 2, Article 6 of Decree No.
96/2023/ND-CP shall fall under the competence of the head of the specialized
health authority under the Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 11 of Appendix II enclosed with this Decree.
Article 17.
Receipt of declaration of health facility eligible for telemedicine
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2. Applications, procedures shall
comply with Section 12 of Appendix II enclosed with this Decree.
Article 18.
Permission for health facilities to pilot telemedicine
1. Permission for health facilities
to implement pilot telemedicine as prescribed at Point a, Clause 6, Article 87
of Decree No. 96/2023/ND-CP shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 13 of Appendix II enclosed with this Decree.
Article 19.
Registration for medical practice
1. The receipt of applications for
medical practice registration as prescribed in Article 29 of Decree No.
96/2023/ND-CP shall fall under the competence of the head of the specialized
health authority under the Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 14 of Appendix II enclosed with this Decree.
Section 3.
DELEGATION IN THE FIELD OF MEDICAL DEVICES
Article 20.
Continuation of circulation of medical devices in case the owner ceases
production or is bankrupt/dissolved (applicable to Class A and B medical
devices)
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2. Applications, procedures shall
comply with Section 1 of Appendix IV enclosed with this Decree.
Article 21.
Issuance of certificate of free sale for medical devices
1. The issuance of certificates of
free sale (CFS) for Class A and B medical devices as prescribed in Clause 1,
Article 50 of Decree No. 98/2021/ND-CP as amended in 2025 shall fall under the
competence of the head of the specialized health authority under the Province-level
People’s Committee.
2. Applications, procedures shall
comply with Section 2 of Appendix IV enclosed with this Decree.
Article 22.
Receipt of declaration on concentration and content in raw materials for
medical device manufacturing and reference substances containing narcotic
substances and precursors
1. The receipt of declarations on
the concentration and content of narcotic substances and precursors as
prescribed in Clause 2, Article 60 and receipt of reports on the sale, export,
import, or transfer of medical devices, raw materials, or reference substances
containing narcotic substances and precursors as prescribed in Clause 4,
Article 74 of Decree No. 98/2021/ND-CP as amended in 2025 shall fall under the
competence of the head of the specialized health authority under the
Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 3 of Appendix IV enclosed with this Decree.
Article 23.
Revocation of medical device classification results
1. The head of the specialized
health authority under the Province-level People’s Committee shall be
responsible for revoking medical device classification results as prescribed in
Article 6 of Decree No. 98/2021/ND-CP as amended in 2025.
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Article 24.
Price declaration of medical devices
1. The receipt of price declaration
documents for medical devices as prescribed in Subsection 15, Appendix V
enclosed with Decree No. 85/2024/ND-CP dated July 10, 2024 of the Government on
elaboration of the Law on Prices, shall fall under the competence of the head
of the specialized health authority under the Province-level People’s
Committee.
2. The publication of the List of
medical device trading entities conducting price declaration, and the receipt
and implementation of price declarations shall comply with Section 5 of
Appendix IV enclosed with this Decree, under the competence of the head of the
specialized health authority under the Province-level People’s Committee.
Section 4.
DELEGATION IN THE FIELD OF FOOD SAFETY
Article 25.
Issuance, amendment, supplementation, and reissuance of certificates of free
sale (CFS) for food products
1. The issuance, amendment, supplementation,
and reissuance of certificates of free sale (CFS) for exported food products
under the management of the Ministry of Health as prescribed in Article 11 of
Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government on elaboration of
the Law on Foreign Trade Management, shall fall under the competence of the
head of the specialized health authority under the Province-level People’s
Committee or the specialized agency assigned by the Province-level People’s
Committee.
2. Applications, procedures:
a) Issuance of certificate of free
sale (CFS) for exported food products under the management of the Ministry of
Health shall comply with Section 1 of Appendix V enclosed with this Decree;
b) Amendment, supplementation, or
reissuance of certificate of free sale (CFS) for exported food products under
the management of the Ministry of Health shall comply with Section 2 of
Appendix V enclosed with this Decree.
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1. The receipt of registration for
advertising contents of medical nutrition foods, foods for special dietary
uses, and nutritional products for children up to 36 months of age as
prescribed in Clause 2, Article 26 of Decree No. 15/2018/ND-CP dated February 2,
2018 of the Government on elaboration of the Law on Food Safety, shall fall
under the competence of the head of the specialized health authority under the
Province-level People’s Committee or a specialized agency authorized by the
Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 3 of Appendix V enclosed with this Decree.
Article 27.
Issuance of certificate of eligibility for food safety
1. The issuance of certificates of
eligibility for food safety for food production facilities under the management
of the Ministry of Health as prescribed in Chapter III of Decree No.
67/2016/ND-CP dated July 1, 2016 of the Government on conditions for food
production and trading under the specialized management of the Ministry of Health,
as amended in 2018, shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee or a
specialized agency authorized by the Province-level People’s Committee.
2. Applications, procedures shall
comply with Section 4 of Appendix V enclosed with this Decree.
Article 28.
Registration of product declaration for medical nutrition foods, foods for
special dietary uses, and nutritional products for children up to 36 months of
age
1. The receipt of applications for
registration of product declaration for imported and domestically produced
medical nutrition foods, foods for special dietary uses, and nutritional
products for children up to 36 months of age as prescribed in Clause 1, Article
8 of Decree No. 15/2018/ND-CP shall fall under the competence of the head of
the specialized health authority under the Province-level People’s Committee or
a specialized agency authorized by the Province-level People’s Committee.
2. Applications, procedures:
a) Registration of product
declaration for imported products for medical nutrition foods, foods for
special dietary uses, and nutritional products for children up to 36 months of
age shall comply with Section 5 of Appendix V enclosed with this Decree;
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Article 29.
Designation of food testing facilities for state management purposes
1. The designation of food testing
facilities for state management purposes as prescribed in Clause 6, Article 37
of Decree No. 15/2018/ND-CP shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee or a
specialized agency authorized by the Province-level People’s Committee.
2. Applications, procedures:
a) Designation of food testing
facilities for state management purposes shall comply with Section 7 of
Appendix V enclosed with this Decree;
b) Designation of food testing
facilities accredited by legally recognized organizations in Vietnam or by
foreign accreditation organizations that are members of the Mutual Recognition
Arrangement of the International Laboratory Accreditation Cooperation (ILAC) or
the Asia-Pacific Accreditation Cooperation (APAC), assessed and certified under
TCVN ISO/IEC 17025 or ISO/IEC 17025 international standards, shall comply with
Section 8 of Appendix V enclosed with this Decree.
c) Modification or supplementation
of the designated scope of food testing facilities serving state management
purposes shall comply with Section 9 of Appendix V enclosed with this Decree;
d) Extension of designation of food
testing facilities serving state management purposes shall comply with Section
10 of Appendix V enclosed with this Decree;
dd) Exemption from inspection and
supervision for food testing facilities accredited by legally recognized
organizations in Vietnam or by foreign accreditation bodies that are members of
the Mutual Recognition Arrangement of the International Laboratory
Accreditation Cooperation (ILAC) or the Asia-Pacific Accreditation Cooperation
(APAC), and certified under National Standard TCVN ISO/IEC 17025 or
International Standard ISO/IEC 17025, shall comply with Section 11 of Appendix
V enclosed with this Decree.
Article 30.
Issuance of certificates for exported food products
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2. Applications and procedures for
issuance shall comply with Section 12 of Appendix V enclosed with this Decree.
Article 31.
Assignment or designation of competent authorities for inspection of imported
food safety with respect to products under the management of the Ministry of
Health
The assignment or designation of
competent authorities for inspection of imported food safety for products under
the management scope of the Ministry of Health as prescribed in Clause 1,
Article 15 and Clause 1, Article 37 of Decree No. 15/2018/ND-CP shall fall
under the competence of the head of the specialized health authority under the
Province-level People’s Committee or the specialized agency assigned by the
Province-level People’s Committee.
Section 5.
DELEGATION IN THE FIELDS OF MATERNAL AND CHILD HEALTH, SCIENCE, TECHNOLOGY AND
TRAINING
Article 32.
Recognition of health facilities eligible to perform in vitro fertilization
(IVF)
1. The recognition of health
facilities eligible to perform in vitro fertilization (IVF) as prescribed in
Article 8 of Decree No. 10/2015/ND-CP dated January 28, 2015 of the Government on
childbearing through in vitro fertilization and conditions for altruistic
surrogacy, as amended in 2016 and 2018, shall fall under the competence of the
head of the specialized health authority under the Province-level People’s
Committee.
2. Applications, procedures for
recognition of health facilities eligible to perform in vitro fertilization
(IVF) shall comply with Section 1 of Appendix VI enclosed with this Decree.
Article 33.
Issuance of certificate to educational institutions eligible to assess and
certify Vietnamese language proficiency or other language proficiency or
interpreting competence in medical examination and treatment
1. The issuance of certificates to
educational institutions eligible to assess and certify Vietnamese language
proficiency, foreign language proficiency, or interpreting competence in
medical examination and treatment as prescribed in Clause 3, Article 141 of
Decree No. 96/2023/ND-CP shall fall under the competence of the head of the
specialized health authority under the Province-level People’s Committee.
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Chapter IV
IMPLEMENTATION
PROVISIONS
Article 34.
Entry into force
1. This Decree comes into force as
of July 1, 2025.
2. The administrative procedures
listed in Appendix VIII enclosed with this Decree shall be repealed from the
effective date of this Decree.
3. This Decree shall cease to be
effective as of March 1, 2027, except in the following cases:
a) Ministries or ministerial-level
agencies report to the Government and are approved by the National Assembly to
extend the application of this Decree in whole or in part;
b) If laws, resolutions of the
National Assembly, ordinances, resolutions of the Standing Committee of the
National Assembly, decrees or resolutions of the Government, or decisions of
the Prime Minister related to state management competence, responsibilities,
applications, or procedures prescribed in this Decree are passed or issued
between July 1, 2025 and March 1, 2027, the relevant provisions of this Decree
shall cease to be effective from the effective date of such legal instruments.
4. During the effective period of
this Decree, if its provisions on state management competence,
responsibilities, applications, or procedures differ from those in other legal
normative documents, the provisions of this Decree shall prevail.
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For applications submitted prior to
the effective date of this Decree, the receiving authority shall continue
to process them in accordance with the current regulations until the
administrative procedure is completed.
ON
BEHALF OF THE GOVERNMENT
PP. PRIME MINISTER
DEPUTY PRIME MINISTER
Nguyen Hoa Binh
APPENDIX I
ADMINISTRATIVE PROCEDURES IN THE FIELD OF FORENSIC
ASSESSMENT
(Enclosed with Decree No. 148/2025/ND-CP dated June 12, 2025 of the
Government)
Section 1. Applications and
procedures for appointment of forensic examiners and forensic psychiatric
examiners
1. Application for appointment of
forensic examiners and forensic psychiatric examiners includes:
a) A written request for
appointment of forensic examiners and forensic psychiatric examiners from a
competent agency or organization;
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Diplomas granted by foreign
educational institutions must be recognized for use in Vietnam under agreements
on diploma equivalence, mutual recognition, or relevant international treaties
to which the Socialist Republic of Vietnam is a signatory;
c) A curriculum vitae as
prescribed;
d) A certificate from the agency or
organization where the appointee works, confirming their actual experience in
the relevant professional field;
dd) A certificate of training or
professional development in forensic assessment for the appointee in the fields
of forensic science, forensic psychiatry, or criminalistics.
2. Procedures for appointment of
forensic examiners and forensic psychiatric examiners:
a) Institutions such as the
Institute of Criminal Science under the Ministry of Public Security; the
Military Institute of Forensic Medicine under the Ministry of National Defense;
the National Institute of Forensic Medicine; the Central Institute of Forensic
Psychiatry; the Central Bien Hoa Institute of Forensic Psychiatry; five
regional forensic psychiatry centers; and other forensic or forensic psychiatry
organizations shall review, select, and compile applications for submission to
the specialized health authority under the Province-level People’s Committee
where the organization is headquartered (hereinafter referred to as the
receiving authority).
b) The receiving authority shall
review and verify the validity of the application. If the application is
incomplete, it shall issue a written notice requesting the applicant to
supplement or amend it accordingly;
c) Within 20 days from the date of
receipt of a complete and valid application, the receiving authority shall
organize the assessment of the application and submit it to the head of the
receiving authority for consideration and decision on the appointment of the
forensic examiner or forensic psychiatric examiner.
If the appointment is denied, a
written response stating the reasons must be provided;
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Section 2. Applications and
procedures for dismissal of forensic examiners and forensic psychiatric
examiners
1. Application for dismissal of
forensic examiners and forensic psychiatric examiners includes:
a) A written request for dismissal
submitted by the managing agency or organization, or an application for
dismissal submitted by the forensic examiner or forensic psychiatric examiner;
b) Supporting documents proving
that the the forensic examiner or forensic psychiatric examiner falls under one
of the grounds for dismissal.
2. Procedures for dismissal of
forensic examiners and forensic psychiatric examiners:
a) The Institute of Criminal
Science under the Ministry of Public Security; the Military Institute of
Forensic Medicine under the Ministry of National Defense; the National
Institute of Forensic Medicine; the Central Institute of Forensic Psychiatry;
the Central Bien Hoa Institute of Forensic Psychiatry; five regional forensic
psychiatry centers; and other forensic or forensic psychiatry assessment
organizations shall prepare and submit the dismissal application to the
receiving authority.
b) The receiving authority is
responsible for verifying the legality of the application. If the application
is incomplete or invalid, the Province-level People’s Committee shall issue a
written instruction requesting the applicant to complete the application.
Within 10 days from the date of
receiving a complete and valid application, the receiving authority shall
submit the case to the head of the authority for review and decision on
dismissal, revoke the the forensic examiner’s or forensic psychiatric
examiner’s card, update the list of examiners on the web portal of the
Province-level People’s Committee, and notify the Ministry of Justice to update
the national registry of judicial experts.
If the dismissal is not approved,
the receiving authority shall notify the requesting organization in writing,
stating the reasons.
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APPENDIX II
ADMINISTRATIVE PROCEDURES IN THE FIELD OF MEDICAL
EXAMINATION AND TREATMENT
(Enclosed with Decree No. 148/2025/ND-CP dated June 12, 2025 of the Government)
Section 1.
Procedures for adjustment of medical operation license in case of changes to
operational scale, scope of professional activities, or addition/removal of
medical techniques (excluding special-category techniques) for private
hospitals
1. Submit 01 application set as
prescribed in Clause 2, Article 64 of Decree No. 96/2023/ND-CP (in person, by post,
or electronically) and pay the fee as regulated to the specialized health
authority under the Province-level People’s Committee (hereinafter referred to
as the receiving authority).
2. Upon receipt of the application,
the receiving authority shall issue an application receipt slip to the
applicant.
3. If revisions or supplements are
required, within 07 working days from the date indicated on the receipt slip,
the receiving authority must issue a written notice to the applicant clearly
specifying the documents or contents that must be revised or supplemented.
The applicant must submit the
revised or supplemented application within 06 months from the date of the
notice. After this deadline, if the applicant fails to submit, the initial
application shall be considered void.
4. Upon receipt of the
revised/supplemented application, the receiving authority shall issue a receipt
for the revised application.
If the revised application remains
inadequate, the authority shall reissue a written notice in accordance with
Clause 3 of this Article.
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If the applicant still fails to
submit or if more than 12 months have passed since the initial submission and
the revised application still fails to meet requirements, the entire
application shall be considered void.
5. If no revision is required or
the application has been completed in accordance with Clause 3 or 4 of this
Article, the receiving authority shall:
a) Issue a decision approving the
change in operational scale, scope of professional activities, or adjustment of
the medical techniques list within
20 days from the date on the
receipt slip, in cases where on-site verification is not required;
b) The receiving authority shall
conduct an on-site appraisal at the applicant facility and prepare an appraisal
report within 60 days from the date indicated on the application receipt slip
in cases where on-site verification is required. The appraisal report must
clearly state any required modifications or supplements (if applicable).
6. After conducting the on-site
appraisal, the receiving authority shall:
a) Issue a written approval for
changes to the operational scale, professional service scope, or adjustments to
the medical techniques list within 10 working days from the date of the
appraisal report, if no modifications or supplements are required;
b) Issue a written notice
specifying required corrections or modifications within 5 working days from the
date of the appraisal report if such modifications or supplements are needed.
If the applicant fails to complete
the required modifications or supplements within 06 months from the date of the
notice, the submitted application shall become invalid.
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a) Issue a written approval for
changes to the operational scale, professional service scope, or adjustments to
the medical techniques list, if no on-site reinspection is required;
b) Conduct an on-site reinspection
of the modifications or supplements, and:
- Issue a written approval for
changes to the operational scale, professional service scope, or adjustments to
the medical techniques list if the modifications or supplements meet
requirements;
- Issue a written notice of refusal
with reasons not approving the changes to the operational scale, professional
service scope, or adjustments to the medical techniques list if the
modifications or supplements are deemed inadequate.
8. Within 5 working days from the
date of approval of the license adjustment, the receiving authority shall
publish and update the relevant information on its official website or portal
and on the health examination and treatment management information system.
9. The license adjustment document
shall be made in two copies: one for the applicant and one to be retained by
the licensing authority, unless the result has been returned via electronic
means.
Section 2.
Procedures for issuance of new medical practice certificates
1. During the period from the
effective date of this Decree until December 31, 2026, the procedures for
issuance of new medical practice certificates for the professional titles of
doctor, physician assistant, nurse, midwife, medical technician, clinical
dietitian, and emergency medical technician shall be as follows:
a) The applicant shall submit 01
application set corresponding to the applicable case under Clauses 1 to 4,
Article 130 of Decree No. 96/2023/ND-CP (in person, by post, or
electronically), and pay the fees as prescribed to the specialized health
authority under the Province-level People’s Committee (hereinafter referred to
as the receiving authority);
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In cases where verification of
documents involving foreign elements is required, the 30-day period shall be
counted from the date of receipt of the verification results.
2. From January 1, 2027, the
procedures for issuance of new medical practice certificates for the
professional titles of doctor, physician assistant, nurse, midwife, medical
technician, clinical dietitian, and emergency medical technician shall be as
follows:
a) The applicant shall submit 01 application
set corresponding to the applicable case under Clauses 1 to 5, Article 14 of
Decree No. 96/2023/ND-CP (in person, by post, or electronically), and pay the
fees as prescribed to the receiving authority;
b) The receiving authority shall
process the application and issue the medical practice certificate within 30
days from the date of receipt of a complete application. If the certificate is
not granted, a written explanation stating the reasons must be provided.
In cases where verification of
documents involving foreign elements is required, the 30-day period shall be
counted from the date of receipt of the verification results.
3. Procedures for issuance of
medical practice certificates for traditional medicine practitioners or holders
of traditional remedies or treatment methods
a) The applicant shall submit 01
application set corresponding to the applicable case under Clauses 1 to 6,
Article 22 of Decree No. 96/2023/ND-CP (in person, by post, or electronically),
and pay the prescribed fees to the receiving authority;
b) The receiving authority shall
process the application and issue the medical practice certificate within 30
days from the date of receipt of a complete application. If the certificate is
not granted, a written explanation stating the reasons must be provided.
In cases where verification of
documents involving foreign elements is required, the 30-day period shall be
counted from the date of receipt of the verification results.
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1. From the effective date of this
Decree to December 31, 2026, procedures for reissuance of medical practice
certificates for the professional titles of doctor, physician assistant, nurse,
midwife, medical technician, clinical dietitian, and emergency medical
technician shall be as follows:
a) The applicant whose original
medical practice certificate or practicing license was issued before January 1,
2024, shall submit 01 application set corresponding to the applicable case
under Clauses 1 to 17, Article 132 of Decree No. 96/2023/ND-CP (in person, by
post, or electronically), and pay the prescribed fees to the receiving
authority;
b) The receiving authority shall
reissue the certificate within 15 days from the date of receipt of a complete
application. If the certificate is not reissued, the authority must provide a
written response stating the reason;
c) In cases where verification of
documents involving foreign elements is required, the time limit for reissuance
shall be 15 days from the date the verification result is received.
2. From January 1, 2027, procedures
for reissuance of medical practice certificates for the professional titles of
doctor, physician assistant, nurse, midwife, medical technician, clinical
dietitian, and emergency medical technician shall be as follows:
a) The applicant for reissuance of
a medical practice certificate shall submit 01 application set corresponding to
the applicable case under Clauses 1 to 14, Article 16 of Decree No.
96/2023/ND-CP (in person, by post, or electronically), and pay the prescribed
fees to the receiving authority;
b) The receiving authority shall
reissue the medical practice certificate within 15 days from the date of
receipt of a complete application. If the certificate is not reissued, the authority
must provide a written response stating the reason;
c) In cases where verification of
documents involving foreign elements is required, the time limit for reissuance
shall be 15 days from the date the verification result is received.
3. Procedures for reissuance of
medical practice certificates for traditional medicine practitioners or holders
of traditional remedies or treatment methods
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b) The receiving authority shall
reissue the medical practice certificate within 15 days from the date of
receipt of a complete application. If the certificate is not reissued, the
authority must provide a written response stating the reason;
c) In cases where verification of
documents involving foreign elements is required, the time limit for reissuance
shall be 15 days from the date the verification result is received.
Section 4.
Procedures for extension of medical practice certificates
1. From the effective date of this
Decree to December 31, 2026, procedures for extension of medical practice
certificates for the professional titles of doctor, physician assistant, nurse,
midwife, medical technician, clinical dietitian, and emergency medical
technician shall be as follows:
a) The applicant for extension of a
medical practice certificate shall submit 01 application set as prescribed in
Clause 1, Article 134 of Decree No. 96/2023/ND-CP (in person, by post, or
electronically), and pay the prescribed fees to the receiving authority at
least 60 days before the certificate expiry date;
In case of illness, accident, or
force majeure at the time of submission, the applicant must notify the
receiving authority in writing to postpone the submission deadline;
The practitioner may request to
postpone the extension deadline multiple times, but the total deferred time
must not exceed 22 months from the certificate expiry date.
b) From the time of receipt of a
complete application until the expiration date stated on the medical practice
certificate, the receiving authority is responsible for extending the
certificate or providing a written response with reasons for refusal; in case
no written response is issued by the expiry date, the medical practice
certificate shall remain valid as prescribed;
c) If verification of continuous
medical education is required, conducted under a program by a foreign
organization or agency, the extension process shall be completed within 15 days
from the date of verification results.
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a) The applicant shall submit 01
application set as prescribed in Clause 1, Article 18 of Decree No.
96/2023/ND-CP (in person, by post, or electronically), and pay the prescribed
fees to the receiving authority at least 60 days prior to the expiration of the
certificate;
In case of illness, accident, or force
majeure at the time of submission, the applicant must notify the receiving
authority in writing to postpone the submission deadline;
In case of illness, accident, or
force majeure at the time of submission, the applicant must notify the
receiving authority in writing to postpone the submission deadline;
The practitioner may request to
postpone the extension deadline multiple times, but the total deferred time
must not exceed 22 months from the certificate expiry date.
b) From the time of receipt of a complete
application until the expiration date stated on the medical practice
certificate, the receiving authority is responsible for extending the
certificate or providing a written response with reasons for refusal; in case
no written response is issued by the expiry date, the medical practice
certificate shall remain valid as prescribed;
c) If verification of continuous
medical education is required, conducted by a foreign organization or agency,
the extension process shall be completed within 15 days from the date of
verification results.
3. Procedures for extension of
medical practice certificates for traditional medicine practitioners or holders
of traditional remedies or treatment methods shall be as follows:
a) The applicant for extension of a
medical practice certificate shall submit an application as prescribed in
Clauses 1 and 2, Article 26 of Decree No. 96/2023/ND-CP (in person, by post, or
electronically), and pay the prescribed fees to the receiving authority at
least 60 days prior to the expiration of the certificate;
In case of illness, accident, or
force majeure at the time of submission, the applicant must notify the
receiving authority in writing to postpone the submission deadline;
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b) From the time of receipt of a
complete application until the expiration date of the medical practice
certificate, the receiving authority is responsible for extending the
certificate or providing a written response with reasons for refusal; in case
no written response is issued by the expiry date, the medical practice
certificate shall remain valid as prescribed.
Section 5.
Procedures for modification of medical practice certificates
1. From the effective date of this
Decree to December 31, 2026, procedures for modification of medical practice
certificates in the cases specified in Clause 1, Article 135 of Decree No.
96/2023/ND-CP shall be as follows:
a) The applicant for modification
of the medical practice certificate shall submit 01 application set
corresponding to the applicable case under Clauses 1 to 3, Article 136 of
Decree No. 96/2023/ND-CP (in person, by post, or electronically), and pay the
prescribed fees to the receiving authority;
b) The receiving authority shall
process and issue the modification within 15 days from the date of receipt of a
complete application; if not modified, the authority must issue a written
response stating the reason;
The form of modification shall be
a decision on modification of the scope of practice using Form 10 of
Appendix I enclosed with Decree No. 96/2023/ND-CP. This decision shall
constitute an integral part of the issued medical practice certificate;
c) If verification of documents
involving foreign elements is required, the time limit for modification shall
be 15 days from the date the verification result is received.
2. From January 1, 2027, procedures
for modification of medical practice certificates for cases specified in Clause
1, Article 19 of Decree No. 96/2023/ND-CP shall be as follows:
a) The applicant for modification
of the medical practice certificate shall submit 01 application set
corresponding to each case specified in Clause 1 or Clause 2, Article 20 of
Decree No. 96/2023/ND-CP (in person, by post, or electronically), and pay the
fees as prescribed by the law on fees and charges to the receiving authority;
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The form of modification shall be
a decision on modification of the scope of practice using Form 10 of
Appendix I enclosed with Decree No. 96/2023/ND-CP. This decision shall
constitute an integral part of the issued medical practice certificate;
c) If verification of documents
involving foreign elements is required, the time limit for modification shall
be 15 days from the date the verification result is received.
Section 6.
Procedures for suspension of medical practice and post-suspension measures
1. For cases where the practitioner
is suspended based on the conclusion of the Professional Council as prescribed
in Article 101 of the Law on Medical Examination and Treatment (Point a, Clause
1, Article 34), the suspension procedures are as follows:
a) In case the Professional Council
is established by the health facility in accordance with Point a, Clause 4,
Article 101 of the Law:
- Within 05 working days from the
date of the conclusion, the Chairperson of the Professional Council must sign
and send the written conclusion to the health facility;
- Within 05 working days from the
date of receipt of the above document, the health facility must submit a
written report to the specialized health authority under the Province-level
People’s Committee, clearly stating the reasons for proposing the suspension;
- Within 05 working days from the
date of receipt of the health facility’s report, the specialized health
authority under the Province-level People’s Committee must issue a decision on
suspension. The content of the suspension decision must be based on the
Professional Council’s conclusion;
b) In case the Professional Council
is established by the specialized health authority under the Province-level
People’s Committee as prescribed in Point b, Clause 4, Article 101 of the Law:
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- Within 05 working days from the
date of receipt of the proposal from the Chairperson as prescribed in point b of
this clause, the specialized health authority under the Province-level People’s
Committee must issue a decision on suspension. The content of the
decision must be based on the Council’s conclusion.
2. For cases where the practitioner
is suspended based on the conclusion of a competent authority for violating
medical ethics, but not to the extent of revoking the medical practice
certificate (Point b, Clause 1, Article 34 of the Law), the procedures are as
follows:
In case the competent authority
concludes that the practitioner has violated professional ethics but does not
have the authority to suspend or revoke the medical practice certificate:
- The competent authority shall
send a written conclusion of the ethical violation, including the
recommendation and justification for suspension, to the state health management
authority directly supervising the practitioner;
- Within 05 working days from the
receipt of the conclusion, the competent state health management authority must
issue a suspension decision, which must be based on the written
conclusion;
b) Where the authority concluding
the ethical violation has the function to suspend or revoke the certificate:
Within 05 working days from the
issuance of the written conclusion, the competent authority must issue the
suspension decision, which must be based on that written conclusion.
3. For cases where the practitioner
is suspended due to unfitness for practice based on health reasons (Point c,
Clause 1, Article 34 of the Law), the procedures are as follows:
Within 05 working days from the
date of receiving the conclusion from a competent authority (including: courts,
forensic examination bodies, or health examination facilities) regarding the
practitioner’s unfitness for medical practice, the competent state health
management authority must issue a decision on suspension. The content of the
decision must be based on the conclusion of the competent authority.
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a) Whether the suspension is
partial or full; if partial, the specific scope of suspension must be
specified;
b) Duration of the suspension;
c) Requirements for continuing
medical education for the practitioner, except in the case of traditional
medicine practitioners, those possessing family-inherited remedies, or
traditional treatment methods;
d) Conditions for resumption of
medical practice.
5. Within 05 working days from the
date of issuance of the decision on partial or full suspension of the scope of
practice of a practitioner, the issuing authority shall:
a) Deliver the decision to the
practitioner and enforce the restriction of the practitioner’s scope of
practice on the information system for medical examination and treatment management,
or notify the health facility where the practitioner is employed for
implementation, and notify the professional medical association for supervision
purposes;
b) Send the decision to the
authority that issued the medical practice certificate to the practitioner, in
case the suspending authority is not the same as the licensing authority.
6. Post-suspension actions shall be
carried out in accordance with Article 31 of Decree No. 96/2023/ND-CP.
Section 7.
Applications, procedures for revocation of medical practice certificates
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The application for revocation of a
medical practice certificate under Point i, Clause 1, Article 35 of the Law on
Medical Examination and Treatment shall include:
1. An application form;
2. The original (if available) or a
valid copy of the issued medical practice certificate (not applicable if the
certificate has been integrated and shared on the Information system for
medical examination and treatment management or the national health database).
B. Applications, procedures:
1. For the cases specified under
Points a, b, c, and d, Clause 1, Article 35 of the Law on Medical Examination
and Treatment:
a) The organization or individual
detecting that the practitioner falls under a case requiring certificate
revocation must notify the specialized health authority under the
Province-level People’s Committee;
b) The specialized health authority
shall verify the dossier, documents, and information provided. If the case
falls under a revocation condition, it shall issue a decision on revocation of
the medical practice certificate.
2. For the case specified under
Point dd, Clause 1, Article 35 of the Law on Medical Examination and Treatment:
The specialized health authority
under the Province-level People’s Committee shall issue a decision on
revocation of the practitioner’s certificate within 05 working days from the
receipt of the notification or service of process from the competent authority
indicating that the practitioner is subject to prohibition from medical practice
under Clauses 1, 2, 3, 4, and 6 of Article 20 of the Law on Medical Examination
and Treatment.
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a) In case the Professional Council
is established by the health facility in accordance with Point a, Clause 4,
Article 101 of the Law:
- Within 05 working days from the
date of the conclusion, the Chairperson of the Professional Council must sign
and send the written conclusion to the health facility;
- Within 05 working days from the
date of receipt of the conclusion, the health facility must submit a report to
the specialized health authority under the Province-level People’s Committee,
clearly stating the reason for proposing revocation of the medical practice
certificate;
- Within 05 working days from the
date of receipt of the written request from the health facility, the
specialized health authority under the Province-level People’s Committee shall
issue a decision on revocation of the medical practice certificate. The
revocation decision must be based on the conclusion of the Professional
Council.
b) In case the Professional Council
is established by the specialized health authority under the Province-level
People’s Committee as prescribed in Point b, Clause 4, Article 101 of the Law:
- Within 05 working days from the
date of the conclusion, the Chairperson of the Professional Council shall sign
and send a written request to the specialized health authority under the
Province-level People’s Committee, clearly stating the reasons for proposing
revocation of the medical practice certificate;
- Within 05 working days from the
date of receipt of the request from the Chairperson of the Professional
Council, the specialized health authority under the Province-level People’s
Committee shall issue a decision on revocation. The revocation decision must be
based on the conclusion of the Professional Council.
4. For the case specified in Point
h, Clause 1, Article 35 of the Law on Medical Examination and Treatment:
Within 05 working days from the
date of receipt of the written conclusion by a competent authority stating that
the practitioner has, for the second time during the validity period of their
medical practice certificate, violated professional ethics to the extent that
suspension is required, the competent health authority managing the
practitioner shall issue a decision on revocation. The revocation decision must
be based on the written conclusion of the competent authority.
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The receiving authority shall issue
a decision on revocation of the medical practice certificate 15 days after
receiving the application for revocation from the practitioner (submitted
directly, by post, or electronically).
6. The revocation decision must
include the following:
a) Full name of the practitioner
and number of the medical practice certificate;
b) The revocation decision and
reasons for revocation;
c) Conditions for resuming medical
practice.
7. Within 10 working days from the
issuance of the revocation decision, the revoking authority shall send the
decision to the practitioner and the health facility where the practitioner is
working, and shall cancel the practitioner’s registration on the electronic
portal or website of the receiving authority and the information system for
medical examination and treatment management.
Section 8.
Procedures for receipt of declaration of eligibility for health examination and
HIV/AIDS diagnosis and treatment
1. Prior to performing initial
health examinations, health facilities (except those under the management of
the Ministry of Public Security or the Ministry of National Defense) must
submit one application set as prescribed in Article 68 of Decree No.
96/2023/ND-CP (in person, by post, or electronically) to the receiving
authority.
2. Upon receipt of the application
for declaration of eligibility for health examination and HIV/AIDS diagnosis
and treatment, the receiving authority shall issue a receipt form to the
declaring facility using Form 02 in Appendix I enclosed with Decree No.
96/2023/ND-CP.
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3. If the application is complete
and valid as prescribed in Article 68 of Decree No. 96/2023/ND-CP and no
further documents are requested, within 15 working days from the date of
receipt confirmation, the declaring facility is allowed to commence health
examination and HIV/AIDS diagnosis and treatment activities in accordance with
the declared scope of practice.
4. In case a facility that has
declared its eligibility for conducting health examinations and providing
HIV/AIDS diagnosis and treatment undergoes any changes to their name, address,
physical infrastructure, personnel, or declared scope of professional practice,
the facility must submit a written notice to the authority that received the
original declaration.
Section 9.
Procedures for granting permission for foreign nationals to enter Vietnam to
transfer medical techniques or engage in medical training with clinical
practice
1. Health facilities (except for
those under the management of the Ministry of Health, Ministry of Public
Security, or Ministry of National Defense) shall submit 01 application set as
prescribed in Clause 2, Article 86 of Decree No. 96/2023/ND-CP (in person, by
post, or electronically) to the receiving authority.
2. Within 15 days from the date of
receipt of a complete application, the receiving authority in the locality
where the health facility is based shall provide a written response on whether
it agrees to the entry of foreign nationals for medical technique transfer or
collaboration in medical training with clinical practice in Vietnam. In case of
disapproval, a written response specifying the reasons must be provided.
Section 10.
Procedures for organizing periodic humanitarian medical missions and mobile
medical services
1. Organizations and individuals
conducting periodic humanitarian medical missions or mobile medical services
shall submit 01 application set as prescribed in Clause 1 or Clause 2, Article
83 of Decree No. 96/2023/ND-CP, depending on the specific case (in person, by
post, or electronically), to the receiving authority in the locality where the
medical activities are intended to be carried out (except in cases involving
two or more centrally-affiliated provinces/cities or medical activities at
health facilities under the Ministry of National Defense or the Ministry of
Public Security).
2. Within 10 days from the date of
receipt of a complete application, the receiving authority shall issue a
written response regarding the approval of periodic humanitarian medical
missions or mobile medical services. In case of disapproval, a written response
specifying the reasons must be provided.
Section 11.
Applications, procedures for declaration of health facilities eligible to serve
as practice-based training facilities
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The application for declaration of
a health facility eligible to serve as a practice-based training facility
includes:
1. Declaration form of the health
facility's eligibility to serve as a practice-based training facility, using
Form 01 in Appendix I enclosed with Decree No. 96/2023/ND-CP.
2. Specific training content
applicable to the intended professional titles.
3. A valid original or copy of the
cooperation contract with another health facility that meets the practice
requirements, in cases where the applying facility does not have sufficient
departments as prescribed in Article 3 of Decree No. 96/2023/ND-CP.
B. Applications, procedures:
The procedures for declaration of a
health facility eligible to serve as a practice-based training facility are as
follows:
1. Prior to providing practical
training, the health facility must submit 01 application set (in person, by
post, or electronically) to the receiving authority.
2. Upon receipt of the declaration
application, the receiving authority shall issue a receipt form to the facility
using Form 02 in Appendix I enclosed with Decree No. 96/2023/ND-CP.
3. Within 15 days from the date
recorded on the receipt form prescribed in Clause 3, Article 6 of Decree No.
96/2023/ND-CP, the receiving authority shall publish the information of the
practice-based training facility on its web portal or electronic information
page and on the information system for medical examination and treatment
management.
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The published information must
include at minimum: name and address of the practice-based training facility,
scope of training (if there is collaboration with other facilities, the scope
and names of the partner facilities must also be disclosed), and training fees.
In the event that, after 15 days
from the date recorded on the receipt form, the receiving authority neither
provides a written notice that the facility does not meet the requirements nor
publishes the required information as per Clause 4, Article 6 of Decree No.
96/2023/ND-CP, the facility shall be deemed eligible to commence training
activities.
Section 12.
Procedures for declaration of health facilities eligible to provide
telemedicine services
1. Health facilities shall submit
01 application set as prescribed in Clause 2, Article 87 of Decree No.
96/2023/ND-CP (in person, by post, or electronically) to the receiving
authority.
2. Upon receipt of the application,
the receiving authority shall issue the facility a receipt of application using
Form 02 in Appendix I enclosed with Decree No. 96/2023/ND-CP.
3. Within 10 days from the date
stated on the receipt of application as prescribed in Clause 2, Article 87 of
Decree No. 96/2023/ND-CP, the receiving authority shall publish the information
of the eligible facility for telemedicine services on its web portal or
information page and on the information system for medical examination and
treatment management.
In case the facility does not meet
the requirements, the receiving authority must issue a written notice
specifying the reasons.
If, after 10 days from the date on
the receipt of application, the receiving authority neither sends a written
response nor publishes the required information as prescribed in Point c of
this Clause, the health facility may commence the provision of telemedicine
services.
Section 13.
Applications and procedures for pilot implementation of telemedicine services
by health facilities
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The application for permission to
pilot telemedicine services shall include:
1. A written request for pilot
implementation, indicating the expected start date of telemedicine services;
2. Medical operation license of the
facility (not applicable if the license is already connected/shared on the
information system for medical examination and treatment management or the
national health database);
3. List of telemedicine services
intended to be provided;
4. Supporting documents proving
compliance with the requirements specified in Point d, Clause 1 of this
Article;
5. A list of practitioners expected
to participate in the pilot, including full names and license numbers of their
issued medical practice certificates;
6. Other supporting documents
demonstrating compliance with applicable requirements.
B. Procedures:
The procedures for granting
permission to pilot telemedicine services shall be as follows:
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2. Upon receipt of the application,
the receiving authority shall issue a receipt to the applicant facility.
3. If no request for amendments or
supplements is made, the receiving authority must conduct an appraisal within
30 days from the date indicated on the receipt. Where necessary, an
on-site appraisal may be conducted.
4. Within 15 days from the date of
the appraisal report, the receiving authority shall issue a written approval
for pilot implementation of telemedicine services, specifying the number of
pilot cases allowed. If the request is denied, a written explanation must be
provided.
5. If amendments or supplements are
required, within 15 days from the date on the receipt, the receiving authority
shall notify the applicant facility in writing, specifying the required
documents and contents to be amended or supplemented.
6. Upon receiving the
amended/supplemented application, the receiving authority shall issue a new
receipt and repeat the procedures under Clauses 3 and 4 of this Article.
7. If the amended/supplemented
application fails to meet the requirements, the receiving authority shall
notify the applicant facility in accordance with Clause 5 of this Article.
Section 14.
Applications and procedures for registration of medical practice
A. Applications
The application for registration of
medical practice consists of the list of practitioners to be registered, using
Form 01 in Appendix II enclosed with Decree No. 96/2023/ND-CP.
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The procedures for registration of
medical practice are as follows:
1. Health facilities shall register
their practitioners as follows:
a) Submit the list of practitioners
for registration concurrently with the application for a new medical operation
license (in person, by post, or electronically) to the receiving authority
where the health facility is located;
b) In case of any changes in
practitioners while awaiting issuance of the operation license, the facility
must submit the updated list of practitioners using Form 01 in Appendix II
enclosed with Decree No. 96/2023/ND-CP (in person, by post, or electronically)
to the receiving authority;
c) In case of changes in practitioners
during operation, the facility must submit a written registration (in person,
by post, or electronically) to the receiving authority, specifically as
follows:
- If a practitioner no longer works
at the facility: report to the specialized health authority under the
Province-level People’s Committee where the facility is located within 03
working days from the date the practitioner ceases working at the facility;
- If adding a new practitioner:
submit the updated list of practitioners for registration using Form 01 in
Appendix II enclosed with Decree No. 96/2023/ND-CP to the receiving authority
within 10 days from the date of addition.
2. The receiving authority is
responsible for publicly posting the list of practitioners on its web portal or
information page and on the information system for medical examination and
treatment management as follows:
a) At the same time as issuing the
medical operation license for cases specified at Points a and b, Clause 1 of
this Article;
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c) If the registration is rejected,
a written response with reasons must be provided.
APPENDIX III
ADMINISTRATIVE PROCEDURES IN THE FIELD OF DISEASE
PREVENTION
(Enclosed with Decree No. 148/2025/ND-CP dated June 12, 2025, of the
Government)
Section 1.
Application and procedures for issuance of certificate of occupational HIV
exposure
1. The application for issuance of a
certificate of occupational HIV exposure includes:
a) Official dispatch requesting the
issuance of the certificate of occupational HIV exposure, using Form 01
enclosed with Decision No. 24/2023/QD-TTg;
b) Occupational accident report
using Form 03 enclosed with Decision No. 24/2023/QD-TTg;
c) Original or certified copy of
HIV negative test result;
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2. Procedures for issuance of the
certificate of occupational HIV exposure:
a) The agency, organization, or
unit managing the person exposed to HIV due to occupational accident
(hereinafter referred to as the managing agency) shall submit 01 application
set to the specialized agency assigned by the Province-level People’s Committee
where the managing agency is located (hereinafter referred to as the receiving
authority);
b) Method of submission: in
person, by post, or electronically.
3. Procedures for verifying,
receiving the application, and issuing the certificate:
a) In case the application is
valid, within 05 working days from the date of receipt of a complete
application, the competent authority shall issue the Certificate of
Occupational HIV Exposure, using Form No. 04 enclosed with Decision No.
24/2023/QD-TTg; Certificate of Occupational HIV Exposure, using Form No. 04 is
enclosed with Decision No. 24/2023/QD-TTg.
b) In case the application is
invalid, within 02 working days from the date of receipt, the receiving
authority must provide a written notice stating the reasons and instructions
for the managing agency to supplement the application.
Section 2.
Application and procedures for issuance of certificate of HIV infection due to
occupational accidents
1. The application for issuance of
the certificate includes:
a) Official dispatch requesting
issuance of the certificate of HIV infection due to occupational accident,
using Form No. 02 enclosed with Decision No. 24/2023/QD-TTg;
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2. Procedures for issuance of the
certificate:
a) The agency, organization, or
unit managing the HIV-infected person due to occupational accident (hereinafter
referred to as the managing agency) shall submit 01 application set to the
receiving authority;
b) Method of submission: in
person, by post, or electronically.
3. Procedures for verifying,
receiving the application, and issuing the certificate:
a) If the application is valid,
within 05 working days from the date of receipt of a complete application, the
receiving authority shall issue the Certificate of HIV infection due to
occupational accident. Certificate of HIV infection due to occupational
accident, using Form No. 05 is enclosed with Decision No. 24/2023/QD-TTg;
b) If the application is invalid,
within 02 working days from the date of receipt, the receiving authority must
issue a written notice stating the reasons and instructions for the managing
agency to supplement the application.
Section 3.
Procedures for new issuance of certificate of compliance with Biosafety Level
III standards for testing facilities
1. A facility with a laboratory
meeting the Biosafety Level III standards as prescribed in Article 7 of Decree
No. 103/2016/ND-CP dated July 01, 2016 of the Government on ensuring biosafety
at laboratories shall prepare 01 application set for the issuance of the
certificate of compliance with Biosafety Level III standards and submit it in
person, by post, or online via electronic means to the receiving authority and
pay the applicable fees as prescribed by law. The application includes:
a) Application form for biosafety
certification using Form No. 02 in the Appendix enclosed with Decree No.
103/2016/ND-CP;
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c) Equipment declaration using Form
No. 04 in the Appendix enclosed with Decree No. 103/2016/ND-CP;
d) Certified copy of documents
proving the establishment and operation of the testing facility in accordance
with the law;
dd) Maintenance and servicing
report of laboratory equipment for testing facilities operating before the
effective date of this Decree;
e) Biosafety incident prevention
and response plan.
2. Procedures for new issuance of
the biosafety certificate:
a) The testing facility shall
submit the application to the receiving authority;
b) Upon receiving a valid
application, the receiving authority shall issue a Receipt of Application using
Form No. 06 in the Appendix enclosed with Decree No. 103/2016/ND-CP;
c) Within 10 days from the date of
receipt of the application, the receiving authority must conduct the
application appraisal. The appraisal includes checking the conditions
related to infrastructure, equipment, personnel, and operational regulations of
the testing facility applying for the biosafety certificate;
d) If the application is
incomplete, within 05 working days from the date of dossier appraisal, the
receiving authority must issue a written notice to the applicant facility,
clearly stating the contents to be supplemented or amended;
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e) If the testing facility fully
satisfies the requirements according to the appraisal report, the receiving
authority shall report to the head of the authority to issue the Certificate of
Biosafety within 07 working days from the date of on-site appraisal;
g) If the testing facility fails to
fully meet the requirements as specified in the appraisal report, the receiving
authority must notify the applicant facility in writing within 07 working days
from the date of on-site appraisal.
Section 4.
Procedures for reissuance of Certificate of compliance with Biosafety Level III
standards due to expiration
1. A facility with a laboratory
meeting Biosafety Level III standards as prescribed in Article 7 of Decree No.
103/2016/ND-CP dated July 1, 2016 of the Government on biosafety assurance at
laboratories shall prepare 01 application set for reissuance of the Certificate
of compliance with Biosafety Level III standards and submit it directly, by
post, or electronically to the receiving authority, and pay the fees as
prescribed by law. The application includes:
a) Application for reissuance of
the Biosafety Certificate using Form No. 05 in the Appendix enclosed with
Decree No. 103/2016/ND-CP;
b) Copy of the previously issued
Biosafety Certificate;
c) Report on changes related to
personnel (if any);
d) Report on changes in equipment:
clearly state name, quantity, condition of newly added or replaced
equipment compared to the previously declared list;
dd) Report on changes in
infrastructure;
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2. Procedures for reissuance of the
Biosafety Certificate:
a) The testing facility must submit
the application to the receiving authority no later than 60 days before the
certificate expires. If this deadline is missed, the application shall follow
the procedures for new issuance;
b) Upon receiving a valid
application, the receiving authority shall issue a Receipt of Application using
Form No. 06 in the Appendix enclosed with Decree No. 103/2016/ND-CP;
c) Within 10 days from the date of
receipt, the receiving authority shall appraise the dossier and review the
previously issued biosafety certificate;
- If the dossier is incomplete,
within 05 working days from the date of dossier appraisal, the receiving
authority shall notify the facility in writing, clearly stating the contents to
be supplemented or amended;
- If necessary, on-site appraisal
shall be conducted within 10 days from the date of dossier appraisal
completion. If the dossier is complete and the testing facility fully meets the
conditions according to the appraisal report, the receiving authority shall
report to its head for reissuance of the certificate within 07 working days
from the date of on-site appraisal;
- If the dossier is complete and no
on-site appraisal is required, the Biosafety Certificate shall be reissued
within 10 days from the date of dossier appraisal.
Section 5.
Procedures for reissuance of the Certificate of compliance with Biosafety Level
III standards due to damage or loss
1. A facility with a laboratory
meeting Biosafety Level III standards as prescribed in Article 7 of Decree No.
103/2016/ND-CP dated July 1, 2016 of the Government on biosafety assurance at
laboratories shall prepare 01 application set for reissuance of the Certificate
of compliance with Biosafety Level III standards due to damage or loss, and
submit it directly, by post, or electronically to the receiving authority, and
pay the fees as prescribed by law. The application includes: an application for
reissuance of the Biosafety Certificate using Form No. 05 in the Appendix
enclosed with Decree No. 103/2016/ND-CP.
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a) The testing facility must submit
the application to the receiving authority no later than 60 days before the
certificate expires. If the application is submitted past this deadline, the
facility must follow procedures for new issuance;
b) Upon receipt of a valid
application, the receiving authority shall issue a Receipt of Application using
Form No. 06 in the Appendix enclosed with Decree No. 103/2016/ND-CP;
c) Within 10 days from the date of
receipt, the receiving authority shall appraise the dossier and review the
previously issued biosafety certificate;
- If the dossier is incomplete,
within 05 working days from the date of dossier appraisal, the receiving
authority shall notify the facility in writing, clearly stating the contents to
be supplemented or amended;
- If necessary, on-site appraisal
shall be conducted within 10 days from the date of dossier appraisal
completion. If the dossier is complete and the testing facility fully meets the
conditions according to the appraisal report, the receiving authority shall
report to its head for reissuance of the certificate within 07 working days
from the date of on-site appraisal;
- If the dossier is complete and no
on-site appraisal is required, the Biosafety Certificate shall be reissued
within 10 days from the date of dossier appraisal.
Section 6.
Procedures for reissuance of the Certificate of compliance with Biosafety Level
III standards due to change of facility name
1. A facility with a laboratory
meeting Biosafety Level III standards as prescribed in Article 7 of Decree No.
103/2016/ND-CP dated July 1, 2016 of the Government shall prepare 01
application set for reissuance of the Certificate of compliance with Biosafety
Level III standards due to damage or loss, and submit it directly, by post, or
electronically to the receiving authority at the location of the facility’s
headquarters, and pay the fees as prescribed by law. The application includes:
a) Application for reissuance of
the Biosafety Certificate using Form No. 05 in the Appendix enclosed with
Decree No. 103/2016/ND-CP;
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2. Procedures for reissuance of the
Biosafety Certificate:
a) The testing facility must submit
the application to the receiving authority no later than 60 days before the
certificate expires. If the application is submitted past this deadline, the
facility must follow procedures for new issuance;
b) Upon receipt of a valid
application, the receiving authority shall issue a Receipt of Application using
Form No. 06 in the Appendix enclosed with Decree No. 103/2016/ND-CP;
c) Within 10 days from the date of
receipt, the receiving authority shall appraise the dossier and review the
previously issued biosafety certificate;
- If the dossier is incomplete,
within 05 working days from the date of dossier appraisal, the receiving
authority shall notify the facility in writing, clearly stating the contents to
be supplemented or amended;
- If necessary, on-site appraisal
shall be conducted within 10 days from the date of dossier appraisal
completion. If the dossier is complete and the testing facility fully meets the
conditions according to the appraisal report, the receiving authority shall
report to its head for reissuance of the certificate within 07 working days
from the date of on-site appraisal;
- If the dossier is complete and no
on-site appraisal is required, the Biosafety Certificate shall be reissued
within 10 days from the date of dossier appraisal.
Section 7.
Application and procedures for new issuance of the Certificate of eligibility
for confirmatory HIV testing
1. The application for new issuance
of the Certificate of eligibility for confirmatory HIV testing shall comply
with Clause 1 Article 43 of Decree No. 141/2024/ND-CP.
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a) The testing facility shall
submit 01 application set for the Certificate of eligibility for confirmatory
HIV testing to the receiving authority;
b) Method of submission: in
person, by post, or electronically.
3. Procedures for dossier review,
receipt, and certificate issuance:
a) The receiving authority shall
verify the validity of the dossier:
- If the dossier is valid, within
05 working days from the date of receipt, the receiving authority shall establish
an appraisal team and conduct an on-site appraisal in accordance with Point c
Clause 1 Article 44 of Decree No. 141/2024/ND-CP;
- If the dossier is invalid, within
05 working days from the date of receipt, the receiving authority must issue a
written notice stating the reasons and instruct the testing facility to
supplement the dossier. The facility must complete the dossier within 05
working days from the date of notification. After this deadline, the
application process must be restarted from the beginning.
b) Appraisal process at the testing
facility:
- The head of the receiving
authority shall issue a decision to establish an appraisal team, which
includes: the responsible official and assigned personnel of the
professional unit under the receiving authority; an HIV testing expert with at
least 05 years of experience in confirmatory HIV testing; and, if necessary,
other experts (in law, laboratory quality assurance, biosafety);
- Within 30 days from the issuance
of the decision, the appraisal team shall carry out the appraisal of conditions
as prescribed in Article 40 of Decree No. 141/2024/ND-CP and HIV testing
technical requirements as guided by the Ministry of Health, and prepare an
appraisal report. The report shall be made in 04 copies: 02 copies kept at the
receiving authority, 01 sent to the Ministry of Health, and 01 retained by the
testing facility.
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- If the testing facility is
assessed by the appraisal team as meeting the eligibility requirements, within
05 working days from the conclusion of the appraisal (calculated based on the
date recorded in the appraisal report), the receiving authority shall issue the
Certificate of eligibility using Form No. 23 provided in the Appendix enclosed
with Decree No. 141/2024/ND-CP;
- If the testing facility is
assessed by the appraisal team as having outstanding issues that must be
addressed, it must rectify these issues within 30 days and submit a corrective
report based on the appraisal team’s recommendations to the receiving authority
for issuance of the Certificate of eligibility using Form No. 23 provided in
the Appendix enclosed with Decree No. 141/2024/ND-CP;
- If the testing facility is assessed
by the appraisal team as not meeting the eligibility requirements, or fails to
remedy the issues within 30 days in accordance with the appraisal team’s
recommendations, the receiving authority shall notify the testing facility to
restart the application process for issuance of the Certificate of eligibility;
- The Certificate of eligibility
for confirmatory HIV testing shall be issued once and shall have indefinite
validity;
- Within 10 days from the date of
issuance of the Certificate of eligibility, the receiving authority shall
publish the certificate on its official website.
Section 8.
Application and procedures for reissuance of the Certificate of eligibility for
confirmatory HIV testing
1. The application for reissuance
of the Certificate of eligibility for confirmatory HIV testing shall comply
with Clause 2 Article 43 of Decree No. 141/2024/ND-CP.
2. Procedures for reissuance of the
Certificate of eligibility for confirmatory HIV testing:
a) The testing facility shall
submit 01 application set for reissuance of the Certificate of eligibility for
confirmatory HIV testing to the receiving authority;
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3. Procedures for verification,
receipt, and reissuance of the certificate:
a) If the application is valid,
within 05 working days from the date of receipt, the receiving authority shall
reissue the Certificate of eligibility for confirmatory HIV testing using Form
No. 23 provided in the Appendix enclosed with Decree No. 141/2024/ND-CP;
b) If the application is invalid,
within 05 working days from the date of receipt, the receiving authority must
issue a written notice stating the reasons and guiding the testing facility to
complete the dossier;
c) Within 10 days from the date of
reissuance of the Certificate of eligibility, the receiving authority shall
publish the certificate on its official website.
Section 9.
Application and procedures for amendment of the Certificate of eligibility for
confirmatory HIV testing
1. The application for amendment of
the Certificate of eligibility for confirmatory HIV testing shall comply with
Clause 3 Article 43 of Decree No. 141/2024/ND-CP.
2. Procedures for amendment of the
Certificate of eligibility for confirmatory HIV testing:
a) The testing facility shall
submit 01 application set for amendment of the Certificate of eligibility for
confirmatory HIV testing to the receiving authority;
b) Method of submission: in
person, by post, or electronically.
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a) If the application is valid,
within 05 working days from the date of receipt, the receiving authority shall
issue the amended Certificate of eligibility in accordance with the amendment
details using Form No. 23 provided in the Appendix enclosed with Decree No.
141/2024/ND-CP;
b) If the application is invalid,
within 05 working days from the date of receipt, the receiving authority must
issue a written notice stating the reasons and guiding the testing facility to
complete the dossier; The testing facility must complete the application within
a maximum of 05 working days from the date of receiving the notice.
Within 05 working days from the date of receiving the completed
application, the receiving authority shall issue the amended Certificate of
eligibility for confirmatory HIV testing based on the amended details using
Form No. 23 provided in the Appendix enclosed with Decree No. 141/2024/ND-CP.
If the completion deadline is missed, the application process for amendment must
be restarted from the beginning;
c) Within 10 days from the date of
amendment of the Certificate of eligibility, the receiving authority shall
publish the amended certificate on its official website.
Section 10.
Application and procedures for declaration of eligibility for occupational
environment monitoring
1. The application for declaration
of eligibility for occupational environment monitoring shall be prepared as 01
set in accordance with Clause 1 Article 34 of Decree No. 44/2016/ND-CP.
2. Procedures for declaration of
eligibility for occupational environment monitoring:
a) Before conducting occupational
environment monitoring, the head of the organization performing such monitoring
shall prepare 01 application set as prescribed in Clause 1 of this Section and
submit it in person, by post, or electronically to the receiving authority;
b) Within 30 days from the date of
receipt, the receiving authority shall publish the declaration of eligibility
for occupational environment monitoring on the website of the unit. If the
conditions are not met, a written response stating the reason shall be issued;
c) The application submitted
electronically must meet the following requirements:
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- The information in the request
and documents must be complete and accurate according to the electronic
documents;
- The organization submitting the
electronic application must retain a physical copy of the dossier.
3. During operation, the
organization conducting occupational environment monitoring must maintain the declared
conditions as specified in Article 33 of Decree No. 44/2016/ND-CP dated May 15,
2016 of the Government on elaboration of several articles of the Law on
Occupational Safety and Hygiene regarding technical safety inspection, safety
and hygiene training, and occupational environment monitoring, and Clause 19
Article 1 of Decree No. 140/2018/ND-CP dated October 8, 2018 of the Government
on amendments to decrees on business investment conditions and administrative
procedures under the management of the Ministry of Labor, War Invalids and
Social Affairs;
4. Organizations may only conduct
occupational environment monitoring after their eligibility has been publicly
announced in accordance with Point b Clause 2 of this Section.
Section 11.
Application and procedures for registration of new circulation of insecticidal
and germicidal products used in household and healthcare sectors
I. The application for registration
of new circulation of insecticidal and germicidal products used in household
and healthcare sectors shall comply with Article 22 of Decree No.
91/2016/ND-CP, as amended in 2016 and 2024;
II. Procedures for receiving and
appraising applications for new circulation registration of insecticidal and
germicidal products used in household and healthcare sectors:
1. The applicant shall submit the
application directly or by post to the receiving authority. If the
receiving authority in the locality where the applicant is based provides
online registration, the applicant shall submit the application electronically.
Online registration shall follow the provisions of Chapter VIII of Decree
No. 91/2016/ND-CP, as amended in 2018 and 2024 (hereinafter referred to as
Decree No. 91/2016/ND-CP).
2. Upon receipt of the application
and the appraisal fee for registration of new circulation, the receiving
authority shall issue to the applicant an Application Receipt Note The
Application Receipt Note using Form No. 04 in Appendix III is enclosed with
Decree No. 91/2016/ND-CP.
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a) For applications for circulation
registration of products specified at Point b, Clause 6, Article 22 of Decree
No. 91/2016/ND-CP, the receiving authority shall issue a written notice to the
applicant requesting supplementation or amendment of the application or
granting or refusal to grant the registration number;
In case of a request for
supplementation or amendment, the written notice must clearly state the
contents to be supplemented or amended. In case of refusal to grant the
registration number, the reason must be clearly stated.
b) For applications for circulation
registration of products not falling under Point b, Clause 6, Article 22 of
Decree No. 91/2016/ND-CP, the receiving authority shall issue a written notice
to the applicant requesting supplementation or amendment of the application or
approval or rejection of the testing. The processing time for
applications for new registration as specified at Point c, Clause 6, Article 22
of Decree No. 91/2016/ND-CP shall not exceed 90 days;
In case of a request for
supplementation or amendment, the written notice must clearly state the
contents to be supplemented or amended. In case of rejection of the
testing, the reason must be clearly stated.
4. If the receiving authority
issues a written request for supplementation or amendment, within 90 days from
the date stated in the notice, the applicant must submit a written response
explaining the supplemented or amended contents. If the deadline is exceeded,
the new registration application shall be annulled. The date of receipt of the
supplemented or amended dossier shall be stated in the Application Receipt
Note;
If the applicant fails to submit
the dossier within the prescribed time due to force majeure events such as
natural disasters, catastrophes, epidemics, or fire, the dossier may be
submitted late but not exceeding 12 months from the expiry date of the
supplementation period, accompanied by an explanatory document;
Supplemented or amended
applications shall be reviewed and appraised in accordance with Clause 3,
Section II of this Part.
5. If there are no further requests
for supplementation or amendment, the Ministry of Health shall issue a written
notice to the applicant regarding approval or disapproval of the testing. In
case of disapproval, the reason must be clearly stated.
6. Upon receiving the written
approval for testing, the applicant shall be responsible for completing the
testing and submitting the Test Result Response Form to the dossier within 36
months from the date stated in the testing approval document. The date of
receipt of the Test Result Response Form shall be stated in the Application
Receipt Note. If the 36-month deadline is exceeded, the new registration
application shall be annulled.
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In case of a request for
supplementation or amendment, the written notice must clearly state the
contents to be supplemented or amended.
If the registration number is
refused, the reason must be clearly stated.
If the applicant uses imported raw
materials to manufacture the product, the Certificate of Circulation
Registration must clearly state the authorization for raw material importation,
using the form prescribed in Appendix IV enclosed with Decree No.
91/2016/ND-CP.
8. Within 03 working days from the
date of issuance of the new circulation registration number, the receiving
authority shall publish the following information on its official website:
a) Name of the product;
b) Circulation registration number;
c) Full text of the Certificate of
Circulation Registration.
9. The receiving authority shall
not accept new registration applications or issue registration numbers for
applications submitted within 02 years for applicants or manufacturers whose products
have had their registration numbers revoked under any of the cases specified in
Clauses 1, 4, and 9, Article 38 of Decree No. 91/2016/ND-CP.
Section 12.
Application and procedures for extension of the circulation registration number
for insecticidal and germicidal products used in household and healthcare
sectors
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1. Application dossier for extension
of circulation registration number, comprising the following documents:
a) Application form for extension
of circulation registration number, using Form No. 06 in Appendix I enclosed
with Decree No. 91/2016/ND-CP;
b) Legal documents proving the legal
status of the applicant and the manufacturer;
c) Authorization letter for
circulation registration, except as specified at Point a Clause 1 Article 20 of
Decree No. 91/2016/ND-CP;
d) Report on the circulation
process of the product, using the template specified in Appendix VI enclosed
with Decree No. 91/2016/ND-CP.
2. The application for extension
must be submitted at least 03 months and no later than 12 months before the
expiration of the existing circulation registration number;
In case the applicant fails to
submit the application on time due to force majeure events such as
natural disasters, catastrophes, epidemics, or fire, late submission is
permitted but not exceeding 12 months from the expiration date, accompanied by
an explanatory document.
II. Procedures for receipt and
appraisal of the application for extension of circulation registration number
for insecticidal and germicidal products used in household and healthcare
sectors:
1. The applicant shall submit the
application directly or by post to the receiving authority. If the
receiving authority provides an online registration platform, the applicant
shall submit the application online. Online registration shall comply with
Chapter VIII of Decree No. 91/2016/ND-CP.
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3. Within 30 days from the date
stated in the Application Receipt Note under Clause 2 of this Article, the
receiving authority must issue a written notification to the applicant
regarding the request for supplementation or amendment, or the approval or
refusal of the extension of the circulation registration number.
If supplementation or amendment is
required, the written notification must clearly state the required contents.
If the extension is refused, the
reason must be clearly stated.
4. Upon receiving a written request
for supplementation or amendment, the applicant must submit the revised dossier
with an explanatory note to the receiving authority within 30 days from the
date of the written request, and no later than 10 days prior to the expiration
of the circulation registration number. The date of receipt of the
revised dossier shall be recorded in the Application Receipt Note.
Failure to comply within this deadline shall result in cancellation of
the extension application.
If the applicant cannot meet the
deadline due to force majeure events such as natural disasters,
catastrophes, epidemics, or fire, the dossier may be submitted late but not
exceeding 12 months from the expiry date of the supplementation period,
accompanied by an explanatory document;
The supplemented or amended dossier
shall be appraised in accordance with Clause 3, Section II of this Part.
5. If no further supplementation or
amendment is required, the receiving authority shall proceed with the extension
of the circulation registration number.
6. Within 03 working days from the
date of extension, the receiving authority shall publish the full text of the
renewed Certificate of Circulation Registration on its official website,
replacing the information specified at Point c, Clause 8, Article 27 of Decree
No. 91/2016/ND-CP.
Section 13.
Application and procedures for additional circulation registration due to
change of ownership of the circulation registration number for insecticidal and
germicidal products used in household and healthcare sectors
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1. Application form for additional
registration, using Form No. 05 in Appendix I enclosed with Decree No.
91/2016/ND-CP;
2. Authorization letter for
circulation registration, except as specified at Point a Clause 1 Article 20 of
Decree No. 91/2016/ND-CP;
3. Document on the transfer of
ownership of the circulation registration number from the current holder;
4. Document on the receipt of
ownership of the circulation registration number and a written commitment to
continue product distribution in compliance with the approved application;
5. Legal documents of the new
holder of the registration number;
6. New label sample of the product.
II. Procedures for receipt and
appraisal of the application for additional registration due to change of
ownership of the circulation registration number for insecticidal and
germicidal products used in household and healthcare sectors :
1. The applicant shall submit the
application dossier directly or by post to the receiving authority. In case
online registration is available, the applicant shall register online in
accordance with Chapter VIII of Decree No. 91/2016/ND-CP;
2. Upon receipt of the application
and appraisal fee, the receiving authority shall issue an Application Receipt
Note using Form No. 05 in Appendix III enclosed with Decree No. 91/2016/ND-CP;
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4. If supplementation or amendment
is requested, the applicant must submit a completed dossier with an explanatory
note within 90 days from the date of the written request. The date of receipt
shall be recorded in the Application Receipt Note. If this deadline is
missed, the application shall be canceled.
In case of force majeure (e.g.,
natural disasters, epidemics, fire, etc.), late submission shall be accepted
within 12 months from the deadline, accompanied by a written explanation;
5. If no further supplementation is
required, the receiving authority shall proceed with the issuance of the
supplementary circulation registration certificate;
6. Within 03 working days from the
date of such issuance, the receiving authority shall publish the full text of
the supplementary circulation registration certificate on its official website.
Section 14.
Application and procedures for additional registration due to product name
change for insecticidal and germicidal products used in household and
healthcare sectors
I. Application for additional
registration due to product name change for insecticidal and germicidal
products used in household and healthcare sectors
1. Application form for additional
registration, using Form No. 05 in Appendix I enclosed with Decree No. 91/2016/ND-CP;
2. Authorization letter for
circulation registration of the product under its new name, except as specified
at Point a Clause 1 Article 20 of Decree No. 91/2016/ND-CP;
3. Certificate of free sale for the
product under the new name (for imported products);
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5. Document issued by a competent
authority regarding intellectual property rights violation concerning the
product name.
II. Procedures for receipt and
appraisal of the application for additional registration due to product name
change of the insecticidal and germicidal products used in household and
healthcare sectors :
1. The applicant shall submit the
application dossier directly or by post to the receiving authority. If the
receiving authority provides an online registration platform, the applicant
shall submit the application online. Online registration shall comply with
Chapter VIII of Decree No. 91/2016/ND-CP.
2. Upon receipt of the application
and appraisal fee, the receiving authority shall issue an Application Receipt
Note using Form No. 05 in Appendix III enclosed with Decree No. 91/2016/ND-CP;
3. Within 30 days from the date
stated in the Application Receipt Note, the receiving authority shall issue a
written notification to the applicant regarding the request for
supplementation/amendment or the approval/refusal of the additional
registration, with reasons clearly stated.
4. If supplementation or amendment
is requested, the applicant must submit a completed dossier with an explanatory
note within 90 days from the date of the written request. The date of receipt
shall be recorded in the Application Receipt Note. If this deadline is
missed, the application shall be canceled.
If the applicant fails to submit
the dossier within the prescribed time due to force majeure events such as
natural disasters, catastrophes, epidemics, or fire, the dossier may be
submitted late but not exceeding 12 months from the expiry date of the
supplementation period, accompanied by an explanatory document;
5. If no further supplementation is
required, the receiving authority shall proceed with the issuance of the
supplementary circulation registration certificate;
6. Within 03 working days from the
date of such issuance, the receiving authority shall publish the full text of the
supplementary circulation registration certificate on its official website.
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I. Application for additional
registration due to change of manufacturing site or manufacturer of
insecticidal and germicidal products used in household and healthcare sectors
shall include:
1. Application form for additional
registration, using Form No. 05 in Appendix I enclosed with Decree No.
91/2016/ND-CP;
2. Legal documents of the
manufacturer with the new address (for manufacturers in Vietnam), or a written
notice of the change of manufacturing site/manufacturer (for manufacturers
abroad);
3. Test result response sheet of
the product manufactured at the new facility;
4. Authorization letter for
circulation registration, except as specified at Point a Clause 1 Article 20 of
Decree No. 91/2016/ND-CP;
5. Certificate of free sale, except
where the product has already been granted a circulation registration number
for manufacturing in Vietnam and the additional registration is for a foreign
manufacturer;
6. New label sample of the product.
II. Procedures for receipt and
appraisal of the application for additional registration due to change of
manufacturing site or manufacturer:
1. The applicant shall submit the
application dossier directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
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3. Within 30 days from the date
stated in the Application Receipt Note, the receiving authority shall issue a
written notice to the applicant regarding the request for
supplementation/amendment of the application, or the approval/refusal of
testing, with clear reasons;
4. If testing is approved, within a
maximum of 12 months from the date stated in the approval document, the
applicant must submit the test results to be added to the application. If this
deadline is missed, the application shall be canceled.
5. If supplementation or amendment
is requested, the applicant must submit a completed dossier with an explanatory
note within 90 days from the date of the written request. The date of receipt
shall be recorded in the Application Receipt Note. If this deadline is
missed, the additional registration application shall be canceled.
If the applicant fails to submit
the dossier within the prescribed time due to force majeure events such as
natural disasters, catastrophes, epidemics, or fire, the dossier may be
submitted late but not exceeding 12 months from the expiry date of the
supplementation period, accompanied by an explanatory document;
6. If no further supplementation is
required, the receiving authority shall proceed with the issuance of the
supplementary circulation registration certificate;
7. Within 03 working days from the
date of such issuance, the receiving authority shall publish the full text of
the supplementary circulation registration certificate on its official website.
Section 16.
Application and procedures for additional registration due to change of name or
contact address of the applicant or manufacturer of insecticidal and germicidal
products used in household and healthcare sectors
I. Application for additional
registration due to change of name or contact address of the applicant or
manufacturer of insecticidal and germicidal products used in household and
healthcare sectors
1. Application form for additional
registration, using Form No. 05 in Appendix I enclosed with Decree No.
91/2016/ND-CP;
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3. New label sample of the product.
II. Procedures for receipt and
appraisal of the application for additional registration due to change of name
or contact address of the applicant or manufacturer of insecticidal and
germicidal products used in household and healthcare sectors:
1. The applicant shall submit the
application dossier directly or by post to the receiving authority. If the
receiving authority provides an online registration platform, the applicant
shall submit the application online. Online registration shall comply with
Chapter VIII of Decree No. 91/2016/ND-CP.
2. Upon receipt of the application
and the appraisal fee for registration of new circulation, the receiving
authority shall issue to the applicant an Application Receipt Note The
Application Receipt Note using Form No. 05 in Appendix III is enclosed with
Decree No. 91/2016/ND-CP.
3. Within 30 days from the date
stated in the Application Receipt Note, the receiving authority shall issue a
written notification to the applicant regarding the request for
supplementation/amendment or the approval/refusal of the additional
registration, with reasons clearly stated;
4. If supplementation or amendment
is requested, the applicant must submit a completed dossier with an explanatory
note within 90 days from the date of the written request, the registrant must
complete the application, provide a written explanation, and send it to the
receiving authority. The date of receipt shall be recorded in the Application
Receipt Note. If this deadline is missed, the application shall be
canceled.
In case of force majeure (natural
disasters, epidemics, catastrophes, fires, etc.), the application may be
submitted late but not more than 12 months after the deadline, with a written
explanation enclosed;
5. If no further supplementation is
required, the receiving authority shall proceed with the issuance of the
supplementary circulation registration certificate;
6. Within 03 working days from the
date of such issuance, the receiving authority shall publish the full text of
the supplementary circulation registration certificate on its official website.
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I. Application for additional
registration due to changes in efficacy, dosage, method of use, active
ingredient content, synergistic additive content, product form, shelf life, or
source of active ingredient
1. Application form for additional
registration, using Form No. 05 in Appendix I enclosed with Decree No.
91/2016/ND-CP, Decree No. 155/2016/ND-CP, and Decree No. 129/2024/ND-CP;
2. Response sheet of testing
results for the product after the changes (except for changes in product shelf
life);
3. Stability study documentation
(for cases of changes in product shelf life);
4. Test results of active
ingredient content for cases involving changes in active ingredient content or
product form;
5. New label sample of the product.
II. Procedures for receiving and
appraising applications for additional registration due to changes in efficacy,
dosage, method of use, active ingredient content, synergistic additive content,
product form, shelf life, or source of active ingredient
1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
2. Upon receipt of the application
and the appraisal fee for registration of new circulation, the receiving
authority shall issue to the applicant an Application Receipt Note The
Application Receipt Note using Form No. 05 in Appendix III is enclosed with
Decree No. 91/2016/ND-CP.
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a) Request for supplementation or
amendment of the application, or approval or disapproval of the additional
registration request with reasons (for applications not subject to testing);
b) Request for supplementation or
amendment of the application, or approval or disapproval of testing with
reasons (for applications subject to testing);
4. If testing is approved, within a
maximum of 12 months from the date stated in the approval document, the
applicant must submit the test results to be added to the application. If this
deadline is missed, the application shall be canceled.
5. If supplementation or amendment
is requested, the applicant must submit a completed dossier with an explanatory
note within 90 days from the date of the written request. The date of receipt
shall be recorded in the Application Receipt Note. If this deadline is
missed, the application shall be canceled.
If the applicant fails to submit
the dossier within the prescribed time due to force majeure events such as
natural disasters, epidemics, fires,… late submission is allowed but no later
than 12 months from the deadline, accompanied by a written explanation;
6. If no further supplementation is
required, the receiving authority shall proceed with the issuance of the
supplementary circulation registration certificate;
7. Within 03 working days from the
date of such issuance, the receiving authority shall publish the full text of
the supplementary circulation registration certificate on its official website.
Section 18.
Application and procedures for reissuance of the circulation registration
certificate for insecticidal and germicidal products used in household and
healthcare sectors
I. Application for reissuance of
the circulation registration certificate for insecticidal and germicidal
products used in household and healthcare sectors
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2. Damaged circulation registration
certificate.
II. Procedures for reissuance of
the certificate of registration of circulation of insecticidal and germicidal
products used in household and healthcare sectors:
1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
2. Upon receipt of the application,
the receiving authority shall issue an Application Receipt Note using Form No.
07 in Appendix III enclosed with Decree No. 91/2016/ND-CP;
3. Within 10 days from the date
indicated in the Application Receipt Note, the receiving authority shall
reissue the circulation registration certificate. If not reissued, a written
response stating the reasons must be provided.
Section 19.
Dossier and procedures for notifying changes to product label contents or
formats for insecticidal and germicidal products used in household and
healthcare sectors
I. Dossier for notifying changes
to product label contents or formats for insecticidal and germicidal products
used in household and healthcare sectors
1. Written notice of changes to the
product label contents or format;
2. New product label sample
(including samples for all packaging sizes in actual dimensions; if multiple
packaging sizes share the same label design, the owner of the registration
number shall submit the smallest packaging size label).
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1. No later than 15 days prior to
the circulation of the new label, the holder of the circulation registration
number shall submit the application directly or by post to the receiving
authority. If the receiving authority provides an online registration
platform, the applicant shall submit the application online. Online
registration shall comply with Chapter VIII of Decree No. 91/2016/ND-CP.
2. Within 05 working days from the
date of receipt of the notification of label change (the date of receipt is the
date indicated on the incoming document stamp of the receiving authority), if
the receiving authority does not issue a written request for amendments or
supplements:
a) The holder of the circulation
registration number shall be entitled to circulate the product with the new
label;
b) The receiving authority shall be
responsible for adding the new label sample to the circulation registration
dossier.
Section 20.
Application and procedures for issuance of import permits for insecticidal and
germicidal products used in household and healthcare sectors for research
purposes
I. Application for issuance of
import permits for insecticidal and germicidal products used in household and
healthcare sectors for research purposes
1. Application form for import
permit, using Form No. 09 in Appendix I enclosed with Decree No. 91/2016/ND-CP
and Decree No. 129/2024/ND-CP;
2. Technical documents of the
chemical or product as specified in Appendix V enclosed with Decree No.
91/2016/ND-CP and Decree No. 129/2024/ND-CP;
3. Research proposal certified by
the legal representative of a qualified research institution or a manufacturer
that has declared eligibility for production.
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1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
2. Upon receipt of the import
application, the receiving authority shall issue an Application Receipt Note
using Form No. 09 in Appendix III enclosed with Decree No. 91/2016/ND-CP;
3. If there is no request for
supplementation or amendment, the receiving authority shall issue the import
permit. If not issued, a written response with reasons shall be provided;
4. If the application is incomplete,
the receiving authority shall issue a written notice requesting the applicant
to supplement or amend the application within 15 days from the date indicated
in the Application Receipt Note. The notice must specify the contents to be
supplemented or amended;
5. If supplementation or amendment
is requested, the applicant must complete the application and provide written
explanations to the receiving authority within 60 days from the date stated in
the request. The date of receipt shall be recorded in the Application Receipt
Note. Failure to meet the deadline shall result in cancellation of the
import application;
6. If no further supplementation or
amendment is required, the receiving authority shall proceed with issuing the
import permit as per Clause 3, Section II;
7. Within 03 working days from the
date of issuance, the receiving authority shall publicly disclose the following
information on its official website:
a) Name of the product;
b) Import permit number;
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Section 21.
Application and procedures for issuance of import permits for insecticidal and
germicidal products used in household and healthcare sectors for aid purposes
I. Application for issuance of
import permits for insecticidal and germicidal products used in household and
healthcare sectors for aid purposes
1. Application form for import
permit, using Form No. 09 in Appendix I enclosed with Decree No. 91/2016/ND-CP
and Decree No. 129/2024/ND-CP;
2. Technical documents of the
chemical or product as specified in Appendix V enclosed with Decree No.
91/2016/ND-CP and Decree No. 129/2024/ND-CP;
3. A valid copy of the decision on
approval of aid receipt issued by the competent authority and documents related
to the aid shipment.
II. Procedures for issuance of import
permits for insecticidal and germicidal products used in household and
healthcare sectors for aid purposes
1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
2. Upon receipt of the import
application, the receiving authority shall issue an Application Receipt Note
using Form No. 09 in Appendix III enclosed with Decree No. 91/2016/ND-CP;
3. If there is no request for
supplementation or amendment, the receiving authority shall issue the import
permit. If not issued, a written response with reasons shall be provided;
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5. If supplementation or amendment
is requested, the applicant must complete the application and provide written
explanations to the receiving authority within 60 days from the date stated in
the request. The date of receipt shall be recorded in the Application Receipt
Note. Failure to meet the deadline shall result in cancellation of the
import application;
6. If no further supplementation or
amendment is required, the receiving authority shall proceed with issuing the
import permit as per Clause 3, Section II;
7. Within 03 working days from the
date of issuance, the receiving authority shall publicly disclose the following
information on its official website:
a) Name of the product;
b) Import permit number;
c) Full text of the import permit.
Section 22.
Application and procedures for issuance of import permits for insecticidal and
germicidal products used in household and healthcare sectors as gifts or
donations
I. Application for issuance of
import permits for insecticidal and germicidal products used in household and
healthcare sectors as gifts or donations
1. Application form for import
permit, using Form No. 09 in Appendix I enclosed with Decree No. 91/2016/ND-CP
and Decree No. 129/2024/ND-CP;
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3. Notification letter of donation
or gift and documents proving that the product to be imported has been
permitted for use by the competent authority in the exporting country;
4. Certified copies of the
manufacturer's Good Manufacturing Practice (GMP) or ISO certificate and
Certificate of Free Sale (if the total weight of a single import request is 50
kg or more).
II. Procedures for issuance of
import permits for insecticidal and germicidal products used in household and
healthcare sectors as gifts or donations
1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
2. Upon receipt of the import
application, the receiving authority shall issue an Application Receipt Note
using Form No. 09 in Appendix III enclosed with Decree No. 91/2016/ND-CP;
3. If there is no request for
supplementation or amendment, the receiving authority shall issue the import
permit. If not issued, a written response with reasons shall be provided;
4. If the application is
incomplete, the receiving authority shall issue a written notice requesting the
applicant to supplement or amend the application within 15 days from the date
indicated in the Application Receipt Note. The notice must specify the contents
to be supplemented or amended;
5. If supplementation or amendment
is requested, the applicant must complete the application and provide written
explanations to the receiving authority within 60 days from the date stated in
the request. The date of receipt shall be recorded in the Application Receipt
Note. Failure to meet the deadline shall result in cancellation of the
import application;
6. If no further supplementation or
amendment is required, the receiving authority shall proceed with issuing the
import permit as per Clause 3, Section II;
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a) Name of the product;
b) Import permit number;
c) Full text of the import permit.
Section 23.
Application and procedures for issuance of import permits for insecticidal and
germicidal products used in household and healthcare sectors due to absence of
suitable products or usage methods on the domestic market
I. Application for issuance of
import permits for insecticidal and germicidal products used in household and
healthcare sectors due to absence of suitable products or usage methods on the
domestic market
1. Application form for import
permit, using Form No. 09 in Appendix I enclosed with Decree No. 91/2016/ND-CP
and Decree No. 129/2024/ND-CP;
2. Technical documents of the
chemical or product as specified in Appendix V enclosed with Decree No.
91/2016/ND-CP and Decree No. 129/2024/ND-CP;
3. Documents proving the product is
authorized for use by the competent authority in the exporting country;
4. Certified copies of the
manufacturer's Good Manufacturing Practice (GMP) or ISO certificate and
Certificate of Free Sale (if the total weight of a single import request is 50
kg or more).
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1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online. Online registration shall comply with Chapter VIII of
Decree No. 91/2016/ND-CP.
2. Upon receipt of the import
application, the receiving authority shall issue the Application Receipt Note
for import as per Form No. 09 in Appendix III enclosed with Decree No.
91/2016/ND-CP.
3. If there is no request for
supplementation or amendment, the receiving authority shall issue the import
permit. If not issued, a written response with reasons shall be provided;
4. If the application is
incomplete, the receiving authority shall issue a written notice requesting the
applicant to supplement or amend the application within 15 days from the date
indicated in the Application Receipt Note. The notice must specify the contents
to be supplemented or amended;
5. If supplementation or amendment is
requested, the applicant must complete the application and provide written
explanations to the receiving authority within 60 days from the date stated in
the request. The date of receipt shall be recorded in the Application Receipt
Note. Failure to meet the deadline shall result in cancellation of the
import application;
6. If no further supplementation or
amendment is required, the receiving authority shall proceed with issuing the
import permit as per Clause 3, Section II;
7. Within 03 working days from the
date of issuance, the receiving authority shall publicly disclose the following
information on its official website:
a) Name of the product;
b) Import permit number;
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Section 24.
Application and procedures for issuance of the Certificate of Free Sale (CFS)
for insecticidal and germicidal products used in household and healthcare
sectors for export under the Ministry of Health’s authority
I. Application and procedures
for issuance of the Certificate of Free Sale (CFS) for insecticidal and
germicidal products used in household and healthcare sectors for export under
the Ministry of Health’s authority
1. A bilingual application for CFS
(in Vietnamese and English), clearly indicating the product name, HS code,
registration number, composition, active ingredient concentration, and
destination country, using the form provided in Section 27 of this Appendix;
2. Investment certificate or
certificate of business registration or enterprise registration;
3. A list of manufacturing
facilities (if any), including names, addresses, and the exported products;
4. Certificate of registration for
circulation of the insecticidal/germicidal product used in household and
healthcare sectors;
5. Product label specimen.
II. Procedures for issuance of
the Certificate of Free Sale (CFS) for insecticidal and germicidal products
used in household and healthcare sectors for export under the Ministry of
Health’s authority
1. The applicant shall submit the
application dossier directly or by post to the receiving authority. If the
receiving authority provides an online registration platform, the applicant
shall submit the application online.
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3. Within 03 days from the date
stated on the Application Receipt Note, the receiving authority shall notify
the applicant in writing of the request for supplementation/amendment, or
whether the CFS is granted or refused, with reasons provided in case of
refusal.
4. If the receiving authority
issues a written request for supplementation or amendment, within 30 days from
the date indicated in such document, the applicant must complete the
application, provide written explanations, and submit it to the receiving
authority. The date of receipt shall be recorded in the Application
Receipt Note. If this deadline is missed, the CFS application will be
cancelled.
5. If no further supplementation or
amendment is required, the receiving authority shall issue the Certificate of
Free Sale.
Section 25.
Application and procedures for amendment, supplementation, or reissuance of the
Certificate of Free Sale (CFS) for insecticidal and germicidal products used in
household and healthcare sectors for export under the Ministry of Health’s
authority
I. Application and procedures
for amendment, supplementation, or reissuance of the Certificate of Free Sale
(CFS) for insecticidal and germicidal products used in household and healthcare
sectors for export under the Ministry of Health’s authority
1. A bilingual application for
amendment, supplementation, or reissuance of CFS (in Vietnamese and English),
specifying the changes related to product name, HS code, registration number,
composition, active ingredients, destination country, using the form provided
in Section 27 of this Appendix;
2. Investment certificate or
certificate of business registration or enterprise registration;
3. A list of manufacturing
facilities (if any), including names, addresses, and the exported products;
4. Certificate of registration for
circulation of the insecticidal/germicidal product used in household and
healthcare sectors;
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II. Procedures for amendment,
supplementation, or reissuance of the Certificate of Free Sale (CFS) for
insecticidal and germicidal products used in household and healthcare sectors
for export under the Ministry of Health’s authority
1. The applicant shall submit the
application directly or by post to the receiving authority. If the receiving
authority provides an online registration platform, the applicant shall submit
the application online.
2. After receiving the application
for modification, supplementation, or reissuance of the CFS, along with the
application appraisal fee, the receiving authority shall issue to the applicant
a receipt of application.
3. Within 03 days from the date
indicated on the Application Receipt Note, the receiving authority shall notify
the applicant in writing of whether the application requires supplementation/amendment,
or whether the issuance of CFS is approved or rejected, with reasons provided
in case of rejection;
4. If the receiving authority
issues a written request for supplementation or amendment, within 30 days from
the date indicated in the request, the applicant must complete and explain the
application in writing and submit it to the receiving authority. The date of
receipt of the supplemented/amended application shall be recorded in the
Application Receipt Note. If this deadline is missed, the application will be
cancelled;
5. If no further supplementation or
amendment is required, the receiving authority shall issue the Certificate of
Free Sale.
Section 26.
Procedures for suspension from circulation and revocation of the registration
number of insecticidal and germicidal products used in household and healthcare
sectors
I. Procedures for suspension
from circulation of products
1. Suspension procedures may be
initiated upon a warning by the product owner or the registration holder
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b) If the product defect or risk
factor affeting user’s health or the environment can be remedied: Within
05 working days from the date of receipt of the notification from the product
owner or the holder of the circulation registration number, the
application-receiving authority shall issue a decision on suspension of
circulation of the product; within 90 days from the date on which the decision
on suspension of circulation is issued, the holder of the circulation
registration number shall be responsible for completing the rectification of
defects or risk factors that adversely affect users’ health or the environment;
upon completion of the rectification, the holder of the circulation
registration number shall submit a written report to the application-receiving
authority, enclosed with supporting documents proving that the rectification
has been completed; within 30 days from the date of receipt of the
rectification report, the application-receiving authority shall issue a decision
to terminate the suspension of circulation of the product. If the receiving
authority does not agree to terminate the suspension, it must provide a written
response with reasons;
c) In case the product is
irreparable due to defects or risk factors that adversely affect users’ health
or the environment, or if the rectification is not completed within the
timeframe specified in the decision on suspension of circulation, the
application-receiving authority shall issue a decision on recall of the
suspended product. The decision on recall of the suspended product must be
published on the website of the application-receiving authority;
d) The contents of a decision on
suspension or revocation of a product shall include: the name of the product
subject to suspension or revocation; the suspended or revoked batch number; the
registration number; suspension duration; and handling requirements for the
revoked product.
2. Procedures for suspension of
circulation upon warnings by competent authorities regarding the product
a) Within 05 working days from the
date of receiving a notification on risk factors affecting human health or the
environment from a country where the product is circulated, or from the World
Health Organization or the Ministry of Health, the receiving authority shall
issue a decision on suspension of circulation and send a written request for
clarification to the registration holder;
b) Within 05 working days from the
date of receiving the written request, the registration holder must submit a
written report to the receiving authority;
c) Within 05 working days from the
date of receiving the report from the holder of the circulation registration
number, the receiving authority shall assess the risk factors of the active
ingredient or product that may adversely affect human health and the
environment;
d) If the ingredient or product is
determined to pose no risk, the receiving authority shall, within 05 working
days from the conclusion of the assessment, issue a decision to terminate the
suspension;
dd) If the ingredient or product
poses risk factors that adversely affect users’ health or the environment which
are remediable, the receiving authority shall notify the registration holder to
carry out remediation as per Clause 2, Article 36 of this Decree;
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II. Procedures for revocation of
the registration number
1. Within 15 days from the
identification of cases specified in Article 38 of this Decree, the receiving
authority shall review and issue a decision on revocation of the registration
number.
2. The revocation decision shall be
sent to the registration holder, the Ministry of Finance (Customs Department),
the Ministry of Health (Department of Preventive Medicine), and shall be
publicly disclosed on the website of the receiving authority.
APPLICATION FOR ISSUANCE OF CFS
TÊN
ĐƠN VỊ
Company name
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CỘNG
HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Socialist Republic of Viet Nam
Độc lập - Tự do - Hạnh phúc
Independence - Liberty – Happiness
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Số:
... / ...
No:.../...
...,
ngày... tháng... năm ...
..., dated: ...
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Kính
gửi: [Tên Cơ quan cấp CFS]
Dear:………………………………..
Tên đơn vị:...........................................................................................................................
Company name
- Địa chỉ: ... Số điện thoại: ... Số
fax:... Email:...
Address: ... Phone number
...fax:... Email:...
Để đáp ứng yêu cầu của nước nhập khẩu,
(đơn vị) đề nghị được cấp Giấy chứng nhận lưu hành
tự do (CFS) đối với các sản phẩm, hàng hoá sau:
To meet the requirements of the
importing country, (company name) request to be issued a Certificate of Free
Sale (CFS) for the following product/goods:
STT
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Tên
chế phẩm
Product
name
Mã
HS của chế phẩm
HS
code
Số
đăng ký lưu hành
Registration
number
Thành
phần, hàm lượng hoạt chất
Composition
active ingredient content
Nước
nhập khẩu
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1
2
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(Đơn vị) xin chịu mọi trách nhiệm
trước pháp luật về nội dung trên.
(Company name) hereby assumes full
responsibility before the law for the contents above.
Người
đại diện theo pháp luật của thương nhân
Legal Representative of the Company/General Director
(Ký tên, ghi rõ họ tên, chức danh và đóng dấu)
APPENDIX IV
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Section 1.
Applications and procedures for continued circulation of medical devices where
the device owner ceases production or is declared bankrupt or dissolved,
applicable to Class A and B medical devices
1. Class A and B medical devices
that have been granted registration numbers but whose owners have declared
discontinuation of production or are declared bankrupt or dissolved may continue
to circulate for a maximum period of 24 months from the date of such
declaration, provided that the registration holder in Vietnam commits to be
responsible for warranty, maintenance, and provision of replacement supplies or
consumables for the operation of the medical devices for a period of 08 years,
except where the registration holder is a representative office in Vietnam of a
foreign trader who owns the medical devices.
2. Class A and B medical devices
that have been granted registration numbers but whose registration holders are
declared bankrupt or dissolved may continue to circulate on the market for a
maximum period of 24 months from the date of such declaration, provided that
the distributor commits to be responsible for warranty, maintenance, and
provision of replacement supplies or consumables for the operation of the
medical devices for a period of up to 08 years.
3. The registration holder or
distributor shall submit the commitment dossier to the provincial-level
specialized health authority where the entity is headquartered (hereinafter
referred to as the receiving authority) via the electronic portal for medical
device management within 60 days from the date the device owner or registration
holder declares discontinuation of production, bankruptcy, or dissolution.
4. The commitment dossier includes
the following documents:
a) A written request for continued
circulation of medical devices and a commitment to be responsible for warranty,
maintenance, and provision of consumables for the operation of the medical
devices, using Form 01 in Section 6 of this Appendix;
b) A list of medical devices with
registration numbers being held by the entity, which are affected by the
discontinuation of production or dissolution.
5. Procedures for continued circulation
of medical devices in case the device owner ceases production or is dissolved
or declared bankrupt:
a) Within 15 working days from the
date of receipt of the commitment dossier as prescribed in Clause 4 of this
Section, the receiving authority shall issue a written response on whether
continued circulation is permitted or not. The written consent shall use
Form 02 in Section 6 of this Appendix. If continued circulation is not
permitted, the reasons must be clearly stated.
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6. If the receiving authority does
not grant permission for continued circulation as specified in Clause 1 of this
Section, the registration holder or distributor must recall the medical devices
from the market, except for those already sold to end users.
Section 2.
Applications and procedures for issuance of the certificate of free sale (CFS)
for Class A and B medical devices
1. Application for the certificate of
free sale for Class A and B medical devices includes:
a) A written request for the
certificate of free sale, using Form 03 in Section 6 of this Appendix;
b) A valid ISO 13485 quality
management certificate: Original, certified copy, or a copy certified by
the applicant;
c) Method of submission: Online via
the electronic portal for medical device management.
2. Issuance, reissuance, and
revocation of the certificate of free sale shall comply with the regulations of
the law on foreign trade management.
3. The certificate of free sale for
Class A and B medical devices shall be issued using Form 05 in Section 6 of
this Appendix.
Section 3.
Application and procedures for receipt of declaration dossier for raw materials
used in the manufacture of medical devices and reference substances containing
narcotic substances and precursors
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a) Declaration document for raw
materials used in the manufacture of medical devices and reference substances
containing narcotic substances and precursors, using Form 05 in Section 6 of
this Appendix;
b) Certificate of quality
management system;
c) Technical documentation using
Form 06 in Section 6 of this Appendix.
3. Procedures for declaration of
raw materials used in the manufacture of medical devices and reference
substances containing narcotic substances and precursors:
a) Prior to the import or export of
the said raw materials, the importer or exporter must upload a complete and
valid declaration dossier as prescribed;
b) Method of submission:
Online via the electronic portal for medical device management;
c) Upon receipt of a complete and
valid dossier, the receiving authority shall publish on the electronic portal
for medical device management the information and declaration dossier regarding
the said materials.
4. Responsibilities of
establishments importing, exporting, and trading in raw materials for medical device
manufacturing and reference substances containing narcotic substances and
precursors:
a) Establishments importing or
exporting raw materials for medical device manufacturing and reference
substances containing narcotic substances and precursors shall re-declare the
concentration and content of narcotic substances and precursors upon any change
to the previously declared information;
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c) Establishments trading,
exporting, importing, or transferring raw materials for medical device manufacturing
and reference substances containing narcotic substances and precursors shall be
responsible for submitting annual reports to the application-receiving
authority and the Ministry of Public Security before January 15 of the
following year.
Section 4. Procedures
for revocation of medical device classification results
1. Cases subject to revocation of
classification results:
a) Incorrect classification results
that reduce the risk level of the medical device;
b) Forged classification result
documents.
2. Revocation procedures:
a) Within 01 working day from the
date of conclusion that the classification result falls under the cases
specified in Clause 1 of this Section, the receiving authority shall issue a
written decision on revocation of the classification result. The decision must
require the classification entity to take remedial measures (if any), and shall
delete the revoked classification result from the electronic portal for medical
device management.
The revocation decision shall be
sent to the classification entity, the Ministry of Health, the General
Department of Customs, and relevant customs offices, and published on the
electronic portal for medical device management.
b) Upon receipt of the revocation
decision, the classification entity must withdraw all affected classification
results stated in the decision and shall be held responsible for addressing the
consequences caused by its legal violations.
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Section 5.
Procedures for receipt of medical device price declaration documents
1. Issuance of the List of medical device
trading entities required to declare prices (hereinafter referred to as the
List of price declaration entities) shall be carried out as follows:
a) The receiving authority shall
take the lead and coordinate with relevant agencies and units to conduct an
overall review and propose the issuance of the List of price declaration
entities under its jurisdiction by the deadline specified in Point b of this
Clause. The List shall include the company name, enterprise code, and
branch code (if any);
b) The List of price declaration
entities shall be compiled and issued on a regular basis by February 15 of each
year. If any updates arise during the year, the receiving authority shall
review and issue a supplementary list. If no changes are required at the annual
review deadline, the issuance of a new list is not necessary;
c) The receiving authority must
publish the annual and supplementary Lists of price declaration entities on its
electronic portal within 05 days from the date of issuance and notify relevant agencies
and organizations and submit to the Ministry of Finance for updating in the
National Price Database;
d) The receiving authority shall
review and select medical device trading entities headquartered in the province
to be included in the List based on the requirements for price aggregation,
analysis, market forecasting, and state price management at the local level.
2. Methods for receiving and
declaring medical device prices:
a) Medical device trading entities
subject to price declaration are responsible for submitting the Price
Declaration Document to the authority receiving the price declaration specified
in Clause 1 Article 24 of this Decree within a maximum of 05 working days from
the date of price decision. Specific cases:
- In case the trading entity only
engages in wholesale, it shall declare the wholesale price; in case it only
engages in retail, it shall declare the retail price;
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- In case the trading entity is an
importer and concurrently the exclusive distributor, it shall declare the
wholesale price and the retail price (if any);
- In case the trading entity is an
exclusive distributor, it shall declare the wholesale and retail prices;
general agents with the authority to set and adjust prices shall declare both
wholesale and retail prices; agents with the authority to set and adjust prices
shall declare the retail price.
b) Forms of receiving price
declarations:
- Via digital platforms/software,
including: public service portals; price database software; other online
platforms approved by competent authorities in accordance with the law;
- By other means: direct submission
at the price declaration authority; by postal service (submission date based on
date stamp); via electronic documents through email.
c) The receiving authority shall
select one or more forms of declaration based on actual conditions to
facilitate compliance.
In case the online platform for
price declaration via software is already available, such method shall be given
priority; in case of technical issues that prevent online submission, the
trading entity may apply other methods of price declaration as prescribed in
Point b Clause 2 of this Section, and shall resume the online price declaration
once the conditions for online submission are ensured.
d) The receiving authority must
connect and update the declared medical device pricing information to the
National Price Database as specified in Point a, Clause 2 of this Section.
dd) The Price Declaration Document
shall use Form 07 or Form 08 in Section 6 of Appendix IV on medical devices
enclosed with this Decree.
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A. Forms for continuation of
circulation of medical devices in cases where the medical device owner ceases
production or is declared bankrupt/dissolved for Class A and B medical devices
Form 01
Name
of the facility
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
…………….
[Location].......
1, [date]..................
REQUEST FOR CONTINUED CIRCULATION OF MEDICAL DEVICE
AND COMMITMENT TO WARRANTY, MAINTENANCE, AND SUPPLY OF MATERIALS FOR MEDICAL
DEVICE USE
To:
............................................
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Tax identification number:
.........................................................................................................................
Address:
................................................................................................................................
Legal representative:
...................................................................................................
Contact phone number:
............................................................................................................
We are ...2..., currently
distributing the following medical devices:
Name of medical device: ...........................................................................................................
Circulation number:
..................................................... Date of issuance:
.......................................
Due to the fact that .............3.............
can no longer operate, but we are still capable of ensuring the quality of the
aforementioned medical device, we respectfully request that ……………. permit
continued circulation of the said medical device and we hereby commit as follows:
- Take responsibility for the
quality, specifications, and quantity of the medical devices granted
circulation numbers;
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- Be responsible for warranty,
servicing, and maintenance of the medical device;
- Provide materials and replacement
accessories during use for a period of 8 years;
- Meet all requirements and
conditions regarding personnel in charge of technical matters and ensure the
effectiveness and safety of the medical device for users and the environment;
ensure appropriate facilities and transport conditions do not affect the
quality of imported medical devices; comply with labeling requirements in
accordance with applicable regulations;
- Ensure the medical device is used
for the intended purpose; be subject to inspection and examination by competent
authorities.
If we violate the above
commitments, we shall be fully liable before the law.
Legal
representative of the facility
(Signature, full name, and title)
Seal or digital signature affixed
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Form
of approval of continued circulation of medical device
……………………….
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
……………….
Hanoi,
[date]………………..
To:
............................................
Pursuant to Decree No.
98/2021/ND-CP, dated November 8, 2021, of the Government, on management of
medical devices;
Pursuant to Decree No. .../2025/ND-CP,
dated ... ... 2025, of the Government, on ...;
...
...
...
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Name of medical device:
........................................................................................................
Circulation number:
..................................................... Date of issuance:
.......................................
The product is permitted to circulate
until:
.............................................................................
Company .... shall be responsible
for:
- Ensuring the quality,
specifications, and quantity of the medical device granted circulation number;
- Providing warranty, servicing,
and maintenance of the medical device;
- Provide materials and replacement
accessories during use for a period of 8 years;
- Meet all requirements and
conditions regarding personnel in charge of technical matters and ensure the
effectiveness and safety of the medical device for users and the environment;
ensure appropriate facilities and transport conditions do not affect the
quality of imported medical devices; comply with labeling requirements in
accordance with applicable regulations;
- Ensure the medical device is used
for the intended purpose; be subject to inspection and examination by competent
authorities.
...
...
...
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TITLE
OF THE SIGNATORY
(Signature, full name, and title)
Seal or digital signature affixed
B. Forms regarding the issuance
of Certificate of Free Sale (CFS) for Class A and B medical devices
Form 03
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
....[Location].......
1, [date]..................
REQUEST FORM
For issuance of the Certificate of Free Sale for
medical devices
To:
............................................
...
...
...
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1.1. Name of applicant:
1.2. Head office
address:.......................... 2
1.3. Phone number:...............................
Fax:
2. Owner of the medical device:
2.1. Name of owner:
2.2. Address:
3. Manufacturer(s):
3.1. Manufacturer No. 1:
- Name of manufacturer:
...
...
...
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3.2. Manufacturer No. 2:
- Name of manufacturer:
- Manufacturing address:
To meet the requirements of the
importing country, we respectfully request the issuance of the Certificate of
Free Sale (CFS) for the following medical devices:
No.
Name
of medical device
Trade
name (if any)
Model/type
Product
code (if any)
...
...
...
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Manufacturer
3
1
2
...
...
...
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3
...
...
...
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We hereby commit to:
1. Provide complete application
documents and accurate, lawful information in accordance with applicable regulations.
We shall bear full responsibility and be subject to legal penalties in case of
any falsification or misrepresentation.
2. Ensure and maintain compliance
with declared conditions throughout the manufacturing process.
Legal
representative of the applicant
(Signature, full name, and title)
Seal or digital signature affixed
_____________________________
...
...
...
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² As stated in the business
registration certificate
³ Number the manufacturers as per
Section 3
Form 04
ISSUING
AUTHORITY
CERTIFICATE OF FREE SALE
-------
CỘNG
HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Độc lập - Tự do - Hạnh phúc
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
---------------
.............,
ngày … tháng … năm ……
......, date... month... year...
...
...
...
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1. Giấy chứng nhận số/ Certificate
No: ....................../CFS/SYT-......
2. Chủ
sở hữu thiết bị y tế:
Product Owner:
Địa chỉ:
Address:
3. Thông tin chi tiết thiết bị y tế (Tên thiết
bị y tế; Chủng loại; Mã sản phẩm; Số lưu hành tại Việt Nam và Cơ sở sản
xuất): Theo phụ lục đính kèm.
Information of medical devices:
(Product name; Model; Product code; Market Authorization number in Vietnam and
Manufacturing site): See attached annex.
Văn bản này là để xác nhận rằng các
sản phẩm nêu trên tuân theo các quy định của Việt Nam về quản lý thiết bị y tế và được phép bán tại Việt Nam.
This is to certify that the above
product(s) complies with the Medical Device regulations of Vietnam and is (are)
allowed to be sold in Vietnam.
...
...
...
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QUYỀN
HẠN, CHỨC VỤ CỦA NGƯỜI KÝ
(Chữ ký của người có thẩm quyền, dấu của cơ quan, tổ chức ban hành
văn bản)
Họ và tên
PHỤ
LỤC ĐÍNH KÈM
Attached
Annex
Giấy chứng
nhận lưu hành tự do số/ Certificate of Free sale No:.............
CFS/SYT ...
1. Cơ sở sản xuất (Manufacturing
site(s)):
...
...
...
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Tên cơ sở sản xuất:
Name of Manufacturer:
Địa chỉ:
Address:
2.
Tên cơ sở sản xuất:
Name of Manufacturer:
Địa chỉ:
Address:
...
...
...
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1.
Tên thiết
bị y tế (Product name):
Chủng loại (Model):
Mã sản phẩm (Product code):
Số lưu hành tại Việt Nam (Market Authorization
number in Vietnam):
Tên cơ sở sản xuất (Name of
Manufacturer)
2.
Tên thiết
bị y tế (Product name):
Chủng loại (Model):
...
...
...
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Số lưu hành tại việt Nam (Market
Authorization number in Vietnam):
Tên cơ sở sản xuất (Name of
Manufacturer):
Trang (Page).../
C. Forms regarding the
declaration of raw materials for medical device manufacturing and reference
substances containing narcotic substances and precursors
Form 05
NAME
OF THE FACILITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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[Location].......
1, [date]..................
DECLARATION
Regarding raw materials for medical device
manufacturing and reference substances containing narcotic substances and
precursors
To: …
1. Name of the declaring facility:
Tax identification number:
Address: …………………… 2.............................................................................................
Business office (if any):
...
...
...
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Full name:
…………………………………………………………………………
ID/Personal ID/Passport No.: …………… Issued
on: ……… Place of issue: …………
Telephone:
Mobile phone: ……………
3. Information on raw materials for
medical device manufacturing and reference substances containing narcotic
substances and precursors:
Product name: ...
Model/type:
Product code (if any):
Packaging specification (if any):
Intended use:
...
...
...
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Name of manufacturing facility:
Manufacturing address:
Name of product owner:
Address of product owner:
4. Information on narcotic
substances and precursors in the raw material/reference substances:
Name of narcotic
substance/precursor:
Scientific name:
CAS number:
Concentration/content:
...
...
...
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Declaration
for raw materials for medical device manufacturing and reference substances
containing narcotic substances and precursors
Attached application:
1.
Certificate of quality management
system
□
2.
Technical documentation
□
The declaring facility commits to:
...
...
...
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2. Ensuring the quality of raw
materials and reference substances containing narcotic substances and
precursors; using them for the correct purpose and in compliance with
applicable laws.
Legal
representative of the applicant
(Signature, full name, and title)
Seal or digital signature affixed
___________________
1 Place name
2 As stated in the Business
Registration Certificate
Form No. 06
...
...
...
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Name and address of the declaring
facility:
[Date]..................
No.
Heading
Content
I
Description of raw materials for
medical device manufacturing and reference substances containing narcotic
substances and precursors
1.1
Description of raw materials for
medical device manufacturing and reference substances containing narcotic
substances and precursors
...
...
...
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Constituents of the product:
- Name of the narcotic substance
or precursor; scientific name; CAS number; content; and manufacturer information.
- Other excipients with their
respective concentrations.
Physicochemical properties of the
product.
Product form.
Storage conditions.
Shelf life.
Packaging specifications.
1.2
...
...
...
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Clearly state the intended use
and indications of the product.
1.3
Instructions for use
Provide a summary of instructions
for use and attach the original user manual of the product.
1.4
Contraindications
Information related to
contraindications of the product.
1.5
Warnings and precautions
...
...
...
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Warnings and precautions
specifically related to narcotic substances and precursors.
1.6
Possible adverse effects
Information on adverse effects
related to the use of the product.
II
Product manufacturing
2.1
Manufacturer
Specify the manufacturers
involved in the production process and the quality management system applied.
...
...
...
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Manufacturing and quality control
process
Provide documents related to production
and quality control stages, including:
- Manufacturing process diagram.
- Quality standards and testing
procedures for narcotic substances and precursors, including test reports.
- Quality standards and testing
procedures for the product, including product test reports.
III
Product marketing information
3.1
Provide information on countries
that have approved the marketing of the product.
...
...
...
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The declaring facility hereby certifies
that the above information is true and assumes full legal responsibility for
the declared contents.
Legal
representative of the entity
(Signature, full name, and title)
Affixed with seal or digital signature
D. Forms regarding the price declaration
of medical devices
Form No. 07
…………(1)…………
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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[Location].......,
[date]..................
To:
Pursuant to the Law on Prices;
Decree No. 85/2024/ND-CP dated July 10, 2024, of the Government, on elaboration
of a number of articles of the Law on Prices; Decree No. .../2025/ND-CP
dated .../.../2025, of the Government,
.........................
…………(1)………… hereby submits the Price Declaration Sheet for medical devices for
domestic sale or export (attached).
The declared price will take effect
from …/…/………. /.................................
…………(1)………… undertakes to be held
accountable before the law for the accuracy of the prices declared herein.
HEAD
OF THE ENTITY
(Signature and seal)
...
...
...
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- Address of the declaring
facility: ..................................................
- Phone number:
............................................................................
- Email:
............................................................................................
- Fax: ..............................................................................................
ACKNOWLEDGEMENT
OF DATE OF PRICE DECLARATION SUBMISSION
(The receiving authority shall
record the date of receipt and affix the official stamp)
Form No. 08
……(1)……
-------
...
...
...
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[Location].......,
[date]..................
PRICE DECLARATION SHEET
(Enclosed
with Official Dispatch No. … dated …/…/… of … regarding price declaration of
medical devices for domestic sale or export)
1. Declared price for domestic
sale:
No.
Name
of medical device
Economic-technical
characteristics, specifications
...
...
...
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Price
type (wholesale, retail)
Declared
price in previous period (incl. Official Dispatch No.)
Declared
price in this period
Pricing/price
adjustment date
Increase/decrease
compared to previous period
Increase/decrease
rate compared to previous period
Remarks
...
...
...
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...
...
...
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...
...
...
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No.
Name
of medical device
Economic-technical
characteristics, specifications
Export
market
Unit
Declared
price in previous period (incl. Official Dispatch No.)
Declared
price in this period
Pricing/price
adjustment date
Increase/decrease
compared to previous period
...
...
...
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Remarks
...
...
...
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...
...
...
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3. Analysis of reasons for price
adjustment compared to the most recent previous declaration period: Clearly state
the reasons for price changes between this declaration period and the previous
one, including fluctuations in cost components and other contributing factors
affecting the increase or decrease in prices of medical devices.
4. Specify the VAT amount already
included in the declared price.
Notes:
(1) Name of the entity
submitting the price declaration.
(2) Reference number of the
document.
(3) Name of the competent
authority receiving the price declaration.
...
...
...
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- For exported medical devices,
the declared price is the invoice price in Vietnamese dong or in foreign
currency (if any), accompanied by information on the export market, exchange
rate, effective date of exchange rate, and the bank of transaction.
- Where, in a declaration
period, the medical device trading entity sets or adjusts multiple prices for
different customer groups, all applicable prices must be declared.
APPENDIX V
ADMINISTRATIVE PROCEDURES IN THE FIELD OF FOOD SAFETY
(Enclosed with Decree No. 148/2025/ND-CP, of the Government, dated June 12,
2025)
Part 1. Application, procedures
for issuance of the Certificate of Free Sale (CFS) for exported food products
under the management of the Ministry of Health
1. Application for issuance of the
Certificate of Free Sale (CFS) for exported food products under the management
of the Ministry of Health:
- The trader shall submit 01 set of
the application in person or by post or online (if applicable) to the
specialized health authority under the Province-level People’s Committee or the
specialized authority assigned by the Province-level People’s Committee
(hereinafter referred to as the receiving authority). The application
comprises:
- An application for issuance of
the CFS specifying the name of the goods, HS code of the goods, certificate
number of product standards or registration number, standard code (if any),
composition and content of compounds (if any), importing country: 01 original,
presented in Vietnamese and English;
...
...
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- The list of manufacturing
establishments (if any), including names, addresses of the establishments,
types of products manufactured for export: 01 original;
- The applicable standards
declaration for the products or goods enclosed with the method of presentation
(on the product label or product packaging or attached documents): 01 copy
affixed with the trader’s seal;
2. Procedures for issuance of the
Certificate of Free Sale (CFS) for exported food products under the management
of the Ministry of Health:
a) In case the application is
incomplete or not in compliance with regulations, within 3 working days from the
date of receipt, the receiving authority shall notify the trader for
application completion;
b) The time limit for issuance of
the CFS shall not exceed 03 working days from the date the trader submits a
complete and compliant application. In case the CFS is not issued, the
receiving authority shall issue a written reply stating the reasons;
c) The receiving authority may
conduct an inspection at the manufacturing site if the application-based
assessment is insufficient to serve as the basis for issuance of the CFS or if
there are indications of violations relating to previously issued CFS;
dd) The quantity of CFS issued for
goods shall be as requested by the trader.
Part 2. Application, procedures
for modification, supplementation, reissuance of the Certificate of Free Sale
(CFS) for exported food products under the management of the Ministry of Health
1. Application for modification,
supplementation, reissuance of the Certificate of Free Sale (CFS) for exported
food products under the management of the Ministry of Health:
...
...
...
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b) Documents related to the
modification, supplementation, or reissuance of the CFS.
2. Procedures for modification,
supplementation, reissuance of the Certificate of Free Sale (CFS) for exported
food products under the management of the Ministry of Health:
In case of supplementation or
modification of the CFS; or reissuance due to loss or misplacement of the CFS,
the trader shall submit the written request and relevant documents to the
issuing authority. Within 3 working days from the date of receipt of a
complete and compliant application, the issuing authority shall consider and
adjust or reissue the CFS for the trader.
Part 3. Application and
procedures for registration of advertising content for medical nutritional
foods, foods for special dietary uses, nutritional products for children up to
36 months of age
1. Application for registration of
advertising content includes:
a) An application form for
confirmation of advertising content according to Form 01 enclosed with this
Appendix;
b) The receipt of registration for
the product declaration and the product declaration confirmed by the competent
authority (a copy certified by the organization or individual);
c) The product label sample (a copy
certified by the organization or individual);
d) For advertisements on audio and
visual media, a draft advertising script and the expected advertising content recorded
on video discs or audio discs shall be provided; for advertisements on other
media, a maquette (draft content) of the intended advertisement shall be
provided (a copy certified by the organization or individual);
...
...
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The documents in the application
for registration of confirmation of advertising content must be presented in
Vietnamese; in case of documents in foreign languages, they must be translated
into Vietnamese and notarized.
2. Procedures for registration of
advertising content:
a) Organizations or individuals
with products to be advertised shall submit the application for registration of
confirmation of advertising content to the authority issuing the Receipt of
registration for the product declaration;
b) Within 10 working days from the
date of receipt of a complete and valid application, the receiving authority
shall review the application and provide the result using Form 02 enclosed with
this Appendix. This period shall be counted from the date of receipt stamp
affixed by the receiving authority if the application is submitted by post, or
from the date the complete application is received on the online public service
system.
In case the receiving authority
does not agree with the advertising content of the organization or individual
or requests amendments or supplementation, it must issue a written document
specifying the reasons and legal basis for such request. The receiving
authority shall only request amendments or supplementation one time.
Within 10 working days from the
date of receipt of the amended or supplemented application, the receiving
authority shall appraise the application and issue a written response. After 90
working days from the date of issuance of the request for amendment or
supplementation, if the organization or individual fails to make the amendments
or supplementation, the application shall be no longer valid;
c) Authorities receiving
applications for registration of confirmation of advertising content shall
publicly announce the names and products of organizations and individuals
granted the Certificate of Advertising Content Confirmation for food products
on their websites and in the food safety database;
d) Organizations and individuals
registering for confirmation of advertising content shall be responsible for
paying the application appraisal fees to the receiving authority.
3. Organizations and individuals
with products to be advertised, as well as organizations and individuals
publishing the advertisements, shall only advertise products that have been
granted the Certificate of Advertising Content Confirmation and shall only
advertise in accordance with the content so confirmed.
...
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1. Application for issuance of the
Certificate of eligibility for food safety:
a) An application for issuance of
the Certificate of eligibility for food safety;
b) A copy of the Business
registration certificate;
c) An explanatory document
describing the facilities, equipment, and utensils ensuring food hygiene and safety
conditions in accordance with regulations of the competent state management
authority;
d) The certificate of health
eligibility of the establishment owner and the persons in person engaged in
food production and trading, issued by a qualified medical examination and
treatment establishment;
dd) The certificate of having
completed training on food hygiene and safety knowledge of the establishment
owner and the persons in person engaged in food production and trading as
prescribed by the Minister of the line management ministry.
2. Procedures for issuance of the
Certificate of eligibility for food safety:
a) Organizations and individuals
engaged in food production and trading shall submit the application for
issuance of the Certificate of eligibility for food safety to the receiving
authority;
b) Within 15 days from the date of
receipt of a complete and valid application, the competent state authority
shall conduct an on-site inspection of food safety assurance conditions at the
food production or trading establishment; if the conditions are satisfied, the
Certificate of eligibility for food safety must be issued; in case of refusal,
a written response clearly stating the reasons must be provided.
...
...
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1. Application for product
declaration registration:
a) The product declaration
according to Form 03 enclosed with this Appendix;
b) The Certificate of Free Sale or
the Certificate of Exportation or the Health Certificate issued by the
competent authority of the country of origin/export certifying that the product
is safe for consumers or is freely sold on the market of the
producing/exporting country (legalized by consulate);
c) The certificate of food safety
testing results for the product within 12 months prior to the date of
submission of the application, issued by a designated testing laboratory or a testing
laboratory accredited in accordance with ISO 17025, including safety criteria
issued by the Ministry of Health under risk management principles consistent
with international regulations, or safety criteria under relevant standards
declared by the organization or individual in case there are no regulations
issued by the Ministry of Health (original or certified copy);
d) Scientific evidence proving the
efficacy of the product or the ingredient that constitutes the declared
efficacy (original or copy certified by the organization or individual).
Where scientific evidence of ingredient efficacy is used to substantiate the
product’s efficacy, the minimum daily intake of the product must be equal to or
greater than 15% of the intake level of such ingredient as specified in the
documents;
dd) All documents in the
application for registration of product declaration must be presented in
Vietnamese; where documents are in foreign languages, they must be translated
into Vietnamese and notarized. All documents must remain valid at the time of
submission of the application for registration of product declaration.
2. Procedures for product
declaration registration:
Organizations and individuals
engaged in food production and trading shall submit the application for
registration of product declaration via the online public service system, by
post, or in person to the receiving authority as follows:
a) Submission to the receiving
authority. In cases where organizations or individuals have two or more
production establishments producing the same product, the organization or
individual shall only complete the product declaration registration procedures
at one state management authority in the locality where a production
establishment is located, as chosen by the organization or individual. Once the
state management authority has been chosen for registration, all subsequent
registrations must be submitted to the same authority;
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The application appraisal time
shall be counted from the time the application is submitted via the online
public service system or from the date of receipt stamp affixed by the
receiving authority in case of submission by post or direct submission.
c) In cases where the authority
does not agree with the product declaration application of the organization or
individual or requires amendments or supplementation, a written response
stating clearly the reasons and legal basis for the request must be
issued. The receiving authority shall only request amendments or
supplementation one time;
Within 07 (seven) working days from
the date of receipt of the amended or supplemented application, the receiving
authority shall appraise the application and issue a written response. After 90
working days from the date of the official letter requesting amendments or
supplementation, if the organization or individual fails to make the amendments
or supplementation, the application shall no longer be valid.
d) In case of changes in the
product’s name, origin, or composition, the organization or individual must
re-declare the product. For other changes, the organization or individual shall
notify in writing the changes to the receiving authority specified in Clause 1
of this Part and may produce and trade the product immediately after sending
the notification;
dd) The authority receiving the
product declaration application shall publicly announce the names and products
of organizations and individuals whose product declarations have been accepted
on their websites and in the food safety database.
Part 6. Application, procedures
for registration of product declaration for domestically produced products of
medical nutritional foods, foods for special dietary uses, nutritional products
for children up to 36 months of age
1. Application for product
declaration registration:
a) The product declaration
according to Form 03 enclosed with this Appendix;
b) The certificate of food safety
testing results for the product within 12 months prior to the date of
submission of the application, issued by a designated testing laboratory or a
testing laboratory accredited in accordance with ISO 17025, including safety criteria
issued by the Ministry of Health under risk management principles consistent
with international regulations, or safety criteria under relevant standards
declared by the organization or individual in case there are no regulations
issued by the Ministry of Health (original or certified copy);
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d) The Certificate of eligibility
for food safety in case the establishment is subject to the requirement of
obtaining the Certificate of eligibility for food safety as prescribed (a copy
certified by the organization or individual);
dd) All documents in the application
for registration of product declaration must be presented in Vietnamese; where
documents are in foreign languages, they must be translated into Vietnamese and
notarized. All documents must remain valid at the time of submission of the
application for registration of product declaration.
2. Procedures for product
declaration registration:
Organizations and individuals
engaged in food production and trading shall submit the application for
registration of product declaration via the online public service system, by
post, or in person to the receiving authority as follows:
a) Submission to the receiving
authority. In cases where organizations or individuals have two or more
production establishments producing the same product, the organization or individual
shall only complete the product declaration registration procedures at one
state management authority in the locality where a production establishment is
located, as chosen by the organization or individual. Once the state management
authority has been chosen for registration, all subsequent registrations must
be submitted to the same authority;
b) Within 07 (seven) working days
from the date of receipt of a complete application for registration of product
declaration for medical nutritional foods, foods for special dietary uses,
nutritional products for children up to 36 months of age, the receiving
authority shall appraise the application and issue the Receipt of registration
for product declaration according to Form 04 enclosed with this Appendix;
The application appraisal time
shall be counted from the time the application is submitted via the online
public service system or from the date of receipt stamp affixed by the
receiving authority in case of submission by post or direct submission.
c) In cases where the authority
does not agree with the product declaration application of the organization or
individual or requires amendments or supplementation, a written response
stating clearly the reasons and legal basis for the request must be issued.
The receiving authority shall only request amendments or supplementation one
time;
Within 07 (seven) working days from
the date of receipt of the amended or supplemented application, the receiving
authority shall appraise the application and issue a written response. After 90
working days from the date of the official letter requesting amendments or
supplementation, if the organization or individual fails to make the amendments
or supplementation, the application shall no longer be valid.
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dd) The authority receiving the
product declaration application shall publicly announce the names and products
of organizations and individuals whose product declarations have been accepted
on their websites and in the food safety database.
Part 7. Designation of food
testing establishments serving state management
1. Conditions applicable to testing
establishments:
a) Legal entity requirements:
Being established in accordance
with law; having the function of food testing or a Decision on assignment of
tasks by competent authorities.
b) Competency requirements:
The competency of the testing
establishment regarding the criteria for which designation is sought must
satisfy the following requirements:
- The quality management system
complies with the National Standard TCVN ISO/IEC 17025 or the International
Standard ISO/IEC 17025;
- Having adequate equipment and
facilities appropriate to the testing requirements and the field of designation
registration;
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- Testing methods are updated and
validated, and the analytical/testing capacity for the designated test
parameters/methods meets the applicable regulations or corresponding technical
regulations and other relevant requirements prescribed by the line management
ministry;
- Proficiency testing or
inter-laboratory comparison results are satisfactory for at least one of the
designated test parameters/methods.
2. Application for designation
registration:
a) The application form for
designation of the testing establishment according to Form 05 enclosed with
this Appendix;
b) The Establishment decision or
the Business registration certificate (certified copy);
c) Technical documents, records,
and procedures relating to the designated test parameters/methods;
d) Competency application:
- The list and records of the main
equipment, infrastructure consistent with the content of the capacity report of
the testing establishment according to Form 06 enclosed with this Appendix;
- The list and records of testing
technicians corresponding to the field of designation registration, enclosed
with certified copies of professional certificates;
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- The capacity report of the
testing establishment according to Form 06 enclosed with this Appendix;
- The sample of the testing result
certificate according to Form 07 enclosed with this Appendix;
- The record of testing activities
in the field of designation registration during the latest twelve (12) months
according to Form 08 enclosed with this Appendix.
3. Procedures for designation of
food testing establishments serving state management:
a) The testing establishment
satisfying the requirements specified in Clause 1 of Part 7 of this Appendix
shall submit one (01) set of application for designation registration
(submitted in person, by post, or online) to the receiving authority;
b) Within no more than 10 working
days from the date of receipt of the application, the receiving authority shall
appraise the application. If the application is invalid, the authority
must notify the submitting unit to complete the application in accordance with
regulations;
c) Within 15 working days from the
date of receipt of a valid application, the receiving authority shall issue a
decision to establish an assessment team for the testing establishment;
d) Procedures for assessment of the
testing establishment:
- The assessment team shall
comprise members possessing professional knowledge and experience in the field
of assessment and designation;
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+ Assessing the compliance and
conformity of the testing establishment with the requirements specified in
Clause 1 of Part 7 of this Appendix;
+ Preparing the assessment report
of the testing establishment according to Form 09 enclosed with this Appendix;
+ Preparing the assessment team’s
conclusion according to Form 10 enclosed with this Appendix. Based on the
corrective action report of the testing establishment, if necessary, the
receiving authority shall consider and re-assess at the testing establishment;
- Within 05 (five) working days
from the conclusion of the assessment at the establishment, the assessment team
must submit the conclusion to the receiving authority (the Minutes of the
testing establishment assessment as specified in Form 10 enclosed with this
Appendix);
dd) Within 15 (fifteen) working
days from the date of receipt of the assessment team’s conclusion, the
receiving authority shall consider and designate the testing establishment if
the requirements are met (the Decision on designation shall be issued according
to Form 11 enclosed with this Appendix). If the requirements are not met, the
receiving authority must issue a written notification stating the reasons for
refusal to designate the testing establishment;
e) Where necessary, the receiving
authority may establish an advisory council prior to signing and issuing the
Decision on designation;
g) Validity period of the Decision
on designation: The Decision on designation shall be valid for three (03) years
from the date of signing.
Part 8. Designation of food
testing establishments accredited by a legally recognized accreditation body of
Vietnam or an overseas accreditation body which is a signatory to the Mutual Recognition
Arrangements of the International Laboratory Accreditation Cooperation (ILAC)
or the Asia Pacific Accreditation Cooperation (APAC) for assessment and
issuance of accreditation certificates in accordance with the National Standard
TCVN ISO/IEC 17025 or the International Standard ISO/IEC 17025
1. Application for designation
registration:
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b) The Establishment Decision or
the Business registration certificate (certified copy);
c) Technical documents, records,
and procedures relating to the designated test parameters/methods;
d) Competency application:
- The list and records of the main
equipment, infrastructure consistent with the content of the capacity report of
the testing establishment according to Form 06 enclosed with this Appendix;
- The list and records of testing
technicians corresponding to the field of designation registration, enclosed
with certified copies of professional certificates;
- Documents evidencing assurance of
testing quality: plans and results of proficiency testing or inter-laboratory
comparison; report on the proficiency testing results of technicians regarding
the designated test parameters/methods;
- The capacity report of the
testing establishment according to Form 06 enclosed with this Appendix;
- The sample of the testing result
certificate according to Form 07 enclosed with this Appendix;
- The record of testing activities
in the field of designation registration during the latest twelve (12) months
according to Form 08 enclosed with this Appendix;
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2. Procedures for designation:
a) The testing establishment satisfying
the requirements specified in Clause 1 of Part 7 of this Appendix shall submit
one (01) set of application for designation registration (submitted in person,
by post, or online) to the receiving authority;
b) Within no more than 10 working
days from the date of receipt of the application, the receiving authority shall
appraise the application. If the application is invalid, the authority
must notify the submitting unit to complete the application in accordance with
regulations;
c) Within no more than 30 working
days from the date of receipt of a complete and valid application, the
receiving authority shall appraise the application. If the application meets
the requirements, the receiving authority shall sign and issue the Decision on
designation of the testing establishment, enclosed with the list of
parameters/methods. If the application fails to meet the requirements, the
receiving authority must issue a written notification stating the reasons for
refusal to designate the testing establishment;
d) Where necessary (the application
appraisal results are insufficient to conclude that the analytical capacity of
the establishment satisfies the requirements specified in Clause 1 of Part 8),
the receiving authority shall establish an assessment team to conduct an
on-site assessment at the testing establishment. The assessment procedures
shall be implemented in accordance with Point d, Clause 3, Part 7 of this
Appendix;
dd) Validity period of the Decision
on designation: The Decision on designation shall be valid for three (03) years
from the date of signing.
Part 9. Changes and
supplementation of the scope of designation of food testing establishments
serving state management
1. Application for registration of
changes and supplementation of the scope of designation:
The application for registration of
changes and supplementation of the scope of designation shall be prepared in
accordance with Clause 2 of Part 7 of this Appendix (for testing establishments
not accredited in accordance with ISO/IEC 17025) or Clause 2 of Part 8 of this
Appendix (for food testing establishments accredited by a legally recognized
accreditation body of Vietnam or an overseas accreditation body which is a
signatory to the Mutual Recognition Arrangements of the International Laboratory
Accreditation Cooperation (ILAC) or the Asia Pacific Accreditation Cooperation
(APAC) for assessment and issuance of accreditation certificates in accordance
with the National Standard TCVN ISO/IEC 17025 or the International Standard
ISO/IEC 17025). Where the designated testing establishment changes its legal
status or address, it must submit a written document specifying such changes.
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a) The testing establishment
registering for changes and supplementation of the scope of designation shall
submit one (01) set of application (submitted in person, by post, or online) to
the receiving authority;
b) The procedures for changes and
supplementation of the scope of designation shall be implemented in accordance
with Clause 3 of Part 7 of this Appendix (for testing establishments not
accredited in accordance with ISO/IEC 17025) or Clause 3 of Part 8 of this
Appendix (for food testing establishments accredited by a legally recognized
accreditation body of Vietnam or an overseas accreditation body which is a
signatory to the Mutual Recognition Arrangements of ILAC or APAC for assessment
and issuance of accreditation certificates in accordance with TCVN ISO/IEC
17025 or ISO/IEC 17025).
Part 10. Registration for
extension of the designation of food testing establishments serving state
management
1. Application for registration for
extension of designation:
a) The application form for extension
of the designation of the testing establishment according to Form 05 enclosed
with this Appendix;
b) The results of inter-laboratory
comparison or proficiency testing for the parameters/methods conducted by the
competent state management authority or from proficiency testing providers,
relevant to the registered scope;
c) The report on testing activities
performed during the designated period according to Form 08 enclosed with this
Appendix.
2. Procedures for extension of
designation:
a) No later than 90 days before the
Decision on designation expires, the testing establishment shall submit one
(01) set of application for registration for extension of designation
(submitted in person, by post, or online) to the receiving authority;
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Part 11. Exemption from
inspection and supervision for food testing establishments accredited by a
legally recognized accreditation body of Vietnam or an overseas accreditation
body which is a signatory to the Mutual Recognition Arrangements of the
International Laboratory Accreditation Cooperation (ILAC) or the Asia Pacific
Accreditation Cooperation (APAC) for assessment and issuance of accreditation
certificates in accordance with the National Standard TCVN ISO/IEC 17025 or the
International Standard ISO/IEC 17025
1. Application for exemption from
inspection and supervision:
a) The official letter requesting
exemption from inspection;
b) The monitoring record issued by
the accreditation body certifying conformity with TCVN ISO/IEC 17025 or ISO/IEC
17025 (within twelve (12) months prior to the date of application submission);
c) The report on operational
results within twelve (12) months prior to the date of application submission,
specifying the self-assessment of the analytical capacity of the testing
establishment compared to relevant regulations of the line management ministry.
2. Procedures for exemption from
inspection and supervision:
a) A food testing establishment
accredited by a legally recognized accreditation body of Vietnam or an overseas
accreditation body which is a signatory to the Mutual Recognition Arrangements
of ILAC or APAC for assessment and issuance of accreditation certificates in
accordance with TCVN ISO/IEC 17025 or ISO/IEC 17025, and which fully satisfies
the requirements specified in Clause 1 of Part 8 of this Appendix and other
relevant regulations issued by the line management ministry, shall submit one
(01) set of application (submitted in person, by post, or online) to the
receiving authority;
b) Within no more than 05 working
days from the date of receipt of a complete and valid application, the
receiving authority shall appraise the application and provide a written
response to the testing establishment.
3. Annually, the testing establishments
granted exemption as prescribed in Clause 1 of this Article shall still be
subject to ad-hoc inspection and supervision by the competent authority.
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1. Application for issuance of
certificate:
The application for issuance of
certificate for one (01) exported consignment or an establishment producing
exported food shall include:
a) The application form for
issuance of certificate according to Form 12 enclosed with this Appendix;
b) The Certificate of eligibility
for food safety or one of the following certificates: Good Manufacturing
Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000
Food Safety Management System, International Food Standard (IFS), Global
Standard for Food Safety (BRC), Food Safety System Certification (FSSC 22000),
or equivalent certificates which are still valid (a copy certified by the
exporting organization or individual), except in the cases specified in Clause
1 Article 12 of Decree No. 15/2018/ND-CP;
c) The certificate of food safety
testing results of samples from the consignment of exported food products (for
health certificates and other certificates related to the exported
consignment), containing complete information about the product name and
consignment, issued by a designated testing laboratory or a testing laboratory
accredited in accordance with ISO 17025 (original or certified copy), meeting
the requirements of the corresponding technical regulations (for products with
existing technical regulations) or meeting criteria according to
regulations/technical requirements (for products without existing technical
regulations), based on one of the following documents in order of priority:
- Circulars of ministries;
- National Standards (where there
are no national technical regulations, Circulars of ministries, or local
technical regulations);
- Codex standards, regional
standards, or foreign standards (where there are no national technical
regulations, Circulars of ministries, local technical regulations, or national
standards);
- Manufacturer’s standards attached
(where there are no national technical regulations, Circulars of ministries,
local technical regulations, national standards, Codex standards, regional
standards, or foreign standards);
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2. Where the importing country
requires the certificate in a format specified by the importing country
containing information beyond that specified in Clause 5 of this Part, in
addition to the documents specified in Clause 1 of this Part, the organization
or individual must submit relevant documents proving such information.
3. Where the importing country
requires the organization or individual to submit the certificate in a format
specified by that country, the issuing authority shall issue the certificate
based on the required format.
4. Competence, procedures for
issuance of certificates:
a) Organizations or individuals
producing or trading the exported consignment or the establishment producing
exported food shall submit the application to the receiving authority via the
online public service system, or submit in person or by post to the provincial
one-stop service section;
b) The time limit for issuance
shall not exceed 05 (five) working days from the date the organization or
individual submits a complete and valid application. If the certificate is not
issued or amendments or supplementation are required, the receiving authority
must issue a written response clearly stating the reasons and the legal basis
for the request;
Within 05 (five) working days from
the date of receipt of the amended or supplemented application, the receiving
authority shall appraise the application and issue a written response;
After 90 days from the date of
issuance of the official letter requesting amendments or supplementation, if
the organization or individual fails to amend or supplement, the application
shall no longer be valid;
c) The time for application
appraisal shall be counted from the time the application is submitted via the
online public service system or from the date of receipt stamp affixed by the
receiving authority (in case of direct submission or submission by post to the
provincial one-stop service section);
d) The certificate or the document
stating the reasons for refusal to issue shall be returned in accordance with
the form of application submission;
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e) All application components must
remain legally valid at the time of submission.
5. Certificate for exported food:
a) The certificate (Health
Certificate or other relevant certificates as required by the importing
country) shall be issued for food products, food additives, food processing
aids; tools, packaging materials, and food containers upon request of the
organization or individual;
b) The contents of the certificate
shall be presented in English and must at least include the following
information:
- The title of the certificate
(Health Certificate or other relevant certificate as required by the importing
country);
- Name of the issuing authority;
- Number and date of issuance of
the certificate;
- Name of the product certified or
the name of the food product group produced by the establishment;
- The shelf life/best-before date
of the batch of exported products for the Health Certificate and other certificates
related to the exported consignment;
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- The name and address of the exporting
organization or individual; the production establishment;
- Based on the testing certificate
of the exported food product batch, confirmation that the batch complies with
the current regulations of Vietnam on food safety and is fit for human consumption;
or that the food production establishment complies with the current regulations
of Vietnam on food safety in case the Certificate of eligibility for food
safety or equivalent certificate is still valid;
- Signature and seal of the
competent authority.
PART
13. FORMS
Form 01
Application for confirmation of advertising content
NAME
OF ENTITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
/Entity Code
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APPLICATION
For
confirmation of advertising content
To:
……………
1. Name of the entity applying for
confirmation:
...................................................................................
2. Registered office address: 2 ..................................................................................................
Phone
number:.......................................................................
Fax:...................
Request for confirmation of
advertising content for the following:
No.
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Number
and code of the Receipt of product declaration registration
Date
of Receipt of product declaration registration
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Advertising media: .............................................................................................................
The application includes the
following
documents:...................................................................................
I hereby certify that the
information and documents stated above are true and undertake to advertise the
food product(s) in accordance with the confirmed content.
Kindly request the competent
authority to consider and issue the Certificate of Advertising Content
Confirmation./.
Director
or legally authorized representative of the entity
(Signed with full name and title)
Seal
____________________
1 Place name
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Form 02
Result of confirmation of advertising content
NAME
OF GOVERNING BODY
NAME OF AUTHORITY RECEIVING THE REGISTRATION OF ADVERTISING CONTENT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
/XNQC-...1...
[Location].......,
[date]..................
CERTIFICATE
OF ADVERTISING CONTENT CONFIRMATION
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Address: ……………………………………………………
Phone number:………
Fax:…………………………………..
No.
Product
name
Number
and code of the Receipt of Product Declaration Registration
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Advertising media:
…………………………………………………………………………………………..…….
The advertising content (attached)
has been approved in compliance with current regulations.
The organization/individual is
required to advertise strictly in accordance with the confirmed content.
Confirming
authority
(Signature, full name, and seal)
___________________
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Form 03
Product Declaration
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
PRODUCT
DECLARATION
No.
……………….
I. Information on the
organization or individual declaring the product
Name of the
organization/individual:...................................................................................................
Address:........................................................................................................................
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E-mail:............................................................................................................
Enterprise code: ....................................................................................................
Certificate number of the
Certificate of eligibility for food
safety:.................................................
Date of issuance/Place of issuance:.......................................................................................................
(for establishments subject to
issuance of the Certificate of eligibility for food safety as prescribed)
II. Information on the product
1. Product name:..........................................................................................................
2.
Ingredients:.............................................................................................................
3. Shelf
life:.....................................................................................
4. Packaging specifications and
packaging materials:........................................................
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III. Sample of the product
label (attached sample label or draft sample label)
IV. Food safety requirements
The organization or individual
producing, trading the food product meets food safety requirements in
accordance with:
- National Technical Regulation
No.…; or
- Circulars of ministries; or
- Local Technical Regulations; or
- National Standards (where no
national technical regulations, Circulars of ministries, or local technical regulations
are available); or
- Codex Standards, regional
standards, or foreign standards (where no national technical regulations,
Circulars of ministries, local technical regulations, or national standards are
available); or
- Manufacturer’s standards attached
(where no national technical regulations, Circulars of ministries, local
technical regulations, national standards, Codex standards, regional standards,
or foreign standards are available).
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[Location].......,
[date]..................
REPRESENTATIVE OF THE ORGANIZATION/INDIVIDUAL
(Signature, seal)
Form 04
Receipt of registration for product declaration
NAME
OF GOVERNING BODY
NAME OF AUTHORITY RECEIVING THE REGISTRATION FOR PRODUCT DECLARATION
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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RECEIPT
OF REGISTRATION FOR PRODUCT DECLARATION
No.
/year/DKSP
........................ (Name of
the authority receiving the registration for product declaration) hereby
certifies receipt of the Product Declaration of: …..(name of the
organization/individual)
Address:........................................................................Phone
number:….. Fax:….. Email:…..for the product: ...............produced by …………
(name, address of the place of manufacture and country of origin) ………………in
conformity with the technical regulations/regulations/standards …. (number, code,
title).......................................................
The enterprise shall be fully
responsible for the conformity of the declared product./.
AUTHORIZED
REPRESENTATIVE OF THE ISSUING AUTHORITY
(Signature, seal)
Form 05
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TESTING
ESTABLISHMENT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
…./…
[Location].......,
[date]..................
APPLICATION
FOR DESIGNATION/EXTENSION OF DESIGNATION OF TESTING ESTABLISHMENT
To:
(Designating authority)
1. Name of the testing
establishment:
Address:
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2. Full name, title of the person
in charge of the testing establishment:
Address:
Phone number:
Fax:
E-mail:
3. Type of designation application:
Initial
registration Registration
for changes/supplementation Registration for extension
4. Scope of designation
application:
No.
Field
Name
of test
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Detection
limit (if any)/measurement range
Remarks
(1)
(2)
(3)
(4)
(5)
(6)
Note: Mark () for tests already
accredited and specify the name of the corresponding accreditation body in
column (6).
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6. We undertake to fully comply
with the provisions of Decree No. ……… on decentralization and delegation in the
health sector dated .... month .... year…… issued by the Ministry of Health.
Head
of the unit
(Signed and sealed)
Person
in charge of the testing establishment
(Signed and full name)
Form 06
Capacity report of the testing establishment
TESTING
ESTABLISHMENT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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[Location].......,
[date]..................
REPORT
CAPACITY
OF THE TESTING ESTABLISHMENT
1. Name of the testing
establishment:
Address:
Phone number:
Fax:
E-mail:
2. Full name, title of the person
in charge of the testing establishment:
Address:
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3. Full name, title of the person
in charge of the testing establishment:
No.
Full
name
Certificate
of professional training
Certificate
of management system training
Current
assigned work
Years
of experience in testing
Remarks
(1)
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(3)
(4)
(5)
(6)
(7)
4. Equipment:
4.1. Equipment requiring
verification/calibration:
No.
Name
of measuring instrument
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Verification/calibration
cycle
Date
of last verification/calibration
Verifying/calibrating
entity
Remarks
(1)
(2)
(3)
(4)
(5)
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(7)
4.2. Other equipment:
No.
Equipment
name
Technical
specifications
Date
of commissioning
Remarks
1
2
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4
5
5. Area and environment of the testing
establishment
5.1. Layout diagram and area of
each section of the testing establishment
5.2. Environmental conditions of
the sections of the testing establishment:
- Air conditioning;
- Ventilation and toxic vapor
extraction capability;
- Other assurance conditions
(vibration, dust, noise, lighting, radiation, etc.).
5.3. Occupational safety and
protection conditions for staff and personnel of the testing establishment
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No.
Field
Name
of test
Test
method
Detection
limit (if any)
Testing
capacity (samples/year)
Proficiency
test/inter-laboratory comparison results
1
2
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4
5
6
7
Remarks: In column (7), specify
the program name, parameter and matrix, and the results.
7. Testing activities performed by
the establishment in the latest three (03) years
No.
Field
Name
of test
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Total
number of samples
Remarks
1
2
3
4
5
6
8. The testing establishment
undertakes to:
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- Meet the requirements of the
assessment authority during the assessment process.
Head
of the unit
(Signed and sealed)
Person
in charge of the testing establishment
(Signed and full name)
Form 07
Testing
Result Certificate
TESTING
ESTABLISHMENT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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TESTING RESULT CERTIFICATE
(The
testing result is valid only for the submitted sample)
1. Sample name: (Enter the name
of the tested sample)
2. Sample code:
3. Sample description: (condition
upon receipt, sample weight, production date, expiry date, sample retention
status)
4. Sample retention period:
5. Sampling date:
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7. Testing duration:
8. Sample submitting entity:
9. Attached documents: (specify
content, number, date, month, year of accompanying documents or official
letters)
10. Testing results (parameters
designated by the testing establishment):
No.
Testing
parameter
Testing
method
Unit
Result
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1
2
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…
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……
……
……
…………
11. Conclusion:
(State clearly whether the
sample meets the requirements)
12. Remarks: (if any)
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[Location].......,
[date]..................
Head
of the unit
(Signed and sealed)
Person
in charge of the testing establishment
(Signed and full name)
Testing
technician
(Signed and full name)
Form 08
Report on testing activities of the establishment
TESTING
ESTABLISHMENT
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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[Location].......,
[date]..................
REPORT
ON TESTING ACTIVITIES OF THE ESTABLISHMENT
1. Name of the testing
establishment:
Address:
Phone number:
Fax:
E-mail:
Full name, title of the person in
charge of the testing establishment:
Phone number:
Fax:
E-mail:
3. Training: Professional capacity
improvement training for the testing establishment’s staff during 6 months (or
12 months) of year ……
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Full
name
Position
Training
course attended
Duration
Achieved
results
Remarks
(1)
(2)
(3)
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(5)
(6)
(7)
4. Equipment:
4.1. Equipment verified/calibrated in
6 months (or 12 months) of year ……
No.
Name
of measuring instrument
Measurement
range, accuracy class
Verification/calibration
cycle
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Verifying/calibrating
entity
Remarks
(1)
(2)
(3)
(4)
(5)
(6)
(7)
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No.
Equipment
name
Technical
specifications
Date
of commissioning
Remarks
1
2
3
4
...
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5. Fields and tests conducted by
the testing establishment during 6 months (or 12 months) of year ……
No.
Field
Name
of test
Test
method
Testing
capacity (total samples/6 or 12 months)
Detection
limit (if any)
Remarks
1
...
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3
4
5
6
7
6. Quality assurance of testing
results (participation in proficiency testing/inter-laboratory comparison) during
6 months (or 12 months) of year ………………………………………… : :
No.
Name
of test
Test
method
...
...
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Organizing
entity
Participation
period
Result
1
2
3
4
5
6
...
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7. Testing activities conducted by
the establishment during 6 months (or 12 months) of year ……
No.
Field
Type
of food
Name
of test
Test
method
Total
number of samples
Number
of non-compliant samples
1
...
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3
4
5
6
7
Head
of the unit
(Signed and sealed)
Person
in charge of the testing establishment
(Signed and full name)
...
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Testing establishment assessment report
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
[Location].......,
[date]..................
ASSESSMENT
REPORT
OF TESTING ESTABLISHMENT
1. Name of the assessed testing
establishment:
Address:
Phone number:
Fax:
E-mail:
2. Scope of designation
application: Fields and tests proposed for designation.
3. Assessment team or team members:
(specify full names)
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5. Bases for assessment:
- Quality management system of the
testing establishment;
- Technical procedures of the
testing establishment;
- Standards and regulatory
requirements for testing establishment competency.
6. Assessment contents:
- TCVN ISO/IEC 17025 or other
equivalent standards;
- The compliance and conformity of
the testing establishment in accordance with regulations on conditions for
testing establishments.
7. Assessment results:
Conclusions for each assessment
item (with attached records and assessment minutes).
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…………………………………………………………………………………………………………
…………………………………………………………………………………………………………
Assessment
team leader
(Signed and full name)
Form 10
Minutes of assessment of the testing establishment
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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MINUTES
OF
ASSESSMENT OF TESTING ESTABLISHMENT
The assessment team of the testing
establishment …………….. was established under Decision No. .... /QD-....
dated ......... of the competent state management authority, comprising:
(full name of the assessment
team leader, secretary, and members)
1. Name of the testing
establishment:
Address:
Phone
number:
Fax:
E-mail:
2. Conclusion of the Assessment
Team Leader:
2.1. Compliant items:
2.2. Non-compliant items:
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Non-compliant
items
Level
1
Level
2
Basis/Standard
(1)
(2)
(3)
(4)
(5)
...
...
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No.
Field
Test
name or type of test
Test
method
Remarks
(1)
(2)
(3)
(4)
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3. These minutes have been adopted
with the consent of ……………….. members of the assessment team.
4. Other comments, if any (specify the
content and name of the person with comments):
5. Other documents attached to the
minutes
include:........................................................................
Representative
of the testing establishment
(Signed and full name)
Secretary
of the assessment team
(Signed and full name)
Assessment
team leader
(Signed and full name)
Form 11
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DESIGNATING
AUTHORITY
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
.../QD-…
Hanoi,
[date]…
DECISION
ON
DESIGNATION OF FOOD TESTING ESTABLISHMENT SERVING STATE MANAGEMENT OF FOOD
SAFETY
Pursuant to the Law on Food Safety
dated June 17, 2010;
Pursuant to Decree No.
................. on decentralization and delegation in the health sector dated
....month .... year .... issued by the Ministry of Health;
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HEREBY
DECIDES:
Article 1. To designate
……………(name of the testing establishment), address …………….. as a designated food
testing establishment for the technical criteria listed in the appendix
attached to this Decision.
- Testing establishment code:
..../20..../Provincial People's Committee symbol -KNTP(1).
Article 2. This Decision is
valid for three (03) years from the date of signing.
Article 3. (Name of the
testing establishment) ....................... shall be responsible for
conducting testing activities serving state management as required and must
comply with the regulations and instructions of the competent state management
authority.
HEAD
OF THE DESIGNATING AUTHORITY
(Signed and sealed)
___________________
1. The code of the testing
establishment shall be formatted as follows:
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Example:
001/2025/HN-KNTP
LIST
OF DESIGNATED PARAMETERS
(Enclosed
with the Decision on designation of the testing establishment No. …/QD-…. dated
…… issued by the Designating authority)
No.
Name
of designated parameter
Scope
of application
Detection
limit (if any)/Measurement range
...
...
...
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2
3
...
...
...
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…
………………
………………
………………….
Form 12
Application for issuance of certificate for exported
food products
Name
of organization/individual
-------
...
...
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No.
[Location].......,
[date]..................
To:
Name of the organization/individual
applying for issuance of the certificate (in Vietnamese and English):……
……………………………………….
Address (in Vietnamese and
English):
……………………………………………..
Phone number: ………………………….Email:
……………………………………………
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………………………………………………………………………………………
Importing country:
………………………………………………………………………………………
To fulfill the requirements of the
importing country, our Company hereby requests the issuance of the Certificate
(name of Certificate – Health Certificate or other relevant Certificate as
required by the importing country) with the following specific information:
1. Name of the manufacturing
establishment (in Vietnamese and English):
…………………………….…………………………………………………………
2. Address (in Vietnamese and
English):
………………………………………………………………………………………
3. Group of exported food products
(applicable for Certificates issued to food production establishments):
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4. Name and composition of the
exported product:
………………………………………………………………………………………
5. Quantity of the exported product
consignment:
………………………………………………………………………………………
6. Shelf life of each product
batch:
………………………………………………………………………………………
7. Batch number of each product
batch (if any):
………………………………………………………………………………………
8. Product label (attached):
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9. The exported product meets food
safety requirements in accordance with: National technical regulation No....;
or Circulars of ministries; or Local technical regulations; or National
standards; or Codex standards, regional standards, or foreign standards; or
Manufacturer’s attached standards;
10. The manufacturing establishment
meets food safety requirements under the Certificate of eligibility for food
safety or equivalent Certificate No…., validity period:
………………………………………………………………………………………
11. Other requirements of the
importing country: ………………………………………………………
(Note: Sections 4 to 9 apply only
to Certificates for food, food additives, processing aids, tools, packaging
materials, and food containers.)
Attached application:
-
…………….………………………………………………………………………………………
-
……………..………………………………………………………………………………………
I/We take full responsibility
before the law for the accuracy of the declared information and documents in
the application.
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(Legal
representative or authorized person of the exporting organization signs,
stamps, or individual signs and stamps)
APPENDIX VI
ADMINISTRATIVE PROCEDURES IN MATERNAL AND CHILD HEALTH
(Enclosed with Decree No. 148/2025/ND-CP dated June 12, 2025, of the
Government)
Applications, procedures for
recognition of health facilities eligible to perform in vitro fertilization
(IVF)
1. Application for assessment
and decision on recognition of a health facility eligible to perform in vitro
fertilization includes:
a) Request for assessment using
Form No. 01 enclosed with Decree No. 10/2015/ND-CP;
b) Personnel declaration, equipment
list, and floor plan of the IVF-performing unit;
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d) Confirmation that the medical
staff directly performing IVF has conducted at least 20 IVF treatment cycles;
dd) Certified copy of the medical
operation license of the health facility and the medical practice certificate
of the IVF practitioner.
The application dossier shall be
compiled into one (01) set and submitted directly or by post to the specialized
health authority under the Province-level People’s Committee (hereinafter
referred to as the application-receiving authority).
2. Procedure for requesting
recognition of a health facility eligible to perform IVF:
Within 15 working days from the
date of receipt of a complete application, the application-receiving authority
shall review the dossier. If the application is not valid, the
application-receiving authority must issue a written notice stating the reasons
to the establishment applying for the performance of in vitro fertilization
(IVF) technique so that the application can be completed. If the dossier is
valid, within 60 days from the date of receipt, the authority must establish an
assessment team and conduct an on-site evaluation at the applicant facility.
3. Assessment and issuance of
decision on recognition of a health facility eligible to perform IVF:
a) The assessment team is
established under a decision by the head of the application-receiving
authority;
b) The assessment shall be
conducted at the applicant health facility and include the following:
- Verification of practical skills,
degrees, certificates, and professional qualifications of personnel in the IVF
unit and related departments;
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c) Preparation of the assessment
report using Form No. 02 enclosed with Decree No. 10/2015/ND-CP;
d) Within 05 working days from the
date of completion of the assessment, the head of the assessment team shall
submit the assessment report and draft decision to the head of the
application-receiving authority;
dd) Within 05 working days from
receipt of the assessment report and draft decision, the head of the
application-receiving authority shall issue a decision on recognition of the
health facility eligible to perform IVF; if not recognized, a written response
stating the reasons must be provided.
Form No. 01
REQUEST LETTER FOR ASSESSMENT AND RECOGNITION OF A
HEALTH FACILITY ELIGIBLE TO PERFORM IN VITRO FERTILIZATION (IVF)
HEALTH
FACILITY...
-------
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
/………
Re: Request for assessment and recognition of eligibility to perform in vitro
fertilization
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To:
…
Health facility was established in …
and has been granted Medical Operation License No. … dated … In order to meet
the demand for medical examination and treatment, especially for infertility
treatment, our health facility has prepared sufficient infrastructure,
equipment and human resources in accordance with the provisions of Decree No.
10/2015/ND-CP dated January 28, 2015 of the Government on giving birth by IVF
technique and altruistic surrogacy, and Decree No. 155/2018/ND-CP dated
November 12, 2018 of the Government on amendments to investment and business
conditions under the management of the Ministry of Health. The application
includes:
1. Personnel declaration, equipment
list, and floor plan of the IVF-performing unit;
2. Certified copies of degrees and
certificates of personnel directly performing IVF techniques;
3. Confirmation that personnel
directly performing IVF techniques have completed at least 20 IVF treatment
cycles;
4. Certified copies of the Medical
Operation License and medical practice certificates of IVF practitioners.
Health facility respectfully
submits this application and requests the Chairperson of the Province-level
People’s Committee to establish an Assessment Team and issue a decision
recognizing … unit of … health facility as eligible to perform in vitro fertilization./.
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APPENDIX VII
ADMINISTRATIVE PROCEDURES IN TRAINING AND SCIENTIFIC
RESEARCH
(Enclosed with Decree No. 148/2025/ND-CP dated June 12, 2025 of the Government)
Application and procedures for
issuance of Certificate of eligibility for educational institutions to assess
and certify Vietnamese language proficiency, foreign language proficiency, or
interpretation skills in medical examination and treatment
1. Application for issuance of
certificate of eligibility for educational institutions to assess and certify
Vietnamese language proficiency, foreign language proficiency, or
interpretation skills in medical examination and treatment shall comply with
Clause 1 and Clause 2, Article 141 of Decree No. 96/2023/ND-CP.
2. Procedures:
a) The educational institution
shall submit one (01) application for issuance of the certificate of
eligibility for language assessment (hereinafter referred to as “language
assessment”) as prescribed in Clause 1 of this Article to the specialized
health authority under the Province-level People’s Committee (hereinafter
referred to as the application-receiving authority);
b) Upon receipt of the application,
the application-receiving authority shall issue a receipt slip using Form No.
02 in Annex I enclosed with this Decree;
c) Within 15 days from the date of
receipt of a valid application, the application-receiving authority shall issue
the Certificate of eligibility for language assessment in medical examination
and treatment using Form No. 02 in Annex III enclosed with this Decree.
If the application is rejected, a written explanation stating the reasons
must be provided;
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dd) Within 15 days from the date of
receiving the revised and supplemented application, the application-receiving
authority shall issue the Certificate of eligibility for language assessment
using Form No. 02 in Annex III enclosed with this Decree; if not issued, a
written explanation stating the reasons must be provided;
e) Within 10 days from the date of
issuance of the Certificate of eligibility for language assessment, the
application-receiving authority shall publicly announce the name of the
certified educational institution on its official portal and on the information
system for medical examination and treatment management.
APPENDIX VIII
LIST OF ABOLISHED ADMINISTRATIVE PROCEDURES
(Enclosed with Decree No. 148/2025/ND-CP dated June 12, 2025 of the Government)
1. Approval of changes or additions
to the legal representative, professional in charge; name, head office address
or administrative contact information of an organization supporting research
(Administrative procedure code: 2.000711).
2. Declaration of meeting
requirements as a practice-based training facility in health sector education
for medical examination and treatment facilities under the Ministry of National
Defense and Ministry of Public Security (Administrative procedure code:
1.004553).
3. Declaration of meeting
requirements as a practice-based training facility in health sector education
for medical examination and treatment facilities under the Ministry of Health
and other central-level ministries/agencies excluding the Ministry of National
Defense and Ministry of Public Security (Administrative procedure code:
1.004565).
4. Initial registration of an
organization supporting research with clinical trial monitoring activities
(Administrative procedure code: 1.001012).
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6. Initial registration of an
organization supporting research with clinical trial monitoring activities
(Administrative procedure code: 1.000996).
7. Initial registration of an
organization supporting research with clinical trial statistical analysis and
data management activities (Administrative procedure code: 2.000003).
8. Initial registration of an
organization supporting research with laboratory testing activities for
clinical trials (Administrative procedure code: 2.000452).
9. Approval of first-aid training
programs (Administrative procedure code: 1.001960).
10. Issuance of confirmation of
advertising contents for medical examination and treatment services under the
jurisdiction of the Ministry of Health (Administrative procedure code:
1.002587).
11. Re-issuance of confirmation of
advertising contents for medical examination and treatment services under the
jurisdiction of the Ministry of Health due to changes in name or address of the
responsible entity, without changes to advertisement content (Administrative
procedure code: 1.001375).
12. Re-issuance of confirmation of
advertising contents for medical examination and treatment services under the
jurisdiction of the Ministry of Health in case of loss or damage
(Administrative procedure code: 1.001377).
13. Approval of non-official aid
programs for partially free-of-charge medicine support (Administrative
procedure code: 1.002418).
14. Issuance of confirmation of
advertising contents for medical examination and treatment services under the
jurisdiction of the Department of Health (Administrative procedure code:
1.002464).
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16. Re-issuance of confirmation of
advertising contents for medical examination and treatment services under the
jurisdiction of the Department of Health in case of loss or damage
(Administrative procedure code: 1.000562).
17. Final decision-making re-evaluation
for forensic medical examination (Administrative procedure code: 1.002057).
18. Medical examination for
one-time social insurance benefit (Administrative procedure code: 1.002168).
19. Medical examination for
retirement entitlement for employees (Administrative procedure code: 1.002671).
20. Medical examination for
survivor benefit entitlement (Administrative procedure code: 1.002208).
21. Medical examination to
determine whether a female employee is unfit to care for a child after
childbirth, surrogacy, or requires prenatal rest (Administrative procedure
code: 1.002190).
22. Medical examination in cases
where a person with disabilities or their legal representative (individual,
agency, or organization) provides valid proof that the disability assessment by
the Disability Assessment Council was biased or inaccurate (Administrative
procedure code: 1.011799).
23. Re-examination for recurrent
occupational diseases (Administrative procedure code: 1.002136).
24. Re-examination for recurrent
injuries caused by occupational accidents (Administrative procedure code:
1.002146).
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26. Disability assessment in cases
where the Disability Assessment Council is unable to conclude on the disability
level (Administrative procedure code: 1.000281).
27. Disability assessment in cases
where the person with disabilities or their legal representative (including
individuals, agencies, or organizations) disagrees with the conclusion of the
Disability Assessment Council (Administrative procedure code: 1.011798).
28. Final decision-making
re-examination due to exceeding professional competence (Administrative
procedure code: 1.002100).
29. Final decision-making on
disability level in cases where the person with disabilities or their legal
representative disagrees with the conclusion of the provincial Medical
Assessment Council (Administrative procedure code: 1.011797).
30. Final decision-making on
disability level in cases where the person with disabilities or their
representative (individual, agency, or organization) disagrees with the
conclusion of the Medical Assessment Council that issued the assessment report
(Administrative procedure code: 1.011800).
31. Final decision-making medical
examination upon request of organizations or individuals (Administrative
procedure code: 1.002076).
32. First-time injury assessment
due to occupational accidents (Administrative procedure code: 1.002706).
33. Comprehensive medical assessment
(Administrative procedure code: 1.002118).
34. Re-issuance of the Certificate
of Registration for medical equipment inspection activities (Administrative
procedure code: 1.002301).
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36. Evaluation of compliance with
good manufacturing practices for pharmaceutical ingredient manufacturers using
herbal materials (Administrative procedure code: 1.004573).
37. Request for remediation of withdrawn
lots of traditional medicinal ingredients or traditional medicines
(Administrative procedure code: 1.010743).
38. Request for re-export of
withdrawn lots of traditional medicinal ingredients or traditional medicines
(Administrative procedure code: 1.010744).