Thông tư 13/2021/TT-BYT cấp số nhập khẩu thiết bị y tế phòng chống COVID19 trường hợp cấp bách

• Số hiệu: 13/2021/TT-BYT
• Loại văn bản: Thông tư
• Nơi ban hành: Bộ Y tế
• Người ký: Trương Quốc Cường
• Ngày ban hành: 16/09/2021

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ----------------
No. 13/2021/TT-BYT	Hanoi, September 16, 2021

CIRCULAR

ISSUANCE OF REGISTRATION NUMBER AND IMPORT OF MEDICAL EQUIPMENT SERVING COVID-19 EPIDEMIC MANAGEMENT IN CASE OF EMERGENCIES

Pursuant to Resolution No. 86/NQ-CP dated August 6, 2021 of the Government Resolving urgent solutions for COVID-19 epidemic management for implementation of Resolution No. 30/2021/QH15 dated July 28, 2021 of the 15^th National Assembly;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;

Pursuant to Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on managing medical equipment and amendment thereto under Decree No. 169/2018/ND-CP dated December 31, 2018 and Decree No. 03/2020/ND-CP dated May 15, 2016;

At request of Director of Medical Equipment and Construction Department,

Minister of Health promulgates Circular on registration number and import of medical equipment serving COVID-19 epidemic management in case of emergencies.

Chapter I

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Article 1. Scope

This Circular prescribes:

1. Application and procedures for issuance of registration number for medical equipment, medical devices, testing biologicals, and chemicals for use in COVID-19 epidemic management specified in the list under Annex 1 attached hereto.

2. Import of medical equipment for COVID-19 epidemic management.

Article 2. Adoption requirements for form of registration number issuance

Medical equipment shall be eligible for rapid issuance of registration if the medical equipment:

1. is specified under the list in Annex 1 attached hereto; and

2. Falls under any of the following circumstances:

a) Has been licensed for circulation or emergency use by: Food and Drug Administration (FDA) - United States of America; Therapeutic Goods Administration (TGA) - Australia; Health Canada; Ministry of Health, Labor, and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency – Japan; or

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c) Falls under list of SARS-CoV-2 testing equipment for emergency use publicized by World Health Organization (WHO) on https://extranet.who.int (Coronavirus disease (COVID-19) Pandemic - Emergency Use Listing Procedure (EUL) open for IVDs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control); or

d) Falls under list of popular products for testing SARS-CoV-2 publicized by Health Security Committee (EUHSC) on https://ec.europa.eu (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu); or

dd) Has been licensed for import for commercial purposes in Vietnam before the effective date hereof; or

e) Has been domestically produced in form of technology transfer in case of medical equipment mentioned under Point a, Point b, Point c, Point d, or Point dd of this Clause; or

g) Has been domestically produced in form of toll manufacturing in case of medical equipment mentioned under Point a, Point b, Point c, Point d, or Point dd of this Clause.

Article 3. Regulations on registration number

1. Form of registration:

a) Declare applied standards for type B medical equipment;

b) Issue certificate of registration for type C and type D medical equipment.

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a) Confirmation number of Medical Equipment and Construction Department in documents declaring applied standards using Form No. 1 under Annex 3 attached hereto for type B medical equipment;

b) Number of certificate of registration for medical equipment issued by Medical Equipment and Construction Department using Form under Annex 4 attached hereto for type C and type D medical equipment.

3. Registration number issued as per this Circular remains valid from the date of issue until December 31, 2022.

Article 4. Entitlement for receiving, appraising, and issuing registration number

1. Minister of Health shall assign Medical Equipment and Construction Department to receive and appraise applications for issuance of registration number for medical equipment serving COVID-19 epidemic management in case of emergency.

2. Minister of Health shall authorize Director of Medical Equipment and Construction Department to issue registration number for medical equipment serving COVID-19 epidemic management in case of emergency.

Chapter II

ISSUANCE OF REGISTRATION NUMBER FOR MEDICAL EQUIPMENT SERVING COVID-19 EPIDEMIC MANAGEMENT

Section 1. DECLARATION OF APPLIED STANDARDS FOR TYPE B MEDICAL EQUIPMENT

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1. Declaration of applied standards using Form No. 1 under Annex 3 attached hereto: 2 copies.

2. Documents under Clauses 4, 6, 7, 8, and 9 Article 22 of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government and amendment thereto under Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on managing medical equipment (hereinafter referred to as “Decree No. 36/2016/ND-CP”).

3. Documents proving permission of competent authority allowing medical equipment to be in circulation, including any of the following document:

a) Certificate for free trade of medical equipment;

b) Certificate for trade or permit for use in case of emergency for imported medical equipment.

4. Import permit for cases under Point dd Clause 2 Article 2 hereof.

5. Technology transfer contracts for cases under Point e Clause 2 Article 2 hereof.

6. Toll manufacturing contracts for cases under Point g Clause 2 Article 2 hereof.

Article 6. Requirements for declaration of applied standards

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1. Documents issued by foreign parties must be consular legalized, cases where consular legalization is not available:

a) For power of attorney, provide original copies;

b) For documents under Clause 3 Article 5 hereof, provide a link to website of permitting authority for looking up registration and use permit of medical equipment and attach documents providing information on the link to facilities responsible for registering trade. Lookup results of trade permit on the website must include the following mandatory information: name, type, model, manufacturing country, brand, and country of ownership.

2. All documents in the applications must bear confirmation seals of facilities responsible for declaring applied standards. For documents with 2 pages or more, issue adjoining seals.

Article 7. Procedures for declaring applied standards

1. Facilities responsible for declaring applied standards shall submit application for declaring applied standards according to Article5 hereof to Medical Equipment and Construction Department. For documents submitted via post service, conform to Decision No. 45/2016/QD-TTg dated October 19, 2016 of Prime Minister.

2. After receiving adequate applications (including documents confirming submission of fees for declaring applied standards according to regulations of Ministry of Finance), Medical Equipment and Construction Department shall:

a) Issue seals of receipt on both declarations of applied standards and return 1 declaration to declarant facility (seals of receipt must include date and time of receiving application);

b) Verify on declaration of applied standards within 1 working day from the date of receiving applications under Point a Clause 2 of this Article.

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Section 2. CERTIFICATE OF REGISTRATION FOR TYPE C AND TYPE D MEDICAL EQUIPMENT

Article 8. Application for issuance of registration certificate

1. Application for issuance of registration certificate using Form No. 2 under Annex 3 attached hereto: 2 copies.

2. Documents under Points d, g, i, and m Clause 1 Article 26 of Decree No. 36/2016/ND-CP.

3. Documents proving permission of competent authority allowing medical equipment to be in circulation, including any of the following document:

a) Certificate for free trade of medical equipment;

b) Certificate for trade or permit for use in case of emergency for imported medical equipment.

4. Import permit for cases under Point dd Clause 2 Article 2 hereof.

5. Technology transfer contracts for cases under Point e Clause 2 Article 2 hereof.

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7. Certificate for quality inspection/assessment issued by any entity under lists publicized on website of Ministry of Health for chemicals (biologicals) for PCR machines for SARS-CoV-2 testing, test kit for quick antigen/SARS-CoV-2 resistance test for any of the following cases:

a) Domestically manufactured medical equipment;

b) Medical equipment permitted by competent authority under Point b Clause 2 Article 2 hereof for trade and use in case of emergency.

Article 9. Requirements for application for issuance of registration certificate

Application for issuance of registration certificate shall be compiled into 1 set. Documents in the applications shall be arranged following the order under Article 8 hereof, must satisfy requirements under Clause 1 Article 6 hereof, and must bear confirmation seals of facilities responsible for registering for circulation. For documents with 2 pages or more, issue adjoining seals.

Article 10. Procedures for issuance of registration certificate

1. Facilities applying for issuance of registration certificate shall submit applications online according to Article 8 hereto to Medical Equipment and Construction Department. For documents submitted via post service, conform to Decision No. 45/2016/QD-TTg dated October 19, 2016 of Prime Minister.

2. After receiving adequate applications (including documents confirming submission of fees for appraising and issuing registration permit according to regulations of Ministry of Finance), Medical Equipment and Construction Department shall:

a) Issue seals of receipt on both applications for issuance of registration certificate and return 1 copy to applicants (seals of receipt must display time and date of receiving applications);

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3. Appraise and issue registration certificate:

a) In case applications require no revision: Medical Equipment and Construction Department shall appraise documents under Clauses 1, 3, 4, 5, and 6 Article 8 hereof and Point d Clause 1 Article 26 of Decree No. 36/2016/ND-CP to issue new registration certificate within 10 working days from the date on which applications are received (date of receiving applications shall be calculated based on the date on arriving Official Dispatch of Medical Equipment and Construction Department). In case of rejection, provide written response and explanation;

Within 3 working days from the date on which registration certificate is issued, Medical Equipment and Construction Department is responsible for publicizing application for declaration of applied standards on the website: https://dmec.moh.gov.vn.

b) In case applications for issuance of registration certificate are inadequate:

- Medical Equipment and Construction Department must inform applicants to revise within 3 working dates from the date on which applications are received while clarifying contents requiring revision;

- Upon receiving documents requesting revision to applications for issuance of registration certificate, the applicants must revise according to the request and submit to Ministry of Health.

c) In case of unsatisfactory revision, Ministry of Health shall inform the applicants to revise the applications further as specified in Point b Clause 3 of this Article;

d) If the applicants fail to adequately revise the applications after 30 days from the date on which Medical Equipment and Construction Department issues request or if the applicants fail to adequately revise the applications 3 consecutive times, the applicants must follow procedures for issuance of registration certificate again.

Chapter III

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Article 11. Management of imported medical equipment serving as aid

1. Medical equipment imported as aid for COVID-19 epidemic management without registration number must be approved by competent authority according to applicable regulations and law on managing and using foreign aid.

Customs clearance must rely on decision on receiving aid of competent authority and does not require import permit of medical equipment of Ministry of Health.

2. For other cases, comply with Article 42 of Decree No. 36/2016/ND-CP.

Article 12. Responsibilities of organizations and individuals receiving and using aid

1. Responsibilities of organizations and individuals applying for approval of medical equipment aiding COVID-19 epidemic management:

a) Examining documents of medical equipment received as aid;

b) Using medical equipment for the correct purpose;

c) Conducting inspection regarding quantity, type, and quality of aid commodities;

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dd) Transferring received materials and equipment to users as per Decisions of competent authority.

2. Responsibilities of users of aid medical equipment:

a) Conducting inspection regarding quantity, type, expiry date, and quality of aid commodities;

b) Using medical equipment for the right purpose;

c) Ceasing to use and immediately reporting to competent authority which allows receiving of aid in case of defects or failure to guarantee safety.

Chapter IV

IMPLEMENTATION

Article 13. Entry into force

This Circular comes into force from the date of signing until December 31, 2022 inclusively.

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If the legislative documents and provisions referred to in this Circular are amended, supplemented or replaced, the new legislative documents or provisions will be applied.

Article 15. Responsibilities for implementation

1. Responsibilities of owners of registration number:

Owners of registration number, in addition to responsibilities under Decree No. 36/2016/ND-CP , shall assume the following responsibilities:

a) assuming legal responsibilities for accuracy and truthfulness of application for issuance of registration number;

b) guaranteeing that medical equipment is manufactured, imported, and accompanied by use instruction according to applications for issuance of registration number;

c) publicizing price of medical equipment on website of Ministry of Health prior to introducing the medical equipment to the market;

d) informing Ministry of Health about medical equipment under Article 2 hereof in case of any change to circulation and use of products of competent authority.

2. Responsibilities of Medical Equipment and Construction Department:

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b) publicizing price of medical equipment and list of medical equipment suspended, medical equipment with registration number revoked on website of Ministry of Health.

3. Inspectorate of Ministry of Health shall take charge and cooperate with relevant agencies in inspecting compliance with this Circular of business facilities trading and importing medical equipment on a nationwide scale.

4. Departments of Health of provinces and central-affiliated cities are responsible for inspecting compliance with this Circular of business facilities trading medical equipment within their competence.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry (Medical Equipment and Construction Department) for consideration./.

PP. MINISTER
DEPUTY MINISTER




Truong Quoc Cuong