Circular No. 13/2021/TT-BYT stipulates the issuance of circulation numbers and importation of medical equipment for the prevention and control of COVID-19 in emergency situations.

CIRCULAR

PROVISIONS ON THE ISSUE OF CIRCULATION NUMBERS AND IMPORTATION OF MEDICAL EQUIPMENT TO SERVE THE PREVENTION AND CONTROL OF THE COVID-19 EPIDEMIC IN EMERGENCY SITUATIONS

Pursuant to Resolution No. 86/NQ-CP dated August 6, 2021 of the Government on implementing urgent measures to prevent and control the COVID-19 epidemic as stipulated in Resolution No. 30/2021/QH15 dated July 28, 2021 of the National Assembly, term XV;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on the management of medical equipment, which has been amended and supplemented by Decree No. 169/2018/NĐ-CP dated December 31, 2018 and Decree No. 03/2020/NĐ-CP dated May 15, 2020;

At the proposal of the Director of the Department of Medical Equipment and Health Facilities,

The Minister of Health issues this Circular providing for the issuance of circulation numbers and importation of medical equipment to serve the prevention and control of the COVID-19 epidemic in emergency situations.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates:

1. Documents and procedures for issuing circulation numbers for medical equipment, medical supplies, testing reagents, and chemicals used for the prevention and control of the COVID-19 epidemic as specified in Appendix 1 attached hereto.

2. Importation of medical equipment with the purpose of aid to serve the prevention and control of the COVID-19 epidemic.

Article 2. Conditions for applying the expedited issuance of circulation numbers

Medical equipment shall be eligible for the expedited issuance of circulation numbers if it meets all of the following conditions simultaneously:

1. Included in the list specified in Appendix 1 attached hereto;

2. Belongs to one of the following cases:

a) Has been approved for circulation or emergency use by one of the following organizations: the U.S. Food and Drug Administration (FDA) - United States; the Australian Therapeutic Goods Administration (TGA) - Australia; Health Canada - Canada; the Japanese Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceuticals and Medical Devices Agency (PMDA) - Japan;

b) Has been approved for circulation or emergency use by the competent authority of one of the countries listed in Appendix 2 attached hereto;

c) Is included in the list of SARS-CoV-2 test products for emergency use published by the World Health Organization (WHO) at the website address 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));

d) Is included in the list of commonly used SARS-CoV-2 test products published by the European Union Health Security Committee (EUHSC) at the website address https://ec.europa.eu (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu));

đ) Has been granted an import permit under commercial terms in Vietnam before the effective date of this Circular;

e) Is produced domestically through technology transfer for medical equipment falling within one of the cases prescribed in points a, b, c, d or đ of this Clause;

g) Is produced domestically through contract manufacturing for medical equipment falling within one of the cases prescribed in points a, b, c, d or đ of this Clause.

Article 3. Provisions on circulation numbers

1. Registration for circulation:

a) Announcement of applicable standards for Class B medical equipment;

b) Issuance of certificates of registration for circulation for Class C and D medical equipment.

2. Circulation numbers for medical equipment issued in accordance with this Circular include:

a) The confirmation number of the Department of Medical Equipment and Health Facilities on the announcement of applicable standards according to Form No. 1 prescribed in Appendix 3 attached hereto for Class B medical equipment;

b) The certificate of registration for circulation number for medical equipment issued by the Department of Medical Equipment and Health Facilities according to the form prescribed in Appendix 4 attached hereto for Class C and D medical equipment.

3. Validity of circulation numbers: Circulation numbers issued in accordance with this Circular shall be valid from the date of issuance until December 31, 2022.

Article 4. Competence to organize the acceptance, examination, and issuance of circulation numbers

1. The Minister of Health shall instruct the Department of Medical Equipment and Works to organize the acceptance and examination of applications for issuing circulation numbers for medical equipment serving the prevention and control of COVID-19 in urgent cases.

2. The Minister of Health shall authorize the Director of the Department of Medical Equipment and Works to issue circulation numbers for medical equipment serving the prevention and control of COVID-19 in urgent cases.

Chapter II

ISSUING CIRCULATION NUMBERS FOR MEDICAL EQUIPMENT SERVING THE PREVENTION AND CONTROL OF COVID-19

Section 1. ANNOUNCEMENT OF STANDARDS APPLICABLE TO CLASS B MEDICAL EQUIPMENT

Article 5. Documents for announcing applicable standards

1. A document announcing applicable standards according to Model No. 1 stipulated in Appendix 3 attached to this Circular: Two copies.

2. The documents specified in Clauses 4, 6, 7, 8, and 9 of Article 22 of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government, amended and supplemented by Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government on the management of medical equipment (hereinafter referred to as Decree No. 36/2016/ND-CP).

3. Documentation proving that the medical equipment has been permitted for circulation by the competent authority, including one of the following documents:

a) Free Circulation Certificate for medical equipment;

b) Import Permit or Emergency Use Authorization for imported medical equipment.

4. Import Permit for the case stipulated in point d Clause 2 of this Circular.

5. Technology Transfer Agreement for the case stipulated in point e Clause 2 of this Circular.

6. Manufacturing Contract for the case stipulated in point g Clause 2 of this Circular.

Article 6. Requirements for documents announcing applicable standards

The application for announcing applicable standards must be compiled into one set. The documents in the application must be arranged in the correct order as prescribed in Article 5 of this Circular and must meet the following requirements:

1. Documents issued abroad must be legalized by consular authentication; in cases where there is no consular authentication:

a) For power of attorney, the original must be provided;

b) For the documents specified in Clause 3 of Article 5 of this Circular, a link to search for information on circulation and permission to use medical equipment from the website of the issuing authority must be provided, along with a document providing information about the search link of the entity registering for circulation. The search results for the circulation permit information on the website must include at least the following information in English: name; type; manufacturer, country of manufacture; brand, country of ownership.

2. All documents in the application must be stamped with confirmation by the entity named in the announcement of applicable standards. For documents consisting of two pages or more, a cross-stamp must be affixed.

Article 7. Procedures for announcing applicable standards

1. The entity named in the announcement of applicable standards shall submit directly one set of the application for announcing applicable standards in paper form as prescribed in Article 5 of this Circular to the Department of Medical Equipment and Works. For applications submitted through postal services, they shall be processed in accordance with Decision No. 45/2016/QĐ-TTg dated October 19, 2016 of the Prime Minister on receiving administrative procedures and delivering results through public postal services.

2. After receiving a complete and valid application (including the certificate confirming payment of the announcement fee as prescribed by the Ministry of Finance), the Department of Medical Equipment and Works shall perform:

a) Stamping the receipt of the application on both documents announcing applicable standards and returning one copy to the applicant (The receipt stamp must clearly indicate the time, date, and year of receipt of the application);

b) Directly confirming on the document announcing applicable standards within one working day from the date of receipt of the application as stipulated in point a Clause 2 of this Article.

3. Within a maximum period of two working days from the date of issuance of the receipt number for the application for announcing applicable standards, the Department of Medical Equipment and Works shall be responsible for publicly disclosing the entire application for announcing applicable standards on the online service portal for managing medical equipment at the address: https://dmec.moh.gov.vn.

Section 2. ISSUANCE OF REGISTRATION PERMIT FOR CIRCULATION FOR CLASS C AND D MEDICAL DEVICES

Article 8. Documents for Application for Issuance of Registration Permit for Circulation

1. A request for issuance of registration permit for circulation in accordance with Form No. 02 stipulated in Appendix 3 attached to this Circular: Two copies.

2. The documents specified in Points d, g, i, m Clause 1 Article 26 of Decree No. 36/2016/NĐ-CP.

3. Documentation proving that the medical equipment has been permitted for circulation by the competent authority, including one of the following documents:

a) Free Circulation Certificate for medical equipment;

b) Import Permit or Emergency Use Authorization for imported medical equipment.

4. Import Permit for the case stipulated in point d Clause 2 of this Circular.

5. Technology Transfer Agreement for the case stipulated in point e Clause 2 of this Circular.

6. Manufacturing Contract for the case stipulated in point g Clause 2 of this Circular.

7. Certificate of product quality testing/appraisal issued by one of the units listed on the Ministry of Health's official website for chemicals (biological products) running PCR tests for SARS-CoV-2, rapid antigen/antibody test kits for SARS-CoV-2 if they fall under any of the following cases:

a) Medical devices manufactured domestically;

b) Medical devices that have been permitted for emergency use by the competent authority as stipulated in Point b Clause 2 Article 2 of this Circular.

Article 9. Requirements for Documents for Application for Issuance of Registration Permit for Circulation

The application for issuance of registration permit for circulation shall be compiled into one set. The documents in the application must be arranged in the correct order as prescribed in Article 8 of this Circular, comply with the requirements stipulated in Clause 1 Article 6 of this Circular, and be stamped with confirmation by the entity named in the application for circulation registration. For documents consisting of two pages or more, they must be stamped across the join.

Article 10. Procedure for Issuance of Registration Permit for Circulation

1. The entity applying for issuance of registration permit for circulation shall submit the application directly in accordance with Article 8 of this Circular at the Department of Medical Equipment and Construction. For applications submitted via postal service, they shall be processed in accordance with Decision No. 45/2016/QĐ-TTg dated October 19, 2016 of the Prime Minister regarding the receipt of applications and delivery of results for administrative procedures through public postal services.

2. After receiving complete and valid documents (including certificates confirming payment of the registration permit issuance fee as prescribed by the Ministry of Finance), the Department of Medical Equipment and Construction shall perform:

a) Stamping the date and time of receipt on both copies of the request for issuance of registration permit for circulation and returning one copy to the applicant (the stamp must clearly indicate the hour, day, month, and year of receipt);

b) Implementing the process of examination and issuance of registration permit for circulation as prescribed in Clause 3 of this Article.

3. Examination and Issuance of Registration Permit for Circulation:

a) In cases where there is no need to amend or supplement the application: The Department of Medical Equipment and Construction shall organize the examination of the documents specified in Clauses 1, 3, 4, 5, and 6 of Article 8 of this Circular and Point d Clause 1 of Article 26 of Decree No. 36/2016/NĐ-CP to issue a new registration permit for circulation within ten working days from the date of receipt of the application (the date of receipt of the application is calculated based on the date recorded on the Department of Medical Equipment and Construction's incoming document stamp). If the registration permit for circulation is not issued, a written response must be provided with clear reasons stated;

Within a maximum period of three working days from the date of issuance of the registration permit for circulation, the Department of Medical Equipment and Construction shall be responsible for publicly disclosing the entire application for circulation registration on the online service portal for medical equipment management at the address: https://dmec.moh.gov.vn.

b) In cases where the application for issuance of registration permit for circulation is incomplete:

- The Department of Medical Equipment and Construction must notify the organization applying for circulation number to supplement and amend the application within three working days from the date of receipt of the application for issuance of registration permit for circulation, specifying in detail which documents and contents need to be supplemented or amended;

- Upon receiving the notification requesting supplementation and amendment of the application for issuance of registration permit for circulation, the entity applying for issuance of registration permit for circulation must supplement and amend according to the contents specified in the notification and send it back to the Ministry of Health;

c) In cases where the entity applying for issuance of registration permit for circulation has supplemented and amended the application but does not meet the requirements, the Ministry of Health will notify the entity to continue completing the application in accordance with Point b Clause 3 of this Article;

d) After thirty days from the date the Department of Medical Equipment and Construction issues a notification requesting supplementation and amendment, if the entity does not supplement and amend the application or if after three rounds of supplementation and amendment from the date the Department of Medical Equipment and Construction first requests supplementation and amendment, the application still does not meet the requirements, the procedure for application for issuance of registration permit for circulation must be restarted.

Chapter III

PROVISIONS ON IMPORTATION OF MEDICAL DEVICES FOR THE PURPOSE OF ASSISTING IN THE PREVENTION AND CONTROL OF THE COVID-19 EPIDEMIC

Article 11. Management of medical equipment imported for aid purposes

1. Medical equipment without circulation number imported to serve prevention and control of the COVID-19 pandemic with aid purposes must be approved by the competent authority according to the current regulations on management and use of foreign aid.

Clearance shall be based on the decision to accept aid from the competent authority and does not require a medical equipment import permit from the Ministry of Health.

2. Other cases shall be implemented in accordance with the provisions of Article 42 of Decree No. 36/2016/NĐ-CP.

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

1. Responsibilities of organizations and individuals proposing approval of medical equipment aid to serve prevention and control of the COVID-19 pandemic:

a) Shall have the responsibility to check the file of medical equipment proposed to receive aid;

b) Use for the intended purpose of the aid;

c) Check the actual quantity, type, and quality of goods received as aid;

d) In case the check on the file is insufficient basis to allocate to the user unit, the organization or individual proposing to receive aid shall cooperate with the organization having the function of inspecting and evaluating the quality of medical equipment to assess the quality, ensure safety and effectiveness before putting into use;

đ) Hand over materials and medical equipment received to the user unit according to the Decision of the competent authority.

2. Responsibilities of the user unit of medical equipment aid:

a) Check the actual quantity, type, expiration date, and quality of goods received as aid;

b) Use for the intended purpose of the medical equipment;

c) During the use process, if the medical equipment aid has defects and does not ensure safety, it must stop being used and promptly report to the competent authority that granted the aid for examination and resolution.

Chapter IV

IMPLEMENTING PROVISIONS

Article 13. Effective Date

This Circular takes effect from the date of signature until December 31, 2022.

Article 14. Cross-referencing Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 15. Responsibility for Implementation

1. Responsibilities of the Circulation Number Owner:

In addition to implementing the responsibilities stipulated in Decree No. 36/2016/NĐ-CP, the circulation number owner shall also bear the following responsibilities:

a) Shall be responsible under the law for the accuracy and truthfulness of the application file for circulation number;

b) Ensure that medical equipment must be produced, imported, and usage instructions must comply with the circulation number application file;

c) Publicly announce the price of medical equipment on the Ministry of Health's electronic portal before bringing the medical equipment to market;

d) Report to the Ministry of Health any changes in the circulation and use of medical equipment as specified in Article 2 of this Circular if there are any changes in the circulation and use of products authorized by the competent authority.

2. Responsibilities of the Department of Medical Equipment and Health Works:

a) Based on the needs for preventing and controlling the COVID-19 pandemic at each stage, the Department of Medical Equipment and Health Works shall take the lead in coordinating with relevant units to study and submit to the Minister of Health for consideration and issuance of decisions regarding updating the list of medical equipment subject to expedited circulation as specified in Appendix 01 attached to this Circular;

b) Publicly announce the price of medical equipment and the list of medical equipment whose circulation numbers have been suspended or revoked on the Ministry of Health's electronic portal.

3. The Inspectorate of the Ministry of Health shall take the lead and coordinate with relevant agencies to inspect and audit the implementation of this Circular for medical equipment business and import establishments nationwide.

4. Provincial Departments of Health under central cities shall be responsible for inspecting and auditing the implementation of this Circular for medical equipment business establishments within their jurisdiction.

Any difficulties or obstacles encountered during implementation should be reported to the Ministry of Health (Medical Equipment and Construction Department) for consideration and resolution./.