– View and download Circular: Circular 13/2021/TT-BYT Regulations on issuance of circulation numbers and aid for medical equipment
————
CIRCULAR
REGULATIONS ON ISSUING CIRCULATION NUMBERS AND IMPORTING MEDICAL EQUIPMENT FOR PREVENTION AND CONTROL OF COVID-19 EPIDEMIC IN EMERGENCY CASES
Pursuant to Resolution No. 86/NQ-CP dated August 6, 2021 of the Government on implementing urgent solutions to prevent and control the COVID-19 epidemic according to Resolution No. 30/2021/QH15 dated July 28, 2021 of the 15th National Assembly;
Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management, as amended and supplemented by Decree No. 169/2018/ND-CP dated December 31, 2018 and Decree No. 03/2020/ND-CP dated May 15, 2016;
At the request of the Director of the Department of Medical Equipment and Construction,
The Minister of Health issued a Circular regulating the issuance of circulation numbers and import of medical equipment for COVID-19 prevention and control in urgent cases.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Circular provides:
1. Records and procedures for granting circulation numbers for medical equipment, medical supplies, testing reagents, and chemicals used in COVID-19 prevention and control in the List specified in Appendix 1 issued with this Circular.
2. Importing medical equipment for the purpose of providing aid to prevent and fight the COVID-19 epidemic.
Article 2. Conditions for applying the form of circulation number issuance
Medical equipment is eligible for quick circulation number issuance if it simultaneously meets the following conditions:
1. Belonging to the List specified in Appendix 1 issued with this Circular;
2. Belonging to one of the following cases:
a) Has been authorized for circulation or emergency use by one of the following organizations: US Food and Drug Administration (FDA) – USA; Therapeutic Goods Administration (TGA) – Australia; Health Canada; Ministry of Health, Labour and Welfare of Japan (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) – Japan;
b) Has been permitted for circulation and emergency use by competent authorities of European countries specified in Appendix 2 attached to this Circular;
c) Belong to the list of SARS-CoV-2 testing products for emergency use published by the World Health Organization (WHO) on the website at 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) Belong to the list of popular products for SARS-CoV-2 testing issued by the European Health Security Committee (Health Security Committee – EUHSC) published on the website at https://ec.europa.eu (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu);
d) Has been granted a commercial import license in Vietnam before the effective date of this Circular;
e) Domestically produced in the form of technology transfer for medical equipment falling into one of the cases specified in Points a, b, c, d or dd of this Clause;
g) Domestically manufactured in the form of processing for medical equipment falling into one of the cases specified in Points a, b, c, d or dd of this Clause.
Article 3. Regulations on circulation numbers
1. Registration form:
a) Announcement of applicable standards for type B medical equipment;
b) Granting of circulation registration certificates for medical equipment types C and D.
2. Circulation numbers of medical equipment issued under the provisions of this Circular include:
a) Confirmation number of the Department of Medical Equipment and Construction on the document announcing the applicable standards according to form No. 1 specified in Appendix 3 issued with this Circular for medical equipment of type B;
b) The number of the certificate of registration for circulation of medical equipment issued by the Department of Medical Equipment and Construction according to the form prescribed in Appendix 4 issued with this Circular for medical equipment of type C and D.
3. Value of circulation number: The circulation number issued under the provisions of this Circular is effective from the date of signing and promulgation until December 31, 2022.
Article 4. Authority to organize reception, appraisal and issuance of circulation numbers
1. The Minister of Health assigns the Department of Medical Equipment and Construction to receive and appraise applications for circulation numbers for medical equipment serving COVID-19 prevention and control in urgent cases.
2. The Minister of Health authorizes the Director of the Department of Medical Equipment and Construction 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 FOR COVID-19 PREVENTION AND CONTROL
Section 1.
ANNOUNCEMENT OF STANDARDS APPLICABLE TO TYPE B MEDICAL EQUIPMENT
Article 5. Dossier for declaring applicable standards
1. Document announcing applicable standards according to form No. 1 specified in Appendix 3 attached to this Circular: Quantity 02 copies.
2. Documents specified in Clauses 4, 6, 7, 8, 9, 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 medical equipment management (hereinafter referred to as Decree No. 36/2016/ND-CP).
3. Documents proving that the medical equipment has been permitted for circulation by the competent authority, including one of the following documents:
a) Certificate of free circulation of medical equipment;
b) License for circulation or license for emergency use of imported medical equipment.
4. Import license for the case specified in Point d, Clause 2, Article 2 of this Circular.
5. Technology transfer contract for the case specified in Point e, Clause 2, Article 2 of this Circular.
6. Processing contract for the case specified in Point g, Clause 2, Article 2 of this Circular.
Article 6. Requirements for dossiers declaring applicable standards
The application for publication of applicable standards shall be made in 01 set. The documents in the application shall be arranged in the correct order prescribed in Article 5 of this Circular and must meet the following requirements:
1. Documents issued by foreign countries must be consularly legalized. In case of no consular legalization:
a) For authorization letters, the original must be provided;
b) For documents specified in Clause 3, Article 5 of this Circular, a link must be provided to look up information on the circulation and permission to use medical equipment from the website of the licensing authority, along with a document providing information on the lookup link of the facility registered for circulation. The results of the search for information on circulation licensing on the website must include at least the following information in English: name; type; manufacturer, country of manufacture; manufacturer, country of ownership.
2. All documents in the file must have the confirmation stamp of the establishment that publishes the applicable standards. For documents with two or more pages, the seal must be stamped on both sides.
Article 7. Procedures for announcing applicable standards
1. The establishment that announces the applicable standards shall directly submit a set of documents announcing the applicable standards in paper form as prescribed in Article 5 of this Circular to the Department of Medical Equipment and Construction. For documents submitted by post, the provisions of Decision No. 45/2016/QD-TTg dated October 19, 2016 of the Prime Minister on receiving documents and returning results of administrative procedures via public postal services shall apply.
2. After receiving complete and valid documents (including documents confirming payment of applicable standard announcement fee as prescribed by the Ministry of Finance), the Department of Medical Equipment and Construction shall:
a) Stamp the application receipt on both documents announcing the applicable standards and return one copy to the publishing facility (The receipt stamp must fully show the time, date, month, and year of application receipt);
b) Direct confirmation on the document announcing the applicable standards within 01 working day from the date of receiving the dossier specified in Point a, Clause 2 of this Article.
3. Within a maximum of 02 working days from the date of issuance of the receipt number for the application for declaration of applicable standards, the Department of Medical Equipment and Construction is responsible for publicly disclosing all application for declaration of applicable standards on the electronic information portal of the Online Public Service System for Management of Medical Equipment, at: https://dmec.moh.gov.vn.
Section 2
ISSUANCE OF CIRCULATION REGISTRATION CERTIFICATES FOR TYPE C, D MEDICAL EQUIPMENT
Article 8. Application for issuance of certificate of circulation registration
1. Application for issuance of certificate of circulation registration according to form No. 02 specified in Appendix 3 attached to this Circular: Quantity 02 copies.
2. Documents specified in points d, g, i, m, Clause 1, Article 26 of Decree No. 36/2016/ND-CP.
3. Documents proving that the medical equipment has been permitted for circulation by the competent authority, including one of the following documents:
a) Certificate of free circulation of medical equipment;
b) License for circulation or license for emergency use of imported medical equipment.
4. Import license for the case specified in Point d, Clause 2, Article 2 of this Circular.
5. Technology transfer contract for the case specified in Point e, Clause 2, Article 2 of this Circular.
6. Processing contract for the case specified in Point g, Clause 2, Article 2 of this Circular.
7. Certificate of inspection/assessment of product quality from one of the units on the list published on the Ministry of Health's Electronic Information Portal for chemicals (biological products) used to run SARS-CoV-2 PCR testing machines, SARS-CoV-2 antigen/antibody rapid test kits if one of the following cases applies:
a) Domestically produced medical equipment;
b) Medical equipment has been permitted for circulation and emergency use by the competent authority specified in Point b, Clause 2, Article 2 of this Circular.
Article 9. Requirements for application dossiers for issuance of circulation registration certificates
The application for a certificate of circulation registration is made into 01 set. The documents in the application are arranged in the correct order prescribed in Article 8 of this Circular, must meet the requirements prescribed in Clause 1, Article 6 of this Circular and must be stamped with confirmation by the establishment that is registered for circulation. For documents with two or more pages, the edges must be stamped.
Article 10. Procedures for granting circulation registration certificates
1. The facility requesting the issuance of a certificate of registration for circulation shall directly submit the application as prescribed in Article 8 of this Circular to the Department of Medical Equipment and Construction. For applications submitted by post, the provisions of Decision No. 45/2016/QD-TTg dated October 19, 2016 of the Prime Minister on receiving applications and returning results of administrative procedures via public postal services shall apply.
2. After receiving a complete and valid dossier (including documents confirming payment of the licensing appraisal fee as prescribed by the Ministry of Finance), the Department of Medical Equipment and Construction shall:
a) Stamp the receipt of the application on both documents requesting the issuance of a certificate of circulation registration and return one copy to the requesting facility (The receipt stamp must fully show the time, date, month, and year of receipt of the application);
b) Carry out the appraisal process and issue a certificate of registration for circulation according to the provisions of Clause 3 of this Article.
3. Appraisal and issuance of circulation registration certificate:
a) In case there is no request to amend or supplement the dossier: The Department of Medical Equipment and Construction shall organize the appraisal of the documents specified in Clauses 1, 3, 4, 5, 6, Article 8 of this Circular and Point d, Clause 1, Article 26 of Decree No. 36/2016/ND-CP to issue a new certificate of registration for circulation within 10 working days from the date of receipt of the dossier (the date of receipt of the dossier is calculated according to the date recorded on the stamp of the incoming dispatch of the Department of Medical Equipment and Construction). In case of not issuing a certificate of registration for circulation, there must be a written reply stating the reason;
Within a maximum of 03 working days from the date of issuance of the certificate of registration for circulation, the Department of Medical Equipment and Construction is responsible for publicly disclosing all registration dossiers for circulation on the electronic information portal of the Online Public Service System for Medical Equipment Management, at: https://dmec.moh.gov.vn.
b) In case the application for a certificate of circulation registration is not complete:
– The Department of Medical Equipment and Construction must issue a written notice to the organization requesting the issuance of a circulation number to supplement or amend the dossier within 03 working days from the date of receipt of the dossier requesting the issuance of a circulation registration certificate, which must specifically state which documents need to be supplemented and which content needs to be amended;
– Upon receiving a document requesting to supplement or amend the application for a certificate of circulation registration, the facility requesting the certificate of circulation registration must supplement or amend in accordance with the contents stated in the document and send it to the Ministry of Health.
c) In case the facility requesting the issuance of a certificate of circulation registration has supplemented or amended the dossier but it does not meet the requirements, the Ministry of Health will notify the facility to continue completing the dossier according to the provisions at Point b, Clause 3 of this Article;
d) After 30 days from the date the Department of Medical Equipment and Construction has a written request, if the facility does not supplement or amend the dossier, or if after 03 times of amending or supplementing the dossier from the date the Department of Medical Equipment and Construction has the first request for amending or supplementing the dossier, the dossier still does not meet the requirements, the procedure for requesting a certificate of circulation registration must be re-conducted from the beginning.
Chapter III
REGULATIONS ON IMPORT OF MEDICAL EQUIPMENT FOR THE PURPOSE OF AID TO SERVE THE PREVENTION AND CONTROL OF COVID-19 EPIDEMIC
Article 11. Management of imported medical equipment for aid purposes
1. Medical equipment without a circulation number imported to serve the prevention and control of COVID-19 for aid purposes must be approved by a competent authority in accordance with current regulations of law on management and use of foreign aid.
Customs clearance must be based on the decision to receive aid from the competent authority and does not require a license to import medical equipment from the Ministry of Health.
2. Other cases shall comply with the provisions of 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 requesting approval of medical equipment aid for COVID-19 prevention and control:
a) Responsible for checking the records of medical equipment proposed to receive aid;
b) Use aid for the right purposes;
c) Actual inspection of quantity, type and quality of aided goods;
d) In case the examination of the records does not provide sufficient basis for allocation to the using unit, the organization or individual requesting to receive aid shall coordinate with the organization with the function of inspecting and evaluating the quality of medical equipment to evaluate the quality, ensure safety and effectiveness before putting it into use;
d) Hand over received materials and equipment to the using unit according to the Decision of the competent authority.
2. Responsibilities of the unit using donated medical equipment:
a) Actual inspection of quantity, type, expiry date and quality of donated goods;
b) Use medical equipment for its intended purpose;
c) During use, if the donated medical equipment is defective or unsafe, it must be stopped and promptly reported to the competent authority that allows the receipt of aid for consideration and resolution.
Chapter IV
TERMS OF IMPLEMENTATION
Article 13. Entry into force
The Circular takes effect from the date of signing until December 31, 2022.
Article 14. Terms of reference
In case the legal documents and regulations cited in this Circular are changed, supplemented or replaced, the new legal documents shall apply.
Article 15. Responsibility for implementation
1. Responsibilities of the Circulation Number Owner:
In addition to implementing the provisions on responsibilities in Decree No. 36/2016/ND-CP, the owner of the circulation number has the following additional responsibilities:
a) Be responsible before the law for the accuracy and honesty of the application for circulation number;
b) Ensure that medical equipment is manufactured, imported, and has instructions for use in accordance with the issued circulation number;
c) Immediately publicly announce the price of medical equipment on the Ministry of Health's electronic information portal before putting medical equipment on the market;
d) Notify the Ministry of Health of the medical equipment cases specified in Article 2 of this Circular if there is any change in the circulation and use of the product by the competent authority licensing the circulation and use.
2. Responsibilities of the Department of Medical Equipment and Construction:
a) Based on the need to prevent and control the COVID-19 epidemic in each period, the Department of Medical Equipment and Construction shall preside over and coordinate with relevant units to research and submit to the Minister of Health for consideration and issuance of a decision on updating the list of medical equipment subject to rapid circulation as prescribed in Appendix 01 issued with this Circular;
b) Publicly announce the prices of medical equipment and the list of medical equipment whose circulation numbers have been suspended or revoked on the Ministry of Health's electronic information portal.
3. The Inspectorate of the Ministry of Health shall preside over and coordinate with relevant agencies to inspect and examine the implementation of this Circular for medical equipment trading and importing establishments nationwide.
4. The Department of Health of provinces and centrally run cities is responsible for inspecting and examining the implementation of this Circular for medical equipment business establishments within their management scope.
During the implementation process, if there are any difficulties or problems, agencies, organizations and individuals should report to the Ministry of Health (Department of Medical Equipment and Construction) for consideration and resolution./.