DOCUMENT OF ANNOUNCEMENT OF STANDARDS APPLICABLE TO TYPE B MEDICAL EQUIPMENT
1. Document announcing applicable standards according to form No. 1 specified in Appendix 3 attached to this Circular: Quantity 02 copies;
2. Authorization letter from the owner of the medical equipment to the organization that publishes the applicable standards according to the form specified in Appendix VI of Decree 169;
3. Documents summarizing the technical description of medical equipment in Vietnamese according to Form No. 01 specified in Appendix VIII issued with this Decree, together with technical documents describing the functions and technical parameters of the medical equipment issued by the owner of the medical equipment;
Particularly for reagents, calibrators, and in vitro control materials: Technical documents in Vietnamese according to Form No. 02 specified in Appendix VIII issued with this Decree, together with documents on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports; (Decree 169)
4. Certificate of conformity according to regulations or product standard published by the owner of the medical equipment, accompanied by the results of the assessment of chemical, physical, microbiological parameters and other parameters issued by a qualified facility according to the provisions of law on conformity assessment for domestically produced medical equipment. The assessment results must be consistent with the standards published by the owner;
5. Instructions for use of medical equipment;
6. Label sample to be used when circulating in Vietnam of medical equipment;
7. 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.
8. Import license in the following cases: Having been granted an import license in the form of commerce in Vietnam before the effective date of this Circular;
9. Technology transfer contract in case of technology transfer;
10. Processing contract for processing cases.
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APPLICATION FORM FOR ISSUANCE OF CIRCULATION REGISTRATION CERTIFICATE FOR TYPE C, D MEDICAL EQUIPMENT
1. Document requesting for issuance of certificate of circulation registration according to form No. 02 specified in Appendix 3 attached to this Circular: Quantity 02 copies;
2. Authorization letter from the owner of the medical equipment for the facility to carry out the registration for circulation according to the form prescribed in Appendix VI issued with Decree 169;
3. Documents summarizing the technical description of medical equipment in Vietnamese according to Form No. 01 specified in Appendix VIII issued with this Decree, together with technical documents describing the functions and technical parameters of the medical equipment issued by the owner of the medical equipment;
Particularly for reagents, calibrators, and in vitro control materials: Technical documents in Vietnamese according to Form No. 02 specified in Appendix VIII issued with this Decree, together with documents on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports; (Decree 169)
4. Instructions for use of medical equipment;
5. Label sample to be used when circulating in Vietnam of medical equipment;
6. 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.
7. Import license in the following cases: Having been granted an import license in the form of commerce in Vietnam before the effective date of this Circular;
8. Technology transfer contract in case of technology transfer;
9. Processing contract for processing cases;
10. 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. (Has been permitted for circulation and emergency use by the competent authority of the countries in the European region specified in Appendix 2 attached to this Circular).
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>> See more Circulars: Circular 13/2021/TT-BYT on granting circulation numbers and providing medical equipment aid
>> See more Decree: Decree 36/2016/ND-CP dated May 15, 2016 on Medical Equipment Management
>> See more Decree: Decree 169/2018/ND-CP dated December 31, 2018 Amending Decree 36/2016/ND-CP on Medical Equipment Management
>> See more Decree: Decree 03/2020/ND-CP dated January 1, 2020 amending Article 68 of Decree 36/2016/ND-CP
>> See more Consolidated documents: Consolidated Document 01/VBHN-BYT March 16, 2020