Publishing on Chinhphu.vn, the Ministry of Health (MoH) report, as of October 20, 2021, MoH has licensed 127 SARS-CoV-2 diagnostic test kit products, original from the U.S, Germany, France, Finland, China, Turkey, Malaysia, Singapore, and domestically produced, a part of them, including 43 genetic material tests (PCR, LAMP), 56 antigen tests and 26 antibody tests.
The procedure for granting a license to import SARS-CoV-2 diagnostic test kit (test kit) shall comply with the provisions of Decree 36/2016/ND-CP, Decree 169/2018/ND-CP, Circular 47/2010/TT-BYT, Circular 30/2015/TT-BYT and most recently an Official Letter 1592/BYT-TB-CT on production and import of medical equipment, in vitro diagnostic biological products Corona virus (SARS-CoV-2), its will vary and depending on the purpose of importing this product. Specifically, importing test kits for sponsorship, aid or commercial use in conjunction with medical equipment or commerce importation for independent use.
Herein we discussed in detail the importing test kit for commerce. The procedure to obtain the import licenses are carried out on the National Single Window Portal (NSWP) as prescribed in Circular 30/2015/TT-BYT dated Oct 12, 2015 of the MoH on importation medical equipment.
Documents list, its including:
- Application form as required;
- The Certificate of Free Sale (CFS) for imported medical equipment, it is still valid at the time of application submission;
- The manufacturer’s certificate of qualify international quality management system standards ISO 13485 or ISO 9001 (hereinafter referred to as ISO certificate), it is still valid at the time of application submission;
- An authorization letter of the owner of the medical equipment to the importers as the form required;
- Technical documents describing types of imported medical equipment in Vietnamese as the form required;
- Catalog describing the functions and specifications of imported medical equipment;
- Report on import of medical equipment as the form required.
If the test kit is licensed by the manufacturer country for emergency use, it has not been circulated in the manufacturing country, the CFS has not satisfied the requirements of the Government as prescribed in Decree 69/2018/ND-CP detailing a number of articles of Law on Foreign Trade Management, importers are allowed to import a number of samples for evaluation and testing at a quality inspection unit assigned by the MoH, and if it has satisfactory results, the MoH will quickly issue an import license.
The main procedure for implementation, the importer contact to the National Institute for Testing of Vaccines and Medical Biologicals requires for an official letter to test the product (if applicable), after that apply for an import license for testing purposes (if applicable), then carry out product testing at a quality inspection unit assigned by the MoH (if applicable), contact to MoH (specialized unit is Department of Medical Equipment and Construction) to apply for an import license for commerce use.
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Note: This article is for informational purposes only and it is not a legal advice. The content of the article represents its own of TTVN Legal, it subject to change without prior notice.