In line with the current Covid-19 outbreak in Vietnam, the Vietnam Ministry of Health issued two Official Dispatches to provide guidance on registration routes and submission dossiers to import SARS-CoV-2 Test Kit for aid, commercial purpose, and product registration.
While submission dossier to import Test Kit for aid purpose is in accordance with Article 42 of Circular 169, SARS-CoV-2 IVD Test Kit imported into Vietnam for the commercial purpose shall be classified into two categories which consequently determine its dossier and route.
1. If a Test Kit is used with medical devices (i.e., Immunology Analyzer), the application is submitted according to Circular 30/2015/TT-BYT and a fast approval route for an Import License.
2. If a Test Kit is used without medical devices (i.e., Antigen Rapid Test Kit), the application is submitted according to Circular 47/2010/TT-BYT Guidance on Import-Export activities of Drug and Primary Packaging for IVD.
Lastly, application for product registration of a Test Kit shall conform to Article 26 of Circular 169.
The announcement takes effect immediately and replaces Official Dispatch 1592/BYT-TB-CT.
Official Dispatch 5514/BYT-TB-CT Import-Export SARS-CoV-2 IVD medical devices and biologicals
Official Dispatch 5650/BYT-TB-YT on Import SARS-CoV-2 Antigen diagnostic biological and IVD medical devices to combat Covid-19