Vietnam produced SARS-CoV-2 Test Kit and Regulation for the Importation of Test Kits during the pandemic
Scientists in Vietnam have successfully manufactured an in vitro (kit) real-time RT-PCR to detect novel coronavirus (SARS-CoV-2), which has been shown to deliver highly accurate results within 1 hour
On 5th March, The Ministry of Science and Technology announced that scientists in Vietnam had successfully manufactured an in vitro (kit) real-time RT-PCR to detect novel coronavirus (SARS-CoV-2), which was shown to be highly accurate with result within 1 hour. Vietnam could manufacture 10,000 kits per day with productivity reaching three times that if required.
The manufacturing process strictly follows quality requirements for medical device manufacturing, ISO 13485. The testing laboratory also follows ISO Class 8. The kit has been tested for its accuracy, sensibility, specificity, repeatability and compared with the kit provided by the US CDC and WHO. The Ministry of Health released Decision no. 774/QĐ-BYT to circulate the list of 02 IVD products for detection of SARS-CoV-2 in Vietnam. The productivity could serve the domestic requirement and production by order for sponsorship of many other countries. Vietnam has become one of the few countries that can produce the test kit, alongside the WHO, Japan, Germany and China.
The Ministry of Health also issued the dispatch no 1592/BYT-TB-CT regarding the manufacturing and importation of the SARS-CoV-2 test kit in which, the MOH encourages companies, importers and manufacturers to manufacture and import medical devices and IVD products related to the detection of SAR-CoV-2. For test kits used for sponsorship or donation, the import license could be approved through a special route: medical devices for sponsorship, aiding and donation, according to Decree 169/2018/ND-CP. For test kits to be used with medical devices, without sponsorship or donation, it is required that they have an import license according to Circular 30/2015/TT-BYT. For independent test kits (IVDs), it is required to have importation permission in accordance with Circular 47/2010/TT-BYT on the Import and Export of Pharmaceutical Products and Packaging Directly Connected With Pharmaceutical Products, IVDs part.