Vietnam Releases Draft Letter on Medical Devices

Late last year, Vietnam’s MOH issued a draft letter addressing device registration.  First, Class C and D device applications will now be submitted initially to Conformity Assessment Bodies (CABs) starting on September 1, 2023.  Certificates from CABs will go into effect on January 1, 2024.  Then the MOH will review the dossier and confirmation letter and determine approval.

Second, device import licenses issued from January 1, 2018 will be extended until December 31, 2023. Third, the MOH will announce which medical devices need to publish their pricing by July 1, 2023. Fourth, the names of the product owners and where the products are sourced will need to be added to all Vietnamese medical device ads.