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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.