Several months ago, Vietnam’s MOH released Circular 10/2023/TT-BY updating pre-market requirements. There is now a new document list for device dossiers. While Class D and Class D devices still need CER reports for submission, Class B devices no longer have this requirement. Starting in January 2025, dossier applications will need to use the CSDT format – which is also not required now.
Right now, only some Class C and D products listed in Circular May 2022 need full registration. Products that need registration include MRIs, ventilators, osteoporosis meters, etc. For devices not mentioned in this Circular, they can be imported without registration until the end of 2024. In addition, Vienam has overhauled other device regulations and requirements for technical reports and records. For example, the following templates have been updated – 1. Declaration letters for Applicable Standards for Class A and B medical devices, 2. Application Forms for Class C and Class D registration, 3. Import licenses for medical devices, etc. Unfortunately, for higher-risk devices, there is still a backlog of medical device applications that the Vietnamese government is trying to review.
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.
Source used in the article: https://www.trade.gov/market-intelligence/vietnam-medical-device-registration-0