Market Access Overview
Overview of the two pathways to place a medical device on the Vietnamese market — Declaration and Marketing Authorisation.
Declaration — Type A & B
The Công bố (Declaration) procedure for Type A and Type B medical devices in Vietnam under Decree 98/2021.
Marketing Authorisation — Type C & D
The Đăng ký lưu hành (Marketing Authorisation) procedure for Type C and Type D medical devices in Vietnam.
Clinical Evidence
Clinical data requirements for medical device market access applications in Vietnam — clinical evaluation, trials, and use of foreign data.
Special Device Types
Regulatory treatment of SaMD, IVDs, single-use devices, second-hand devices, and accessories in Vietnam.