Medical Device Registration — Circular 36/2016/TT-BYT and Amendments
The Drug Administration of Vietnam (DAV), under the Ministry of Health, regulates medical devices through Circular 36/2016/TT-BYT and its amendments. Medical devices are classified under the ASEAN AMDD framework (Class A, B, C, D) and must obtain either:
- A Registration Number (số đăng ký) for Class B, C, and D devices — full technical dossier, clinical evidence, and quality system documentation.
- An Import Licence for Class A devices or devices in certain transitional categories — lighter documentation requirements.
Key requirements include:
- Vietnamese Authorised Representative: A locally registered entity that applies for and holds the Registration Number on behalf of the foreign manufacturer.
- Technical documentation: Aligned with ASEAN CSDT format, including essential principles checklist, risk management, clinical evidence, and quality system evidence.
- Vietnamese-language labelling: Mandatory on all device packaging and IFU.
- Post-market obligations: Adverse event reporting to DAV within required timeframes.
📅 Effective / published: 2016 (Circular 36); multiple amendments issued subsequently
Vietnam has extended transitional periods for re-registration of existing devices on several occasions. Manufacturers with existing approvals should monitor Ministry of Health announcements for re-registration deadlines. New submissions should follow the current DAV guidance and CSDT structure.
View official source (DAV — Drug Administration of Vietnam) ↗