Vietnam Medical Device Regulation
Welcome to the RAPath guide for Vietnam — a plain-English reference for manufacturers, importers, distributors, and regulatory professionals navigating the Vietnamese medical device regulatory framework.
Who regulates medical devices in Vietnam?
Medical devices in Vietnam are governed by the Ministry of Health (MOH) through the Drug Administration of Vietnam (DAV). Provincial-level health departments also play an active role in local enforcement and market surveillance.
The core legislation
The primary law is Decree 98/2021/ND-CP on medical device management, which came into force on 1 January 2022. It replaced the earlier Decree 36/2016/ND-CP and introduced a streamlined dual-track system:
- Declaration (Công bố) — for lower-risk Type A and Type B devices
- Marketing Authorisation (Đăng ký lưu hành) — for higher-risk Type C and Type D devices
Decree 03/2023/ND-CP introduced further amendments, and several MOH Circulars provide procedural detail on import, clinical trials, and classification.
What this site covers
| Section | What you'll find |
|---|---|
| Getting Started | Definitions, framework overview, who must comply |
| Device Classification | Type A–D rules, IVD classification, borderline devices |
| Market Access | Declaration and registration pathways, DMEC portal, clinical evidence |
| Import, Customs & Distribution | Authorised representative, import permits, GDP |
| Post-Market | Vigilance, FSCA, labelling, change notification |
| Quality Management | ISO 13485, GMP, inspections |
| Legislation | Decree 98/2021, key circulars, procurement law |
| ASEAN & International | AMDD, CSDT, international comparison |
| Digital Health & SaMD | Software devices, AI/ML, cybersecurity |
| Special Access | Emergency import, compassionate use, donations |
| Resources | Glossary, legislation list, useful links |
Important disclaimer
This site is a regulatory reference resource only — it is not legal advice. Regulations change frequently. Always verify current requirements directly with the Drug Administration of Vietnam (DAV) or consult a qualified regulatory professional before making compliance decisions.
Questions or corrections?
Found an error or want to discuss a regulatory question? Use GitHub Discussions on the RAPath hub repository.