Decree 98/2021/ND-CP — Medical Device Management
Decree 98/2021/ND-CP (Nghị định 98/2021/NĐ-CP về quản lý trang thiết bị y tế), issued by the Government of Vietnam on 8 November 2021 and effective from 1 January 2022, is the primary legislative instrument governing medical devices in Vietnam.
Background
Decree 98/2021 replaced Decree 36/2016/ND-CP (as amended) and introduced a streamlined, ASEAN-harmonised framework addressing lessons learned from the earlier legislation. Key improvements included:
- Introduction of the dual-track Declaration/Registration system
- Adoption of the ASEAN Type A–D classification framework
- Introduction of online submission via the DMEC national portal
- Clearer delineation of responsibilities between MOH, DAV, and provincial health departments
- Strengthened post-market surveillance and enforcement provisions
Structure of Decree 98/2021
The Decree is organised in chapters covering:
| Chapter | Subject |
|---|---|
| Chapter I | General provisions — scope, definitions, governing principles |
| Chapter II | Classification of medical devices |
| Chapter III | Declaration of conformity (Công bố) — Type A/B |
| Chapter IV | Marketing authorisation (Đăng ký lưu hành) — Type C/D |
| Chapter V | Import and export of medical devices |
| Chapter VI | Manufacture of medical devices |
| Chapter VII | Circulation and use |
| Chapter VIII | Post-market surveillance and recall |
| Chapter IX | Organisation, authority, and responsibilities of MOH, DAV, provincial departments |
| Chapter X | Transitional provisions and entry into force |
Key definitions (Chapter I)
Decree 98/2021 defines:
- Medical device (Trang thiết bị y tế) — as covered in What is a Medical Device?
- Manufacturer — the natural or legal entity responsible for design, manufacture, packaging, and labelling of a device
- Authorised Representative (Đơn vị bảo lãnh) — the Vietnamese legal entity appointed by a foreign manufacturer to act on its behalf
- Importer — the entity that brings a device into Vietnam from abroad
- Distributor — an entity in the supply chain between manufacturer/importer and end user
Decree 07/2023/ND-CP — amendments
Decree 07/2023/ND-CP, issued 3 March 2023, introduced amendments to Decree 98/2021 addressing:
- Clarification of transition timelines for devices previously registered under Decree 36/2016
- Adjustments to specific classification rules
- Procedural refinements to the DMEC submission process
- Updated penalty provisions
Always read Decree 98/2021 together with the Decree 07/2023 amendments to understand the current law.
Decree 37/2026/ND-CP — medical device labeling
Decree 37/2026/ND-CP, effective 26 January 2026, governs medical device labeling requirements in Vietnam.
Consolidated Document 08/VBHN-BYT
The Ministry of Health issued Consolidated Document 08/VBHN-BYT on 6 March 2026, merging Decree 98/2021 and Decree 07/2023 into a single consolidated reference text.
Official source
The official consolidated text of Decree 98/2021 (as amended) is available at the Vietnam Legal Document Portal: vbpl.vn and through the MOH website at moh.gov.vn.
Vietnamese regulatory instruments are frequently amended by subsequent decrees and circulars. Subscribe to MOH and DAV notifications and use