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 03/2023/ND-CP — amendments
Decree 03/2023/ND-CP, issued in February 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 03/2023 amendments to understand the current law.
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 the DMEC portal to stay informed of regulatory changes.