Regulatory Framework Overview

Vietnam's medical device regulatory system is a centralised national framework administered by the Ministry of Health (MOH) and its Drug Administration of Vietnam (DAV), with provincial health departments responsible for local enforcement.

The two-track market access system

Decree 98/2021/ND-CP introduced a risk-proportionate dual-track system:

Track	Applies to	Process
Declaration (Công bố)	Type A and Type B devices	Self-declaration via DMEC portal; no pre-market review by DAV for Type A
Marketing Authorisation (Đăng ký lưu hành)	Type C and Type D devices	Full registration dossier submitted to DAV; DAV technical review required

Regulatory bodies

Ministry of Health (MOH) — Bộ Y tế

The MOH sets overall health policy, issues circulars (Thông tư) and decrees, and has ultimate authority over medical device regulation. The MOH Minister can issue emergency decisions on device access or restriction.

Drug Administration of Vietnam (DAV) — Cục Quản lý Dược

DAV is the operational regulator for medical devices. It:

• Accepts and reviews Type C and Type D registration dossiers
• Manages the DMEC national information system
• Issues and revokes marketing authorisations
• Conducts and coordinates post-market surveillance
• Publishes official guidance and Q&A documents

Provincial Health Departments (Sở Y tế)

Each of Vietnam's 63 provinces and municipalities has a health department responsible for:

• Receiving notifications for Type A and B declarations within the province
• Local market surveillance and inspection activities
• Receiving FSCA and recall notifications
• Coordinating with DAV on enforcement matters

The DMEC system

The National Medical Device Information System (DMEC) at dmec.gov.vn is the central online portal for all regulatory submissions — Type A/B declarations, Type C/D registration applications, import permit requests, and post-market reporting.

ASEAN harmonisation

Vietnam is a member of the Association of Southeast Asian Nations (ASEAN) and has adopted the ASEAN Medical Device Directive (AMDD) classification framework. The Type A–D classification rules and the Common Submission Dossier Template (CSDT) are harmonised with ASEAN standards, making it easier to leverage registration materials prepared for other ASEAN markets.

Key legislation at a glance

Instrument	Subject
Decree 98/2021/ND-CP	Core medical device regulation
Decree 03/2023/ND-CP	Amendments to Decree 98
Circular 05/2022/TT-BYT	Import/export procedures
Circular 29/2022/TT-BYT	Clinical trial requirements
Circular 14/2020/TT-BYT	Device classification rules

For full legislative coverage, see the Legislation section.