How to Register Medical Devices for Export to Vietnam

Direct answer: To export medical devices to Vietnam, first determine the risk class (A, B, C or D) under Decree 98/2021/ND-CP. Class A and B devices follow the declaration of applicable standards route; Class C and D devices require registration and a registration number. Applications are submitted to the Department of Medical Equipment and Construction (DAV) of the Vietnamese Ministry of Health (MoH), and an in-country license holder must bear post-market obligations. Specific review timelines are subject to publication by the competent authority.

Key requirements

• Competent authority: Ministry of Health (MoH), Department of Medical Equipment and Construction (DAV) — https://dav.gov.vn/
• Regulatory basis: Decree 98/2021/ND-CP (medical device management)
• Classification: Class A (low risk), Class B, Class C and Class D (high risk)
• Route: Class A/B — declaration of applicable standards; Class C/D — registration review and issuance of a registration number
• Core documents: (1) basis for classification; (2) quality management system evidence (ISO 13485); (3) technical file and instructions for use in Vietnamese; (4) reference-country approvals such as CE/FDA; (5) local license holder and authorization documents
• Language requirements: labels and instructions for use must be in Vietnamese

Professional notes

Ministry of Health: https://moh.gov.vn/

DAV: https://dav.gov.vn/

Verified date: 2026-11-02.

Frequently asked questions

Do Class A and B devices also need a registration number?

No. Class A and B follow the declaration route and do not require the registration number used for Class C and D devices. However, the manufacturer must complete the declaration of standards conformity and keep the documentation available for inspection.

Is a local Vietnamese company mandatory?

Yes, in practice a Vietnamese entity is needed to bear the declaration and post-market obligations. This is usually handled through a local license holder or authorized representative.

How long does registration take?

Official review timelines are not uniformly published for all classes. The actual timeline depends on the device class and the completeness of the dossier.

Source note: Based on public information from the MoH and DAV websites; verified on 2026-11-02.

Ameli is an overseas registration work platform for medical device companies; it is not a CRO or an agent.

This article is a regulatory information summary and does not constitute legal advice. The latest requirements of the competent authority prevail.