Vietnam Class A Device Registration: Provincial Declaration Route
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How is a Class A device placed on the Vietnamese market?
A: Through the Declaration of Applicable Standards (Bản công bố tiêu chuẩn áp dụng) route, filed with the provincial Department of Health (Sở Y tế) where the MAH is based. This is a declaration regime, not a review regime: once the materials are complete, the Department of Health publishes them on the MOH medical device management portal, and the published record on that portal is itself the market access credential.
Q: What materials must be submitted?
A: Under the declaration route in Decree 98 (the relevant provisions of Articles 25 and 26, together with the templates in Circular 44/2025), a typical list comprises:
- Declaration of Applicable Standards document (on the MOH template);
- Letter of Authorization (LoA) from the overseas manufacturer to the Vietnamese MAH, on the Circular 44/2025/TT-BYT template;
- conformity and quality documents issued by the product owner;
- an ISO 13485:2016 certificate (imported devices);
- a Certificate of Free Sale (CFS) (imported devices, depending on the route);
- drafts of the Vietnamese labelling and instructions for use;
- the classification result and the publication record.
The exact list follows what the MOH publishes at the time and how the provincial Department of Health accepts filings. Practice varies between provinces, and this is the single most important point on the Class A route.
Q: What are the timelines and fees?
A: The declaration route is short by design. In practice it is counted as “publication completed within a few working days of a complete file“, and provincial practice differs. Under Circular 59/2023/TT-BTC the standard fee is VND 1,000,000 for Class A. During the 50% discount window under Circular 64/2025/TT-BTC (30 June 2025), which runs from 1 July 2025 to 31 December 2026, the fee is VND 500,000. The discount applies only to applications newly submitted on or after 1 July 2025; files submitted earlier are not refunded retroactively.
Q: What are the most common grounds for rejection of a Class A file?
A: Four: (1) the LoA does not use the current template, and old templates are no longer accepted after Circular 44/2025; (2) the ISO 13485 scope does not cover the device being declared; (3) the Vietnamese labelling or instructions for use are missing items, in particular the new requirements introduced by Decree 37/2026; (4) the classification has not been published before the declaration is filed.
Practical note: a Class A filing is a declaration regime, but it should not be treated as a low-requirement route. A declaration regime places responsibility on the applicant: the holder bears the consequences of inaccurate information, and a post-market inspection that finds problems is handled no less severely than under the review route. Preparing Class A materials to Class C rigour carries a low marginal cost and a far smaller risk exposure.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Articles 25 and 26 (declaration route) and Article 22 (conditions for circulation); (2) Circular No. 44/2025/TT-BYT (LoA template); (3) Circular No. 59/2023/TT-BTC (standard fees); (4) Circular No. 64/2025/TT-BTC (30 June 2025, 50% discount from 1 July 2025 to 31 December 2026); (5) MOH Notice No. 645/TB-HTTB (2 July 2025); (6) Decree No. 37/2026/NĐ-CP (23 January 2026, labelling).
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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