Vietnam: Circulation Number, Import Licence or Standards Declaration
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What is Vietnam’s “registration certificate” actually called?
A: Vietnam has no single document called a registration certificate. Three routes to market run in parallel, and a manufacturer must first tell them apart:
- Declaration of Applicable Standards (Bản công bố tiêu chuẩn áp dụng): for Class A and Class B, filed with the provincial Department of Health; a declaration-based route;
- Circulation Registration Number (số lưu hành): for Class C and Class D, applied for from the MOH/IMDA; a review-based route, commonly called the “circulation number”;
- Import Licence (Giấy phép nhập khẩu): the import authorisation for the specific cases set out in Article 48 of Decree 98, not a routine registration route.
Q: What is the substantive difference between the three routes?
A: The intensity of review. Class A/B is “declare and publish”: once the documents are complete, the provincial Department of Health publishes them on the portal. Class C/D is “review, then issue”: the MOH substantively examines the CSDT, the risk analysis and the clinical evidence. The import licence covers the cases listed in Article 48 — aid, humanitarian aid, gifts, exhibitions and trade shows, and urgent national defence, security or epidemic-control needs — and is an exception, not the standard route.
Q: Is the “import on a classification document” route still available?
A: No, and it expired on 30 June 2025. Decree 04/2025 allowed Class C/D products that were not on the import licence list to be imported on a classification conclusion until 30 June 2025, with no quantity limit and without an MOH device confirmation document at customs. From 1 July 2025 all transitional arrangements lapsed, and Class C/D imports require a circulation registration number issued by the MOH. Claims still circulating in Chinese-language sources that “Vietnam allows import on a classification document” describe a rule that no longer applies.
Q: Does a circulation number have a validity period?
A: A circulation number issued under Decree 98/2021 has no fixed term — what is usually called “permanently valid” — and there is no five-year renewal. This differs from the old Decree 36 regime and from Malaysia and Indonesia, both of which use five years, and it is the point most often got wrong. “Permanently valid” is not “maintenance-free”: the ISO 13485 certificate must stay valid, product changes must be notified, post-market vigilance obligations continue, and Article 39 sets out the grounds for revocation.
Practical note: when budgeting for Vietnam, do not copy the five-year renewal model used in Malaysia or Indonesia. The recurring cost in Vietnam is not a renewal fee but maintenance: ISO 13485 surveillance audits, renewal of an expiring CFS, change notifications, price declaration updates and running the vigilance system. Build all of these into the annual budget.
Verification checklist (26 October 2026): (1) Articles 21(2) (owner of the circulation number, as amended by 07/2023), 26-27 (declaration and registration), 48 (import licence cases) and 76 (transitional provisions) of Decree 98/2021/NĐ-CP; (2) Article 1 of Decree 04/2025/NĐ-CP (transition extended to 30 June 2025); (3) MOH Notice No. 645/TB-HTTB (2 July 2025) on fees.
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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