Vietnam Circulation Number Validity: Indefinite but Revocable
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How long is a Vietnamese circulation number valid?
A: No fixed term is set. Circulation registration numbers issued under the Decree 98/2021 system are generally described as valid indefinitely, with no five-year renewal. This is a significant change from the previous system, under which Class B, C and D registration numbers were valid for five years and had to be renewed.
Q: Does valid indefinitely mean nothing needs to be done?
A: Not at all. Three things continue to bear on the validity of a circulation number:
- The ISO 13485 certificate must remain valid: if the certificate lapses or is withdrawn, the underlying evidence for the circulation number is incomplete;
- Changes to product information must be notified: changes of name, model, manufacturer, manufacturing site, labelling or instructions for use must go through notification or fresh review according to their nature;
- Revocation under Article 39: where the statutory grounds are met, the MOH may revoke the circulation number, a matter now assigned to IMDA.
Q: When can a number be suspended or revoked?
A: The relevant provisions of Decree 98, Article 34 on suspension of circulation and recall, Article 37 on whether a device may remain on the market, and Article 39 on revocation, set out the handling mechanism. Triggers typically include a device that endangers user health, a serious public health risk or a death, a failure to eliminate the hazard as required, a decision by the competent authority not to permit continued use, and inaccurate information in the application.
Q: What happens after revocation?
A: Article 37(6), as amended by Decree 07/2023, provides that where the MOH has issued a document stating that continued circulation is not permitted, the circulation number holder or the distributing organisation is responsible for recalling devices on the market, except those already sold to medical institutions or users. Articles 38 and 39 set out the parallel arrangements for handling devices whose circulation number has been revoked.
Practical note: treat the cost of holding a Vietnamese registration as an annual maintenance cost rather than a renewal cost incurred once every five years. GRZAN’s standard annual list for clients has five items: the ISO 13485 surveillance audit, reissue of the CFS with attention to continuity of validity, change notifications, updates to the price declaration, and records showing the vigilance system in operation. If any one of the five lapses, a circulation number that is valid indefinitely can cease to be effective in actual circulation.
Verification checklist (26 October 2026): (1) Articles 34 (suspension and recall), 37 (paragraph 6 as amended by Decree 07/2023), 38 (paragraph 14 added by Decree 07/2023) and 39 (revocation) of Decree 98/2021/NĐ-CP; (2) Article 1(4), (5) and (6) of Decree 07/2023/NĐ-CP; (3) the MOH delegation decision assigning suspension, recall and revocation for Class C and D to IMDA; (4) Article 22 of Decree 98/2021/NĐ-CP (conditions for circulation).
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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GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
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What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
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