How to Verify a Vietnamese Medical Device Circulation Number
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How do you check whether a Vietnamese circulation number is genuine?
A: Three steps:
- Search at the source: use the publication section of the MOH electronic device portal, searching by circulation number or by product name or MAH name;
- Check the three identifiers: whether the published product name and model, MAH name and risk class match what is claimed;
- Cross-check: confirm that the MAH has published its Trading Eligibility Declaration and that the product has a price declaration. If any of the three is missing, the product does not in fact meet all the conditions for lawful circulation.
Q: Why check three things rather than just the circulation number?
A: Because lawful circulation in Vietnam is three conditions stacked: (1) a circulation number (Article 22(a)); (2) labelling that complies with the labelling rules (Article 22(b)); (3) a Vietnamese IFU (Article 22(c)) and warranty information (Article 22(d)). The Trading Eligibility Declaration is a requirement on the company (the seller), while the price declaration is a requirement on the product’s pricing. Checking only the number misses two real blockers: an MAH without trading eligibility, and a product that may not be sold because no price has been declared.
Q: What forms of forgery or misrepresentation are common?
A: Five frequent patterns:
- Presenting an expired old import licence or a transitional document that has already lapsed;
- Using another product’s circulation number for one’s own model;
- Claiming that a classification document is enough to import (invalid after 30 June 2025);
- Claiming, in the name of a distributor, to “hold the registration”, when the holder is a different MAH;
- Providing edited portal screenshots instead of a searchable public link.
Q: Does “not found” mean invalid?
A: Broadly, yes, subject to one distinction: publication lag (just issued and not yet online), which can be confirmed with the MOH through the MAH, versus no record at all. The practical test is whether a verifiable record can be retrieved on the portal. If it cannot, treat the number as invalid and do not accept any verbal explanation that it is “being updated”.
Practical note: keep a written record of the verification. Ask the counterparty for the portal link, a screenshot and the issue date, run an independent search, and save the timestamp. If a channel dispute, a tender qualification check or a regulatory enquiry follows, this is the only effective evidence of due diligence.
Verification checklist (26 October 2026): (1) the publication sections of the MOH electronic device portal (circulation numbers, Trading Eligibility Declarations, price declarations); (2) Article 22 of Decree 98/2021/NĐ-CP (the four conditions for circulation, as amended by 07/2023); (3) Decree 04/2025/NĐ-CP (transitional arrangements ended on 30 June 2025); (4) Decision 2495/QĐ-BYT (4 August 2025), list of administrative procedures.
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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