ISO 13485:2016 for Vietnam: IAF Accreditation and Scope Gaps
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What quality system certificate does Vietnam require?
A: ISO 13485:2016. The dossier for an imported device must include the manufacturer’s ISO 13485:2016 certificate as evidence of the quality system. Domestic manufacturers in Vietnam fall under the declaration of manufacturing eligibility instead (the related fees are covered in part 38).
Q: Are there requirements on the certification body?
A: Yes. The certificate must be issued by a certification body operating under IAF (International Accreditation Forum) accreditation. In practice, certificates without IAF accreditation are not accepted in Vietnamese filings and lead directly to rejection. This is one of the most frequent structural rejection grounds for imported devices, because it cannot be cured by a deficiency response — only by recertification.
Q: Why is the “scope” of the certificate critical?
A: Because Vietnamese review examines whether the scope covers the product being filed. Vague wording such as “design and manufacture of medical devices”, or a scope covering only part of the product family, triggers a request for an updated certificate. Extending a scope requires the certification body’s scope-extension audit, which takes months — the classic “invisible delay” in Vietnamese projects.
Q: Must the certificate stay valid?
A: Yes. A Vietnamese circulation number has no fixed expiry, but ISO 13485 is one of the foundational pieces of evidence in the dossier and must remain valid and pass annual surveillance audits. Deficiencies or refusals caused by ISO 13485 validity fall within the priority processing provisions of Decree 96/2023. The safer course is to renew before expiry rather than rely on a later remedy.
Q: Can a group certificate be used?
A: Yes, provided the sites and legal entity named on the certificate cover the actual manufacturing site and manufacturer of the product being filed. A common problem is a certificate covering only the parent company’s site while production takes place at a subsidiary or contract manufacturer; in that case a certificate for the relevant site will be requested.
Practical note: in the first week of a project, run the ISO 13485 “three checks”: whether the certification body sits within the IAF accreditation system, whether the scope covers the product family being filed, and whether the sites named on the certificate match the actual manufacturing sites. Each check takes half a day and avoids months of rework.
Verification checklist (26 October 2026): (1) the Decree 98/2021/NĐ-CP provisions on quality system evidence for imported devices (dossier requirements for Class C/D circulation registration); (2) Article 147 of Decree 96/2023/NĐ-CP (priority processing where ISO 13485 validity causes a deficiency or refusal); (3) the ISO 13485:2016 standard; (4) the IAF accreditation directory (as accredited at the time); (5) current MOH/IMDA guidance on acceptable certificates.
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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