Vietnam Class C and D Registration: MOH Circulation Number Review
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How are Class C and Class D devices registered?
A: By filing a circulation registration application with the MOH, processed by IMDA, which issues a circulation registration number (số lưu hành). This is a substantive review regime, fundamentally different from the declaration regime for Class A and Class B.
Q: How many steps does the process have?
A: Six:
- Classify the device and publish the result (Circular 05/2022 rules, published on the portal);
- Complete the legal document volume: application form (MOH template), CFS (legalised as required), ISO 13485:2016 and LoA (Circular 44/2025 template);
- Complete the technical file volume: classification conclusion, technical file in CSDT format, Vietnamese instructions for use, labelling and packaging drafts, product catalogue, risk analysis report, performance test reports, biocompatibility data and clinical evidence, depending on the device;
- Submit the file and obtain acceptance;
- Undergo review and respond to deficiencies (under Article 32 and the response rules as amended by Decree 07/2023);
- Receive the circulation number and have it published on the portal.
After issuance the MOH may also carry out a post-licensing inspection (Decree 98, Article 32(3) and (4), processed by IMDA).
Q: How long does review take?
A: There are two timelines:
- Fast track: where a CFS or marketing authorisation has already been issued by a reference country (US FDA, Australia TGA, Health Canada, Japan MHLW/PMDA, EU member states, the United Kingdom and Switzerland, China NMPA, Korea MFDS and others), review can be shortened to as little as about 10 working days;
- Standard route: technical review takes up to about 90 days.
Separately, Article 147 of Decree 96/2023 provides for prioritized processing: for an eligible file the MOH decides within 10 working days of receiving the application whether to grant priority, and where it refuses it must give written reasons.
Q: Is CSDT mandatory?
A: Yes. Since 1 January 2024, applications for Class C and Class D devices must use the ASEAN Common Submission Dossier Template (CSDT). The earlier transition arrangement, which allowed a technical summary with a Vietnamese instructions for use and labelling in place of a CSDT, has ended.
Practical note: on a Class C or D project the critical path is not after submission but before it. GRZAN runs the file as two parallel tracks, the legal document volume and the technical file volume. The legal volume (LoA, CFS, ISO certificate, notarisation and legalisation) usually takes longer, so it starts first; the technical volume is rebuilt into CSDT format from existing CE or FDA material. The two tracks merge two weeks before submission for a consistency check, because one of the most common grounds for rejection in Vietnamese review is the two volumes contradicting each other, for example where the models on the LoA do not match the CSDT.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 32 (as amended by Decree 07/2023), Article 32a (fast track) and Article 30 (as amended by Article 147.19 of Decree 96/2023); (2) Decree No. 96/2023/NĐ-CP, Article 147 (prioritized processing, clinical investigation chapter); (3) Circular No. 05/2022/TT-BYT; (4) Circular No. 44/2025/TT-BYT; (5) the date CSDT became mandatory (1 January 2024); (6) the MOH delegation decision assigning Class C and D matters to IMDA.
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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