Entering Vietnam: Six-Step Medical Device Registration Roadmap
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How many steps does an overseas manufacturer need to enter Vietnam?
A: Six:
- Classification: classify as A/B/C/D under Circular 05/2022 and publish the result on the MOH portal;
- Appoint the certificate holder: appoint a Vietnamese legal entity as the MAH (an overseas manufacturer cannot hold the registration itself);
- Build the document chain: LoA (Circular 44/2025 template), CFS, ISO 13485:2016, notarisation and legalisation (from 11 September 2026, member states move to Apostille), and Vietnamese labels and IFU;
- Submit the filing: for Class A/B, a Declaration of Applicable Standards with the provincial Department of Health; for Class C/D, a circulation registration application in CSDT format to the MOH/IMDA;
- Price declaration: declare the price before the device is placed on the Vietnamese market and keep it updated on the MOH portal;
- Post-market maintenance: vigilance, recalls, change notifications and updates to the Trading Eligibility Declaration.
Q: How fast can it be?
A: On the fast track, review of a Class C/D file can be cut to about 10 working days; otherwise a Class C/D file takes up to about 90 days. The Class A/B declaration route has a short statutory timeline, but the overall project also includes notarisation and legalisation, Vietnamese translation and coordination with the MAH. In real projects the variable is the front-end document chain, not the review stage.
Q: Where is the biggest time sink?
A: Three: (1) the notarisation and legalisation chain — documents issued in the home country need notarisation plus legalisation (after 11 September 2026, decide between Apostille and consular legalisation under the convention rules) plus certified Vietnamese translation; the chain is long and cannot be compressed in parallel; (2) ISO 13485 scope — a certificate whose scope does not cover the filed product leads to immediate rejection, and widening the scope runs through the certification body; (3) writing the CSDT — Class C/D must use the ASEAN common template, and the first attempt carries a steep learning cost.
Q: Can existing CE/FDA material be reused?
A: The technical content can be reused, but it must be restructured to the Vietnamese format. Class C/D must be filed in CSDT format; labels and IFU must be in Vietnamese; the LoA must use the Circular 44/2025 template. The main value of an existing CE mark or FDA approval is fast-track eligibility: products with a reference-country CFS or MA can use the shortened review route.
Practical note: manage the document chain as the critical path, not the submission. Experience says the document chain takes two to three times as long as the review. Lock the ISO 13485 scope, the CFS issuing body and the LoA template version at project kick-off; rework on any of the three delays the project by months.
Verification checklist (26 October 2026): (1) Articles 21, 22, 25-27, 48 and 62 of Decree 98/2021/NĐ-CP; (2) Circular 05/2022/TT-BYT; (3) Circular 44/2025/TT-BYT (LoA template); (4) Circular 59/2023/TT-BTC and Circular 64/2025/TT-BTC (official fees); (5) the Law on Prices 16/2023/QH15 and Decree 85/2024/NĐ-CP (price declaration); (6) the date the Apostille Convention entered into force for Vietnam (11 September 2026).
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.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
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.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
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