Vietnam Registration Timeline: From Project Start to Approval
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How long does the whole Vietnamese registration process take?
A: The answer depends on whether the question is about the review stage or the full project cycle:
| Route | Review timeline (official) |
|---|---|
| Class A and B Declaration of Applicable Standards | Published once the file is complete; handled provincially, usually a few working days, varying by province |
| Class C and D standard route | Technical review up to about 90 days |
| Class C and D fast track (with reference-country approval) | As little as about 10 working days |
The full project cycle also includes the steps before and after: classification and publication, preparation of the LoA, CFS and ISO certificate, the notarisation and legalisation chain, Vietnamese translation, CSDT drafting, and the price declaration. In practice the upstream document chain usually takes two to three times as long as the review stage.
Q: Where does the time go?
A: In our project reviews, four activities absorb the most time:
- The notarisation and legalisation chain: notarisation, legalisation and certified Vietnamese translation, which run in series and cannot be compressed;
- Extending the ISO 13485 scope: where the certificate does not cover the device, the certification body’s scope extension process is measured in months;
- First-time CSDT drafting: particularly the clinical evidence and risk analysis sections;
- Deficiency rounds: each round resets part of the clock.
Q: How can the cycle be compressed?
A: Four workable routes:
- Parallel working: prepare the legal document volume and the technical file volume in parallel rather than as a single series;
- Start early: lock the ISO 13485 scope, the CFS issuing body and the LoA template version in the first week of the project;
- Use the fast track: where reference-country approval exists, take it immediately, as this is the single largest compression available, from 90 days to about 10 working days;
- Apply for prioritized processing: where the file falls into one of the eight categories in Decree 96/2023, file the request at the same time, since the MOH replies within 10 working days.
Q: When should a project start?
A: Work backwards from the target launch date. For Class C and D on the standard route, start 9 to 12 months before launch. On the fast track, start 5 to 7 months before launch. For Class A and B, start 4 to 6 months before launch. Where the clinical investigation completion certificate added by Decree 96/2023 applies, in force for Class C and D from 1 January 2026, add the clinical scheduling time on top of these figures.
Practical note: when scheduling a Vietnamese project, treat the official 90-day review figure as a floor rather than a ceiling. It excludes deficiency time, document-chain time and translation time. GRZAN builds client schedules in three parts, document chain, review and deficiency buffer, and sets out the division of responsibility for each part in the contract, so that delays of the waiting-for-the-other-side kind do not become unattributable.
Verification checklist (26 October 2026): (1) Articles 32 and 32a of Decree 98/2021/NĐ-CP and the amendments made by Decree 07/2023; (2) Article 147 of Decree 96/2023/NĐ-CP (10 working days for prioritized processing, clinical investigation completion certificate from 1 January 2026); (3) Circular No. 05/2022/TT-BYT (classification); (4) Circular No. 44/2025/TT-BYT (LoA); (5) Circular No. 59/2023/TT-BTC and Circular No. 64/2025/TT-BTC (official fees); (6) the date the Hague 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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