Vietnam medical device registration timeline
Source-linked clocksMinistry of Health - Department of Medical Equipment and Health Works (Ministry of Health) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class A(Declaration of applied standards (provincial Department of Health)) Decree 98/2021 Art. 28(2): once the provincial Department of Health receives the declaration dossier together with proof of fee payment, it publishes the declaration number on the medical device portal. No appraisal period is prescribed because no appraisal takes place — the number is issued on receipt and the declarant carries responsibility for the file. Decree 148/2025/NĐ-CP moved the Class A and B declaration to the provincial level, so the filing goes to the Department of Health where the business is based rather than to the Ministry | 0 days | 1-2 weeks | — | Verified |
| Class B(Declaration of applied standards (provincial Department of Health)) Decree 98/2021 Art. 28(2): once the provincial Department of Health receives the declaration dossier together with proof of fee payment, it publishes the declaration number on the medical device portal. No appraisal period is prescribed because no appraisal takes place — the number is issued on receipt and the declarant carries responsibility for the file. Changes of owner, type, model, intended use or indication, and additions of a manufacturing site or product code, require the declaration to be made again rather than amended | 0 days | 1-2 weeks | — | Verified |
| Class C(Circulation number registration (Ministry of Health)) Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day | 45 days | 4-5 months | 10 working days | Verified |
| Class D(Circulation number registration (Ministry of Health)) Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day | 45 days | 4-5 months | 10 working days | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Vietnam Medical Device Registration Process
Step-by-step Ministry of Health registration process. Total estimated timeline: 1-2 weeks.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Vietnam Local Agent.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMinistry of Health reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Ministry of Health issues Vietnam market authorization certificate.
Common Submission Dossier Template for ASEAN region
Eligibility: ASEAN member state registrations
- Vietnam Local Agent
- Vietnamese labeling
- ISO 13485 certification
- Free Sale Certificate
- Technical documentation
- Issue-then-verify applies only to the fast-track and emergency routes in Art. 32(3) and 32(4) of Decree 98/2021, where the Ministry appraises the legal documents and checks the remainder after granting; the ordinary Class C/D route in Art. 32(2) and 32(5) is still a full front-loaded appraisal
- Circular 44/2025/TT-BYT (22 Nov 2025) only delegates the Ministry's Class C/D tasks to the Department of Health Infrastructure and Equipment; it changes who decides, not how long they have
- Clinical investigations: the Ministry checks dossier validity within 5 working days and forwards a valid dossier to the National Ethics Committee within 2 working days, which then meets and minutes its appraisal within 25 days (Decree 98/2021 Arts. 16-18)
- Import licence for devices without a circulation number: 15 working days, cut to 2 working days for urgent epidemic-response needs (Art. 48)
- Changes to a granted circulation number must be notified and the published dossier updated within 10 working days; for a Class A/B declaration the window is 5 working days
Reviewed 2026-08-29. End-to-end totals remain planning estimates.