Vietnam medical device registration timeline

Source-linked clocks

Ministry 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.

4 pathways4 of 4 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-29vanban.chinhphu.vn

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.	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.	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	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	45 days	4-5 months	10 working days	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning 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 months

Gather 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 weeks

Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

Ministry of Health reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

0 days

In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, Ministry of Health issues Vietnam market authorization certificate.

Summary: The Vietnam medical device registration process through Ministry of Health - Department of Medical Equipment and Health Works (Ministry of Health) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Expedited pathways

ASEAN CSDT20-30% faster

Common Submission Dossier Template for ASEAN region

Eligibility: ASEAN member state registrations

Prior approval recognition

FDA 510(k)/PMAA US clearance supplies the free sale certificate and the technical evidence the Vietnamese dossier is built on. Decree 98/2021 sets its periods per procedure and class, not by where the device was approved.None published

EU CE MarkServes the same role as a US clearance in the dossier, with no recognition route and no published reduction.None published

ASEAN MRAHarmonized pathway2-3 months

Key requirements

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

Primary regulator sources

vanban.chinhphu.vn · Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D imda.moh.gov.vn · Vietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

Reviewed 2026-08-29. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against Ministry of Health publications · full review 2026-08-29 · row IDs are stable — cite as registration-timeline:vietnam:class-a