Ministry of Health market accessResearch Ministry of Health registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Vietnam medical device resource.
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Statutory appraisal periods for Vietnamese circulation numbers, from the 45-day default to the 10-working-day reference-country fast track.
Common questions about changing a registered medical device in Vietnam. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-10-21
Ministry of Health / IMDA registration fees in VND · reviewed 2026-08-25
Ministry of Health - Department of Medical Equipment and Health Works (Ministry of Health) review clocks and planning ranges · 4-class (A, B, C, D) classification
| Class / pathway | Review clock | Planning total | 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 | 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 | Verified |
Newest official Ministry of Health headlines from the daily-refreshed feed — every row links directly to the authority publication.
VietnamSep 29MOMinistry of Health / Department of Infrastructure and Medical DevicesVietnam MoH Draft Circular: Management of Narcotic Substances and Precursors Used in Medical DevicesVietnamSep 29MOMinistry of Health / Department of Infrastructure and Medical DevicesVietnam MoH Official Letter 7323/BYT-HTTB: Consultation on Draft Circular Regulating Narcotics and Precursors in Medical DevicesVietnamSep 17MOMinistry of Health / Department of Infrastructure and Medical DevicesVietnam MoH Annex IV to Dispatch 1479/HTTB-VPB on Medical Device Legal ConsultationsVietnamSep 17MOMinistry of Health / Department of Infrastructure and Medical DevicesVietnam MoH Annex III to Dispatch 1479/HTTB-VPB on Medical Device Legal ConsultationsVietnamOfficial Ministry of Health rules and guidance · 14 of 14 documents linked to official sources
Computed from 177,249 official MOH classification outcome records · data as of 2026-08-31
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