Decree 98 in full force
Decree 98/2021/ND-CP fully operational since 1 July 2025: Classes A–D, ISO 13485/CFS, local MAH, CSDT format, Vietnamese labeling.
Free field guide · PDF
Vietnam MOH Medical Device Registration2026 Field Guide
Decree 98 in full force, the 90-day clock, and the September 2026 apostille change — with fee and review targets.
- Issuance clock
- 90 days
- Class C/D fee
- VND 5M
- Apostille accepted
- Sep 2026
Sourced from Decree 98 sources and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — Decree 98 sources and verified 2026 publications.
The 90-day clock
Registration number within 90 days of an adequate application — 60 days to amend, rejection after 3 failed amendments.
The apostille change
Since 11 September 2026, apostilles replace consular legalization — plus the DMEC fee schedule and review targets.
Sources & scope
- thema-med.com, medical devices Vietnam: import licensing rules from July 1, 2025.
- thuvienphapluat.vn, integrated document 08/VBHN-BYT (2026 consolidated Decree).
- asiaactual.com, Vietnam DMEC fees, review times, and the 2026 apostille update.
- indexbox.io, Vietnam mechano-therapy appliances market report 2026.
This guide is market-access intelligence, not regulatory or legal advice. Decree 98 amendments, DMEC fees, and review practice change — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your MOH route — Decree 98 sequencing, CSDT dossier planning, and MAH setup.
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