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Lifecycle of a Medical Device in Vietnam

Understanding the end-to-end regulatory journey helps you plan timelines and resource requirements before entering the Vietnamese market.

Stage 1 — Classify your device​

Determine your device's risk class (Type A, B, C, or D) using the rules in Decree 98/2021 and Circular 14/2020. This determines which market access track applies.

→ See Classification Overview

Stage 2 — Appoint an Authorised Representative (foreign manufacturers)​

Foreign manufacturers must appoint a Vietnamese Authorised Representative before submitting any regulatory application. The representative will act on your behalf for all DAV interactions.

→ See Authorised Representative

Stage 3 — Prepare your dossier​

Compile the technical and administrative dossier required for your device type. For Type A/B this is a declaration dossier; for Type C/D it is a full registration dossier aligned with the ASEAN Common Submission Dossier Template (CSDT).

→ See Declaration (Type A/B) or Marketing Authorisation (Type C/D)

Stage 4 — Submit via DMEC portal​

All applications are submitted electronically through the National Medical Device Information System (DMEC) at dmec.gov.vn.

→ See DMEC Portal

Stage 5 — DAV review (Type C/D)​

For Type C and D devices, DAV conducts a technical review of the dossier. Review timelines vary; you may receive requests for additional information (RAI) during this process.

Stage 6 — Obtain import permit (if required)​

Certain device categories require an import permit (Giấy phép nhập khẩu) from DAV before the first consignment can be cleared through Vietnamese customs.

→ See Import Licensing

Stage 7 — Label the device for the Vietnamese market​

All medical devices sold in Vietnam must carry Vietnamese-language labelling. Imported devices typically use a supplementary label (nhãn phụ) affixed over or alongside the original foreign-language label.

→ See Labelling

Stage 8 — Import and distribute​

Ensure GDP-compliant storage and distribution, and maintain full traceability records through the distribution chain.

Stage 9 — Maintain post-market obligations​

Once on the market, ongoing obligations include:

  • Incident reporting and FSCA management
  • Post-market surveillance and periodic reporting
  • Managing labelling and change notifications

Stage 10 — Renew registration (Type C/D)​

Marketing authorisations for Type C/D devices are valid for 5 years. Renewal applications must be submitted before expiry to maintain market access.

Plan ahead for renewal

DAV recommends submitting renewal applications at least 6 months before the existing authorisation expires to avoid gaps in market access.

DAV typically completes initial review within 90–180 days for Type C devices and 120–240 days for Type D devices, depending on dossier completeness. Requests for additional information (RAI) can extend this timeline.