Marketing Authorisation (Đăng ký lưu hành) — Type C & D
Marketing authorisation — Đăng ký lưu hành — is the full registration pathway for Type C and Type D medical devices. It involves submission of a comprehensive technical and administrative dossier to DAV, followed by a technical review before an authorisation number is issued.
Who submits the application?
- Vietnamese manufacturers submit in their own name
- Foreign manufacturers must submit through their appointed Vietnamese Authorised Representative
Step-by-step process
- Confirm classification — ensure your device is correctly classified as Type C or D
- Appoint Authorised Representative (foreign manufacturers)
- Register on DMEC — obtain a DMEC account (dmec.gov.vn)
- Prepare the dossier — compile the full ASEAN CSDT-aligned technical and administrative file
- Submit via DMEC — upload all dossier modules and pay the applicable government fee
- DAV acknowledgement — DAV acknowledges receipt and assigns a file number
- DAV technical review — DAV experts review the dossier; they may issue a Request for Additional Information (RAI)
- Respond to RAI — provide additional or clarifying information within the specified timeframe
- DAV approval — if satisfied, DAV issues a Marketing Authorisation Number
- Import permit (if required) — some device categories require a separate import permit before the first shipment
Dossier structure — ASEAN CSDT modules
Vietnam follows the ASEAN Common Submission Dossier Template (CSDT). The dossier is organised in modules:
| Module | Content |
|---|---|
| Administrative information | Applicant details, device description, classification justification, CFS |
| Device description | Technical specifications, intended purpose, principles of operation |
| Essential Principles | Checklist of conformity with applicable safety and performance requirements |
| Design verification & validation | Testing evidence — bench tests, simulations, usability |
| Manufacturing information | Manufacturing site details, GMP/QMS certification |
| Sterilisation | Sterilisation method validation (if sterile) |
| Biocompatibility | ISO 10993 assessment (if body contact) |
| Clinical evaluation | Clinical evidence — literature and/or clinical investigation data |
| Risk management | ISO 14971 risk management summary |
| Labelling | Vietnamese-language labels and IFU |
| Post-market surveillance plan | Planned PMS activities |
Certificate of Free Sale (CFS)
A CFS from the regulatory authority in the country of manufacture (or country of origin) is a mandatory administrative document. The CFS must:
- Be issued by the relevant national authority (not a private body)
- Cover the specific device(s) being registered
- Be legalised / apostilled in accordance with Vietnamese requirements
- Be valid at the time of submission
Review timelines
Official review timelines under Decree 98/2021:
- Type C: Up to 12 months from submission (can extend if RAIs are issued)
- Type D: Up to 18 months from submission (can extend if RAIs are issued)
In practice, timelines can be longer due to dossier complexity or RAI cycles.
Registration validity and renewal
A marketing authorisation is valid for 5 years from the date of issue. Renewal applications should be submitted at least 6 months before expiry to avoid a gap in market access.
Changes after registration
Changes to a registered device (design, manufacturing, labelling) may require a change notification or a new registration depending on significance. See Change Notification.
Ensure your CFS is correctly legalised well in advance of your intended submission date. Vietnamese authorities require the document chain to be complete before the dossier is accepted.