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

1. Confirm classification — ensure your device is correctly classified as Type C or D
2. Appoint Authorised Representative (foreign manufacturers)
3. Register on DMEC — obtain a DMEC account (dmec.gov.vn)
4. Prepare the dossier — compile the full ASEAN CSDT-aligned technical and administrative file
5. Submit via DMEC — upload all dossier modules and pay the applicable government fee
6. DAV acknowledgement — DAV acknowledges receipt and assigns a file number
7. DAV technical review — DAV experts review the dossier; they may issue a Request for Additional Information (RAI)
8. Respond to RAI — provide additional or clarifying information within the specified timeframe
9. DAV approval — if satisfied, DAV issues a Marketing Authorisation Number
10. 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

Review timelines: Official review timelines under Decree 98/2021 are: Type C: up to 12 months from DAV acknowledgement of submission; Type D: up to 18 months from DAV acknowledgement of submission. These timelines can be extended if DAV issues a Request for Additional Information (RAI), as the review clock does not restart until a substantive RAI response is received. In practice, total timelines often exceed 18 months due to the need for dossier revisions, multiple RAI cycles, or complexity in clinical or manufacturing evidence assessment.

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.

CFS legalisation is frequently the cause of delays

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.

: 'All dossier modules must be submitted together in a single submission to initiate DAV review. The DMEC system does not permit module-by-module submission or hold incomplete dossiers. Ensure all modules are complete and accurate before submission.