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Declaration (Công bố) — Type A & B

The Declaration pathway — Công bố — is the market access route for Type A (lowest risk) and Type B (low-to-medium risk) medical devices. It uses a self-certification model through the DMEC portal, without a pre-market DAV technical review.

Who submits the declaration?​

  • Vietnamese manufacturers submit in their own name
  • Foreign manufacturers must submit through their appointed Vietnamese Authorised Representative (see Authorised Representative)

Type A declaration — procedure​

Type A is the lightest-touch pathway:

  1. Log into the DMEC portal
  2. Complete the device registration form with device details, intended purpose, and manufacturer information
  3. Upload the required administrative documents (see below)
  4. Submit the declaration — the device is considered declared upon submission

No technical dossier upload is required for Type A, though the manufacturer must hold one and make it available for post-market audit.

Documents required (Type A)​

  • Certificate of Free Sale (CFS) or equivalent from country of manufacture (for foreign devices)
  • Letter of Authorisation from foreign manufacturer to Vietnamese representative
  • Labelling and IFU in Vietnamese (or with Vietnamese supplementary label)
  • Declaration of conformity signed by the manufacturer

Type B declaration — procedure​

Type B requires submission of a technical dossier alongside the administrative documents:

  1. Log into the DMEC portal
  2. Complete the declaration form
  3. Upload the administrative documents plus the technical dossier
  4. Submit — DAV may conduct a post-submission dossier review but does not gate the declaration

Documents required (Type B, in addition to Type A set)​

  • Device description and specification
  • Risk management summary (ISO 14971)
  • Summary of safety and performance testing
  • Sterilisation documentation (if sterile)
  • Biocompatibility summary (if applicable — ISO 10993)
  • Clinical evidence summary
  • QMS certificate (ISO 13485 or equivalent)

Declaration validity​

Declarations do not have a fixed expiry date under Decree 98/2021, but must be updated whenever a significant change is made to the device (see Change Notification).

Post-declaration obligations​

Having a valid declaration does not end your regulatory responsibilities. You must:

  • Maintain your technical dossier and make it available on DAV request
  • Report adverse incidents and conduct FSCAs when required
  • Update the declaration when significant changes occur
  • Comply with Vietnamese labelling requirements
Common reasons declarations are rejected or queried
  • Missing or incorrectly legalised CFS
  • Vietnamese labelling not compliant with Decree 98/2021 label requirements
  • Letter of Authorisation not covering the specific device(s) being declared
  • QMS certificate expired or not yet issued