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Market Access Overview

To legally place a medical device on the Vietnamese market, it must either be declared (for Type A/B) or registered (for Type C/D) with the relevant authority via the DMEC national system. Selling an undeclared or unregistered medical device is a regulatory offence.

The two pathways at a glance​

Declaration (Công bố) — Type A & B​

A declaration is a self-assessment process where the responsible party (Vietnamese manufacturer or Authorised Representative) certifies that the device meets applicable requirements and enters the device into the DMEC system.

  • Type A: Largely self-declaration with minimal documentation uploaded
  • Type B: Declaration with a supporting technical dossier
  • No pre-market DAV technical review (though DAV retains post-market audit rights)
  • Faster to market compared to full registration

→ See Declaration (Type A/B)

Marketing Authorisation (Đăng ký lưu hành) — Type C & D​

A marketing authorisation involves submission of a full technical and administrative dossier to DAV, followed by a DAV technical review before approval is granted. This is a pre-market gatekeeping mechanism.

  • Dossier-based — aligned with ASEAN CSDT format
  • DAV technical review — timelines typically 12–24 months depending on device type and complexity
  • 5-year validity — renewal required before expiry
  • Higher scrutiny — DAV may request additional information during review

→ See Marketing Authorisation (Type C/D)

Prerequisites for both pathways​

Regardless of pathway, the following must be in place before submission:

  1. Device classification confirmed (see Device Classification)
  2. Authorised Representative appointed (for foreign manufacturers — see Authorised Representative)
  3. DMEC account registered (see DMEC Portal)
  4. Technical dossier prepared to the applicable standard

What happens after market access is granted?​

Placing a device on the market triggers ongoing post-market obligations — see Post-Market Overview.

Devices not yet declared or registered — emergency and special access​

Limited pathways exist for importing and using unregistered devices in specific circumstances. See Special Access.