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Authorised Representative (Đơn vị bảo lãnh)

Foreign manufacturers cannot submit regulatory applications directly to DAV. They must appoint a Vietnamese Authorised Representative — known in Vietnamese as Đơn vị bảo lãnh — to act on their behalf for all regulatory activities in Vietnam.

Who must appoint a representative?​

Any foreign manufacturer whose devices are to be declared or registered in Vietnam must appoint a Vietnamese Authorised Representative. This applies to:

  • Manufacturers based outside Vietnam submitting a Type A or B declaration
  • Foreign manufacturers seeking a Type C or D marketing authorisation
  • Foreign manufacturers whose devices are imported and distributed by a Vietnamese company
note

Vietnamese manufacturers submit in their own name and do not require a separate representative.

Who can act as Authorised Representative?​

The Authorised Representative must be a legal entity registered in Vietnam — typically a company with a valid Business Registration Certificate. This can be:

  • A wholly owned subsidiary of the foreign manufacturer
  • A local importer or distributor appointed as representative
  • A specialist regulatory affairs company

The representative must be able to demonstrate the capacity to fulfil regulatory obligations in Vietnam, including incident reporting and FSCA coordination.

Responsibilities of the Authorised Representative​

The Authorised Representative is jointly responsible (with the manufacturer) for the device's regulatory compliance in Vietnam. Key responsibilities include:

  • Submitting and maintaining declarations or registration dossiers with DAV
  • Serving as the point of contact for DAV on all regulatory matters
  • Receiving and acting on post-market safety signals from the manufacturer
  • Coordinating and implementing FSCAs and recalls in Vietnam
  • Maintaining records of the devices on the Vietnamese market
  • Ensuring labels comply with Vietnamese requirements

Letter of Authorisation (LoA)​

The appointment of an Authorised Representative is formalised through a Letter of Authorisation (LoA) issued by the foreign manufacturer. The LoA must:

  • Be issued on the manufacturer's official letterhead and signed by an authorised signatory
  • Clearly identify the specific device(s) or product families covered
  • State the scope of authority granted (registration, regulatory affairs, post-market activities)
  • Include a validity period
  • Be legalised / apostilled per Vietnamese requirements if executed abroad

Changing or terminating a representative​

If the Authorised Representative changes, the manufacturer must:

  1. Appoint the new representative and obtain a new LoA
  2. Notify DAV through DMEC of the change
  3. Update all active declarations and registrations to reflect the new representative
  4. Ensure the outgoing representative cooperates with the transition
Continuity of representation

There must be no gap in representative appointment. A device without an active Authorised Representative on record cannot remain legally on the market. Plan representative transitions carefully.