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Special Device Types

Certain categories of medical device have specific regulatory considerations beyond the standard declaration or registration pathway.

Software as a Medical Device (SaMD)​

Software that meets the definition of a medical device — i.e. software intended to be used for a medical purpose without being part of a hardware device — is regulated under Decree 98/2021. DAV is developing its approach to SaMD and digital health software.

Key principles:

  • Classification follows intended purpose and risk (same Type A–D framework)
  • Manufacturers must document the software lifecycle, validation, and cybersecurity measures
  • Updates to SaMD that change the intended purpose or risk profile may constitute a significant change requiring re-declaration or re-registration

→ See SaMD Overview for more detail

IVD devices​

IVD devices have their own classification rules and specific analytical/clinical performance requirements. The market access pathway (Declaration or Marketing Authorisation) depends on IVD class.

→ See IVD Classification

Single-use devices (SUDs)​

Single-use devices must be labelled as such and must not be reprocessed or reused. Vietnamese regulation prohibits the reprocessing of single-use devices for commercial redistribution without specific authorisation.

Second-hand and refurbished devices​

The import and sale of second-hand or refurbished medical devices is a restricted activity in Vietnam. Requirements include:

  • DAV approval (or specific provincial health department authorisation) is typically required
  • The device must still meet applicable safety and performance standards
  • Full documentation of the refurbishment process must be available
Check before importing used devices

Second-hand and refurbished device imports are subject to heightened scrutiny. Confirm the current DAV position with your Authorised Representative before arranging a shipment.

Accessories and kits​

  • Accessories to medical devices are regulated as medical devices in their own right and must be separately declared or registered based on their own risk classification
  • Kits are classified at the highest class of any component; each component retains its individual regulatory status

Humanitarian and emergency access​

Unregistered devices may be imported for emergency or humanitarian use under specific DAV authorisation. See Emergency Import.

Export-only devices​

A device manufactured in Vietnam solely for export is subject to export certificate requirements but does not need to be declared or registered for the Vietnamese domestic market. An export certificate (Certificate of Free Sale) can be obtained from DAV to support market access applications in the destination country.