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Compassionate Use

Compassionate use refers to the use of an unregistered medical device outside of a clinical investigation in a patient with a serious or life-threatening condition for whom no registered treatment option is available. Vietnam's medical device regulation accommodates compassionate use through the emergency import mechanism and specific hospital-level authorisation processes.

Compassionate use for medical devices in Vietnam is addressed through:

  • Decree 98/2021/ND-CP — general provisions on import of devices for urgent individual patient need
  • Circular 05/2022/TT-BYT — procedural details for import permit applications citing compassionate use

There is no single dedicated "compassionate use pathway" for medical devices equivalent to what exists in some other jurisdictions. Instead, the emergency import mechanism is applied on a case-by-case basis.

Who can request compassionate use access?​

Requests for compassionate use access to an unregistered device are typically initiated by:

  • The treating physician at a Vietnamese hospital, who identifies that a specific patient has a clinical need that cannot be met by any registered device
  • The hospital administration, which supports the request and applies to the relevant health authority
  • The device manufacturer or Authorised Representative, who provides supporting documentation

Process​

  1. Clinical justification: The treating physician documents the patient's condition, explains why registered alternatives are inadequate or unavailable, and confirms the expected benefit-risk balance for the unregistered device
  2. Hospital approval: The hospital's medical committee reviews and endorses the request
  3. Application to DAV or provincial health department: An application is submitted with clinical justification, device documentation (technical specs, CFS, adverse event history), and proposed import quantity
  4. DAV or provincial health authority decision: If satisfied, an authorisation is issued permitting import and use for the specific patient(s)
  5. Follow-up reporting: The hospital and treating physician may be required to report the clinical outcome to DAV

Limitations​

  • Compassionate use access is patient-specific and time-limited
  • It does not create a commercial supply channel
  • The manufacturer cannot use compassionate use access to promote the device commercially
  • Ongoing supply requires full registration

Informed consent from the patient (or their legal guardian) must be obtained before using a device under compassionate use authorisation. The patient must be informed that the device is not registered in Vietnam and that safety and efficacy data may be limited.

note

The administrative process for individual compassionate use cases in Vietnam can be time-consuming relative to the urgency of some clinical situations. Building relationships with DAV and provincial health authorities in advance — through your Authorised Representative — helps expedite the process when urgency arises.