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Emergency Import of Unregistered Devices

Decree 98/2021/ND-CP recognises that in certain urgent situations it may be necessary to import medical devices that are not yet declared or registered in Vietnam. A specific authorisation pathway exists for these cases.

When can an unregistered device be imported?​

DAV may grant a one-time or time-limited import authorisation for an unregistered medical device in the following circumstances:

  • Public health emergency — outbreak, pandemic, or disaster declared by competent Vietnamese authorities
  • Urgent unmet clinical need — a specific patient has a life-threatening or serious condition for which no registered device is available in Vietnam
  • Humanitarian or foreign aid — devices donated as part of official humanitarian assistance
  • Clinical investigation — devices imported for use in a DAV/ethics-committee-approved clinical trial
  • Demonstration and exhibition — devices temporarily imported for medical exhibitions or professional training (not for patient use)

How to apply for emergency import authorisation​

Applications for emergency import are submitted to DAV (for most device categories) or to the relevant provincial health department (for some local healthcare facility needs). The process under Circular 05/2022/TT-BYT involves:

  1. Submit a written application to DAV explaining:
    • The device to be imported (full identification details)
    • The urgent clinical or emergency justification
    • The quantity required and proposed use
    • The manufacturer and country of origin
    • Evidence that no registered equivalent device is available in Vietnam
  2. Attach supporting documents:
    • Certificate of Free Sale or equivalent from country of manufacture
    • Technical specifications and safety data
    • For urgent patient need: clinical justification from the treating physician and hospital
  3. Await DAV review — in genuine emergencies DAV can expedite review
  4. On approval, receive a one-time import authorisation specifying the approved quantity and use conditions

Limitations of emergency import​

Emergency import authorisations are:

  • One-time or time-limited — not a route to ongoing commercial supply
  • Device and quantity specific — the authorisation covers the specific devices and quantity applied for
  • Use-restricted — devices imported under emergency authorisation may only be used for the stated purpose
  • Not a substitute for registration — manufacturers intending ongoing supply must pursue full declaration or registration

MOH-level emergency authorisations​

During declared public health emergencies (such as COVID-19), the Minister of Health has authority to issue broader emergency use authorisations covering entire device categories. These are published as MOH Decisions and take precedence over the standard individual application process.

Keep evidence of unavailability

A key condition for emergency import approval is demonstrating that no registered equivalent is available. Maintain a brief evidence file showing the search you conducted for registered alternatives — this significantly speeds up DAV's assessment.