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Donations & Clinical Trial Import

Two specific categories of medical device import in Vietnam — humanitarian donations and clinical investigation imports — follow distinct regulatory pathways under Decree 98/2021 and Circular 05/2022/TT-BYT.

Humanitarian donations of medical devices​

Medical devices donated as part of official humanitarian assistance, foreign aid, or disaster relief may be imported under a simplified procedure.

Eligibility​

The donation must be part of a recognised aid programme — typically involving a foreign government, international organisation (e.g. WHO, UNICEF), or an NGO with a formal agreement with the Vietnamese government or MOH.

Documentation required​

  • Official donation agreement or letter of intent from the donating organisation
  • List of donated devices with specifications and quantities
  • CFS or equivalent certificate for the donated devices
  • Receiving hospital or organisation's acceptance letter

Process​

Applications are submitted to DAV (for large-scale donations) or the relevant provincial health department (for smaller local donations). MOH may issue a blanket authorisation for donations under a specific official humanitarian programme.

Conditions​

  • Donated devices must still meet basic safety requirements — donations of expired, damaged, or obsolete devices are not acceptable
  • Donated devices may only be used for the stated purpose at the identified receiving institution
  • Records of donated devices must be maintained

Import of devices for clinical investigations​

Medical devices imported specifically for use in a DAV-approved clinical investigation follow a dedicated import pathway under Circular 05/2022/TT-BYT.

Prerequisites​

Before applying for clinical investigation import:

  1. Ethics committee approval — obtain written approval from a recognised Vietnamese institutional ethics committee for the investigation protocol
  2. DAV approval of the investigation — submit the investigation plan to DAV and receive written authorisation to proceed (under Circular 29/2022/TT-BYT)

Import permit for investigational devices​

With ethics committee and DAV investigation approval in hand, the sponsor (or Vietnamese partner institution) applies to DAV for an import permit for the investigational devices. The application includes:

  • DAV investigation approval letter
  • Ethics committee approval
  • List of devices to be imported with quantities
  • Technical specifications and safety data for the investigational device
  • Name and address of the receiving investigation site(s)

Conditions on investigational device import​

  • Investigational devices may only be used at the approved investigation site(s) and for the approved protocol
  • Devices may not be sold, redistributed, or used outside the investigation
  • Unused devices at investigation conclusion must be accounted for (returned to manufacturer, destroyed, or retained per the protocol)

Adverse event reporting during investigation​

Serious adverse events during the clinical investigation must be reported to DAV and the ethics committee in accordance with Circular 29/2022/TT-BYT timelines. See Clinical Evidence for investigation requirements.

Coordinate ethics and DAV approvals in parallel

Ethics committee review and DAV investigation approval can sometimes be pursued in parallel to reduce overall timeline. Check with your Vietnamese institution partner on the current sequencing practice — some ethics committees require DAV acknowledgement before they will review.