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Import Licensing

Before medical devices can be imported into Vietnam, they must generally be declared or registered. Some categories also require a specific import permit (Giấy phép nhập khẩu) from DAV before the first consignment can clear Vietnamese customs.

Import permit — overview​

An import permit is a document issued by DAV authorising the importation of a specific medical device. It is separate from, and additional to, the declaration or marketing authorisation.

Which devices require an import permit?​

Under Circular 05/2022/TT-BYT, an import permit is required for:

  • Type C and Type D devices being imported for the first time after marketing authorisation
  • Devices imported for clinical investigation purposes
  • Unregistered devices imported under emergency or special access provisions
  • Second-hand or refurbished devices

Type A and most Type B devices with a valid declaration can generally be imported without a separate permit, but the importer must retain the declaration certificate for customs purposes.

Applying for an import permit​

Applications are submitted through the DMEC portal and must include:

  • Copy of the valid marketing authorisation (Số đăng ký lưu hành) or declaration number
  • Invoice and packing list for the specific import consignment
  • Technical specification of the imported goods
  • CFS (if not already held on file by DAV)
  • Letter of Authorisation (for foreign manufacturer imports)

DAV aims to process import permit applications within 5–10 working days for standard applications.

Customs clearance documentation​

When clearing customs, the importer should have available:

  • Valid import permit (where required)
  • Declaration or registration certificate
  • Commercial invoice and packing list
  • HS code classification for the device
  • Vietnamese-language labels or supplementary labels ready for affixation

HS code classification​

Medical devices are classified under various HS (Harmonised System) codes depending on device type. Correct HS code classification is important for:

  • Applicable import duty rates
  • VAT treatment (medical devices may qualify for reduced or zero VAT in some categories)
  • Customs risk targeting

Work with a licensed customs broker experienced in medical device imports to ensure correct HS code assignment.

VAT and duty​

  • Import duty: Rates vary by HS code; many medical devices attract low or zero duty
  • VAT: Standard VAT rate applies to most imported medical devices; some essential medical devices may qualify for a reduced rate — confirm with DAV and the General Department of Taxation
Pre-clearance consultation

For high-value or complex consignments, consider pre-clearance consultation with the customs office at the port of entry to confirm documentation requirements before the shipment arrives.