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Who Must Comply?

Decree 98/2021/ND-CP imposes obligations on anyone involved in the manufacture, import, distribution, or use of medical devices in Vietnam.

Vietnamese manufacturers​

Domestic manufacturers must:

  • Register or declare their devices before placing them on the market
  • Hold (or comply with) an ISO 13485-aligned quality management system
  • Submit to GMP inspections by MOH/DAV as required
  • Maintain post-market surveillance systems
  • Report incidents and conduct FSCAs when required
  • Comply with Vietnamese labelling requirements

Foreign manufacturers​

Foreign manufacturers cannot deal directly with DAV in most cases. They must appoint a Vietnamese Authorised Representative (Đơn vị bảo lãnh) to act on their behalf for all regulatory submissions. The authorised representative is jointly responsible for the device's regulatory compliance in Vietnam.

For details see Authorised Representative.

Importers​

Vietnamese entities importing medical devices must:

  • Ensure the device is declared or registered before import (with limited exceptions for emergency/special access situations)
  • Hold a valid import permit (Giấy phép nhập khẩu) where required
  • Verify that the device has compliant Vietnamese labelling (including the nhãn phụ supplementary label where required)
  • Keep records of import transactions for audit purposes

Distributors​

Medical device distributors must:

  • Only distribute devices that are legally declared or registered in Vietnam
  • Maintain GDP-compliant storage and distribution practices
  • Keep distribution records traceably linking devices to the market
  • Cooperate with FSCAs and recalls

Healthcare facilities​

Hospitals and clinics that purchase and use medical devices have obligations including:

  • Verifying registration status before procuring devices (particularly important for public tender eligibility)
  • Reporting adverse incidents involving medical devices
  • Cooperating with post-market surveillance activities
  • Maintaining records of devices in use
Procurement law link

For devices procured through public hospital tenders, having a valid marketing authorisation or declaration is a prerequisite for eligibility. See Procurement & Tendering Law for details.

Penalties for non-compliance​

Non-compliance can result in administrative fines, suspension of import rights, revocation of registration, and in serious cases criminal liability. See Enforcement & Compliance.