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Procurement & Tendering Law

Vietnam's public procurement framework has a direct and significant impact on medical device market access. For the large portion of the Vietnamese device market served by public hospitals and healthcare facilities, registration or valid declaration is a prerequisite for tender participation.

Why procurement law matters for medical devices​

Vietnam's healthcare system is predominantly publicly funded at the hospital level. Public hospitals procure medical devices through government tender processes governed by the Law on Bidding (Luật Đấu thầu) and related procurement regulations.

A medical device that is not legally declared or registered in Vietnam cannot be included in a public hospital tender — regardless of its clinical merit. This makes regulatory compliance the gateway to the largest segment of the Vietnamese device market.

The registration requirement for tendering​

Under the public procurement framework:

  • Only devices with a valid Số công bố (declaration number — Type A/B) or Số đăng ký lưu hành (registration number — Type C/D) may be offered in public tenders
  • The declaration or registration must be current (not expired or suspended) at the time of tender participation
  • The tendering entity must be the holder of the registration or the authorised representative/distributor
Plan registration timelines with procurement in mind

If your commercial goal is to supply public hospitals, factor in registration timelines when planning market entry. A Type C device can take 12+ months to obtain marketing authorisation — if you start the registration process after entering a market, you will be frozen out of public tenders during that period.

Sole-source and non-tender procurement​

Not all hospital procurement goes through competitive tender. Some devices are procured through:

  • Sole-source contracts (Chỉ định thầu) — used for devices without comparable alternatives or in urgent situations
  • Framework agreements — pre-agreed supplier lists used by groups of hospitals
  • Direct purchase (Mua sắm trực tiếp) — for low-value purchases within defined thresholds

Even for non-tender procurement, the device must still be declared or registered.

Price transparency and the E-Catalogue​

Vietnam's Ministry of Health maintains a Medical Device Price Disclosure System through which manufacturers and importers are required to declare the import price of registered devices. Declared prices feed into the E-Catalogue used by hospitals to benchmark procurement prices.

Post-tender compliance​

Following a successful tender, suppliers must:

  • Ensure continued regulatory validity of the device throughout the contract period
  • Notify the procuring hospital and DAV if the registration is suspended or the device is subject to recall
  • Maintain supply chain documentation enabling traceability during the contract
note

Procurement law changes frequently in Vietnam. Work with a local commercial and regulatory specialist to understand the current rules applicable to your specific procurement scenario.