Regulatory Affairs Update: Vietnam

Vietnam: Issuance of New Circular Governing the List of Products Eligible for Price Negotiation and Its Processes by Vietnam’s Ministry of Health

On May 14, 2024, the Ministry of Health of Vietnam issued Circular 05/2024/TT-BYT regulating the list of drugs, medical devices, and testing supplies eligible for price negotiation and the process and procedures for selecting contractors for bidding packages and applying for price negotiation. This circular takes effect from May 15, 2024.

Accordingly, the list of medical devices and testing supplies subject to price negotiation includes:

  1. Computed tomography system with photon counting technology.
  2. Laparoscopic surgical robot system
  3. The surgical system in craniofacial surgery uses planning technology and a precision assist robot (ROSA BRAIN).
  4. Surgical system for hip and knee replacement (using planning technology and precise assistive robots).

Developing a price negotiation plan for medical devices and testing supplies is based on one or some or all the following information:

  1. Winning bid price of medical device and testing materials for price negotiation (if any);
  2. Time of circulation in Vietnam;
  3. Information on the value of used medical devices and price negotiation testing supplies provided by Vietnam Social Insurance (if any);
  4. Value and planned quantity of medical devices and testing supplies for price negotiation;
  5. Reference prices of medical devices and testing supplies for price negotiation in countries belonging to the Association of Southeast Asian Nations (ASEAN) (if any). In case there is no reference price in ASEAN, refer to other countries (if any);
  6. Bidder’s proposal documents, proposal evaluation report, and information synthesis of medical device and testing supplies for price negotiation by the expert group;
  7. Other relevant information (if any).

The price negotiation plan includes the following contents:

  1. Estimated time to conduct price negotiations;
  2. Summary information on drugs, medical devices, testing supplies, and price negotiations;
  3. The desired negotiation price is the price used for negotiation and is not the price that must be achieved when conducting price negotiations, including one of the following two cases:
  • Desired price level achieved in price negotiation;
  • The price range includes the range of prices desired to be achieved in price negotiations;

4. Other factors related to price negotiation options.

For more details on the regulation, please refer to this link: Circular 05/2024/TT-BYT (in Vietnamese).

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