List of medical devices or test equipments subject to price negotiation method from May 15, 2024 in Vietnam

List of medical devices or test equipments subject to price negotiation method from May 15, 2024 in Vietnam

Pursuant to Appendix 2 issued together with Circular 05/2024/TT-BYT, the list of medical devices or test equipments subject to price negotiation method is stipulated as follows:

Note: The system must ensure synchronization according to the regulations of the medical device owner.

List of medical devices or test equipments subject to price negotiation method from May 15, 2024 in Vietnam - image from internet

When shall the price negotiation method be applied in Vietnam?

Pursuant to Article 28 of the Law on Bidding in 2023 stipulating price negotiation:

Price negotiation

1. Price negotiation applies to the following packages:

a) Purchase of original brand-name drugs or reference biologicals;

b) Purchase of drugs, medical devices or test equipment of a type which can only be manufactured by 01 or 02 manufacturers.

2. The price negotiation method shall be adopted according to a decision issued by the Minister of Health of Vietnam who shall also issue the list of drugs, medical devices and test equipment to be procured through price negotiation and specific contractor selection procedures and process for packages executed adopting price negotiation method.

As regulated above, price negotiation applies to the following packages:

- Purchase of original brand-name drugs or reference biologicals;

- Purchase of drugs, medical devices or test equipment of a type which can only be manufactured by 01 or 02 manufacturers.

What are criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation in Vietnam?

Pursuant to Article 1 of the Circular 05/2024/TT-BYT stipulating principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation:

Principles and criteria for compiling lists of drugs, medical devices and test equipment procured through price negotiation

1. A drug to be included in the list must meet one of the following principles and criteria:

a) A drug or reference biological must be included in the list of original brand-name drugs and reference biologicals announced by the Ministry of Health of Vietnam;

b) The drug in the requested dosage form is only supplied by 01 - 02 manufacturers (particularly, a vaccine that is used under the Expanded Program on Immunization and contains the requested ingredients/is produced adopting the requested technology is only supplied by 01 - 02 manufacturers).

2. A medical device or test equipment to be included in the list must meet the following principles and criteria:

a) It has been granted a certificate of marketing authorization in Vietnam;

b) The medical device or test equipment produced adopting the requested production principle or technology or for the intended use is only supplied by 01 - 02 manufacturers.

As regulated above, a medical device or test equipment to be included in the list must meet the following principles and criteria:

- It has been granted a certificate of marketing authorization in Vietnam;

- The medical device or test equipment produced adopting the requested production principle or technology or for the intended use is only supplied by 01 - 02 manufacturers.

Which agencies are in charge of price negotiation for medical devices or test equipments in Vietnam?

Pursuant to Article 3 of the Circular 05/2024/TT-BYT stipulating agency in charge of price negotiation:

Agency in charge of price negotiation

1. Negotiation on prices of drugs, medical devices and test equipment included in the lists of drugs, medical devices and test equipment procured through price negotiation prescribed in Article 2 of this Circular shall be conducted by a unit assigned by the Ministry of Health of Vietnam (hereinafter referred to as “price negotiation unit”)

2. Tasks of the price negotiation unit:

a) Formulate, approve and disclose the plan for organization of price negotiation;

b) Formulate the plan for selection of suppliers of drugs, medical devices and test equipment adopting price negotiation method;

c) Organize formulation, appraisal and approval for request for proposals (RFP);

d) Organize evaluation of proposals;

dd) Formulate and approve price negotiation scenarios;

e) Appraise, approve and disclose the price negotiation result;

g) Enter into a framework agreement or contract with the selected supplier;

h) Supervise and regulate the supply and use of drugs, medical devices and test equipment procured through price negotiation;

i) Participate in all stages of the price negotiation process, and consolidate and provide relevant information during the price negotiation;

k) Perform other tasks assigned by the Minister of Health of Vietnam.

As regulated above, price negotiation unit is the unit assigned by the Ministry of Health of Vietnam.

Best regards!