Will the declaration of medical device prices according to the new regulations solve the difficulty in bidding for medical devices in Vietnam?

Will the declaration of medical device prices according to the new regulations solve the difficulty in bidding for medical devices in Vietnam? - Question from Mr. Khuong (Hanoi)

What are the new regulations on posting prices for medical devices on the web portal of the Ministry of Health of Vietnam?

This content is one of the remarkable contents specified in Decree No. 7/2023/ND-CP issued on 03/03/2023.

Specifically, in Clause 9, Article 1 of Decree No. 7/2023/ND-CP amending and supplementing Article 44 of Decree No. 98/2021/ND-CP as follows:

Posting prices of medical devices
1. Manufacturers and traders of medical devices shall post prices of medical devices at the locations prescribed in Article 17 of the Government’s Decree No. 177/2013/ND-CP dated November 14, 2013 or on the web portal of the Ministry of Health of Vietnam.
2. The following information must be provided when posting prices of medical devices on the web portal of the Ministry of Health of Vietnam:
a) Name and category of the medical device;
b) Manufacturer and manufacturing country; product owner and country of product owner;
c) Unit;
d) Configurations, technical functions of the medical device;
dd) Price of medical device.

According to the new regulations, manufacturers and traders of medical devices shall post prices of medical devices at the locations prescribed in the laws on prices or on the web portal of the Ministry of Health of Vietnam.

The following information must be provided when posting prices of medical devices on the web portal of the Ministry of Health of Vietnam:

- Name and category of the medical device;

- Manufacturer and manufacturing country; product owner and country of product owner;

- Unit;

- Configurations, technical functions of the medical device;

- Price of medical device.

Will the declaration of medical device prices according to the new regulations solve the difficulty in bidding for medical devices in Vietnam?

Will the declaration of medical device prices according to the new regulations solve the difficulty in bidding for medical devices in Vietnam?

How to declare prices of medical devices according to the new regulations?

Pursuant to the provisions of Clause 10, Article 1 of Decree No. 7/2023/ND-CP amending the provisions of Article 45 of Decree No. 98/2021/ND-CP as follows:

Declaring prices of medical devices
1. Manufacturers and traders of medical devices shall declare prices of their medical devices; contents and procedures for declaring prices of medical devices shall comply with regulations of law on pricing.
2. Based on actual situations and upon the occurrence of considerable changes in prices which affect the supply of medical devices, payment capacity of buyers and the health insurance fund, the Minister of Health of Vietnam shall promulgate, update and revise the list of medical devices subject to compulsory price declaration and guidelines thereon.
3. Prices of medical devices shall be declared in the forms specified in the law on pricing or on the web portal of the Ministry of Health of Vietnam.

Thus, the current regulations require the declaration of medical devices prices for all more than 200,000 types, each with many different configurations and technical features, etc., causing the health sector, not ensuring timely updates.

The new regulation only requires the declaration of prices for medical devices when there is an unusual price fluctuation affecting the supply of medical devices, the buyer's solvency, and solvency of the Health Insurance Fund.

The Minister of Health shall promulgate, update, amend and supplement the list and content of information on medical devices subject to price declaration. The content, form, order and procedures for declaring prices of medical devices shall comply with the provisions of the law on prices or on the website of the Ministry of Health.

Will the declaration of medical device prices according to the new regulations solve the difficulty in bidding for medical devices in Vietnam?

According to the provisions of Clause 3, Article 52 of Decree No. 98/2021/ND-CP on the obligations of medical device trading establishments, medical device trading establishments are not allowed to trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s Portal on management of medical devices at the time of trading.

According to the new regulations in Clause 13, Article 1 of Decree No. 7/2023/ND-CP as follows:

Post and declare prices of medical devices in accordance with the provisions of this Decree and the law on pricing.

Thus, the new regulation will overcome major obstacles in the application of the regulations on price declaration in bidding, which are causing many difficulties for enterprises and health facilities in the implementation of price declaration and procedures for bidding.

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