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On March 03, 2023, the Government issues Decree No. 07/2023/ND-CP on amending and supplementing a number of articles of Decree No. 98/2021/ND-CP on the management of medical devices.

Accordingly, Decree 07 in 2023 amends a number of regulations on the declaration and list of medical device prices prescribed in Article 44, 45 of Decree No. 98/2021 as follows:

Listing of medical device prices:

Organizations and individuals manufacturing and trading medical devices shall list medical device prices at places specified in Article 17 of the Government’s Decree No. 177/2013/ND-CP or the Ministry of Health’s e-portal.

In case of listing medical device prices on the Ministry of Health's e-portal, the following information is required:

-       Name and type of medical devices;

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

-       Unit;

-       Configuration and technical functions of the medical devices;

-       Listed prices of medical devices.

Declaration of medical device prices

- Manufacturers and traders must declare the prices; declaration contents and procedures shall comply with the law on prices.

- Based on the actual situation and unexpected fluctuations in terms of prices that affect the sources of providing medical devices, and the payment ability of buyers, the solvency of the Health Insurance Fund, the Minister of Health shall issue, update, amend, and supplement the lists and provide guidance on medical devices subject to price declaration.

- Organizations and individuals manufacturing and trading medical devices shall make price declarations according to the forms specified by the law on prices or on the Ministry of Health's e-portal.

Decree No. 07/2023/ND-CP takes effect on March 03, 2023.