The management of medical devices

On November 8, 2021, the Government issued Decree No. 98/2021/ND-CP on the management of medical devices. 

This decree refers regulations related to the management of medical device, including the classification of medical device; production process, clinical research, circulation, trade, export, import and provision of medical device services; regulations on information and advertising of medical device; management of the prices of medical device, as well as the management and use of medical device at healthcare facilities.

According to the decree, medical device is divided into four types based on the level of inherent risk related to technical design and production processes, including:

– Class A medical device – low-risk level.

– Class B medical device – medium-low risk level.

– Class C medical device – medium-high risk level.

– Class D medical device – high-risk level.

On March 3, 2023, the Government issued Decree No. 07/2023/ND-CP with the purpose of amending and supplementing certain provisions of Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

Decree No. 07/2023/ND-CP will be effective from March 3, 2023, and introduces several new important points related to medical equipment. Specifically, these important points include regulations on price listing, price declaration, and conditions related to the circulation of medical devices.

Regarding the listing of prices for medical device

– Manufacturing and trading units of medical devices must list prices at designated locations as specified by law.

– The price listing for medical devices on the Ministry of Health’s electronic portal must include the following minimum information: Name, category of medical device; Manufacturer, country of production; Owner’s company; Unit of measurement; Configuration, technical features of the medical device; Listed price of the medical device.

Price Declaration for Medical Device

– Organizations and individuals engaged in the production and business of medical devices must declare prices. The content and procedures for price declaration for medical devices must comply with legal regulations on pricing.

– In the event of unusual price fluctuations affecting the supply of medical devices, the affordable ability of buyers, and the payment capacity of the Health Insurance Fund, the Minister of Health shall issue, update, amend, and supplement the list and instructions for information on medical device prices.

Circulation Conditions for Medical Device

a) Having a circulation number, registration number, circulation registration certificate, and import license in accordance with regulations on the management of medical devices, except in the following cases: Liquidation according to legal regulations; Expiration of the product’s usage period; Irreparable factors causing adverse effects on the health of users as regulated; When competent state authorities do not permit use.

b) Medical Device must have labels containing all required information according to current legal regulations on product labeling.

c) Medical Device must come with usage instructions in Vietnamese.

d) Information about warranty facilities, terms, and duration must be provided, except for cases where a medical device is for one-time use according to the regulations of the equipment owner or has documentation proving the absence of a warranty.

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