1. What are the regulations on medical devices?

1. Medical device regulations include "Measures for the Standard Management of Medical Devices", "Measures for the Management of Configuration and Use of Large Medical Equipment", "Recall of Medical Devices" "Management Measures", "Medical Device Use Quality Supervision and Management Measures" and other laws and regulations. Relevant laws and regulations in my country stipulate that medical devices cannot be operated illegally and must be supervised and managed.

2. Legal basis: Article 99 of the "Basic Medical Hygiene and Health Promotion Law of the People's Republic of China"

Violating the provisions of this law and failing to obtain a license to practice in a medical institution Anyone who practices without a license shall be ordered by the health administrative department of the people's government at or above the county level to stop practicing activities, confiscate illegal income, medicines, and medical devices, and impose a fine of not less than five times but not more than 20 times of illegal income, if the illegal income is less than 10,000 yuan Yes, calculated as 10,000 yuan.

Anyone who, in violation of the provisions of this Law, forges, alters, buys and sells, rents, or lends a medical institution practice license shall be ordered to make corrections by the competent health department of the people's government at or above the county level, and the illegal gains shall be confiscated and the illegal gains shall be fined. A fine of not less than five times but not more than fifteen times, if the illegal income is less than 10,000 yuan, shall be calculated as 10,000 yuan; if the circumstances are serious, the medical institution's practice license shall be revoked.

2. What are the classifications of medical devices?

The classification of medical devices is as follows:

1. The first category is low risk and can be treated with routine treatment. Medical devices that ensure their safety and usefulness. The product registration process is implemented, and the municipal food and drug supervision and administration department is in charge of approval, certification and registration;

2. The second category is medical devices whose safety and effectiveness should be controlled. The second category is medical devices with moderate risks that require strict control to ensure their safety and effectiveness. Product registration processing is implemented, and the food and drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are in charge of approval, certification and registration;

3. The third category is implanted in the human body, used to support and maintain life, and has no effect on the human body. Medical devices that have potential risks and whose safety and effectiveness must be strictly controlled.