1. Laws and regulations on medical devices include Measures for the Administration of Medical Device Standards, Measures for the Administration of Configuration and Use of Large Medical Devices, Measures for the Administration of Medical Device Recall, and Measures for the Supervision and Administration of Medical Device Use Quality. China's relevant laws and regulations stipulate that medical devices cannot be illegally operated and supervised.

2. Legal basis: Article 99 of People's Republic of China (PRC) Basic Medical Care and Health Promotion Law.

Anyone who, in violation of the provisions of this Law, practices without obtaining the practice license of a medical institution shall be ordered by the competent health department of the people's government at or above the county level to stop practicing, and his illegal income, drugs and medical devices shall be confiscated, and he shall be fined not less than five times but not more than twenty times his illegal income. If the illegal income is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan.

Anyone who, in violation of the provisions of this Law, forges, alters, buys, sells, rents or lends the Practice License of a Medical Institution shall be ordered by the competent health department of the people's government at or above the county level to make corrections, his illegal income shall be confiscated, and he shall be fined not less than five times but not more than fifteen times his illegal income. If the illegal income is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan. If the circumstances are serious, the practice license of the medical institution shall be revoked.

Second, what are the classifications of medical devices?

The classification of medical devices is as follows:

1. The first category is low-risk medical devices, which can be ensured to be safe and useful through routine treatment. Where products are put on record, the municipal food and drug supervision and processing department is responsible for reading, certification and registration;

2. The second category is medical devices, whose safety and effectiveness should be controlled. The second category is medium-risk medical devices, which need strict treatment to ensure their safety and effectiveness. Where products are registered and processed, the food and drug supervision and processing departments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for film reading, certification and registration;

3. The third category is medical devices implanted in human body to support and maintain life, which have potential risks to human body and need to be strictly controlled for their safety and usefulness.