What are the laws and regulations of medical devices?

Legal analysis: The drug supervision and administration department of the State Council is responsible for formulating the classification rules and catalogues of medical devices, analyzing and evaluating the risk changes in time according to the production, operation and use of medical devices, and adjusting the classification rules and catalogues. To formulate and adjust the classification rules and classification catalogue, we should fully listen to the opinions of medical device registrants, filers, production and operation enterprises, users and industry organizations, and refer to international medical device classification practices.

Legal basis: Article 145 of the Criminal Law of People's Republic of China (PRC) shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and a fine of not less than 50% but not more than two times the sales amount shall be imposed; Whoever causes serious harm to human health shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years, and shall be fined not less than 50% but not more than two times the sales amount; If the consequences are especially serious, he shall be sentenced to fixed-term imprisonment of not less than 10 years or life imprisonment, and shall also be fined not less than 50% but not more than 2 times the sales amount or his property shall be confiscated.