Legal analysis
Medical devices are instruments, equipment, appliances, materials, or other items used in the human body, alone or in combination, including the software required, the state of the third class of medical devices safety, effectiveness of the management of the adoption of strict control, medical equipment is a life-threatening thing, but also the state focus on the supervision of the field. The state has implemented the classification management of medical devices, the state has implemented the classification management of medical devices. The state of medical devices to implement classification management, the first class refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices. The second category refers to the safety and effectiveness of medical devices should be controlled. Class III refers to medical devices that are implanted in the human body, used to support and maintain life, potentially dangerous to the human body, and whose safety and effectiveness must be strictly controlled. In addition to meeting the requirements of the industry and commerce department, enterprises in the retail business of Class III medical devices should also apply for a medical device license. Medical device business license is a medical device business enterprises must have the documents, the opening of the third class of medical equipment business enterprises, should be by the provincial, autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department for examination and approval, and issue medical device business enterprise license.
Legal basis
"Chinese People's **** and the Criminal Law" Article 145 The production of medical equipment, medical hygiene materials that do not meet the national standards for the protection of human health, or the sale of medical equipment, medical hygiene materials that are not in accordance with the national standards for the protection of human health, or the sales of medical equipment, medical hygiene materials that are not in accordance with the national standards for the protection of human health, enough to seriously endanger human health. seriously endanger human health, shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall be fined not less than fifty percent of the sales amount and not more than two times the amount of the fine; where serious harm is caused 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 fifty percent of the sales amount and not more than twice the amount of the fine; where the consequences are particularly serious, shall be sentenced to fixed-term imprisonment of not less than ten years or life imprisonment and shall be fined not less than fifty percent of the sales amount or two times the amount of the or confiscation of property.
Article 65 of the Law of the People's Republic of China on Basic Medical Care, Health Care and Health Promotion The State shall strengthen the management of medical devices, improve the standards and norms for medical devices, and enhance the safety and effectiveness of medical devices. The competent health department of the State Council and the competent health department of the people's government of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the technological advancement, appropriateness and accessibility, prepare large-scale medical equipment allocation planning, and promote the rational allocation of medical equipment in the region, fully ****enjoy.