Legal analysis: medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software, the scope of medical devices is very broad. Its purpose is mainly used for disease diagnosis, prevention, monitoring, treatment or mitigation and so on. The state has a strict management of medical devices.
Legal basis: "supervision and management of medical devices regulations" Article 81 One of the following circumstances, by the drug supervision and management department responsible for the confiscation of illegal income, illegal production and operation of medical equipment and tools for illegal production and operation of equipment, raw materials and other items; illegal production and operation of medical devices less than 10,000 yuan of the value of the goods and impose a fine of 50,000 yuan or more than 150,000 yuan; The value of more than 10,000 yuan, and impose a value of more than 15 times the amount of 30 times the following fine; the circumstances are serious, ordered to suspend production and business, 10 years will not be accepted by the person responsible for the unit and the application for a medical device license, on the illegal unit of the legal representative, the main person in charge, directly responsible for the competent person and other responsible personnel, confiscated from the unit of the illegal period of time from the income earned, and impose a fine of 30% of income more than 3 times the following Income more than 30% of more than three times the following fine, a lifetime ban on the production and operation of medical devices: (a) the production and operation of medical devices without obtaining the certificate of registration of the second class, the third class of medical devices; (b) unauthorized to engage in the production of the second and third class of medical devices; (c) unauthorized to engage in the operation of the third class of medical devices. The first paragraph of the preceding circumstances, the circumstances are serious, by the original licensing department to revoke the medical device manufacturing license or medical device license.