Legal analysis: the department responsible for drug supervision and management confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation; illegal production and operation of medical devices less than 10,000 yuan, and impose a fine of 50,000 yuan more than 150,000 yuan; more than 10,000 yuan of the value of the goods and impose a fine of 15 times the amount of more than 30 times the amount of the goods. Fines; the circumstances are serious, shall be ordered to suspend production and business, 10 years will not accept the relevant responsible person and the unit of medical device license application, the legal representative of the unit, the main person in charge, directly responsible for the competent person and other responsible personnel, confiscation of illegal behavior during the period of the unit from the income gained and impose a fine of more than 30% of the income gained more than three times the following fine, a lifetime ban on the production and operation of medical equipment activities. The company shall be prohibited from engaging in medical device production and management activities for life.
Legal basis: "supervision and management of medical devices regulations" Article 81 of the following circumstances, by the drug supervision and management department responsible for the confiscation of the illegal income, illegal production and management of medical equipment and tools used for illegal production and management of equipment, raw materials and other items; illegal production and management of medical devices less than 10,000 yuan of the value of the amount and impose a fine of 50,000 yuan to 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.