Legal analysis: unlicensed sales of Class III medical devices, by the drug supervision and management department responsible for the confiscation of 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 of the value of the goods and impose a fine of 50,000 yuan or more than 150,000 yuan; more than 10,000 yuan of the value of goods and impose a fine of more than 15 times the amount of goods and 30 times the amount; the circumstances are serious, and shall be ordered to suspend production and business for 10 years, and the legal representative of the illegal unit will not accept applications for medical device license. 15 times more than 30 times the amount of fines; the circumstances are serious, ordered to suspend production and business, 10 years will not accept the relevant responsible person and the unit proposed by the medical device license application, the legal representative of the illegal unit, the main person in charge, directly responsible for the competent personnel and other responsible persons, confiscate the illegal behavior during the period of time from the unit of the income gained and impose a fine of more than 30% of the income gained more than three times the amount of fines, a lifetime ban on the production and operation of medical devices. their engagement in medical device production and management activities.
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 of 150,000 yuan or less; 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 of more than 30% of 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 medical devices of the second, third class medical devices;
(b) unauthorized to engage in the production of the second, third class medical devices;
(c) unauthorized to engage in the business activities of the third class 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.