Legal analysis: 1. illegal production and operation of medical devices less than 10,000 yuan in value, and impose a fine of 50,000 yuan or more than 150,000 yuan; 2. value of more than 10,000 yuan, and impose a fine of 15 times the amount of more than 30 times the amount of the value of the fine; 3. the circumstances are serious, and ordered to stop production and business, 10 years will not be admitted to the relevant responsible person as well as the unit of the proposed application for licensing of medical devices, the offending unit of the legal representative of the main responsible person and other responsible persons. The unit's legal representative, the main person in charge, directly responsible for the competent person and other responsible personnel, confiscate the illegal behavior during the period from the unit's income, and impose a fine of more than 30% of the income obtained more than three times the following fine, a lifetime ban on their engagement in the production of medical equipment business activities
Legal basis: "Regulations for the Supervision and Administration of Medical Devices"
Article 13 of the first class of medical devices to implement the Product filing management, the second class, the third class of medical devices to implement product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law.
Eighty-one of the following circumstances, by 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 of the value of the goods and impose a fine of 50,000 yuan or more than 150,000 yuan; value of more than 10,000 yuan of goods and impose a fine of 15 times or more than 30 times the amount of the goods; and the illegal production and operation of medical devices shall be subject to a fine of 15 times or more than 30 times. 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 lifelong ban on the production of medical devices. It is engaged in the production and management of medical devices: (a) the production and operation of medical devices without obtaining the registration certificate of the second class, the third class of medical devices; (b) unauthorized to engage in the second class, the third class of medical devices production activities; (c) unauthorized to engage in the third class of medical devices business activities. 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.