According to the "supervision and management of medical devices regulations" Article 63 of the following circumstances, by the people's government at or above the county level, food and drug supervision and management department confiscate the illegal income, illegal production and operation of medical equipment and tools used for illegal production and operation, 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 100,000 yuan; The value of more than 10,000 yuan, and impose a value of more than 10 times the amount of 20 times the following fine; the circumstances are serious, within five years will not accept the relevant responsible person and the enterprise to apply for a medical device license:
(a) the production and operation of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(b) unauthorized to engage in the production of the second class, the third class of medical devices Activities;
(C) unauthorized to engage in Class III medical device 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.