Article 63 One of the following circumstances, the food and drug supervision and management department of the people's government at or above the county level shall confiscate the illegal income, the illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation of medical devices; the value of the illegal production and operation of medical devices is less than 10,000 yuan, and impose a fine of more than 50,000 yuan of 100,000 yuan; more than 10,000 yuan of the value of the goods. 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.