Article 63 One 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 management of medical devices and tools, equipment, raw materials and other items used for illegal production and management; illegal production and management of medical devices less than 10,000 yuan in value, and impose 50,000 yuan more than 100,000 yuan below Fines; the value of more than 10,000 yuan, and impose a value of more than 10 times the amount of 20 times the amount of fines; the circumstances are serious, within five years will not be accepted by 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 medical equipment activities of the second class, the third class of Medical device production 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.