Article 63 If one of the following circumstances exists, 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 the tools, equipment, raw materials used in the illegal production and operation of
materials and other items; the value of the illegal production and operation of medical devices is less than ten thousand yuan 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 fine of 10 times or more than 20 times the value; the value of the goods 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 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 second, third class of medical devices production activities;
(c) the production of medical devices without obtaining the certificate of registration of medical devices. 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.