Food and drug supervision and management departments of the people's governments 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 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 50,000 yuan above 100,000 yuan; the value of the amount of 10,000 yuan or more and impose a fine of 10 times the amount of 10 times the amount of value of more than 20 times the amount of the value of the goods. Below the fine; the circumstances are serious, within five years will not accept the relevant responsible persons and enterprises to apply for a medical device license:
(a) the production and operation of medical devices without obtaining the certificate of registration 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;
(c) unauthorized to engage in the third class of medical devices business activities. 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.