The previous batch of medical devices is a violation of the regulations, in accordance with 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, the illegal production and operation of medical equipment and tools used for illegal production and operation of equipment, raw materials and other items; illegal production and operation of medical devices less than 10,000 yuan of the value of the amount and impose 50,000 yuan or more than 100,000 yuan fine; 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 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 registration certificate of the second class, the third class of medical devices;