Legal analysis: 1, confiscate the illegal income, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation; 2, illegal production and operation of medical devices less than 10,000 yuan, and impose a fine of 50,000 yuan more than 100,000 yuan; value of more than 10,000 yuan, and impose a fine of more than 10 times the amount of 10 times the amount of 20 times the amount of the fine; 3, the circumstances are serious The seriousness of the case, the responsible person and the enterprise will not be accepted within five years of the medical device license application.
Legal basis: "Regulations on the Supervision and Administration of Medical Devices" (State Council Decree No. 650)
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, illegal production and operation of medical devices and tools, equipment, raw materials and other items used in the illegal production and operation of the items; illegal production and operation of medical devices of less than 10,000 yuan, and shall impose a fine of 20 times the amount of the goods value. Amount of less than 10,000 yuan, and impose a fine of 50,000 yuan more than 100,000 yuan; value of more than 10,000 yuan, and impose a fine of 10 times the amount of more than 20 times the amount of the goods; the circumstances are serious, within five years do not accept the responsibility of the person responsible for the relevant enterprises and the application for licensing of medical devices:
(C) unauthorized to engage in the operation of third-class medical equipment activities.
"Supervision and Administration of Medical Devices" (State Food and Drug Administration Decree No. 8)
Article 55 unauthorized to engage in the operation of medical devices, or "Medical Device License" validity expires after the continuation of the law, still continue to engage in the operation of medical devices, in accordance with the "Supervision and Administration of Medical Devices Regulations" Article 63 of the regulations to be Penalties.