The punishment basis for operating Class II and Class III medical devices without a license is Article 81 of the Regulations on the Supervision and Administration of Medical Devices. The main content is that if a unit engages in the business activities of third-class medical devices without permission, the relevant departments will confiscate the illegal income, medical devices illegally produced and operated, and tools, equipment, raw materials and other items used for illegal production and operation; Impose a fine according to the value of medical devices illegally produced and operated; If the circumstances are serious, it shall be ordered to stop production and business.
Legal objectivity:
Article 3 of the Measures for the Supervision and Administration of Medical Device Operation
China Food and Drug Administration is responsible for the supervision and management of medical device operation throughout the country. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas.
The food and drug supervision and administration department at the higher level is responsible for guiding and supervising the food and drug supervision and administration department at the lower level to carry out the supervision and administration of medical device operation.
Article 4
According to the risk degree of medical devices, medical devices are classified and managed.
There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.