Unlicensed operation of Class II and Class III medical devices penalty based on the supervision and management of medical devices regulations, Article 81. The main content of the unit is unauthorized to engage in the third class of medical equipment business activities, by the relevant departments to confiscate the illegal income, illegal production and operation of medical equipment and tools used for illegal production and operation, equipment, raw materials and other items; according to the illegal production and operation of medical equipment value of the amount of fines to be imposed; the circumstances are serious, and ordered to stop production and business, and so on.
Legal Objective:"Regulations for the Supervision and Administration of Medical Devices" Article 81(1)(3)
If one of the following circumstances exists, the department responsible for the supervision and administration of drugs shall confiscate the illegal income, the illegal production and management of medical devices and tools, equipment, raw materials and other items used in the illegal production and management of such products; and if the amount of the value of the illegally manufactured medical devices is less than ten thousand yuan, it shall impose a fine of fifty thousand yuan or more, or a fine of five hundred thousand yuan. The value of the illegal production and management of medical devices is less than 10,000 yuan, and impose a fine of 50,000 yuan or more than 150,000 yuan; the value of more than 10,000 yuan, and impose a fine of 15 times the value of more than 30 times the value of the fine; the circumstances are serious, and shall order the suspension of production and operation of the unit within 10 years will not be accepted by the person responsible for the unit and the application for a license of medical devices, the illegal unit of the legal representative, the main person in charge of the unit, the supervisors directly responsible for the unit and other responsible persons, confiscated. Violations occurred during the period from the unit's income, and impose a fine of more than 30% of the income received more than three times the following fine, a lifetime ban on the production and operation of medical devices:
(C) unauthorized to engage in the third class of medical equipment business activities.