Current location - Trademark Inquiry Complete Network - Futures platform - Punishment for operating three types of medical devices without a license
Punishment for operating three types of medical devices without a license
Legal analysis: if a medical device is sold without a license, the pharmaceutical supervisory and administrative department at or above the county level shall order it to stop operating, confiscate the illegally operated products and illegal income, and impose a fine of more than 2 times and less than 5 times the illegal income if the illegal income is more than 5,000 yuan; If there is no illegal income or the illegal income is less than 5,000 yuan, a fine of 5,000 yuan to 20,000 yuan shall be imposed; If a crime is constituted, criminal responsibility shall be investigated according to law.

Legal basis: Article 63 of the Regulations on the Supervision and Administration of Medical Devices is under any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall confiscate the illegal income, medical devices illegally produced and operated, and tools, equipment, raw materials and other items used for illegal production and operation; If the value of medical devices illegally produced and operated is less than 654.38+10,000 yuan, a fine of 50,000 yuan to 654.38+10,000 yuan shall be imposed; If the value of the goods is more than 10000 yuan, a fine of more than 10 and less than 20 times shall be imposed; If the circumstances are serious, the application for medical device license put forward by the relevant person in charge and enterprises will not be accepted within 5 years:

(a) the production and operation of Class II and Class III medical devices that have not obtained the medical device registration certificate;

(2) engaging in the production of Class II and Class III medical devices without permission;

(3) engaging in the business activities of Class III medical devices without permission. If the circumstances listed in the first paragraph of the preceding paragraph are serious, the original issuing department shall revoke the production license or business license of medical devices. Unauthorized configuration and use of large medical equipment, by the health and family planning departments of the people's governments at or above the county level shall be ordered to stop using, given a warning, confiscate the illegal income; If the illegal income is less than 6,543,800 yuan, a fine of 6,543,800 yuan and 50,000 yuan shall be imposed; If the illegal income is more than 654.38+00000 yuan, a fine of more than 5 times and less than 654.38+00 times of the illegal income shall be imposed; If the circumstances are serious, the application for large-scale medical equipment configuration license put forward by relevant responsible persons and units will not be accepted within 5 years.