The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
As an important part of the pharmaceutical industry, medical devices are second only to the standards used by doctors to judge medical institutions for consumers. The country has also invested a lot of efforts in the development of medical device industry, but today, the competitiveness of local enterprises in the high-end products of medical device industry is still fragile.
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 produced and operated illegally, 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.
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