"Regulations on the Supervision and Administration of Medical Devices" Article 20 To engage in the production of medical devices, the following conditions shall be met:
(1) Having a production site, environmental conditions, production equipment and professional technicians suitable for the medical devices produced;
(2) Having a quality inspection institution for medical devices produced or full-time inspectors and inspection equipment;
(3) Having a management system to ensure the quality of medical devices;
(4) Having the ability of after-sales service suitable for the medical devices produced;
(five) the requirements specified in the product development and production process documents.
Article 63 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, tools, equipment, raw materials and other articles 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 medical device production license or medical device business license.