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source:Industry news release time:2022-08-05 Article author:yu Popular:face massager
The state implements classified management of medical devices according to the degree of risk.
1. The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management.
2. The second category is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness.
3. The third category is a medical device with a higher risk that requires special measures to be strictly controlled and managed to ensure its safety and effectiveness.
To engage in medical device production activities, the following conditions shall be met:
(1) There are production sites, environmental conditions, production equipment and professional technicians that are compatible with the medical devices produced;
(2) There are institutions or full-time inspectors and inspection equipment for the quality inspection of the medical devices produced;
(3) There is a management system to ensure the quality of medical devices;
(4) Have the after-sales service capability suitable for the medical devices produced;
(5) The requirements stipulated in the product development and production process documents.
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