The state implements classified management of medical devices according to the degree of risk.

1. The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.

2. The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.

3. 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.

Extended data:

Engaged in medical device production activities, shall meet the following conditions:

(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.

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