Second, three types of medical devices need to be registered。
For the registration of Class II and Class III medical devices produced by domestic enterprises, the following materials shall be submitted:
1. Qualification certificate of medical device manufacturer
2. Copy of trial production registration certificate
3, registered product standards
4. Product improvement report during trial production
5, the enterprise quality system assessment (certification) effective certification documents
6, the medical device quality testing institution approved by the State Drug Administration within the past year issued a product registration type test report
7. Product quality tracking report
8. Self-assurance statement of the authenticity of the submitted materials
The first and second class medical devices in the territory are handled by the local provincial or municipal food and drug Administration, and the third class are handled by the State Food and Drug Administration