(1) Class II medical device registration application materials:
1. Application form.
2. Supporting documents: 2.1 A copy of the company’s business license. 2.2 A copy of the organization code certificate.
3. List of basic requirements for the safety and effectiveness of medical devices.
4. Review the information.
5. Research information.
6. Manufacturing information: 6.1 Product production process information description. 6.2 Production site.
7. Clinical evaluation data.
8. Product risk analysis data.
9. Product technical requirements.
10. Product registration inspection report: 10.1 Registration inspection report. 10.2 Pre-evaluation opinions.
11. Instructions and label samples.
12. Declaration of Conformity.
13. Submit materials or completed assessment reports (details acceptance report) for medical device registration quality management system verification.
(2) Processing time limit
Acceptance time limit: 5 working days.
Approval time limit: The legal time limit is 23 working days, and the committed time limit is 23 working days (excluding system verification time and technical review time).
Verification time limit: 30 working days
Technical review time limit: 60 working days
(3) Charge standard: 82,200 yuan/registered unit.