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Application Dossiers of China CFDA (SFDA) Approval for IVD Products

For IVD reagents, the following 22 documents must be collected and submitted to the CFDA. Documents must be in both Chinese and original language or English:

1. CFDA registration application form
2. Legal Certification
3. Research Summary
4. Product Insert
5. Product quality specification
6. Testing report issued by CFDA certified testing center
7. Research information of key raw materials
8. Research information on manufacturing process or reaction system
9. Analytical performance evaluation data
10. Reference value (reference range) determination data
11. Stability data
12. Clinical research data issued by CFDA certified Medical institutions.
13. Production records and QC release report
14. Product package and label artwork
15. Quality management system inspection report
16. Legal Production Qualification
17. Authorization on Registration in China
18. Marketing Approval from Foreign Government
19. Quality Management System Certification  
20. Quality Guarantee Letter  
21. Authorization Letter to a Chinese Agent  
22. Self-guarantee Declaration Letter  
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