| Application Dossier of China CFDA (SFDA) for In Vitro Diagnostics (IVD) Reagent Products | ||
| Documents list | Class III | Class II |
| 1.Application Form | ∨ | ∨ |
| 2.Legal Qualification (ISO13485, 510K, CFG or EC, DoC) | ∨ | ∨ |
| 3.Product Overview | ∨ | ∨ |
| 4. Research Data of Key Raw Material | ∨ | |
| 5. Research Data of Production Process and Reaction System | ∨ | |
| 6. Analytical Performance | ∨ | ∨ |
| 7. Reference Interval | ∨ | ∨ |
| 8. Stability Data | ∨ | ∨ |
| 9. Three consecutive manufacturing Record and self-inspection Record | ∨ | ∨ |
| 10. Clinical Data | ∨ | ∨ |
| 11. Product Risk Analysis Data | ∨ | ∨ |
| 12.Product Technical Requirements | ∨ | ∨ |
| 13. Type Test Report | ∨ | ∨ |
| 14. Instruction For Use | ∨ | ∨ |
| 15. Label Sample | ∨ | ∨ |
| 16. Declaration of Conformity | ∨ | ∨ |
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