List of Documents:
1. Application form
2. supporting documents
3. Overview data
4. Research materials of main raw materials
5. Research materials of main production processes and reaction systems
6. Analyze performance evaluation data
7. Positive judgment value or reference interval determination data
8. Stability study data
9. production and self-test records
10. Clinical evaluation data
11. product risk analysis data
12. product technical requirements
13. product registration inspection report
14. product manual
15. label sample
16. Declaration of Conformity
1. Translation of relevant information
2. Registration document editing, review, and providing correct guidance documents
3. Write technical requirements for registered products
4. Product type inspection, technical service and information feedback
5. Registration information is reviewed and organized in accordance with NMPA's reporting requirements.
6. Fill in various declaration forms
7. Printing, copying, and binding of the declaration documents
8. Reporting of the application documents, notification of acceptance
9. Registration process tracking, review center communication
10. Guidance, review, collation and submission of supplementary information
11. Acquisition and delivery of the registration certificate