List of filing documents:
1. Record form
2. Product technical requirements
3. Security Risk Analysis Report
4. Product inspection report
5. Clinical evaluation data
6. Manufacturing information
7. Product manual and minimum sales unit label design sample
8. Documentary enterprise qualification certificate
9. Proof of marketing and sales
10. Proxy of the agent
11. Declaration of Conformity
12. Copy of the agent's letter of commitment and business license
1. Translation of relevant information
2. Review and edit the filing documents and provide correct guidance documents
3. Prepare the technical requirements for the record product
4. The filing materials are reviewed and organized according to the NMPA reporting requirements.
5. Fill in the various forms
6. Printing, copying, and binding of the filing documents
7. Reporting of the filing documents and obtaining the filing certificate
8. Delivery of the record voucher
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