1. Record form
2. Product technical requirements
3. Security risk analysis report
4. Product inspection report
5. Clinical evaluation data
6. Manufacturing information
7. Sample product design manual and minimum sales unit label design draft
8. Documentary enterprise qualification certificate
9.Certificate for sale
10. Power of attorney of the agent
11. Declaration of conformity
12.A copy of the agent's undertaking and a copy of the business license
1. Translation of related materials
2. Review and edit the filing documents and provide correct guidance documents
3. Preparation of technical requirements for record products
4.The filing information is reviewed and sorted out according to the NMPA's reporting requirements
5. Fill in various forms
6.Printing, copying and binding of record documents
7. Filing of filing documents and obtaining filing vouchers
8. Delivery of record vouchers
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