Service Item
Class I Filing
Beijing RunHge is dedicated to agent and consulting service in registration of medical device for more than 20 years. Our professional teams have rich experience in regulatory affairs with fully equipped process system conforming to the development trend of medical device industry and increased service demands of enterprise at home and abroad. We are committed to provide more professional and all-round one-stop service to customers in demand.


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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