Service Item
Initial Registration of Class II Medical Devices
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. Application form

2. Proof documents

1) Certificate of origin in the country of origin allowing the product to be marketed.

(2)Production enterprise qualification certificate.

(3)A copy of the agent's power of attorney, a copy of the undertaking of the agent and a copy of the business license or a copy of the institution's registration certificate.

3. List of basic requirements for the safety and effectiveness of medical devices

4. Summary data

5. Research data

6. Manufacturing information

7. Clinical evaluation data

8. Product risk analysis data

9. Product technical requirements

10. Product inspection report

11. Sample label of product manual and minimum sales unit

12. Declaration of conformity

1. Translation of related materials

2. Edit and review registration documents and provide correct guidance documents

3. Preparation of technical requirements for registered products

4. Product type testing, technical services and information feedback

5. Registration information is reviewed and sorted out according to NMPA's reporting requirements

6.Fill in various application forms

7. Printing, copying and binding of declaration documents

8. Submission of notification documents and notification of acceptance

9. Track the registration process and communicate with the review center

10.Guidance, review, collation and submission of supplementary materials

11. Acquisition and delivery of registration certificate

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