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

5d47a294e2344.jpg

1、 The first type of medical device 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、 Declaration of conformity


1 Translation of relevant materials

2 Review and edit the filing documents and provide correct guidance documents.

3、 Prepare technical requirements for filing products

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


Forum Contact 010-63311696 Policy