9999js金沙老品牌(中国)有限公司-Macau Future Star

Service Item
Initial Registration
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.

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1、 Application form

2、 supporting documents

3、 medical equipment safety and effective basic requirements list

4、 Summary information

5、 Research data

6、 manufacturing information

7、 Clinical evaluation data

8、 Product risk analysis data

9、 product technical requirements

10、 product inspection report

11、 Product manual and label sample of the smallest sales unit


1、 Edit, review and provide correct guidance documents for registration documents

2、 Write technical requirements for registered products

3、 product type testing, technical services and information feedback

4、 Registration information is reviewed and organized according to NMPA's reporting requirements.

5、 Fill in the various application forms

6、 Printing, copying and binding of the declaration documents

7、 Reporting of the application documents and notification of acceptance

8、 Registration process tracking, evaluation center communication

9、 Guidance, review, collation and submission of supplementary materials

10、 Acquisition and delivery of the registration certificate


Forum
Forum
Scan the code to obtain
Contact
010-63311696
Policy
Policy
Scan the code to obtain
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