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