9999js金沙老品牌(中国)有限公司-Macau Future Star

Service Item
Initial Registration of Class II, Class III IVD
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. Registration document editing, review, and providing correct guidance documents

2. Preparation of technical requirements for registered products

3. Product type inspection, technical service and information feedback

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

5. Fill in various declaration forms

6. Printing, copying, and binding of the declaration documents

7. Reporting of the application documents, notification of acceptance

8. Registration process tracking, review center communication

9. Guidance, review, collation and submission of supplementary information

10. Acquisition and delivery of the registration certificate


List of registration list documents:

1. the application form

2. the supporting documents

3. the summary information

4. Research materials of major raw materials

5. Research materials of major production processes and reaction systems

6. Analytical performance assessment data

7. Positive judgment value or reference interval determination data

8. stability research data

9. Production and self-inspection records

10. Clinical evaluation data

11. Product risk analysis data

12. product technical requirements

13. Product Registration Inspection Report

14. product manual

15. label sample

16. Declaration of Conformityent value or reference interval determination data


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