9999js金沙老品牌(中国)有限公司-Macau Future Star

Service Item
Registration of Import Class II, Class III IVD
Class II refers to medium-risk medical device and its safety and effectiveness can be ensured by strict control. Domestic manufacturers need to register their medical device in the provincial CFDA or municipalities where applicant located. Overseas manufacturers should designate a domestic agent to register in NMPA. Class III refers to higher-risk medical device and its safety and effectiveness can be ensured by taking special measures to strictly control. Both foreign and domestic manufacturers need to register their product in NMPA.

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List of Documents:

1. Application form

2. supporting documents

3. Overview data

4. Research materials of main raw materials

5. Research materials of main production processes and reaction systems

6. Analyze performance evaluation data

7. Positive judgment value or reference interval determination data

8. Stability study data

9. production and self-test 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 Conformity


1. Translation of relevant information

2. Registration document editing, review, and providing correct guidance documents

3. Write technical requirements for registered products

4. Product type inspection, technical service and information feedback

5. Registration information is reviewed and organized in accordance with NMPA's reporting requirements.

6. Fill in various declaration forms

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

8. Reporting of the application documents, notification of acceptance

9. Registration process tracking, review center communication

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

11. Acquisition and delivery of the registration certificate


Forum
Forum
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Contact
010-63311696
Policy
Policy
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