Service Item
Domestic Filing of Medical Device
Class I refers to low-risk IVD which safety and effectiveness can be ensured by strict control. Domestic manufacturers need to register their medical device in the municipal CFDA where applicant located. Overseas manufacturers should designate a domestic agent to register in NMPA.

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

2. Preparation of technical requirements for the registered products

3. The filing materials are reviewed and organized according to the NMPA reporting requirements.

4. fill in the various forms

5. Printing, copying, and binding of the filing documents

6. Reporting of the filing documents and obtaining the filing certificate

7. Delivery of the record voucher


Forum Contact 010-63311696 Policy