Red: Done by Manufacturer
-
Send “Document Request Checklist”
Provides Stage-A documents as requested in the checklist
*Note: IEC60601-1&ISO10993 test reports issued by out-of-China testing laboratories (like TUV) will be recognized by Chinatesting lab. If Manuf-acturer can provide such reports, some testing items can be exempted, to save both time and money.
-
Read stage-A documents provided to learn product characteristics, arrange consulting session with CFDA officials,form an optimized registration scheme,and then draft a product technical requirement (A product technical requirement written in Chinese which is the basis for product testing).
-
Select test sample(s) which can represent technical parameters of the entire product family.
Manufacturer arranges shipment of free samples
-
Select a Chinese testing center; confirm with the testing center on how many samples will be needed. And then inform Manufacturer to arrange shipment (Send “Sample Request Form”).
-
Check the samples upon their arrival.Send both product samples and the drafted product technical requirement to testing center
-
Coordinate and communicate with testing engineers throughout the test until obtaining test report. (60-90 working days)
-
Check the samples upon their arrival.Send both product samples and the drafted product technical requirement to testing center
-
First Submission: Submit a complete set of registration documents (including test report and clinical trial report if necessary) to CFDA Acceptance Center (AC)
-
Format Check: AC performs a format check of the submitted documents. If documents are found to be complete without any errors, AC will issue a “CFDA Acceptance Letter” immediately or get “Acceptance Letter” within 5 working days after submission if necessary.
-
Technical Evaluation: Documents transferred to the Center for Medical Device Evaluation (CMDE), which performs a thorough technical evaluation. CMDE requires additional documents and/or additional testing by sending a “Supplementation Notice”.(Working days: It depends on different classification of medical device)
-
Additional testing (if required): Go back to stage B.(Working days: it depends on how many issues have to be tested and how complex they are
Manufacturer arranges shipment of more samples, if current samples insufficient for the additional testing.
-
Submission of supplementary documents: Submit supplementary documents and/or supplementary test report as requested to CMDE for review. CMDE will make a conclusion; or if necessary, may send another “Supplementation Notice”, and we will go back to Step 10. (45 working days)
Manufacturer provides supplementary documents as requested in the “Supplementation Notice”, within 60 working days upon issue of the notice.
-
Administrative Review: CFDA reviews the conclusion of CMDE and then decides whether to approve the application or not.(30 working days)
-
Informing Applicant: AC informs the applicant the results and sends an approval certificate or if failed, a refusal notice. (10 working days)
- Stage A
Preparation - Stage B
Test - Stage C
Domestic
clinical trial - Stage D
In CFDA - Stage E
In CFDA
Note: Total timeline: 12～18months. Timeline is provided only for reference. Actual timeline may be different at different situations. It heavily depends on the manufacturer’s promptness in providing requested documents/ test samples, the classification of the product, and the test center’s schedule, etc.