Summary of medical device technical review in February 2024

The following is the summary of China CMDE medical device technical review in February 2024:

Submissions OverviewIn Process of Technical Review:1067
Technical Review Completed:1038
Submissions AcceptedDocument Review:1255
Submissions Accepted:1573
Filing Modification :549
Import Class I Device Filing:107
RFEs and Responses to RFEsRFE released:  497
RFE Response Accepted: 477
Advisory MeetingsMeeting initiated:  14
Meeting conducted: 4
PAI (Preapproval QMS Inspection)PAI Initiated: 316
PAI Completed: 277
Special review of innovative medical devicesSubmission: 38
Organize expert review meetings: 40
Complete review: 29
Priority approval of medical device reviewSubmission:5
Review Completes: 3

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