Summary of medical device technical review in June 2024

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

Submissions OverviewIn Process of Technical Review:1066
Technical Review Completed:964
Submissions AcceptedDocument Review:1010
Submissions Accepted:1817
Filing Modification :892
Import Class I Device Filing:160
RFEs and Responses to RFEsRFE released:  381
RFE Response Accepted: 411
Advisory MeetingsMeeting initiated:  14
Meeting conducted: 14
PAI (Preapproval QMS Inspection)PAI Initiated: 203
PAI Completed: 143
Special review of innovative medical devicesSubmission: 21
Organize expert review meetings: 24
Complete review: 37
Priority approval of medical device reviewSubmission:5
Review Completes: 3