The following is the summary of China CMDE medical device technical review in June 2024:
Submissions Overview | In Process of Technical Review:1066 |
Technical Review Completed:964 | |
Submissions Accepted | Document Review:1010 |
Submissions Accepted:1817 | |
Filing Modification :892 | |
Import Class I Device Filing:160 | |
RFEs and Responses to RFEs | RFE released: 381 |
RFE Response Accepted: 411 | |
Advisory Meetings | Meeting initiated: 14 |
Meeting conducted: 14 | |
PAI (Preapproval QMS Inspection) | PAI Initiated: 203 |
PAI Completed: 143 | |
Special review of innovative medical devices | Submission: 21 |
Organize expert review meetings: 24 | |
Complete review: 37 | |
Priority approval of medical device review | Submission:5 |
Review Completes: 3 |