The following is the summary of China CMDE medical device technical review in February 2024:
Submissions Overview | In Process of Technical Review:1067 |
Technical Review Completed:1038 | |
Submissions Accepted | Document Review:1255 |
Submissions Accepted:1573 | |
Filing Modification :549 | |
Import Class I Device Filing:107 | |
RFEs and Responses to RFEs | RFE released: 497 |
RFE Response Accepted: 477 | |
Advisory Meetings | Meeting initiated: 14 |
Meeting conducted: 4 | |
PAI (Preapproval QMS Inspection) | PAI Initiated: 316 |
PAI Completed: 277 | |
Special review of innovative medical devices | Submission: 38 |
Organize expert review meetings: 40 | |
Complete review: 29 | |
Priority approval of medical device review | Submission:5 |
Review Completes: 3 |