China CMDE Technical Review 2023 Annual Report

China CMDE released its annual report of 2023. Some of the important data is as follows:

1.Submissions Overview

• Submissions Accepted: 24,935, which includes：

2.Emergency review

3.Time Spent for Review

Application Type	Product Classification	Average Review Time	Average expert consultation time	Average Supplement time	Total Time
Initial Registration	Class II	72	0	259	332
	Class III	98	1	173	274
	Class II+III	95	1	182	280
Registration Modification	Class II	43	0	68	111
	Class III	66	0	68	136
	Class II+III	62	0	68	131
Registration Renew	Class II	20	0	2	22
	Class III	23	0	6	29
	Class II+III	22	0	5	27

4.Communication with the Applicants

Total: 28534, which includes

5.RFE, Advisory Meeting and Audit Overview

RFEs and Responses to RFEs	RFE released:  6,399
	RFE Response Accepted: 5,867
Advisory Meetings	Meeting initiated:  102
	Meeting conducted: 103
PAI (Preapproval QMS Inspection)	PAI Initiated: 3,439
	PAI Completed: 3,170

6.Innovation review, priority review

Special review of innovative medical devices	Submission: 466, 35.9% ↑(YoY).
	Organize expert review meetings 362
	Complete review 446
Priority approval of medical device review	Submission: 31, same as last year
	Advisory Meeting Conducted: 5
	Review Completes: 30