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:
    Submission Modification Filing: 6,417
    Import Class I Device Filing:  1,861
    In Process of Technical Review: 16,018
    Technical Review Completed: 15,013. YoY: 527(3.6%)↑

    2.Emergency review

    COVID-19 testing reagents: 21
    EMCO Products: 3

    3.Time Spent for Review

    Application TypeProduct ClassificationAverage Review TimeAverage expert consultation timeAverage Supplement timeTotal Time
    Initial RegistrationClass II720259332
    Class III981173274
    Class II+III951182280
    Registration ModificationClass II43068111
    Class III66068136
    Class II+III62068131
    Registration RenewClass II200222
    Class III230629
    Class II+III220527

    4.Communication with the Applicants

    Total: 28534, which includes

    Non-technical consultation before submission: 6,224
    Technical consultation before submission: 8,372
    RFE related consultation: 7,887
    Pre-review of RFE response: 4,832
    Innovative product related consultation: 349
    Priority product related consultation: 29

    5.RFE, Advisory Meeting and Audit Overview

    RFEs and Responses to RFEsRFE released:  6,399
    RFE Response Accepted: 5,867
    Advisory MeetingsMeeting 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 devicesSubmission: 466, 35.9% ↑(YoY).
    Organize expert review meetings 362
    Complete review 446
    Priority approval of medical device reviewSubmission: 31, same as last year
    Advisory Meeting Conducted: 5
    Review Completes: 30