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Weekly CFDA News Roundup (May 6th to May 12th)

  • 1.  Weekly CFDA News Roundup (May 6th to May 12th)

    Posted 15-May-2018 09:55

    Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services. 

     

    Policy

    1. CFDA issued "Innovative Medical Device Special Approval Procedures (Revised Draft for Feedback)". Within 60 days after the application is received by CFDA, the agency will notify the applicant whether the application has been approved.
    2. Hainan provincial government published "Regulation for Urgently Needed Imported Medical Devices in Hainan". Before CFDA registration approval, imported medical device can be clinically used in qualified healthcare facilities.

    For English version of the above documents, please email info@ChinaMedDevice.com.

     

    Guideline

    CFDA issued 2 guidelines on May 11:

    • pre-clinical trial guideline on coronary drug-eluting stent
    • clinical trial guideline on coronary drug-eluting stent

     

    QA/Recall/AE

    CFDA announced recall notices to 5 medical devices from 4 foreign manufactures and 1 domestic one. Foreign manufacturers include:

    • GE: x-ray bone density detector
    • Becton Dickinson: vacuum blood collection tube
    • Smith & Nephew: 1) external fixation system 2) RF plasma surgery system
    • Magellan: blood lead analyzer

     

    Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE

     

    About China Med Device, LLC

    China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ companies' success.



    ------------------------------
    Grace Fu Palma
    China Med Device, LLC
    MA, U.S.
    gpalma@chinameddevice.com
    978-390-4453
    www.chinameddevice.com
    ------------------------------


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