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Weekly CFDA News Roundup (Feb 25th to Mar 4th)

  • 1.  Weekly CFDA News Roundup (Feb 25th to Mar 4th)

    Posted 05-Mar-2018 16:05

    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. 

     

    For a complimentary consultation, email gpalma@ChinaMedDevice.com. Keep yourself updated with CFDA News Roundup, click HERE to opt-in. We also publish market access newsletter, click HERE

     

    Guideline

    CFDA issued technical review guideline on optical coherence tomography system (final).

     

    QA/Recall/AE

    CFDA announced recall notice from 9 manufacturers. Among them are 6 foreign manufactures:

    Howmedica Osteonics: knee joint prostheses

    Boston Scientific: endoprosthesis stent

    Edwards: pericardial aortic bioprosthesis

    Roche: procalcitonin immunoassay

    Abbott: clinical laboratory analyzer

    Smith & Nephew: hinge knee joint

     

    New Approval

    1. Shanghai CFDA office published approval notice to portable ECG recorder. The device is registered by Yuanxin Medtech and manufactured by MicroPort EP MedTech. It is the first approval granted through marketing-authorization holders program.
    2. CFDA published imported device approval notice to 13 foreign manufacturers. 伊藤超短波株式会社, Atmos Medizin Technik, Stryker are on the list.

     

    For more detailed English documents, please contact us at info@ChinaMedDevice.com

     

    Keep yourself updated with CFDA News Roundup, click HERE to opt-in. We also publish 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 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, 60+ western companies' entry.



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