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  • 1.  CFDA Overseas Inspection: 37 Violations from 8 Foreign Device Manufacturers

    Posted 28-Feb-2018 14:53
    Edited by Grace Fu 01-Mar-2018 09:30

    CFDA overseas inspection has intensified. On Feb 27, 2018, CFDA announced overseas inspection results from 8 foreign medical device manufacturers with 37 observations. If you need details of these observations, please email Info@ChinaMedDevice.com

     

    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

     

    • Synthes GmbH in Swistzerland: locking plate and stent
    • NovaBone in US: polymethylmethacrylate (PMMA) bone cement and artificial disc
    • 3M Health Care in US: securement dressing
    • William A. Cook in Australia: endovascular stent graft and semen cryopreservation fluid
    • Covidien in US: endoscopic linear cutting stapler and single use loading unit
    • St. Jude Medical in US: implantable pacemaker
    • Shimadzu in Japan: digital X-ray Imaging System
    • Terumo in Japan: intravascular catheter

     

    The manufacturers have 50 working days to submit their corrective action plan with evidence of improvement and prevention to CFDA in both English and Chinese. If they cannot meet the deadline, they need to tell CFDA when they will be able to complete the corrective action plan and justify for it.

     

    It is very important for foreign manufactures to be prepared and know what to expect from the CFDA overseas inspection trips.  CFDA issued Guideline for Medical Device Overseas Inspection on Dec 28, 2017. Make sure you read this brand-new guideline especially if you have class III sterile and implantable devices. These are the key target areas. We can help you to interpret and understand the inspection guidelines and prepare you for the on-site inspections.  

     

    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
    ------------------------------


  • 2.  RE: CFDA Overseas Inspection: 37 Violations from 8 Foreign Device Manufacturers

    Posted 01-Mar-2018 07:30
    Hello Grace,

    Thank you for this valuable information.  I saw the guideline document published thinking it would take CFDA to get up to speed, logistics, etc., in order to get going on overseas foreign inspections ... guess they were ready !  This is interesting information because I have many clients that are getting stuck in this "regulatory requirements" sinkhole which every market a company sells in, they need to be prepared.  In fact, a recent conversation a person (internal auditor) was asking if they need to be aware of all these regulatory requirements - which the simple answer was: yes !  As these companies expand into other markets, their regulatory and quality compliance needs to keep pace because the expectations are there - as you have provided regulatory authorities conducting foreign device manufacturer inspections.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: CFDA Overseas Inspection: 37 Violations from 8 Foreign Device Manufacturers

    Posted 02-Mar-2018 13:34
    Richard, I hear you.  I gave a talk on CFDA GMP and overseas inspection last January, 2017. The post market compliance in China is starting to pick up in the past 3 years domestically and overseas.  The initial couple of years, the CFDA delegates were learning how to do this and what the process could be especially for overseas inspections.  They learned a lot through the on-sites visits and were able to publish the guideline this year.  Next week is China People's National Congress meeting.  We will expect more changes and announcements.  If you need any assistance in keeping up with CFDA regulations in post market, let us know.  I would be more than happy to have a call with you.

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

    Original Message


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