Regulatory Open Forum

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  • 1.  China

    Posted 01-Oct-2018 09:58
    I need to understand the regulatory environment in China. Does anyone know of a seminar or website I can access?


  • 2.  RE: China

    Posted 01-Oct-2018 11:58

     

    Hi Vincent,

    China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent with offices in U.S. (Boston) and China (Beijing).

    Our CMD blogs and newsletters are a great way to stay up to date on the Chinese MedTech and IVD markets.  Please select https://chinameddevice.com/category/cfda-updates/ to opt in our weekly CFDA updates and featured regulatory articles. For market access newsletter, select https://chinameddevice.com/category/market-access/

    I have enclosed our regulatory brochure and our latest monthly CFDA News Roundup for your reference. We also have webinars on clinical, GMP, IVDs, etc.


    What specific areas are you interested in? We can definitely rock together.



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

    Attachment(s)

    pdf
    CFDA News Roundup 201808.pdf   401 KB 1 version
    pdf
    CMD Brochure.pdf   1.45 MB 1 version


  • 3.  RE: China

    Posted 01-Oct-2018 12:35
    Vincent,
    Here is our post about clinical exemption catalog published by CFDA yesterday:
    https://chinameddevice.com/faster-and-lower-cost-entry-into-china-cfda-new-clinical-exemption-catalog-issued/

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