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  • 1.  Devices Exempted from Clinical Trials (China FDA)

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jul-2018 15:18
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I'm trying to gather some information on the devices exempted from clinical trials in China but couldn't find it from the CFDA website. If anyone have come across it, please share it with me. Thanks!


  • 2.  RE: Devices Exempted from Clinical Trials (China FDA)

    Posted 02-Aug-2018 11:08
    Hello,
    I attached two documents I found for MDs and IVDs. But only the IVD list is translated to English. Worked pretty well with Google translater.
    Hope, you find what you are looking for.
    Best.

    ------------------------------
    Melanie Martini
    Berlin
    Germany
    ------------------------------

    Original Message


  • 3.  RE: Devices Exempted from Clinical Trials (China FDA)

    This message was posted by a user wishing to remain anonymous
    Posted 02-Aug-2018 14:59
    This message was posted by a user wishing to remain anonymous

    Hi Melanie,

    Thank you so much for your help! That's very helpful. Do you mind telling me where you get those documents from? Are those publicly available on the CFDA website? I think CFDA has been constantly updating the exemption list and would like to get the latest update, if possible.

    Thanks again!

    Jingga
    Original Message


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