Regulatory Open Forum

 View Only

  • 1.  IVD classification changes in China

    This message was posted by a user wishing to remain anonymous
    Posted 04-May-2018 09:42
    This message was posted by a user wishing to remain anonymous

    Hi,

    I've been looking into IVD registration in China, after hearing that certain immunohistochemistry and in situ hybridization IVDs have apparently been downgraded from Class III to Class I, but am having trouble finding any detailed information.

    So far my web searching has brought up just a single article, on ChinaMedDevice.com, that mentions "CFDA Circular No. 226 of 2017": 2018 CFDA Changes in IVD Product Classification

    I've not yet been able to find that circular itself on the CFDA website, nor anything else regarding changes to IVD classification.

    Does anyone have any information that would be of use, please, regarding the actual classification changes and what would be required?

    Thanks in advance.


  • 2.  RE: IVD classification changes in China

    Posted 07-May-2018 12:05
    Hi,
    Thank you for your question.
    CFDA's original website is being updated and many documents may not be accessible at this moment. 
    We can send you the re-classification catalogue of immunohistochemistry and in situ hybridization IVDs.
    Please free feel to send me an email at gracefumedical@hotmail.com




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

    Original Message


Related Content