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  • 1.  Health Canada -Class 3 Device New and Licence amendment timeline

    This message was posted by a user wishing to remain anonymous
    Posted 17-Sep-2020 08:54
    This message was posted by a user wishing to remain anonymous

    Hi ,
    Has anyone recently submitted any new or license amendment application for Health Canada?

    Its been more than a month for me (more 20 working days ) and no sign of  screening acceptance letter yet. Are they not adhering to their performance target due to COVID ?

    Please share your experiences.


    Thanks,


  • 2.  RE: Health Canada -Class 3 Device New and Licence amendment timeline

    Posted 19-Sep-2020 18:38
    Hi,

    HC definitely is trying to meet their targets, but from experience, they are taking longer.  I'd follow up by sending in a request to the general device licensing email (quote your application number) and just ask them where in queue it is.  The auto emails I find are not sent always...so a follow up is definitely recommended after this long.

    Shirley

    ------------------------------
    Shirley Furesz RAC
    Director, Regulatory Affairs Medical Devices
    Oakville Canada
    9058474310
    sfuresz@tpireg.com
    ------------------------------

    Original Message


  • 3.  RE: Health Canada -Class 3 Device New and Licence amendment timeline

    This message was posted by a user wishing to remain anonymous
    Posted 22-Sep-2020 08:54
    This message was posted by a user wishing to remain anonymous

    Thank you Shirley, I will follow up.
    Original Message


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