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  • 1.  Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 03-May-2020 01:19
    Does anyone know how Canada is fast tracking devices that may be used for COVID? Thanks in advance!



    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
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  • 2.  RE: Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 03-May-2020 01:59
    This information is needed for Class II Medical Device.

    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
    ---------------------------------



    Original Message


  • 3.  RE: Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 03-May-2020 07:23
    Hi Ritam,

    The infomration you are looking for is available in the below link.

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19.html

    Thanks!

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


  • 4.  RE: Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 03-May-2020 10:27
    Thanks Meenakshi- I really appreciate it.

    If anyone has worked on such a device, I wanted to understand what the application process looked like. So wanted to get their input.

    Thanks,
    Ritam

    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
    ---------------------------------



    Original Message


  • 5.  RE: Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 03-May-2020 15:57
      |   view attached
    This might not be 100% correct as I'm still working on it, but hope it helps you! I don't think there is a big difference in Class I or II process under the interim order (emergency approval), except for MDEL or MDL requirments.

    ------------------------------
    Ravina Vaswani
    Regulatory Specialist
    Montreal QC
    Canada
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    Attachment(s)

    pdf
    PPE HC approval process (1).pdf   127 KB 1 version
    Original Message


  • 6.  RE: Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 03-May-2020 18:56
    Thank you!


    ---------------------------------
    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
    ---------------------------------



    Original Message


  • 7.  RE: Urgent: Fast Tracking Of Device In Canada For COVID

    Posted 04-May-2020 02:02

    Thankyou Ritam. I was not aware of this. Well done Canada.

    Kind regards,

    Patrick Crook

    **************




    Original Message


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