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  • 1.  Canadian Technical File

    This message was posted by a user wishing to remain anonymous
    Posted 10-May-2019 08:51
    This message was posted by a user wishing to remain anonymous

    Could someone please send me a link or name of the the guidance document(s) to the Canadian Technical File requirements for medical devices.

    I am having trouble locating the guidance document(s) on the HC website.

    Thanks


  • 2.  RE: Canadian Technical File

    Posted 12-May-2019 09:08
    This is the link for the MDL itself:  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html

    This is the guidance for the STED format concerning Class III and IV. (Class II application is straight forward needing the application and labeling): https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-supporting-evidence-provided-new-amended-licence-applications-class-class-medical-devices-including-vitro-diagnostic.html

    Just keep in mind that Health Canada from about a month ago is using the RPS format: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/toc-format-notice.html - but there has not been an update to the guidance document yet.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Canadian Technical File

    Posted 13-May-2019 08:24
    As stated in the last guidance: "The Summary Technical Documentation (STED) format will be discontinued as of April 1, 2019, and Health Canada will no longer accept applications in the STED format."

    HEALTH CANADA no longer accepts submission in the STED format.

    ------------------------------
    Nicole Landreville FRAPS, RAC
    Burlington ON
    Canada
    ------------------------------

    Original Message


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