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  • 1.  Class II MDLA Technical dossier format for Canada

    Posted 16-Jun-2020 10:28
    Edited by Nadine Adia 16-Jun-2020 10:34
    Dear all,

    I need please your input base on your recent experience on MDAL submission in Canada For Class III products.

    Do they required STED format or IMDRF format?

    Below 2 links I found from my research but I'm steel confused.

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/toc-format-notice.html  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.  
    Thank you in advance for your advise.
    Rgds,

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    Nadine Adia
    Quebec QC
    Canada
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  • 2.  RE: Class II MDLA Technical dossier format for Canada

    Posted 16-Jun-2020 10:41
    My question is for class III not class II (only forms and labeling are needed).
    Thank you.

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
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    Original Message


  • 3.  RE: Class II MDLA Technical dossier format for Canada

    Posted 17-Jun-2020 03:41
    Hello Nadine,

    If I remember, I had posted something in a thread about Health Canada and STED a few weeks back.  I should have gone back and clarified about what is happening with Health Canada submissions currently.  You are correct in the first link, Health Canada switched from the GHTF (well now IMDRF) STED format to the IMDRF RPS format.  These are a bit similar, but one being more of an index and the other a table of contents (though some would argue there is really not too much difference).  The reason Health Canada switched to the RPS structure is the second link you posted where they are trying to get all electronic submissions.  It is currently in a pilot program making submissions through the CESG - Common Electronic Submission Gateway - you can see it applies to all applications, but is an enrolment in the programme currently.  If your company is interested especially if you are making a few applications, contact them to get enrolled in the program.  I have not heard when it will be required for all applications, but it probably will not be too long.  Plus working with Health Canada is quite interactive, so if your technical documentation is structured in the RPS format and would like to use the electronic submission, contact them.  The RPS (IMDRF table of contents) structure is aligned with their web forms so if you develop your technical documentation in the RPS structure, then theoretically no adjustments or minor adjust would be made for the electronic submission to Health Canada.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Class II MDLA Technical dossier format for Canada

    Posted 18-Jun-2020 08:06
    Thank you do much Richard it's clear. Indeed I had already seen your previous email on this point.
    Rgds,

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    Nadine Adia
    Quebec QC
    Canada
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    Original Message


  • 5.  RE: Class II MDLA Technical dossier format for Canada

    Posted 21-Jun-2020 00:46
    Hi Nadine,

    Please see the below link for the format - new and amendment applications. 
    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html

    You can also download the draft application template under Section 4.2 "Tools" to populate your application.

    Hope you find this helpful!

    Best!



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    Shilpa Pillai
    Naperville IL
    United States
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    Original Message


  • 6.  RE: Class II MDLA Technical dossier format for Canada

    Posted 22-Jun-2020 08:26
    Hi Shilpa,
    Very helpful, thank you.
    Rgds,

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
    ------------------------------

    Original Message


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