Regulatory Open Forum

 View Only

  • 1.  Health Canada IMDRF ToC Folder Structure

    Posted 04-Aug-2020 15:06
    Hello All,

    Thank you to those who answered my last question re: current Health Canada MDL approval timelines. I have a new question related to an upcoming Class III MDL application.

    There is a note on the Health Canada website that states that Health Canada has adopted the IMDRF ToC format and no longer accepts submissions prepared using the STED structure. This I understand. What is unclear to me is whether I must use the folder template from the new "Draft Health Canada IMDRF table of contents for medical device applications guidance" or whether it is acceptable to use the folder template that can be downloaded from Appendix H of the now superseded "Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format".

    Both folder structures appear to be in IMDRF ToC format, but the folder structure referenced in the new draft guidance is WAY more complex than the older one. If anyone has submitted a Class III MDL application recently (since April 2019), can you please let me know which folder structure you followed?

    Thanks,
    Julia



    Has anyone come across this new requirement
    I am about to submit a Class III device licence application, and I would like to know whether I am using the correct format.

    ------------------------------
    Julia Brown
    Sr Manager, Regulatory Affairs
    Brisbane CA
    United States
    ------------------------------


  • 2.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 05-Aug-2020 04:28
    Hello Julia,

    I have worked a bit with those, but maybe to help understand these two guidance documents first would be helpful.  The guidance document "Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format" is an all-encompassing type of guidance document.  If you read through the document especially Section 1.1 you can see this applies to many different types of applications made to Health Canada.  Basically anything else that is not a drug application.  You are correct Appendix H is specific to Medical Devices with some sample folder structures located there.  For me personally I still use the IMDRF ToC guidance document as it is not that old and if you look at the example screen shots they are quite the same.  In basic context, you just need to have a structured folder system for the application so Health Canada reviewers can follow along and understand where everything is - so if you make some slight adjustments or change the names of folders slightly probably not a big issue.  Health Canada are quite responsive, so if you have a specific question about a folder or maybe wanting to add some folders to the structure, contact them directly to get some feedback.

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

    Original Message


  • 3.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 05-Aug-2020 09:49

    Hi Julia, Yes, the new format needs detailed information than the earlier STED. Please refer to the below link

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html#a4.2
    you may download the template (A zip folder) from Section 4.2 Tools section and start populating the information

    Detailed section wise information is available in the below link
    https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum/Class-3-nIVD-eng.pdf

     Just a heads up, the determination on the contents are made in accordance to Section 4.3 Classification matrix (Refer first link). Requirements for amendment and new applications will differ and is explained in this matrix Depending on the type of application, this matrix (an excel sheet) will explain the "Required, Optional or conditionally required sections which could be used to populate your folder structure.

    Hope this helps!
    Best!

     



    ------------------------------
    Shilpa Pillai
    Naperville IL
    United States
    ------------------------------

    Original Message


  • 4.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 05-Aug-2020 16:56
    Hi Julia -
    You can still use the Health Canada Structure, located as a zip file at the end of Appendix H of the Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format. Don't forget to delete empty folders before submitting.
    Structure contents of each folder as outlined in the Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs).
    I've processed several recent Class IV medical device license amendments using the Health Canada folder structure with no issues.
    Hope this helps!

    ------------------------------
    Nomi Steen
    Regulatory Affairs Associate
    Elkton MD
    United States
    ------------------------------

    Original Message


  • 5.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 05-Aug-2020 17:18
    Thank you, Richard, Shilpa, and Nomi for your feedback on my question re: the Health Canada folder structure. Unfortunately, the feedback is conflicting. I like Nomi's answer best, because I have already prepared the submission using the "Health Canada Structure" zip file at the end of Appendix H. However, if Shilpa is correct, then the  submission will be rejected. So I'm torn.

    I think I will submit what I have and wait to hear back from Health Canada. (Re: Richard's suggestion to ask HC directly, I emailed on Monday and left a voicemail yesterday and have not yet heard back from them.) I will report back to the forum in a couple months!

    Julia

    ------------------------------
    Julia Brown
    Sr Manager, Regulatory Affairs
    Brisbane CA
    United States
    ------------------------------

    Original Message


  • 6.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 05-Aug-2020 20:25
    Hi Julia,

    I have typically used the Appendix H Health Canada structure as opposed to the IMDRF ToC structure and have had no issues.  However, I do also reference the IMDRF guidance to help ensure all required content is included (see https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum/class-3-non-vitro-devices-new-amendment-applications.html).

    Camille

    ------------------------------
    Camille Thorpe, RAC (Canada)
    Toronto, ON
    Canada
    ------------------------------

    Original Message


  • 7.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 06-Aug-2020 06:38
    ​

    Hi Julia,

    I submit Medical Device licence applications all the time to Health Canada. Both formats are accepted currently by HC for Class III and IV submissions. Class II and Private Label licence applications need to be in the TOC format.

    You are correct that the HC format is much less onerous and I still prefer to use this format. I do know that they are pushing to move forward and eventually only accept the TOC format, but for now, you can still use the older HC format. If you wish to take advantage of submitting your application through the portal (vs sending it in on a CD or thumb drive), it does have to be in the TOC format though.

    Hope this clarifies things!



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

    Original Message


  • 8.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 06-Aug-2020 08:51
    Hi Everyone,

    Wish I had known this earlier. How recent are your experiences?
    In June, I had written to them asking what structure I should follow and they directed me to the new format.
    I went back and forth with them 3 times seeking clarification and asked why was it titled draft. Then, over a phone call, they confirmed that I had to use the new format.

    This is interesting!
    Thanks everyone for jumping in and sharing your experiences.

    Best!


    ------------------------------
    Shilpa Pillai
    Naperville IL
    United States
    ------------------------------

    Original Message


  • 9.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 06-Aug-2020 21:13
    Hi Shilpa,

    I just submitted a licence application last month in the HC format and it made it through screening without any issues.  I believe that if you ask HC they will point you towards the New TOC format because they are trying to move everyone over to that format.  Just remember that if you submit in the TOC format, then if you need to amend the licence later, then the amendment will have to be in the TOC format as well, you can't switch back to the HC format.

    The draft guidance on the TOC format was open for comment until this past January.  They had it open for comment for longer than normal to allow people to try it out and really understand how it needs to be assembled.  Presumably all the comments will be assembled and incorporated into the final guidance, but with COVID-19, I'm sure this will be delayed.

    Shirley 



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

    Original Message


  • 10.  RE: Health Canada IMDRF ToC Folder Structure

    Posted 06-Aug-2020 12:04
    Thank you, Shirley. I am still conflicted, because this morning Health Canada replied:

    I think Appendix H: Medical Device Sample Folder Structures for IMDRF TOC format have not been update for some time.
     Please use temple from medical device applications guidance 4.2 Tools.

    Perhaps the HC agents are instructed to tell applicants to use the new format, even though they still accept the old format. My fear is that I submit the old format and then three weeks later they tell me I need to submit the new format, and I've wasted three weeks. Ugh.

    Julia

    ------------------------------
    Julia Brown
    Sr Manager, Regulatory Affairs
    Brisbane CA
    United States
    ------------------------------

    Original Message


Related Content