Regulatory Open Forum

 View Only

  • 1.  Canada Class II License Amendment Criteria for SaMD

    This message was posted by a user wishing to remain anonymous
    Posted 10-Oct-2022 09:41
    This message was posted by a user wishing to remain anonymous

    I am looking to get some guidance on which changes require license amendment for a class II medical device (SaMD) in Canada. 

    Article 34 of the regulation states:

    If the manufacturer proposes to make one or more of the following changes, the manufacturer shall submit to the Minister, in a format established by the Minister, an application for a medical device licence amendment including the information and documents set out in section 32 that are relevant to the change:

    • (a) in the case of a Class III or IV medical device, a significant change;

    • (b) a change that would affect the class of the device;

    • (c) a change in the name of the manufacturer;

    • (d) a change in the name of the device;

    • (e) a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

    • (f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.



    The questions I have are:
    - Does the term "significant change" not apply to Class II medical device per point (a) above? This would also mean that the guidance document (Guidance for the Interpretation of Significant Change of a Medical Device, issued Jan 2011) does not apply to Class II device since it is specifically there to provide clarity on what constitutes a "significant change" which only applies to Class III and IV devices.
    - Our SaMD is AI/ML-based and given the current regulatory framework, it would not be unsurprising that Health Canada would require notification / license amendment to AI algorithm changes for a Class II device (this change would not trigger points (b) - (f) in the regs. In this case, would we add change assessment around AI algorithms within our change order procedure? 
    - For a Class II AI/ML-based SaMD, are there any other changes to the product that would require license amendment?


    Please share any insights you might have on this.


  • 2.  RE: Canada Class II License Amendment Criteria for SaMD

    Posted 11-Oct-2022 08:29

    Hi Anon,

     

    You are correct in your interpretation that "significant change" only applies to risk class III and IV medical devices in Canada, and thus the guidance document only applies to those risk classifications as well.

     

    With regards to your Class II SaMD device, if you were to change the AI algorithms, you would document them in your QMS and then at the time of licence renewal you could provide a summary of the changes in tabular format (documentable change table) outlining the changes.  Since the only thing that HC reviews during a Class II licence application is the labelling and you attest that you have all the supporting safety and effectiveness data on file, they really only have that information to compare if things change.  If the change in the AI algorithms end up changing the labelling, you can provide a copy of the revised labelling (redline is good to include, to easily show changes) along with your summary.

     

    Hope this helps,


    Shirley

     

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

    Fax: 888-887-8686

     

    3470 Superior Court

    Oakville ON L6L0C4

    Canada

    www.innomar-strategies.com

     

    United in our responsibility

    to create healthier futures

     




    Original Message


  • 3.  RE: Canada Class II License Amendment Criteria for SaMD

    Posted 12-Oct-2022 08:39
    Jumping onto this thread...

    So, if your Class II device changes (say updating the algorithms) and you want to add the updated device name and part number to your licence is it done by Fax-Back or licence amendment?

    ------------------------------
    Joseph De Croos PhD
    Director, Quality Assurance & Regulatory Affairs
    Kitchener ON
    Canada
    ------------------------------

    Original Message


  • 4.  RE: Canada Class II License Amendment Criteria for SaMD

    Posted 12-Oct-2022 08:46

    Hi Joseph,

     

    Yes, that would be correct.  Remember also that If changing/updating the algorithm impacts the intended use at all, then you would also have to update that at the same time as adding the new version to the licence in the amendment.  This of course would have to be done by a "full" amendment rather than just by "faxback" amendment.

     

    Shirley

     

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

    Fax: 888-887-8686

     

    3470 Superior Court

    Oakville ON L6L0C4

    Canada

    www.innomar-strategies.com

     

    United in our responsibility

    to create healthier futures

     




    Original Message


Related Content