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  • 1.  Summary Reports for Medical Devices - Health Canada

    This message was posted by a user wishing to remain anonymous
    Posted 20-Oct-2022 10:18
    This message was posted by a user wishing to remain anonymous

    Hello!

    My question is regarding the new requirement for submitting 'Summary Reports' to Health Canada, which went into effect December 2021. Our device is a Class III SaMD in Canada, we are trying to decide when we need the first summary reports ready to be submitted. Any thoughts?

    Thank you for your responses!


  • 2.  RE: Summary Reports for Medical Devices - Health Canada

    Posted 21-Oct-2022 01:45
    HI Anonymous,


    There is a guidance paper provided by the HC specifiying the timelines (Guidance on summary reports and issue-related analyses for medical devices: Summary reports - Canada.ca).

    Timelines are specified as: 

    Timelines for preparing summary reports 

    Summary reports must be prepared as follows:

    • for medical device licence holders of Class II devices: every 2 years with information gathered during the previous 24 months
    • for medical device licence holders of Class III and IV devices: every year with information gathered during the previous 12 months

    The reporting period isn't tied to the anniversary date of a medical device licence. Licence holders may choose the reporting period for the report as long as the report falls within the required reporting timeframe. With this flexibility, licence holders are able to use the same timeline for both the Canadian summary report and similar reports created to meet the requirements of international jurisdictions.

    Licence holders are required to prepare summary reports for as long as their device is licensed in Canada.



    FYI: "International jurisdictions" can also be SSCPs as requirement of (EU) MDR 2017/745.



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    Anja Abelmann
    Göttingen
    Germany
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    Original Message


  • 3.  RE: Summary Reports for Medical Devices - Health Canada

    Posted 21-Oct-2022 06:57

    Hello,
    You should plan to have the first reports for this requirement for Class III and IV completed by the end of 2022 and for Class II by the end of 2023. Since the requirement went into effect in December 2021, you need to have your quality management system address the new requirement for summary reports and manufacturers should be prepared to comply with at least a plan that lays out a timeline for completion.

    Kind regards,
    Leigh Harrell



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    Leigh Harrell
    Chetek WI
    United States
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    Original Message


  • 4.  RE: Summary Reports for Medical Devices - Health Canada

    Posted 21-Oct-2022 07:27

    Hello Anon,

     

    As the regulations came into effect on December 23, 2021, it was required that manufacturers of Class III and IV medical devices submit their first summary report before December 23, 2022 (and December 23, 2024 for Class II medical devices).  Whatever date was chosen would then be the anniversary date going forward for submitting future summary reports.  For Class III and IV devices, this would be yearly, however for Class II medical devices, it would be every 2 years.

     

    HC had left the date open so that if manufacturers were preparing similar summary reports for Europe, they could be done at the same time and not have two different anniversary dates for these reports.

     

    Hope this helps

     

    Shirley Furesz, Ph.D., RAC

    Amerisource Bergen

    TPIreg, Innomar Strategies

    Director Regulatory Affairs, Medical Devices

     

    Cell phone: 519-242-6476

    Fax: 888-887-8686

     

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    Original Message


  • 5.  RE: Summary Reports for Medical Devices - Health Canada

    Posted 21-Oct-2022 13:30
    Hi Anon,

    For clarity as I noted you mentioned 'Submitted' in your query. You are only required to submit Summary Reports to Health Canada when it is identified that there has been a change in the benefits and/or risks associated with the device (which is fed out from the Summary Reports). My understanding is that PSURs made under MDR are also acceptable as others have alluded to in this thread and that these reports for Class II/III & IV licenses can be requested at any time. The Health Canada guidance states the following:

    "If you determined that there was no change to the benefits and risks of your medical device since the previous reporting period, you do not need to submit the summary report to Health Canada."

    Hope this is helpful!


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    -----------------------------------------------
    Adam Gregory
    Regulatory Affairs Manager (AWC and Sealants)
    Winsford, United Kingdom
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    Original Message


  • 6.  RE: Summary Reports for Medical Devices - Health Canada

    Posted 22-Oct-2022 13:02

    Also, per the MDSAP Audit Model as of April 2022, your QMS procedures need to address the Canadian summary report requirement.  

     

    Sent from Mail for Windows

     




    Original Message


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