Regulatory Open Forum

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  • 1.  Canada Implant Card

    This message was posted by a user wishing to remain anonymous
    Posted 23-Sep-2021 14:39
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I am seeking advice on the Canada Implant registration cards. Health Canada's definition of implant means 'a medical device that is listed in Schedule 2. (implant).' Does this mean the implant registration card only apply to the devices in Schedule 2 https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-14.html#h-1022215

     However number three states "active implantable device systems" But then has a through e listed. So does that mean for active implantable device system not listed in a through e list that it will not apply?

     
    Thank you.



  • 2.  RE: Canada Implant Card

    This message was posted by a user wishing to remain anonymous
    Posted 27-Sep-2021 23:15
    This message was posted by a user wishing to remain anonymous

    Hello,

    Since "implant" is defined by the products listed in Schedule 2, then an implant not listed on Schedule 2 would not be subject to the implant card requirements.  It is my understanding that only the specific listed products need to meet the implant card requirements, therefore active implantable devices other than those specifically listed would not be subject to the requirements.

    Perhaps others will share their experience/interpretation.  You could also contact Health Canada for clarification.

    Regards,