Regulatory Open Forum

 View Only

  • 1.  Health Canada Guidance for licence application for an equivalent of a medical device

    Posted 07-Jul-2020 13:12
    Dear all,
    I want to find on Health Canada website a guidance on licence application for an equivalent of a medical device but i can't find anything.
    my concern is on document required. As it's an equivalence do we need to submit a clinical trial or clinical data. I don't think so , but I need your experience feed back.
    Thank you for in advance for your reply.
    Rgds,

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


  • 2.  RE: Health Canada Guidance for licence application for an equivalent of a medical device

    Posted 07-Jul-2020 22:53
    If I understand you correctly, Canada does not have the equivalent of what is known as a predicate in the world of FDA. The supporting information will depend on the classification of your device.

    ------------------------------
    Karen Zhou
    ------------------------------

    Original Message


  • 3.  RE: Health Canada Guidance for licence application for an equivalent of a medical device

    Posted 08-Jul-2020 03:19
    Hello Nadine,

    Karen is right, the Health Canada system does not use any type of substantial equivalence or predicate device system.  Health Canada's system more closely resembles the European Union.  Devices must "stand on their own" from the technical, biological, and intended use of device.  It does not mean in the license application some information can be provided your device is the same as another currently marketed device, but there is no document required to prove this aspect.

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

    Original Message


  • 4.  RE: Health Canada Guidance for licence application for an equivalent of a medical device

    Posted 08-Jul-2020 09:26
    Hello Richard,
    Thank you, well noted. If I understand you correctly, I should prepare a full dossier for my product , prove efficacy and safety  of my own product and add that device is the same as another currently marketed device.
    Rgds, 

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

    Original Message


  • 5.  RE: Health Canada Guidance for licence application for an equivalent of a medical device

    Posted 08-Jul-2020 09:13
    Indeed I'm talking about the predicate in the world of FDA.
    For example if we have a product class III for Canada plan to be submitted and we know that an other medical device much like ours is already marketed should we build the technical file avoiding clinical data on humans and prove equivalence or should we build a complete technical file?
    Thank you for your response.

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

    Original Message


  • 6.  RE: Health Canada Guidance for licence application for an equivalent of a medical device

    Posted 08-Jul-2020 09:49
    Hi Nadine,

    2 sections does mention the comparative assessment that you are pointing out.
    For IVD
    Section 2.02 recommends a template developed by MEDEC that has reference to Predicates or Comparative Devices. But this comparison is an optional requirement . So technically you can skip this too.

    Section 2.04.05-Ref-Comparison to Similar Section does require you to make a comparison with a similar device .
    You might need to check if this is an optional section in the matrix . If yes, you can technically omit the comparison under this section too.

    I hope this helps.

    Best!






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

    Original Message


Related Content