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  • 1.  Canada Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 31-Aug-2018 09:26
    This message was posted by a user wishing to remain anonymous

    Hello. Does anybody know if personal lubricants are classified as medical devices in Canada? I was under the impression that they are but cannot locate any documentation to support this. Thank you in advance.


  • 2.  RE: Canada Medical Devices

    Posted 31-Aug-2018 09:56
    Going by the examples in "Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)"., I'd say it is. You'd have to base your classification on intended use, nature of patient contact, risk and presence of animal/human material.



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    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States
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    Original Message


  • 3.  RE: Canada Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 31-Aug-2018 17:26
    This message was posted by a user wishing to remain anonymous

    Thank you, Vidyalakshmi.
    Original Message


  • 4.  RE: Canada Medical Devices

    Posted 31-Aug-2018 11:26
      |   view attached
    They come under cosmetics in Canada. (It all depends on ingredients used in the product)

    Here is the link for Cosmetic product category, where you can find the category for lubricants as well.

    Also attached is the presentation from cosmetic division of health Canada.

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    Amit Jain
    United States
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    Attachment(s)

    pdf
    Regulatory Meeting Canada Cosmetics.pdf   333 KB 1 version
    Original Message


  • 5.  RE: Canada Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 31-Aug-2018 17:26
    This message was posted by a user wishing to remain anonymous

    Thank you!
    Original Message


  • 6.  RE: Canada Medical Devices

    Posted 01-Sep-2018 02:37
    It would be interesting to see if Health Canada is going to align their rules with the new EU Medical Device Regulation.  Considering the couple new rules, one of the new Rules would definitely move lubricants into medical device regulations.  That is if Health Canada updates ...

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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