Regulatory Open Forum

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  • 1.  Assisted Reproductive Tools in Canada

    This message was posted by a user wishing to remain anonymous
    Posted 15-Nov-2018 11:38
    This message was posted by a user wishing to remain anonymous

    What are the requirements for registering/licensing in Canada to distribute assisted reproductive technology tools/accessories that have been classified as a Class II in US by FDA?

    Is a MDEL required?  Is a CE mark required for distribution to physicians at IVF clinics?



  • 2.  RE: Assisted Reproductive Tools in Canada

    Posted 16-Nov-2018 05:18
    You would have to be more clear on what type of assisted reproductive tools you are speaking about because this can be anything from needles, to catheters, to dishes, to plates.  Health Canada regulations are fairly straightforward using a risk-based classification system that is located in the regulation SOR/98-282 specifically Schedule 1.  There are rules for non-invasive and invasive devices which ART products could be either, so would need more definitive information on the type of tools or accessories.  Recommend to look at Schedule 1 and go through all of the Rules to determine classification based on the ART tool - some also are regulated and some are not, i.e. general lab equipment such as storage plates.

    While the classification rules are similar between Health Canada and the European Union, CE Marking of products in Health Canada is not applicable.  Health Canada knows of CE Mark, but does not recognise CE Mark for product registration.  Depending on the Rule and Class of the ART tool, it may require a Medical Device Establishment License for Class I or require a Medical Device License for Class II and above.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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