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In Vitro Culture Media - Medical Device Classification in Canada

  • 1.  In Vitro Culture Media - Medical Device Classification in Canada

    This message was posted by a user wishing to remain anonymous
    Posted 19-Sep-2023 14:21
    This message was posted by a user wishing to remain anonymous

    This is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos. Similar products on MDALL is classified as Class II.

    I'm wondering if this device is an IVDD or nIVDD.

    On one hand, no diagnosis is being made, no detection, screening or identification. Not an IVDD? If it's an IVDD, what is the applicable rule? 

    However, if it's considered to be a nIVDD, which of the nIVVD classification rules is applicable?



  • 2.  RE: In Vitro Culture Media - Medical Device Classification in Canada

    Posted 20-Sep-2023 08:09

    Hi Anon,

    I might be wrong here but as far as I can see this product is no IVDD (and consequently no nIVDD), but a medical device meant to store tissues for later administration. I assume that classification rule 5  for medical devices would apply: "A non-invasive device intended for channelling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class II." (source https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/section-sched1022099.html?txthl=cultured).

    Best regards

    Christoph



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    Christoph Kiesselbach
    Reutlingen
    Germany
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