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  • 1.  Content for MDL - Class II IVD device in Canada

    This message was posted by a user wishing to remain anonymous
    Posted 24-Aug-2022 08:43
    This message was posted by a user wishing to remain anonymous

    Hello Regulatory team,

    Can anyone share the content that needs to included in MDL for a class II IVD device? Are there any guidance documents in place that explains this?

    Thank you in advance!! 


  • 2.  RE: Content for MDL - Class II IVD device in Canada

    Posted 24-Aug-2022 09:00
    Hi there, 

    I suggest reviewing this guidance document here specifically section 2.2.2. 

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html#a2.2.2


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    Karen Zhou
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    Original Message


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