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  • 1.  Health Canada MDEL application

    This message was posted by a user wishing to remain anonymous
    Posted 13-Feb-2018 09:04
    This message was posted by a user wishing to remain anonymous

    Regarding MDEL application form (FRM-0292), Annex I: Class I medical Devices table, what specific information is appropriate for the 'Type of Medical Device' column?  Something similar to the Global Medical Device Nomenclature (GMDN) term – generic descriptors used to identify medical device products?

    Thanks in advance!


  • 2.  RE: Health Canada MDEL application

    Posted 14-Feb-2018 05:13
    I often put in the type of device for a Medical Device License (MDL) option as: Single Device, System, Test Kit, Medical Device Family, Medical Device Group, Medical Device Group Family.  These are defined in the MDL guidance.  Also have put in and seen others put in general descriptive name of the device as you mention without any issues.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: Health Canada MDEL application

    Posted 15-Feb-2018 02:43
    ​I put the device type, e.g.: dental implant; during the audit the inspector didn't raise any question nor comment on that.
    Best regards,
    Elena

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    Elena Cavallini
    Kloten
    Switzerland
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    Original Message


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