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  • 1.  MDEL Canada

    This message was posted by a user wishing to remain anonymous
    Posted 13-Sep-2023 09:03
    This message was posted by a user wishing to remain anonymous

    I am a manufacturer of class I and II medical devices that is located outside of Canada, our distributor in North America is outside Canada as well. Do i need to hold a MDEL if our distributor has already a MDEL?

    Thank you very much



  • 2.  RE: MDEL Canada

    Posted 13-Sep-2023 12:04

    Maybe, maybe not, depending on some details. I explain below.

    Regarding Canadian class II devices: If the manufacturer outside of Canada holds a Medical Device Licence (MDL) [rather than a Medical Device Establishment Licence (MDEL)], then that manufacturer doesn't need an MDEL for those devices and shipments.

    For Canadian class I devices: If the manufacturer outside of Canada ships direct to the user/retailer in Canada, then an MDEL is required. But if that manufacturer instead ships those class I devices to an importer/distributor who holds an MDEL, then that manufacturer doesn't need an MDEL for those devices and shipments.



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    Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: MDEL Canada

    Posted 13-Sep-2023 12:16

    Hello Anon

    You'll find a helpful chart in the Guidance on Medical Device Establishment Licensing (GUI-0016).

    For your class I device, you don't need any license. Your distributor needs an MDEL.

    For your class II device, you need an MDL. Your distributor needs an MDEL, and will be required to verify the existence of your MDL.



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    Anne LeBlanc
    United States
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    Original Message


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