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Medical Devices Active Licence Listing (MDALL)

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html
    The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device licence and are monitored by the Health Products and Food Branch Inspectorate ( Compliance …

Medical device licensing - Canada.ca

    https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html
    Medical device licensing - Canada.ca Canada.ca Health Drug and health products Licensing, authorizing and manufacturing drug and health products Medical …

Medical Devices Establishment Licence Listing

    https://health-products.canada.ca/mdel-leim/index-eng.jsp
    A Medical Device Establishment Licence (MDEL) is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to …

Guidance on Medical Device Establishment …

    https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf
    Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 9 of 42 Do I need a licence? Health Canada issues two different types of licences for …

Medical Device License Health Canada …

    https://qualitysmartsolutions.com/health-canada-medical-device-establishment-licence-and-class-i-ii-iii-iv-medical-device-licensing-solutions/
    Getting COVID Test Kits into Canada Covid-19 test kits, either antigen or molecular (PCR) based, are In-Vitro Diagnostics Tests (class IV) devices. These test kits can …

Health Canada Approval Process for Medical Devices: …

    https://www.joharidigital.com/medical-device-registration-in-canada/
    MDEL (Medical Device Establishment License) – Class I Medical Devices MDL (Medical Device License) – Class II, Class III and Class IV Medical Device …

Obtaining a Health Canada Medical Device …

    https://medicaldeviceacademy.com/health-canada-medical-device-license/
    Obtaining a Health Canada Medical Device License: The Process After reviewing all the requirements for a device license application, I meet with the client to …

Emergo by UL resources

    https://www.emergobyul.com/resources
    Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In …

Understanding Health Canada Medical Device Licensing

    https://www.lookeetech.com/blogs/news/understanding-health-canada-medical-device-licensing
    The regulatory body carries out expedited evaluations of applications regarding COVID-19 medical devices. At LOOKEE® Tech, we are a Medical Device …



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