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Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
    The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Additional information on how …

Approved in 2020: Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/approved-2020-medical-devices.html
    Medical devices: Approved in 2020. There are different classes of medical devices, ranging from Class I to IV. Class I devices are considered low-risk devices, for example, a …

Drug and medical device approval overview - Canada.ca

    https://www.canada.ca/en/services/health/drug-health-products/drug-medical-device-highlights-2017/approval-overview.html
    When a new drug is approved, it is issued a Notice of Compliance (NOC). When a new medical device is approved, it is issued a medical device licence. This does not mean …

Authorized COVID-19 medical devices: Overview

    https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized.html
    The list includes devices first permitted under the Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19 (March 30, 2020, …

Medical Devices Active Licence Listing (MDALL) - Your …

    https://health-products.canada.ca/mdall-limh/index-eng.jsp
    Medical Devices Active Licence Listing (MDALL) - Your reference tool for licensed medical devices in Canada From Health Canada Dear visitor, We have …

Drug and medical device highlights 2020: Medical …

    https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/medical-devices.html
    In Canada, medical devices are categorized into four groups based on the level of risk associated with their use. These groups are called "Classes" and range from I to IV. …

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 …

Regulatory requirements for importing medical devices

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html
    Anyone who imports a medical device into Canada must also meet all applicable requirements of the FDA and associated Regulations. Some requirements include the …



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