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What's new: Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html
    Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name And / Or Address Of Existing Device Licences Only [2020-04-30] Medical Devices Licence Amendment Fax-Back Form - Guidance for Non-Significant …

Medical Devices Regulations ( SOR /98-282) - laws …

    https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/
    Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - …

Recent Changes to Medical Device …

    https://www.regdesk.co/summary-recent-changes-to-medical-device-regulations-in-canada/
    Jul 15, 2021. In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this …

Foreign Risk Notification, Annual Summary Reports, and …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/proposed-amendment-medical-device-regulations/document.html
    Health Canada is proposing regulatory changes to the Medical Devices Regulations (MDR) in order to strengthen the lifecycle approach to the regulation of medical devices …

Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
    Medical devices. 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, …

Legislation and Guidelines - Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html
    The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …

Guidance documents – Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html
    Guidance documents – Medical devices. For industry information about COVID-19, visit our COVID-19 medical devices section. Guidance documents have …

Guidance for the Interpretation of Significant Change of a …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html
    The purpose of this guidance document is to elaborate upon the definition of "significant change" found in the Medical Devices Regulations 1998 (Regulations), in …

Consultation on Changes to Canadian Medical Device …

    https://www.regdesk.co/consultation-on-changes-to-canadian-medical-device-regulations/
    Health Canada, the country’s regulating authority in the sphere of healthcare products, has announced a consultation for proposed amendments to the Medical …

Notice: New regulations strengthening the post-market surveillance …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/post-market-surveillance-medical-device-regulations-notice.html
    Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing …



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