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Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
    Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements. The Government of Canada is …

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

    https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/
    43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold …

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
    For more information about the import requirements of medical devices, contact Border Centres of Health Canada: Toll free (Canada and USA): 1-833-622-0414. From outside …

Health Canada Approval Process for Medical Devices: …

    https://www.joharidigital.com/medical-device-registration-in-canada/
    1. Investigational testing of Medical devices. The process of investigational testing involves evaluating the unlicensed devices for new uses or in new populations. …

Canada - Essential Requirements Checklist for MDD 93/42/EEC

    https://elsmar.com/elsmarqualityforum/threads/canada-essential-requirements-checklist-for-mdd-93-42-eec.60440/
    Canada Medical Device Regulations: 0: Mar 28, 2019: M: CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device: CE Marking …



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