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Guidance Document - Guidance on the …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html
    The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. The safety and effectiveness evidence required to support a medical device …

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 …

Classification of health products at the drug-medical …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/classification-health-products-device-drug-interface.html
    The TPCC includes representatives from various areas of Health Canada, within and outside of HPFB. The guidance document titled, "Guidance Document: Classification of …

About medical devices - Canada.ca

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

    Guidance for Industry- Keyword Index to Assist

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-industry-keyword-assist-manufacturers-class-medical-devices.html
      The purpose of the Medical Device Keyword Index is to assist manufacturers in verifying the classification of medical device products after application of the Classification Rules for …

    Guidance documents – Medical devices - Canada.ca

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html
      Draft Health Canada IMDRF table of contents for medical device applications guidance [2019-02-28] Implementation of Advance Notice of Importation Process for …

    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 …

    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 for the Purposes of …

    Health Canada Medical Device Classification

      https://www.emergobyul.com/services/health-canada-medical-device-classification-consulting
      Medical devices are classified according to Health Canada's risk-based system. There are four device classifications--Class I, II, III and IV--using a set of 16 rules found in Schedule 1, Part 1 of the …

    Classification of products under the Food and Drugs Act …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/classification-products-food-drugs-act.html
      Classification is the first step in any regulatory process at Health Canada. The Food and Drugs Act and its regulations serve as a basis for the classification of drugs, devices, …



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