Health Canada Medical Device Classification List

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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, mitigation, diagnosis or prevention of a disease or abnormal physical …

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

In vitro diagnostic medical devices Neurological devices Plastic surgery and cosmetic devices Radiological devices Various Medical devices: Approved in 2020 There are …

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

Classification is the first step in the review of health products by the Health Products and Food Branch (HPFB). When the classification of a health product is not evident, the …

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 Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is intended to assist manufacturers in confirming the classification of medical device …

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

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

69 - PART 2 - Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access 69 - Application 70 - General 71 - Authorization 73 - Additional …

Health Canada Medical Device Classification - Emergo

https://www.emergobyul.com/services/health-canada-medical-device-classification-consulting

Determining your device classification in Canada 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 …

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 (F&DA) and its regulations serve as a basis for the classification of drugs, …

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