Software As Medical Devices And Digital Health In Canada: What's Next?

Current Regulation of Software as Medical Devices in Canada

Medical devices in Canada are regulated federally by Health Canada's Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada's Food and Drugs Act (Act) and Medical Device Regulations (Regulations). In Canada, a medical device includes an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms.¹ Medical devices are categorized into four classes determined by applying the classification rules for medical devices detailed in Schedule 1 of the Regulations.² Class I represents the lowest perceived risk, and Class IV represents the highest perceived risk.