On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD.

What Constitutes SaMD

Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations of what constitutes a “device” or “medical device” in the Act and Regulations (including by reference to the definition … Continue Reading