Software as Medical Device Classification and Registration in Canada
Health Canada defines software as a medical device (SaMD) as a software intended to be used for one or more medical purposes and peforms these purposes without being part of a hardware medical device. SaMD includes in-vitro diagnostic (IVD) medical devices and these software can run on non-medical purpose computing platforms.
There are inclusion and exclusion criterion that must be met to determine if they meet the definition of a SaMD. Health Canada follows standards developed by the International Medical Device Regulators Forum (IMDRF) in this criterion determination if the software is a medical device.
SaMD can apply to any of the four classes of medical devices that are under the Health Canada medical device classification system.