Health Canada has released its guidance on defining and classifying software as a medical device (SaMD) to support the development community.
Health Canada said:
“This document is intended to clarify how SaMD fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations.
“When the intended or represented use of software is for one or more of the medical purposes set out in the definition of a device as stated in the Act, that software qualifies as a medical device. The regulatory classification of SaMD is dependent on the manufacturer’s labeled intended use for the product and the applicable Classification Rules in Schedule 1 of the Regulations.”
The guidance explains the various functions that software could have to be classified as a medical device, such as diagnosis of an illness or restoring of body-part functionality.
Read the full guidance here.