Guidance Document: Software as a Medical Device (SaMD): Definition and Classification – profile


The guidance document clarifies how Software as a Medical Device (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. This document also provides information on the classification process and includes several SaMD examples. 

Who this guide is for

Medical Device manufacturers

In this guide

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Download PDF (269 KB, 16 pages)

Details and history

Published: December 18, 2019

Consulted: January 23, 2019 - March 29, 2019

Part of topic(s): Guidance on Legislation, Medical Devices and Software as a Medical Device (SaMD)

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