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

Overview

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

• 1. Introduction
  • 1.1 Policy objectives
  • 1.2 Policy statements
  • 1.3 Scope and application
  • 1.4 Definitions
• 2. Guidance for implementation
  • 2.1 What is Software as a Medical Device (SaMD) - inclusion criteria
  • 2.2 Exclusion criteria
  • 2.3 Classification of SaMD
• 3. Appendix 1: Additional International Resources

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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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