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
- 1. Introduction
- 2. Guidance for implementation
- 3. Appendix 1: Additional International Resources
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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