Guidance Document: Software as a Medical Device (SaMD): Definition and Classification (English, HTML)

Guidance Document: Software as a Medical Device (SaMD): Definition and Classification: English HTML file. From Health Canada, updated Oct 2023. View metadata, licence and the direct download on CanQuery.

Format

HTML

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Original download only

Publisher-reported update

2023-10-29

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.

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