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

View metadata and access the original French HTML file: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification.

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HTML

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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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