Guidance Document: Software as a Medical Device (SaMD): Definition and Classification
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.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
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Guidance Document: Software as a Medical Device (SaMD): Definition and ClassificationHTMLEnglish publication HTML
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Guidance Document: Software as a Medical Device (SaMD): Definition and ClassificationHTMLFrench publication HTML
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