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. 2023-10-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safety guidance document medical devices software software as medical-device SaMD definition and classification regulatory framework Guidance Document: Software as a Medical Device (SaMD): Definition and Classification HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html#a1.1 Guidance Document: Software as a Medical Device (SaMD): Definition and Classification HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/logiciels-titre-instruments-medicaux-ligne-directrice-document.html#a1.1
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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