Description

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.

Resources

Name	Format	Description	Link
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

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