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

Name: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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: Health Canada
Resources: 2
Catalogue metadata updated: 2023-10-29

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

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

Related open data

Health Canada