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
Keywords: canada,classification,definitions,framework,guidances,health-canada,medical-devices,regulations,samd,software,software-as-a-medical-device

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Medical Devices Guidance Documents

Published

October 5, 2021

Last updated

June 18, 2020

Description

This document is intended to clarify how Software as a Medical Device (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.

Organization

Health Canada 🇨🇦

Country / Region

Canada

License

Open Government License 2.0 (Canada)

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4 Main files

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

Updated on June 18, 2020

html

URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html
Permalink: https://data.openrid.co/en/datasets/r/1d49fc9d-d022-45e5-8c38-96324d7d2189
MIME Type: text/html

Created on: October 5, 2021
Modified on: June 18, 2020

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

Updated on June 18, 2020

pdf

URL: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document/software-medical-device-guidance-document.pdf
Permalink: https://data.openrid.co/en/datasets/r/62f38551-e71d-4c4c-9b99-38800ecabcd6
MIME Type: application/pdf

Created on: October 5, 2021
Modified on: June 18, 2020

Ligne Directrice: Logiciels à titre d’instruments médicaux: Définition et Classification

Updated on June 18, 2020

html

URL: 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
Permalink: https://data.openrid.co/en/datasets/r/d14521ef-5631-4a40-b51a-a66a4cb88fb5
MIME Type: text/html

Created on: October 5, 2021
Modified on: June 18, 2020

Ligne Directrice: Logiciels à titre d’instruments médicaux: Définition et Classification

Updated on June 18, 2020

pdf

URL: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document/logiciels-titre-instruments-medicaux-ligne-directrice-document.pdf
Permalink: https://data.openrid.co/en/datasets/r/b77975a8-938b-4684-9132-1558b78be525
MIME Type: application/pdf

Created on: October 5, 2021
Modified on: June 18, 2020

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

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

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