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

Name: Guidance Document: Software as a Medical Device (SaMD): Classification Examples
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada
Keywords: canada,classification,definitions,examples,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

September 22, 2021

Last updated

November 15, 2022

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): Classification Examples

Updated on November 15, 2022

html

URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html
Permalink: https://data.openrid.co/en/datasets/r/2a9526b3-4b48-4c6c-b3ac-91744dad230e
MIME Type: text/html

Created on: September 22, 2021
Modified on: November 15, 2022

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

Updated on November 15, 2022

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/examples/examples.pdf
Permalink: https://data.openrid.co/en/datasets/r/89977a30-5717-4844-bea9-24c6d6742d5b
MIME Type: application/pdf

Created on: September 22, 2021
Modified on: November 15, 2022

Ligne Directrice: Logiciels à titre d’instruments médicaux: Exemples de Classification

Updated on November 15, 2022

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/exemples.html
Permalink: https://data.openrid.co/en/datasets/r/759ff47a-b391-4431-8943-66aa965bfc36
MIME Type: text/html

Created on: September 22, 2021
Modified on: November 15, 2022

Ligne Directrice: Logiciels à titre d’instruments médicaux: Exemples de Classification

Updated on November 15, 2022

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/examples/exemples.pdf
Permalink: https://data.openrid.co/en/datasets/r/a966cd43-bdeb-4224-be1a-5011cdc58919
MIME Type: application/pdf

Created on: September 22, 2021
Modified on: November 15, 2022

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

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Type

Regulated products

Topics

Published

Last updated

Description

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