Software Medical Device Health Canada

Guidance Document: Software as a Medical Device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html

Guidance Document: Software as a Medical Device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html

These are software that are intended to transfer, store, convert format, and display medical device data, without controlling or altering the functions or parameters of any connected medical device. …

Draft Guidance Document - Software as a Medical Device (SaMD)

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/software-medical-device-draft-guidance/document.html

CDS software (intended for Health Care Providers (HCP)), and PDS software (intended for patients and caregivers who are not HCPs) can encompass a wide spectrum of software functionalities. Some …

Health Canada Guidance-Software as a Medical Device

https://mcs-associates.com/medical-devices/health-canadas-final-guidance-on-software-as-a-medical-device/

The term “Software as a Medical Device” is defined as software intended to be used for one or more medical purposes as …

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Medical devices - Canada.ca Medical devices What's New Subscribe to our RSS Feeds Device Advice: e-Learning tool The term Medical Devices, as defined in the …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in …

Software Regulated as a Medical Device - canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/questions-answers-software-regulated-medical-device.html

Software used by a patient in the patient's home (or other locations outside of a healthcare setting) to transmit data received from a medical device (for example: blood pressure …

Medical Devices Active Licence Listing (MDALL)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

The Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate, Health Canada is the Canadian federal regulator responsible for licensing medical devices in …

Draft Examples Document - Software as a Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/software-medical-device-draft-guidance/examples.html

The software is intended to analyze digital mammography images and identify regions of interest, such as microcalcification clusters and density masses, which may warrant further review by a radiologist. …

Canada: Software As Medical Devices And Digital Health …

https://www.mondaq.com/canada/Finance-and-Banking/752662/Software-As-Medical-Devices-And-Digital-Health-In-Canada-What39s-Next

Also, on January 26, Health Canada convened a Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) to provide timely scientific, technical, and …