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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
- 2.1 What is Software as a Medical Device (SaMD) - inclusion criteriaHealth Canada uses the definition developed by the International Medical Devic…2.2 Exclusion criteriaThe medical purposes described in the device definition of the Act can … See more
Guidance Document: Software as a Medical …
- 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 …
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.html
- From: Health Canada Overview The guidance document clarifies how Software as a Medical Device (SaMD) fits into Health Canada's regulatory framework for medical …
Notice: Guidance Document: Software as a Medical …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/notice.html
- Health Canada is pleased to announce the finalization of the guidance document on Software as a Medical Device (SaMD): Definition and Classification. …
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: …
Draft Guidance Document - Software as a …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/software-medical-device-draft-guidance/document.html
- The functionality of any software product, and the manner in which it is represented or labeled for use, dictates whether it qualifies as a medical device under …
Software Regulated as a Class I or Class II Medical …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/software-regulated-class-medical-device-notice-2010-12-03.html
- Software that is intended or represented for use in the diagnosis or treatment of an abnormal physical state of a patient meets the definition of a medical device under …
Scientific Advisory Panel on Software as a Medical …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/scientific-expert-advisory-panels/software-medical-device/questions-january-26-2018.html
- A draft guidance document has been developed and is intended to provide a definition of Software as a Medical Device (SaMD), and to provide guidance as to how …
Health Canada Provides Guidance on Regulation of …
- https://www.pharmainbrief.com/2020/01/health-canada-provides-guidance-on-regulation-of-software-as-a-medical-device-samd/
- A software is considered a “medical device” when: 1) it is intended to be used for one or more medical purposes; and 2) it performs these purposes without being part of a …
Medical Devices Regulations ( SOR /98-282) - laws …
- https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/
- Medical Devices Regulations /98-282 - Table of Contents Medical Devices Regulations ( SOR /98-282) Full Document: HTML (Accessibility Buttons available) | XML [299 KB] | …
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