Health Canada Software Medical Device

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

Draft Guidance Document - Software as a Medical Device (SaMD)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

2.1 What is Software as a Medical Device (SaMD) - inclusion criteria. Health Canada uses the definition developed by the International Medical Device Regulators Forum (IMDRF) as provided in …

Health Canada Guidance-Software as a Medical Device

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

On December 18, 2019 Health Canada published a guidance document on Software as a Medical Device (SaMD): Definition and …

Software as Medical Device: Classification and Definitions

https://www.johner-institute.com/articles/software-iec-62304/software-as-medical-device/

b) Examples of software that is not a medical device. Health Canada also helps by giving some examples of software that it does not consider to be medical devices: Pure communication systems such as MDDS, …

MDSAP and Health Canada ISO 13485 QMS Compliance

https://www.emergobyul.com/services/mdsap-and-health-canada-iso-13485-qms-compliance

An Emergo quality system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets. In addition to ISO 13485 consulting, we …

Software as Medical Devices and Digital Health in …

https://www.torys.com/Our%20Latest%20Thinking/Publications/2018/11/software-as-medical-devices-and-digital-health-in-canada/

In 2018, Health Canada has undertaken a multifaceted initiative to establish a revised regulatory approach for the emergent digital health technology sector, while ensuring …

Regulatory Challenges of Software as a Medical Device …

https://globalforum.diaglobal.org/issue/december-2019/regulatory-challenges-of-software-as-a-medical-device-samd/

In 2018, under the Regulatory Review of Drugs and Devices initiative, Health Canada established the Digital Health Division (DHD) in the Medical Devices Bureau. DHD focuses on pre-market review of digital …

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 …

Canada - Medical Devices - International Trade …

https://www.trade.gov/country-commercial-guides/canada-medical-devices

Health Canada – Software as a Medical Device (SaMD) Commercial Services For additional information on this sector, please contact Commercial Specialist …

Software as a Medical Device (SaMD): Definition and …

https://capra.ca/en/blog/software-as-a-medical-device-samd-definition-and-classification-2020-01-27.htm

2. Software that is intended to display, analyze, or print medical information about a patient or other medical information (such as demographic information, drug …