Health Canada Medical Device Software

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. …

Medical devices - Canada.ca

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

Device Advice: e-Learning tool. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the …

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

Health Canada is the federal regulator of therapeutic products, including medical devices. We do not provide medical advice on the use of the products identified in this listing. 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

Guidance documents – Medical devices. For industry information about COVID-19, visit our COVID-19 medical devices section. Guidance documents have …

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 defined in the regulations. Health Canada considers that software is a medical …

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

Electronic Health Record (EHR) - An application software program, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, display, output, and …

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 …

Filing submissions electronically - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html

Dossier ID Process – the Dossier ID Request Form must be the only method used to request for a Dossier ID from Health Canada for REP and eCTD dossiers (Master Files, …

Health Canada CMDCAS, MDSAP and ISO 13485 QMS …

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

Quality system compliance to the ISO 13485 standard is expected in many medical device markets it is not enough in Canada. Health Canada currently requires compliance to the …