Canadian Medical Device Reporting Requirements

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Incident reporting for medical devices: Guidance document

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

One of the study groups within the GHTF has produced a document entitled " Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices" (N54) …

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 have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Medical devices - Canada.ca

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

Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, …

Guidance on summary reports and issue-related …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html

Mandatory Medical Device Problem Reporting Form for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-medical-device-problem-reporting-form-industry-adverse-reaction-reporting.html

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Medical device application and report forms - Canada.ca

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

Application forms listed below can be used in accordance with the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations. Application …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

61.4 - Summary Report 62 - Provision of Information Under Section 21.8 of Act 62.1 - Assessments Ordered Under Section 21.31 of the Act 62.2 - Activities Ordered Under …

Canadian regulators issue new reporting requirements for …

https://www.emergobyul.com/news/canadian-regulators-issue-new-reporting-requirements-medical-device-shortages

What are Health Canada’s new medical device reporting requirements? The CMDR amendments will require Medical Device License (MDL) and Medical …

Health Canada Guidance on Incident Reporting | RegDesk

https://www.regdesk.co/health-canada-incident-reporting/

Health Canada, the country’s regulating authority in the sphere of medical devices, has published updated guidance on incident reporting for medical devices. The present document supersedes the …

Health Canada Medical Device Adverse Event Reporting - Emergo

https://www.emergobyul.com/services/health-canada-adverse-event-reporting-medical-devices

Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance Document for Mandatory Problem Reporting for Medical Devices for the correct reporting …

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