Health Canada Medical Device Reporting Guidance

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Incident reporting for medical devices: …

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 …

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 been …

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

Guidance on summary reports and issue …

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

Medical device licence holders of Class II, III and IV devices are required to complete summary reports at periodic intervals. This requirement is outlined in …

Incident reporting for medical devices: Guidance …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021/incident-reporting-medical-devices-guidance-2021-en.pdf

Reportable incidents involving a medical device that affected one or more patients, users or other persons, on the same, or different, dates are to be reported to Health Canada as …

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

This section contains information about the reporter, who is submitting the report to Canada Vigilance - Medical Devices Problem Reporting Program (CV-MD) to fulfil their …

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, …

Problem Reporting - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting.html

Recall Reporting for Medical Devices: Medical device initial recall reporting form (FRM-0360) Medical device final recall reporting form (FRM-0360) Guide to Recalls of …

Health Canada Guidance on Incident …

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

Health Canada Guidance on Incident Reporting Mar 20, 2021 Health Canada, the country’s regulating authority in the sphere of medical devices, has …

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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