Medical Device Reporting Canada

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) …

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

Report of problems related to medical devices marketed in Canada How to Submit the Report Completed forms should be emailed to: [email protected] or faxed to: 1 …

Medical devices - Canada.ca

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

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, mitigation, …

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

Problem Reporting - Canada.ca

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

Medical device initial recall reporting form (FRM-0360) Medical device final recall reporting form (FRM-0360) Guide to Recalls of Medical Devices (GUI-0054) …

Compliance and enforcement of medical devices

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

Medical devices recall guide (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) Guidance on Risk Classification of …

About medical devices - Canada.ca

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

Report a medical device problem or calling toll-free at 1-800-267-9675 We review all reports and follow up by: seeking more details from the person who submitted the …

Medical Device Incidents - hpr-rps.hres.ca

https://hpr-rps.hres.ca/mdi_landing.php

Medical Devices Drugs Natural Health Products Medical Devices Review Decisions Submit a report Prescription Drug List About Search Medical Device Incidents Search …

Health Canada on Incident Reporting: Timelines and …

https://www.regdesk.co/health-canada-on-incident-reporting-timelines-and-content/

The guidance further describes the following types of reporting: 1. Preliminary report for an incident occurring in Canada. If an adverse event associated with serious consequences for the health of 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 …