Canada Medical Device Reporting

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

Canada Vigilance - Medical Device Problem Reporting Program Marketed Health Products Directorate Health Canada Address Locator 0701E 200 Tunney's Pasture Driveway Ottawa, Ontario K1A …

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

How to Submit the Report. Completed forms should be emailed to: [email protected] or faxed to: 1-866-678-6789 or mailed to: Canada Vigilance - Medical Device …

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, diagnosis …

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

Final Report Form (FRM-0238) Preliminary and Final Report Form (FRM-0255) Consultation: Draft Documents for Medical Devices Program. If you want to report an …

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

Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097) How Health Canada inspects medical device establishments (GUI …

Consumer Medical Device Report Form - Canada

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

Footnote 2. If a doctor, nurse or other health care professional used the device on you, include the name of the professional as well. Return to footnote 2 referrer. Footnote 3. A …

ARCHIVED: Guidance Document for Mandatory Problem …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-mandatory-problem-reporting-medical-devices-health-canada-2011.html

The choice of report type depends on whether all the required information is available within the appropriate report timeframe. The Mandatory Medical Device …

Drug and Medical Device Databases - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-and-medical-device-databases.html

The purpose of this document is to provide a comprehensive list of Health Canada’s drug and medical device databases. These guidelines are designed to …

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 …