Health Canada Medical Device Reporting Requirements

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

Since Health Canada and its regulatory partners have similar reporting requirements, the Regulations enable Health Canada's participation in international alert systems. Health Canada, along with its …

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

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 …

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

Device Identification No: Indicates the device identification number assigned by Health Canada in the license issued for the device. Manufacturer's Medical Device Identifier: …

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

2.3 How do I decide if the incident is reportable to Health Canada? 2.3.1 All Incidents In accordance with section 59 of the Regulations, any incident which meets all …

Industry Guide on Mandatory Reporting under the …

https://www.canada.ca/en/health-canada/services/consumer-product-safety/legislation-guidelines/acts-regulations/canada-consumer-product-safety-act/industry/guide-mandatory-reporting-section-14.html

When mandatory reporting is required 4.1 Paragraph 14 (1) (a) – an occurrence 4.2 Paragraph 14 (1) (b) – defect or characteristic 4.3 Paragraph 14 (1) (c) - incorrect or insufficient information on a label or instructions …

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

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

32 - Application for a Medical Device Licence 32.1 - Quality Management System Certificate 33 - Foreign Manufacturers 34 - Application for a Medical Device Licence Amendment …

Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html

If you are planning a corrective action that fits this definition, then under section 34(a) of the MDR, you must submit an application for an amended medical …

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 …