Health Canada Guidance For Medical Device Complaint Handling

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Incident reporting for medical devices: Guidance …

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

Guidance on Investigation of Reported Medical Device

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/guidance-investigation-reported-medical-device-problems-0065.html

This guidance document is intended to provide an interpretation of sections 57 and 58a of the Medical Devices Regulations (Regulations) in order to assist the …

Reporting complaints about health products - Canada.ca

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

Reporting complaints about health products. Health Canada encourages individuals to send in their complaints about health products to the Regulatory Operations and …

Problem Reporting - Canada.ca

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

Medical device final recall reporting form (FRM-0360) Guide to Recalls of Medical Devices (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI …

Guidance on Medical Device Compliance and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-medical-device-compliance-enforcement-0073.html

in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, …

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 …

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

An act, or omission of an act, by the user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. …

Medical Device Complaint Form (FRM-0317) - Canada

https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html

Medical Device Complaint If you are a consumer looking to report a problem with a medical device, access this online form. If you are an industry representative, looking to …