Health Canada Medical Device Problem Reporting

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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

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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

Canada Vigilance - Medical Device Problem Reporting Program Marketed Health Products Directorate Health Canada Address Locator 0701E 200 Tunney's …

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 …

About medical device problems - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/medical-device-problems.html

Medical device problems. A medical device problem is related to: inadequate labelling or instructions for use. a failure of the device or a deterioration in its …

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 …

Industry Medical Device Report Form - Canada

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

4. Please include street, city, province/state, country and postal/zip code, if known. 5. The device name is usually found on label and may include a brand or trade name. Be sure …

Module 2: Reporting processes to Health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/education/module-2.html

Voluntary Reporting to Health Canada Voluntary Adverse Reaction (AR) and Medical Device Problem (MDP) Reporting. Health Canada builds post …

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

Canada Vigilance - Medical Device Problem Reporting Program Marketed Health Products Directorate Health Canada Address Locator 0701E 200 Tunney's …

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

Manufacturers should incorporate sound risk management principles in their problem investigation procedures. One approach that provides internationally recognized …

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 …

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