Health Canada Medical Device Problem Report Form

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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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Medical device application and report forms - Canada.ca

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

Application forms listed below can be used in accordance with the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations. Application …

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

Problem Reporting 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 …

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) Guidance …

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

The device licence number is issued by Health Canada but does not normally appear on the label. Additionally, some medical devices do not require a device licence. If a …

Incident reporting for medical devices: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

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

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

The device licence number is issued by Health Canada but does not normally appear on the label. Additionally, some medical devices do not require a device licence. If a medical …

Report a medical device problem or incident - Canada.ca

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

Report a medical device problem or incident - Canada.ca Report a medical device problem: reporter Who/what are you? Consumer Hospital Health care …

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

Health Product Complaint Form (FRM-0317) Summary Questions and Answers Mandatory problem reporting for medical devices: Preliminary Report Form …

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

In accordance with section 59 of the Regulations, any incident which meets all of the three basic reporting criteria described in sections 2.4.1 through 2.4.3, below, is …

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