Health Canada Medical Devices 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 Form for an Amendment to a Medical Device Clinical Trial under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations ( …

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 …

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 …

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 …

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 …

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

As is defined in section 1 of the Regulations, in respect of a medical device that has been sold, recall means any action taken by the manufacturer, importer or distributor of the device to recall or correct the …

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

Note: When a manufacturer, or importer, receives a complaint about a device which meets the three basic criteria described in sections 2.4.1 through 2.4.3, it must be …

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