Health Canada Medical Device Mandatory Reporting 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 ( …

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

When the decision has been made to report a foreign incident to Health Canada (see section 2.3.2 above, for the criteria), section 60(1)(b) of the Regulations requires that a preliminary report be submitted as …

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 …

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

Be sure to include information about the type of device involved with the issue. For example: toothbrush, tampon, hip implant. Return to footnote 1 referrer Footnote 2 If a doctor, …

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

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 file a complaint about a …

Mandatory Adverse Reaction Reporting Form for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-adverse-reaction-reporting-form-industry.html

Mandatory Adverse Reaction Reporting Form for Industry Reports must be made within 15 calendar days of receiving or becoming aware of the information about the adverse …

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

A mandatory problem report is required under section 59(2) of the Regulations for any incident occurring outside Canada (foreign incidents), but involving a …

Mandatory reporting of serious adverse drug reactions …

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

The mandatory reporting requirements for hospitals apply to the following products regulated under the Food and Drug Regulations and the Medical Device Regulations: Pharmaceuticals (which includes …

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