Health Canada Medical Device Problem 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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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 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: …

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 Event …

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 …

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 …

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

Industry Medical Device Report Form Industry Medical Device Report Form Step 1: Description of problem Industry representatives can make complaints about a …

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

Medical devices recall guide (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) Guidance on Risk Classification of …

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 Adverse Reaction Reporting Form for Industry

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

You can also use the international Council for International Organizations of Medical Sciences (CIOMS) form to submit a report. If you are submitting an adverse reaction …

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