Medical Device Vigilance Reporting Canada

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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

One of the study groups within the GHTF has produced a document entitled " Medical Devices Post Market Surveillance: Global Guidance for Adverse …

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

This section contains information about the reporter, who is submitting the report to Canada Vigilance - Medical Devices Problem Reporting Program (CV-MD) to fulfil their …

Canada Vigilance Program - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html

The Canada Vigilance Program has collected reports of suspected adverse reactions since 1965. Adverse reaction reports are submitted by health professionals and …

Incident Reporting Medical Devices Guidance 2021

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021/incident-reporting-medical-devices-guidance-2021-en.pdf

Reportable incidents involving a medical device that affected one or more patients, users or other persons, on the same, or different, dates are to be reported to Health Canada as …

Notice for Industry: Mandatory Reporting Requirement …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-industry-mandatory-reporting-requirement-covid-19-pandemic.html

Health Canada's Canada Vigilance Program collects and assesses reports of adverse reactions (ARs) to health products and medical device problems (MDPs). …

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 …

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

Reporter Also Sent Report to the Canada Vigilance Program: Indicate whether the initial reporter also reported the AR to the Canada Vigilance Program. A4. MAH/Source …

Foreign risk notification for medical devices …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance.html

The reporting requirement applies to a medical device licence holder for a Class II to IV device, an establishment licence holder that imports Class II to IV …

Health Canada Medical Device Adverse Event Reporting - Emergo

https://www.emergobyul.com/services/health-canada-adverse-event-reporting-medical-devices

Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance Document for Mandatory Problem Reporting for Medical Devices for the correct reporting …

Do you know the requirements and your …

https://www.bsigroup.com/meddev/LocalFiles/en-US/Whitepapers/bsi-md-whitepaper-vigilance.pdf

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