Canada Vigilance - Medical Device Problem Reporting Program

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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

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 obligations under sections 59, 60, 61 and 61.1 of the Medical Devices Regulations. It …

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 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

One of the study groups within the GHTF has produced a document entitled " Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices" (N54) …

Adverse reactions, medical device incidents and health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html

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 …

Guidance Document for Mandatory Problem …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/pubs/medeff/guide/2011-devices-materiaux/2011-devices-materiaux-eng.pdf

The mandatory problem reporting provisions in the Regulations are intended to improve monitoring and reduce the recurrence of incidents related to medical devices in Canada, …

Guidance document for mandatory problem reporting for …

https://publications.gc.ca/site/eng/432106/publication.html

Guidance document for mandatory problem reporting for medical devices : Canada Vigilance - Medical Device Problem Reporting Program : H164-145/2011E-PDF - …

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

Any questions regarding MedDRA can be forwarded to the Canada Vigilance Program. Please do not hesitate to contact the Canada Vigilance Program if you require further …

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 timeline, …

Marketed Health Products Directorate - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/marketed-health-products-directorate.html

both the Canada Vigilance Program and the Canadian Medical Devices Sentinel Network (CMDSNet) collect reports critically appraising observational studies and scientific …

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