Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness

Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of risks after a product is authorized for sale in Canada. 2024-03-30 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidancesummary reportsissue-related analysessafety and effectivenessmedical devicesmedical device manufacturersMedical Devices Regulationsnew requirementsmonitoring of risksa productauthorized for sale Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectivenessHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/safety-effectiveness.html Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectivenessHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/instruments-medicaux-rapports-analyses-lignes-directrices/surete-efficacite.html

This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of risks after a product is authorized for sale in Canada.

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