Description

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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Name	Format	Description	Link
Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness	HTML		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 effectiveness	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/instruments-medicaux-rapports-analyses-lignes-directrices/surete-efficacite.html

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