Description

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada.

Resources

Name	Format	Description	Link
Guidance on summary reports and issue-related analyses for medical devices: Overview	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html
Guidance on summary reports and issue-related analyses for medical devices: Overview	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/instruments-medicaux-rapports-analyses-lignes-directrices.html

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