00000cam 2200000zi 4500 9.960789 CaOODSP 20260415091616 m o d f cr cn||||||||| 260310e202604##onc ob f000 0 eng d 9780660988894 CaOODSP eng rda CaOODSP n-cn--- H164-309/2026E-PDF Guidance on summary reports and issue-related analyses for medical devices. [April 2026 edition]. Ottawa, ON : Health Canada = Santé Canada, April 2026. ©2026 1 online resource (ii, 18 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux. "Health Products." "Pub.: 250497"--Verso of cover. Includes bibliographical references. "This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39, 61.4 to 61.6 and 68.31 to 68.33 of the Medical Devices Regulations (regulations). Two requirements in the regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada. The 2 requirements concern: the preparation, retention and submission of summary reports (sections 61.4 to 61.6 and 68.31 to 68.33 of the regulations); the completion of issue-related analyses of safety and effectiveness (subsection 25(1) and sections 39 and 68.23 of the regulations). This guidance document: clarifies Health Canada's expectations for the preparation of these summary reports and issue-related analyses; gives an overview of the requirements and procedures for submitting summary reports and issue-related analyses to Health Canada. …"-- Purpose of the guidance document, pages 1-2. Medical instruments and apparatus Government policy Canada. Medical instruments and apparatus Safety regulations Canada. Canada. Health Canada, issuing body. Lignes directrices sur les rapports de synthèse et les analyses liées à un sujet de préoccupation pour les instruments médicaux. (CaOODSP)9.960791 Guidance on summary reports and issue-related analyses for medical devices. [October 2024 edition] (CaOODSP)9.943289 PDF 674 KB https://publications.gc.ca/collections/collection_2026/sc-hc/H164-309-2026-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html 250327