00000cam 2200000zi 4500 9.895017 CaOODSP 20260415082453 m o d f cr cn||||||||| 210104t20212021onc o f000 0 eng d 9780660370385 CaOODSP eng rda CaOODSP n-cn--- H164-309/2021E-PDF Guidance on summary reports and issue-related analyses for medical devices. [January 2021 edition]. Ottawa, ON : Health Canada = Santé Canada, 2021. ©2021 1 online resource (i, 11 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. Issued also in HTML format. "Publication date: January 2021." 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. "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"--Purpose of the guidance document, page 1. 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)9.895018 Guidance on summary reports and issue-related analyses for medical devices. [October 2024 edition] (CaOODSP)9.943289 PDF 688 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-309-2021-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 200333