00000nam 2200000zi 4500 9.895015 CaOODSP 20221107173915 m o d f cr ||||||||||| 210104e202101##onc o f000 0 eng d 9780660370361 CaOODSP eng rda CaOODSP n-cn--- H164-308/2021E-PDF Foreign risk notification for medical devices guidance document. Ottawa, ON : Health Canada = Santé Canada, January 2021. ©2021 1 online resource (9 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices sur les communications étrangères relatives aux risques liés aux instruments médicaux. Issued also in HTML format. "This guidance document is to help manufacturers and importers of medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN). The requirements deal with serious risk of injury to human health and are set out in sections 61.2 and 61.3 of the Medical Devices Regulations"--Background, page 1. Medical instruments and apparatus Safety regulations Canada. Canada. Health Canada, issuing body. Lignes directrices sur les communications étrangères relatives aux risques liés aux instruments médicaux. (CaOODSP)9.895016 PDF 627 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-308-2021-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance.html