00000nam 2200000zi 4500 9.873919 CaOODSP 20221107164043 m o d f cr ||||||||||| 190530t20192019onc |ob f000 0 eng d 9780660311173 CaOODSP eng rda CaOODSP n-cn--- H164-278/2019E-PDF Guidance document : pre-market requirements for medical device cybersecurity. [Ottawa] : Health Canada = Santé Canada, 2019. ©2019 1 online resource (24 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice sur les exigences relatives à la cybersécurité des instrument médicaux avant leur mise en marché. Title from cover. "Date adopted: 2019/06/17; effective date: 2019/06/26." "Publication date: June 2019." Issued also in HTML format. Includes bibliographical references (page 19). "Health Canada considers the inclusion of cybersecurity risk control measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures that can improve the cybersecurity of their device. This guidance also outlines the information to be submitted as part of a medical device licence or licence amendment application to demonstrate that a medical device, consisting of or containing software, is sufficiently secure from threats that may exploit a vulnerability within a medical device possibly causing harm"--Policy objectives, pages 5-6. Medical instruments and apparatus Safety regulations Canada. Canada. Health Canada, issuing body. Ligne directrice sur les exigences relatives à la cybersécurité des instrument médicaux avant leur mise en marché. (CaOODSP)9.873920 PDF 347 KB https://publications.gc.ca/collections/collection_2020/sc-hc/H164-278-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity/document.html 190079