Guidance document : pre-market requirements for medical device cybersecurity. : H164-278/2019E-PDF

"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.

Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.873919&sl=1

Renseignements sur la publication
Ministère/Organisme Canada. Health Canada, issuing body.
Titre Guidance document : pre-market requirements for medical device cybersecurity.
Type de publication Monographie
Langue [Anglais]
Autres langues publiées [Français]
Format Électronique
Document électronique
Note(s) 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).
Information sur la publication [Ottawa] : Health Canada = Santé Canada, 2019.
©2019
Description 1 online resource (24 pages)
ISBN 9780660311173
Numéro de catalogue
  • H164-278/2019E-PDF
Numéro de catalogue du ministère 190079
Descripteurs Medical instruments and apparatus -- Safety regulations -- Canada.
Demander des formats alternatifs
Pour demander une publication dans un format alternatif, remplissez le formulaire électronique des publications du gouvernement du Canada. Utilisez le champ du formulaire «question ou commentaire» pour spécifier la publication demandée.
Date de modification :