{"id":3014,"date":"2021-10-27T09:48:42","date_gmt":"2021-10-27T01:48:42","guid":{"rendered":"https:\/\/regask.com\/?p=3014"},"modified":"2024-10-26T03:19:36","modified_gmt":"2024-10-25T19:19:36","slug":"reglementation-canadienne-sur-les-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/canada-medical-device-regulations\/","title":{"rendered":"Sant\u00e9 Canada a modifi\u00e9 certains r\u00e8glements me concernant\u2026"},"content":{"rendered":"<p>Le 11 ao\u00fbt 2021, la HSA a modifi\u00e9 le R\u00e8glement sur les aliments et drogues et le R\u00e8glement sur les instruments m\u00e9dicaux concernant les p\u00e9nuries d&#039;instruments m\u00e9dicaux et de m\u00e9dicaments au Canada. La modification a \u00e9t\u00e9 publi\u00e9e dans la Gazette du Canada, partie II, le 1er septembre 2021.<\/p>\n<p>Ces nouveaux r\u00e8glements prolongent et modifient certaines mesures d\u00e9j\u00e0 en vigueur par le biais de deux arr\u00eat\u00e9s d\u2019urgence. Ils ont \u00e9t\u00e9 pris pour aider \u00e0 suivre, pr\u00e9venir et att\u00e9nuer les p\u00e9nuries de produits de sant\u00e9 cl\u00e9s au Canada, notamment les m\u00e9dicaments et les instruments m\u00e9dicaux.<\/p>\n<p>Entr\u00e9e en vigueur le <strong>27 novembre 2021<\/strong>, sont des dispositions qui :<\/p>\n<ul>\n<li>Interdire la distribution \u00e0 l\u2019ext\u00e9rieur du Canada de m\u00e9dicaments destin\u00e9s au march\u00e9 canadien qui pourraient causer ou aggraver une p\u00e9nurie,<\/li>\n<li>Permettre au ministre d\u2019exiger des informations concernant les p\u00e9nuries de m\u00e9dicaments.<\/li>\n<\/ul>\n<p>Entr\u00e9e en vigueur le <strong>1er mars 2022<\/strong>, sont des dispositions concernant :<\/p>\n<ul>\n<li>Importation et vente exceptionnelles de m\u00e9dicaments, dispositifs m\u00e9dicaux,<\/li>\n<li>D\u00e9claration obligatoire des p\u00e9nuries de dispositifs m\u00e9dicaux sp\u00e9cifi\u00e9s et pouvoir d&#039;exiger des informations sur les p\u00e9nuries de dispositifs m\u00e9dicaux,<\/li>\n<li>Prolongation des assouplissements en mati\u00e8re de licences pour certains d\u00e9sinfectants pour les mains \u00e0 base de m\u00e9dicaments.<\/li>\n<\/ul>\n<p>Contactez RegASK pour en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux. <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.gazette.gc.ca\/rp-pr\/p2\/2021\/2021-09-01\/html\/sor-dors199-eng.html\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-719636018\">\n\n\t<div id=\"col-315848887\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 11 August 2021, HSA amended the Food and Drug Regulations and Medical Devices Regulations concerning shortages of Medical Devices and Medicinal Drugs in Canada, the amendment was published in the Canada Gazette, Part II on 1 September 2021. These new regulations extend and modify certain measures already in place through 2 interim orders (IOs)&#8230;.<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[513,39],"tags":[40],"class_list":["post-3014","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-canada-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Canada Amends Medical Device Regs | RegASK<\/title>\n<meta name=\"description\" content=\"Health Canada amends regulations concerning medical devices. 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