{"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":"kanadische-vorschriften-fur-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/canada-medical-device-regulations\/","title":{"rendered":"Health Canada hat bestimmte Vorschriften ge\u00e4ndert, die mich betreffen \u2026"},"content":{"rendered":"<p>Am 11. August 2021 \u00e4nderte die HSA die Lebensmittel- und Arzneimittelverordnung sowie die Medizinprodukteverordnung im Hinblick auf Engp\u00e4sse bei Medizinprodukten und Arzneimitteln in Kanada. Die \u00c4nderung wurde am 1. September 2021 im Canada Gazette, Teil II, ver\u00f6ffentlicht.<\/p>\n<p>Diese neuen Regelungen erweitern und modifizieren bestimmte bereits bestehende Ma\u00dfnahmen durch zwei einstweilige Verf\u00fcgungen. Sie sollen dazu beitragen, Engp\u00e4sse bei wichtigen Gesundheitsprodukten in Kanada, darunter Arzneimittel und Medizinprodukte, zu erkennen, zu verhindern und zu mildern.<\/p>\n<p>Inkrafttreten am <strong>27. November 2021<\/strong>sind Bestimmungen, die:<\/p>\n<ul>\n<li>Verbot der Verteilung von f\u00fcr den kanadischen Markt bestimmten Arzneimitteln au\u00dferhalb Kanadas, die einen Mangel verursachen oder verschlimmern k\u00f6nnten,<\/li>\n<li>Erm\u00e4chtigen Sie den Minister, Informationen \u00fcber Medikamentenknappheit anzufordern.<\/li>\n<\/ul>\n<p>Inkrafttreten am <strong>1. M\u00e4rz 2022<\/strong>sind Bestimmungen \u00fcber:<\/p>\n<ul>\n<li>Au\u00dfergew\u00f6hnliche Einfuhr und Verkauf von Arzneimitteln, medizinischen Ger\u00e4ten,<\/li>\n<li>Meldepflicht bei Engp\u00e4ssen bei bestimmten Medizinprodukten und Befugnis zur Auskunftserteilung bei Engp\u00e4ssen bei Medizinprodukten,<\/li>\n<li>Erweiterung der Lizenzierungsflexibilit\u00e4t f\u00fcr einige medikamentenbasierte Handdesinfektionsmittel.<\/li>\n<\/ul>\n<p>Kontaktieren Sie RegASK, um mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte zu erfahren. <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1974741887\">\n\n\t<div id=\"col-1681553788\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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>Am 11. August 2021 \u00e4nderte die HSA die Lebensmittel- und Arzneimittelverordnung sowie die Medizinprodukteverordnung in Bezug auf Engp\u00e4sse bei Medizinprodukten und Arzneimitteln in Kanada. Die \u00c4nderung wurde am 1. September 2021 im Canada Gazette, Teil II, ver\u00f6ffentlicht. Diese neuen Bestimmungen erweitern und modifizieren bestimmte Ma\u00dfnahmen, die bereits durch zwei vorl\u00e4ufige Anordnungen (Interim Orders, IOs) in Kraft waren\u2026.<\/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 v28.0 (Yoast SEO v28.2) - 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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