{"id":4125,"date":"2023-02-20T09:30:09","date_gmt":"2023-02-20T01:30:09","guid":{"rendered":"https:\/\/regask.com\/?p=4125"},"modified":"2024-11-22T04:49:45","modified_gmt":"2024-11-21T20:49:45","slug":"exportzertifikat-fur-medizinprodukte-in-kanada","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/canada-medical-device-export-certificate\/","title":{"rendered":"Kanada: Aktualisierte Leitlinien zur Beantragung einer Herstellerlizenz"},"content":{"rendered":"<div><a href=\"https:\/\/www.canada.ca\/en\/health-canada.html\" target=\"_blank\" rel=\"noopener\">Gesundheit Kanada<\/a> hat am 5. Januar 2022 als Pilotprojekt eine elektronische Version der Herstellerbescheinigung f\u00fcr den Export eingef\u00fchrt. Dieses ist nun abgeschlossen und aufgrund des Erfolgs wird der papierbasierte Prozess nun dauerhaft durch den elektronischen Prozess ersetzt.<\/div>\n<div><\/div>\n<div>Das aktualisierte Leitfadendokument enth\u00e4lt Informationen zum Antragsverfahren und zur Ausstellung einer elektronischen MCE. Es enth\u00e4lt au\u00dferdem Hinweise zur Best\u00e4tigung der G\u00fcltigkeit einer Medizinproduktelizenz und -zulassung vor der Beantragung einer MCE.<\/div>\n<div><\/div>\n<div>Antragsteller einer Herstellerbescheinigung f\u00fcr den Export m\u00fcssen dieses Verfahren k\u00fcnftig befolgen.<\/div>\n<p>M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte erfahren? <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/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.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/application-manufacturer-certificate-cover-export-medical-devices-0097.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-1697486534\">\n\n\t<div id=\"col-1131206792\" 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>Health Canada implemented an electronic version of the manufacturer&#8217;s certificate to export on January 5, 2022 as a pilot project which is now completed and based on the success, the paper-based process is now being replaced permanently by the electronic process. The updated guidance document provides information on the application process and the issuance of&#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-4125","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 v28.4 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Canada Updates Medical Device Export Certificate Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"New guidance from Health Canada on applying for a manufacturer&#039;s certificate to export licensed medical devices. Stay compliant with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/exportzertifikat-fur-medizinprodukte-in-kanada\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Canada Updated Guidance on Applying for a Manufacturer&#039;s Certificate to Export Licensed Medical Devices from Canada\" \/>\n<meta property=\"og:description\" content=\"New guidance from Health Canada on applying for a manufacturer&#039;s certificate to export licensed medical devices. 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