{"id":3041,"date":"2021-11-23T11:31:14","date_gmt":"2021-11-23T03:31:14","guid":{"rendered":"https:\/\/regask.com\/?p=3041"},"modified":"2024-10-25T02:05:32","modified_gmt":"2024-10-24T18:05:32","slug":"eaeu-vorschriften-fur-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/eaeu-medical-device-regulations\/","title":{"rendered":"Zentralisierte Medizinprodukteverordnung der EAWU tritt in Kraft \u2026"},"content":{"rendered":"<p>Ab dem 1. Januar 2022 wird die Eurasische Wirtschaftsunion (EAWU), die aus Wei\u00dfrussland, Kasachstan, Russland, Armenien und Kirgisistan besteht, die neue gemeinsame Verordnung f\u00fcr Medizinprodukte durchsetzen, die ihre Regulierungsbeh\u00f6rde, die Eurasische Wirtschaftskommission (EWG), in den letzten zwei Jahren entwickelt hat.<\/p>\n<p>Die neue Verordnung harmonisiert die Anforderungen an Medizinprodukte mit den EAWU-L\u00e4ndern und f\u00fchrt ein gemeinsames Registrierungsverfahren ein. Diese neue Registrierung wird weiterhin den zust\u00e4ndigen Beh\u00f6rden eines Mitgliedsstaates vorgelegt, der den Prozess leitet, gilt aber f\u00fcr die gesamte EAWU.<\/p>\n<p>Anstehende Registrierungen sollten ab dem 1. Januar 2022 gem\u00e4\u00df dem neuen Verfahren eingereicht werden. Bestehende nationale Registrierungen, die nach diesem Datum ablaufen, bleiben maximal bis zum 31. Dezember 2026 g\u00fcltig. Ab dem 1. Januar 2027 sollten alle auf dem EAWU-Markt in Verkehr gebrachten Medizinprodukte gem\u00e4\u00df der neuen Verordnung registriert werden.<\/p>\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=\"http:\/\/publication.pravo.gov.ru\/Document\/View\/0001202104300101\" 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-1184566615\">\n\n\t<div id=\"col-1023522044\" 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>As of 1st January 2022, the Eurasian Economic Union (EAEU), formed by Belarus, Kazakhstan, Russia, Armenia, and Kyrgyzstan, will enforce the new common regulation for Medical Devices that their regulatory body, the Eurasian Economic Commission (EEC), has been developing during the past two years. The new regulation harmonises the requirements for medical devices along with&#8230;<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[522,39],"tags":[40],"class_list":["post-3041","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-russia-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.3 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EAEU Medical Device Regulations | RegASK<\/title>\n<meta name=\"description\" content=\"New centralized medical device regulations are in force in the EAEU. 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