{"id":35260,"date":"2026-05-28T15:38:04","date_gmt":"2026-05-28T14:38:04","guid":{"rendered":"https:\/\/amcham.mk\/?p=35260"},"modified":"2026-10-14T15:41:40","modified_gmt":"2026-10-14T14:41:40","slug":"amcham-position-paper-on-draft-law-on-medical-devices","status":"publish","type":"post","link":"https:\/\/amcham.mk\/mk\/advocacy-news\/amcham-position-paper-on-draft-law-on-medical-devices\/","title":{"rendered":"\u0410\u041c\u0427\u0410\u041c \u0414\u043e\u043a\u0443\u043c\u0435\u043d\u0442 \u0437\u0430 \u0458\u0430\u0432\u043d\u0430 \u043f\u043e\u043b\u0438\u0442\u0438\u043a\u0430 \u0437\u0430 \u043d\u0430\u0446\u0440\u0442-\u0437\u0430\u043a\u043e\u043d\u043e\u0442 \u0437\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430"},"content":{"rendered":"<p class=\"wp-block-paragraph\">The position paper emphasizes the need for a balanced approach \u2014 one that ensures a high level of patient protection while remaining practically applicable for economic operators, with particular focus on introducing a recognition mechanism for CE-marked devices to avoid redundant regulatory assessments and enable faster patient access to products already available on the EU market. Through a structured set of recommendations, AmCham seeks to support the establishment of a predictable, efficient, and European-aligned regulatory system for medical devices, while remaining a committed partner to the relevant institutions in the continued dialogue and finalization of this legislation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/amcham.mk\/wp-content\/uploads\/2026\/06\/amcham-preporaki_zakon-za-mediczinski-sredstva-2.pdf\">\u041e\u0434\u0433\u043e\u0432\u043e\u0440 \u043d\u0430 \u0458\u0430\u0432\u043d\u0430 \u043a\u043e\u043d\u0441\u0443\u043b\u0442\u0430\u0446\u0438\u0458\u0430: \u041f\u0440\u0435\u043f\u043e\u0440\u0430\u043a\u0438 \u0432\u043e \u043e\u0434\u043d\u043e\u0441 \u043d\u0430 \u041d\u0430\u0446\u0440\u0442-\u0417\u0430\u043a\u043e\u043d\u043e\u0442 \u0437\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430<\/a><\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>The position paper emphasizes the need for a balanced approach \u2014 one that ensures a high level of patient protection while remaining practically applicable for [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":35267,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"page_builder":"","footnotes":""},"categories":[28],"tags":[],"class_list":["post-35260","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-advocacy-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - 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