{"id":18606,"date":"2021-01-28T11:16:09","date_gmt":"2021-01-28T11:16:09","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=18606"},"modified":"2021-09-14T22:36:20","modified_gmt":"2021-09-14T22:36:20","slug":"titck-brexit-sonrasi-tibbi-cihazlarin-kayit-ve-degerlendirme-uygulamalarini-guncelledi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2021\/01\/28\/titck-brexit-sonrasi-tibbi-cihazlarin-kayit-ve-degerlendirme-uygulamalarini-guncelledi\/","title":{"rendered":"T\u0130TCK Brexit Sonras\u0131 T\u0131bbi Cihazlar\u0131n Kay\u0131t ve De\u011ferlendirme Uygulamalar\u0131n\u0131 G\u00fcncelledi"},"content":{"rendered":"<!--[if lt IE 9]><script>document.createElement('audio');<\/script><![endif]-->\n<audio class=\"wp-audio-shortcode\" id=\"audio-18606-1\" preload=\"none\" style=\"width: 100%;\" controls=\"controls\"><source type=\"audio\/mpeg\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/01\/Turkiye-Ilac-ve-Tibbi-Cihaz-Kurumu-Brexit-Sonrasi-Tibbi-Cihazlarin-Kayit....mp3?_=1\" \/><a href=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/01\/Turkiye-Ilac-ve-Tibbi-Cihaz-Kurumu-Brexit-Sonrasi-Tibbi-Cihazlarin-Kayit....mp3\">https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/01\/Turkiye-Ilac-ve-Tibbi-Cihaz-Kurumu-Brexit-Sonrasi-Tibbi-Cihazlarin-Kayit....mp3<\/a><\/audio>\n<p>&nbsp;<\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8221;<strong>Kurum<\/strong>&#8221;), 15 Ocak 2021 tarihli duyurusunda, Brexit sonras\u0131 t\u0131bbi cihazlar\u0131n kay\u0131t ve de\u011ferlendirme uygulama esaslar\u0131n\u0131 belirledi. Kurum&#8217;un duyurusuna <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=SkVGamhTYVcrK2s5dWk1WVlZM2Q1ZjhTQmsxbkNRMEE1Mjg5aE4vSHlHd3hWTzBzL0cwL3NOa2srRW5Lb25aRTliSkM3bXJDOEpiYm0ybmZ5c2ZGMkRycmVKRC9WQXBHUE9neXI3RGhhZEhNcDFOK0dqVGpiblIxbWRROW8zZ0RudWVPSkJLMjV4Q1B4dWxpY3ZUdGI1RlhLaVZJMzZMdmRnalEzRFoybWhoS25MTDV4QjRCS1l4bGorOFNUSlRleEVVdjBqQlk4Ym89&amp;rh=ff007217b69b8dcdd356fbfc4a429bd85d391320__;!!Hj9Y_P0nvg!H0gDO-9fCJkbs0yzKiy1PE3iKTXmAEaBErllfuxuXWhpmoeySs1FO88ah-nE-5Qvs1V4mQ$\">buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek? <\/strong><\/p>\n<p>Kurum, duyurusunda Brexit s\u00fcrecinden etkilenen onaylanm\u0131\u015f kurulu\u015flar taraf\u0131ndan t\u0131bbi cihaz firmalar\u0131na d\u00fczenlenen EC sertifikalar\u0131 ve bu belgelere ba\u011fl\u0131 t\u0131bbi cihaz kay\u0131tlar\u0131n\u0131n de\u011ferlendirilmesinde esas al\u0131nacak uygulamalar\u0131 belirlemektedir. S\u00f6z konusu onaylanm\u0131\u015f kurulu\u015flar, &#8220;British Standard Institute (BSI) Assurance UK Ltd.\u201d, 0088 numaral\u0131 \u201cLloyd\u2019 Register Quality Assurance Ltd.\u201d, 0120 numaral\u0131 \u201cSGS United Kingdom Limited\u201d ve 0843 numaral\u0131 \u201cUL International (UK) Ltd.&#8221; adl\u0131 kurulu\u015flard\u0131r.<\/p>\n<p>Bu kapsamda, a\u015fa\u011f\u0131daki hususlar belirtilmi\u015ftir:<\/p>\n<ul>\n<li>\u0130lgili onaylanm\u0131\u015f kurulu\u015flar\u0131n \u00dcr\u00fcn Takip Sistemi (&#8220;<strong>\u00dcTS<\/strong>&#8220;) kay\u0131tlar\u0131 15 Ocak 2021 tarihi itibariyle pasif hale getirilmi\u015ftir. T\u0131bbi cihaz firmalar\u0131na, ilgili onaylanm\u0131\u015f kurulu\u015flar taraf\u0131ndan d\u00fczenlenen EC sertifikalar\u0131n\u0131 g\u00fcncellemeleri i\u00e7in 60 g\u00fcn s\u00fcre tan\u0131nm\u0131\u015ft\u0131r. \u00dcTS kayd\u0131 ba\u015fka bir onaylanm\u0131\u015f kurulu\u015f taraf\u0131ndan d\u00fczenlenmi\u015f g\u00fcncel ve ge\u00e7erli bir EC sertifikas\u0131yla g\u00fcncellenmeyen t\u0131bbi cihaz kay\u0131tlar\u0131 ret durumuna d\u00fc\u015fecektir.<\/li>\n<li>\u00dcTS \u00fczerinden yap\u0131lacak t\u0131bbi cihaz ba\u015fvurular\u0131nda, s\u00f6z konusu t\u0131bbi cihazla ili\u015fkilendirilmi\u015f olan EC sertifikas\u0131 ile teknik dok\u00fcmanlardaki onaylanm\u0131\u015f kurulu\u015f numaralar\u0131n\u0131n ve AB yetkili temsilcisi bilgilerinin farkl\u0131 olmas\u0131 halinde, bu uyumsuzluklar kayda esas olarak de\u011ferlendirmeye al\u0131nacakt\u0131r. Bu \u015fekilde bir uyumsuzlu\u011fun tespiti halinde, s\u00f6z konusu t\u0131bb\u0131 cihaz ba\u015fvurusu, mevcut \u00dcTS kayd\u0131n\u0131n durumuna g\u00f6re, ret veya revizyon \u015feklinde sonu\u00e7land\u0131r\u0131lacakt\u0131r.<\/li>\n<\/ul>\n<p><strong>Sonu\u00e7<\/strong><br \/>\nT\u0130TCK, t\u0131bbi cihaz firmalar\u0131na yol g\u00f6stermeye devam ediyor. Bu alandaki \u015firketler, T\u0130TCK duyurular\u0131n\u0131 takip etmeli, duyuruda yer alan y\u00f6nlendirmeleri izleyerek \u00dcTS kay\u0131t i\u015flemlerini g\u00fcncellemelidirler.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Yeni Geli\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8221;Kurum&#8221;), 15 Ocak 2021 tarihli duyurusunda, Brexit sonras\u0131 t\u0131bbi cihazlar\u0131n kay\u0131t [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120],"tags":[92],"class_list":["post-18606","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>T\u0130TCK Brexit Sonras\u0131 T\u0131bbi Cihazlar\u0131n Kay\u0131t ve De\u011ferlendirme Uygulamalar\u0131n\u0131 G\u00fcncelledi<\/title>\n<meta name=\"description\" content=\"&nbsp; 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