{"id":14604,"date":"2018-07-30T10:54:40","date_gmt":"2018-07-30T10:54:40","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/07\/30\/titck-tibbi-cihazlar-alaninda-faaliyet-gosterecek-onaylanmis-kuruluslara-dair-teblig-taslagini-yayinladi\/"},"modified":"2022-06-09T12:15:17","modified_gmt":"2022-06-09T12:15:17","slug":"titck-tibbi-cihazlar-alaninda-faaliyet-gosterecek-onaylanmis-kuruluslara-dair-teblig-taslagini-yayinladi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/07\/30\/titck-tibbi-cihazlar-alaninda-faaliyet-gosterecek-onaylanmis-kuruluslara-dair-teblig-taslagini-yayinladi\/","title":{"rendered":"T\u0130TCK T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f Kurulu\u015flara Dair Tebli\u011f Tasla\u011f\u0131&#8217;n\u0131 Yay\u0131nlad\u0131"},"content":{"rendered":"<h4>Yeni Geli\u015fme<\/h4>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<b>T\u0130TCK<\/b>&#8220;) ge\u00e7ti\u011fimiz g\u00fcnlerde internet sitesinde T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f Kurulu\u015flara Dair Tebli\u011f Tasla\u011f\u0131&#8217;n\u0131 (&#8220;<b>Tebli\u011f Tasla\u011f\u0131<\/b>&#8220;) yay\u0131nlad\u0131.<\/p>\n<h3>Tebli\u011f Neler Getiriyor?<\/h3>\n<p>Avrupa Komisyonu taraf\u0131ndan 5 Nisan 2017 tarihinde kabul edilen 2017\/745 say\u0131l\u0131 t\u0131bbi cihazlara ili\u015fkin reg\u00fclasyon ile 2017\/ 746 say\u0131l\u0131 in vitro t\u0131bbi tan\u0131 cihazlar\u0131na ili\u015fkin reg\u00fclasyonun 25 May\u0131s 2017 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girmesi ile birlikte t\u0131bbi cihazlar alan\u0131nda faaliyet g\u00f6stermek isteyen uygunluk de\u011ferlendirme kurulu\u015flar\u0131 ve halihaz\u0131rda faaliyet g\u00f6steren onaylanm\u0131\u015f kurulu\u015flar ile bu onaylanm\u0131\u015f kurulu\u015flar\u0131n atanmas\u0131, g\u00f6zetimi ve izlenmesinden sorumlu otoritelere yeni y\u00fck\u00fcml\u00fcl\u00fckler getirilmi\u015ftir. Bu kapsamda, an\u0131lan mevzuatla uyumlulu\u011fu sa\u011flamak amac\u0131yla T\u0130TCK, bir \u00f6nceki tebli\u011fi y\u00fcr\u00fcrl\u00fckte kald\u0131racak ge\u00e7ti\u011fimiz g\u00fcnlerde yeni bir T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f Kurulu\u015flara Dair Tebli\u011f Tasla\u011f\u0131 yay\u0131nlayarak mevcut tebli\u011fi y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131yor.<\/p>\n<p>Bu \u00e7er\u00e7evede haz\u0131rlanan yeni tebli\u011f tasla\u011f\u0131, tasla\u011fa dayanak olu\u015fturan mevzuat ile tasla\u011f\u0131n kar\u015f\u0131la\u015ft\u0131rmal\u0131 tablosuna <a href=\"https:\/\/www.titck.gov.tr\/Duyurular\/DuyuruGetir?id=3295\">buradan<\/a> ula\u015fabilirsiniz.<\/p>\n<h4>Sonu\u00e7<\/h4>\n<p>T\u0130TCK sa\u011fl\u0131k hukuku mevzuat\u0131n\u0131 Avrupa Birli\u011fi mevzuat\u0131 ile uyumlu hale getirme \u00e7al\u0131\u015fmalar\u0131na devam ediyor. \u015eirketler yeni Tebli\u011f Tasla\u011f\u0131&#8217;n\u0131 ve yeni belgelendirme s\u00fcrecini dikkatle incelemelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8220;) ge\u00e7ti\u011fimiz g\u00fcnlerde internet sitesinde T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f Kurulu\u015flara [&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-14604","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 T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f Kurulu\u015flara Dair Tebli\u011f Tasla\u011f\u0131&#039;n\u0131 Yay\u0131nlad\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&quot;T\u0130TCK&quot;) ge\u00e7ti\u011fimiz g\u00fcnlerde internet sitesinde T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.esin.av.tr\/tr\/2018\/07\/30\/titck-tibbi-cihazlar-alaninda-faaliyet-gosterecek-onaylanmis-kuruluslara-dair-teblig-taslagini-yayinladi\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"T\u0130TCK T\u0131bbi Cihazlar Alan\u0131nda Faaliyet G\u00f6sterecek Onaylanm\u0131\u015f Kurulu\u015flara Dair Tebli\u011f Tasla\u011f\u0131&#039;n\u0131 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