{"id":14638,"date":"2018-02-27T11:10:20","date_gmt":"2018-02-27T11:10:20","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/02\/27\/ab-tibbi-cihaz-tuzugu-turk-mevzuatina-dahil-ediliyor-guncel-gelismeler\/"},"modified":"2022-06-09T12:12:39","modified_gmt":"2022-06-09T12:12:39","slug":"ab-tibbi-cihaz-tuzugu-turk-mevzuatina-dahil-ediliyor-guncel-gelismeler","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/02\/27\/ab-tibbi-cihaz-tuzugu-turk-mevzuatina-dahil-ediliyor-guncel-gelismeler\/","title":{"rendered":"AB T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc T\u00fcrk Mevzuat\u0131na Dahil Ediliyor: G\u00fcncel Geli\u015fmeler"},"content":{"rendered":"<table cellspacing=\"0\">\n<tbody>\n<tr>\n<td>\n<p class=\"s7\"><strong>Yeni Geli\u015fmeler<\/strong><\/p>\n<p class=\"s12\">T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<b>T\u0130TCK<\/b>&#8220;), ge\u00e7ti\u011fimiz g\u00fcnlerde 2017\/745 say\u0131l\u0131 AB T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc&#8217;n\u00fcn (&#8220;<b>T\u00fcz\u00fck<\/b>&#8220;) ulusal mevzuat olarak yay\u0131mlanmas\u0131 \u00e7al\u0131\u015fmalar\u0131n\u0131n devam etti\u011fini duyurarak T\u00fcz\u00fck&#8217;\u00fcn bu s\u00fcre\u00e7te esas al\u0131nacak T\u00fcrk\u00e7e \u00e7evirisini yay\u0131mlad\u0131.<\/p>\n<p class=\"s7\"><strong>T\u00fcz\u00fck Neler Getiriyor?<\/strong><\/p>\n<p class=\"s12\">\u0130lga etti\u011fi d\u00fczenlemeye k\u0131yasla, T\u00fcz\u00fck t\u0131bbi cihazlara ili\u015fkin olarak a\u015fa\u011f\u0131da say\u0131lanlar da dahil olmak \u00fczere daha detayl\u0131 d\u00fczenlemeler ve yeni y\u00fck\u00fcml\u00fcl\u00fckler \u00f6ng\u00f6r\u00fcyor:<\/p>\n<ul id=\"l3\">\n<li>\n<p class=\"s12\">T\u0131bbi cihaz tan\u0131m\u0131, bir cihaz\u0131 y\u00f6neten veya kullan\u0131m\u0131n\u0131 etkileyen yaz\u0131l\u0131mlar\u0131 da kapsayacak \u015fekilde geni\u015fletiliyor.<\/p>\n<\/li>\n<li>\n<p class=\"s12\">Y\u00fcksek risk grubundaki t\u0131bbi cihazlar i\u00e7in daha fazla klinik veri toplanmas\u0131 gerekecek olup bu \u00fcr\u00fcnler i\u00e7in klinik de\u011ferlendirme raporu istenecek.<\/p>\n<\/li>\n<li>\n<p class=\"s12\">Cihazlar\u0131n g\u00fcvenlik ve performans\u0131na ili\u015fkin olarak yeni y\u00fck\u00fcml\u00fcl\u00fckler gelecek. Pazarlama sonras\u0131 denetim raporlar\u0131, d\u00f6nemsel g\u00fcvenlik g\u00fcncelleme raporlar\u0131 gibi belgelerle cihazlar\u0131n g\u00fcvenli\u011fi ve performans\u0131 s\u00fcrekli denetlenecek.<\/p>\n<\/li>\n<\/ul>\n<p class=\"s12\">T\u00fcz\u00fck&#8217;\u00fcn ve eklerinin terc\u00fcmesine <a href=\"https:\/\/www.titck.gov.tr\/Duyurular\/DuyuruGetir?id=3226\">buradan<\/a> ula\u015fabilirsiniz.<\/p>\n<p class=\"s7\"><strong>Sonu\u00e7<\/strong><\/p>\n<p class=\"s12\">T\u0131bbi cihaz \u015firketleri, T\u00fcz\u00fck&#8217;\u00fcn T\u00fcrk mevzuat\u0131na aktar\u0131lmas\u0131ndan \u00f6nce yay\u0131mlanan terc\u00fcmesini dikkatle incelemeli ve uyumlulu\u011fu sa\u011flamak amac\u0131yla gerekli ad\u0131mlar\u0131 atmal\u0131d\u0131r.<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8220;), ge\u00e7ti\u011fimiz g\u00fcnlerde 2017\/745 say\u0131l\u0131 AB T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc&#8217;n\u00fcn (&#8220;T\u00fcz\u00fck&#8220;) ulusal mevzuat [&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-14638","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>AB T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc T\u00fcrk Mevzuat\u0131na Dahil Ediliyor: G\u00fcncel Geli\u015fmeler<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&quot;T\u0130TCK&quot;), ge\u00e7ti\u011fimiz g\u00fcnlerde 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