{"id":14602,"date":"2018-08-10T10:51:57","date_gmt":"2018-08-10T10:51:57","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/08\/10\/titck-tibbi-cihaz-ve-kozmetik-urunlerin-kaydi-hakkinda-genelge-yayinladi\/"},"modified":"2022-06-09T12:15:12","modified_gmt":"2022-06-09T12:15:12","slug":"titck-tibbi-cihaz-ve-kozmetik-urunlerin-kaydi-hakkinda-genelge-yayinladi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/08\/10\/titck-tibbi-cihaz-ve-kozmetik-urunlerin-kaydi-hakkinda-genelge-yayinladi\/","title":{"rendered":"T\u0130TCK T\u0131bbi Cihaz ve Kozmetik \u00dcr\u00fcnlerin Kayd\u0131 Hakk\u0131nda Genelge Yay\u0131nlad\u0131"},"content":{"rendered":"<p class=\"s6\"><strong>Yeni Geli\u015fme<\/strong><\/p>\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 cihaz ve kozmetik \u00fcr\u00fcnlerin kayd\u0131na ili\u015fkin esas usulleri d\u00fczenleyen T\u0131bbi Cihaz ve Kozmetik \u00dcr\u00fcnlerin Kayd\u0131 Hakk\u0131nda Genelge (&#8220;<b>Genelge<\/b>&#8220;) yay\u0131nlad\u0131.<\/p>\n<h4>Genelge Neler Getiriyor?<\/h4>\n<p>T\u0130TCK ge\u00e7ti\u011fimiz y\u0131l T\u00fcrkiye&#8217;de \u00fcretilen veya T\u00fcrkiye&#8217;ye ithal edilen t\u0131bbi cihazlar ile kozmetik \u00fcr\u00fcnlerin kayd\u0131, izlenmesi ve denetlenmesi amac\u0131yla \u00dcr\u00fcn Takip Sistemi&#8217;ni (&#8220;<b>\u00dcTS<\/b>&#8220;) kurdu. 12 Haziran 2017 tarihinden itibaren \u00dcTS \u00fczerinden t\u0131bbi cihazlar ve kozmetik \u00fcr\u00fcnlerin kayd\u0131 yap\u0131labiliyor. Bu kapsamda, T\u0130TCK taraf\u0131ndan duyurulacak tarihlere kadar T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Ulusal Bilgi Bankas\u0131 (T\u0130TUBB) ve Elektronik Uygulamalar Portal\u0131&#8217;nda (EUP) bulunan kay\u0131tlar\u0131n \u00dcTS&#8217;ye aktar\u0131lmas\u0131 gerekmektedir.<\/p>\n<p>Bu kapsamda, kozmetik \u00fcreticiler i\u00e7in \u00fcreticilerin\/ithalat\u00e7\u0131lar\u0131n bildirim i\u015flemlerine dair y\u00fck\u00fcml\u00fcl\u00fcklerini yerine getirebilmesi ama\u00e7lar\u0131na y\u00f6nelik olarak \u00dcTS&#8217;de ilgili alanlar yap\u0131land\u0131r\u0131ld\u0131. Piyasaya yeni arz edilecek kozmetik \u00fcr\u00fcnler ile faaliyete yeni ba\u015flayacak olan firmalar\u0131n \u00dcTS&#8217;ye kaydedilmesi ve kozmetik \u00fcr\u00fcnlerde barkod bulundurulmas\u0131 mecburiyeti getirildi. Bu \u00e7er\u00e7evede bildirim i\u015flemlerinde farkl\u0131 ambalaj boyutlar\u0131 da dahil t\u00fcm \u00fcr\u00fcnlerin m\u00fcnferit barkodlar\u0131n\u0131n ayr\u0131 ayr\u0131 \u00dcTS&#8217;ye kaydedilmesi gerekiyor.<\/p>\n<p>T\u0131bbi cihaz \u00fcretici\/ithalat\u00e7\u0131lar\u0131n\u0131n ise; cihazlar\u0131n\u0131 EC sertifikas\u0131, uygunluk beyan\u0131, etiketi ve ihtiya\u00e7 halinde di\u011fer tan\u0131mlay\u0131c\u0131 bilgi ve belgeleri sisteme y\u00fcklemek suretiyle belge kay\u0131tlar\u0131n\u0131 ger\u00e7ekle\u015ftirmesi ve son olarak her bir cihaz ile ilgili \u00dcTS&#8217;de istenen \u00fcr\u00fcne ili\u015fkin t\u00fcm bilgiler ile birlikte barkod baz\u0131nda \u00fcr\u00fcn kay\u0131t i\u015flemlerini ger\u00e7ekle\u015ftirmesi gerekiyor.<\/p>\n<p class=\"s6\"><strong>Sonu\u00e7<\/strong><\/p>\n<p>T\u0130TCK t\u0131bbi cihaz ve kozmetik \u00fcr\u00fcn \u00fcreticileri ve ithalat\u00e7\u0131lar\u0131na y\u00f6nelik kay\u0131t usulleri hakk\u0131nda bilgi sa\u011flamaya devam ediyor. \u015eirketler yeni Genelge&#8217;de yer alan usulleri dikkatle incelemeli ve gereken ad\u0131mlar\u0131 atmal\u0131d\u0131r.<\/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 cihaz ve kozmetik \u00fcr\u00fcnlerin kayd\u0131na ili\u015fkin [&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-14602","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\/ 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