{"id":14588,"date":"2018-09-12T08:47:08","date_gmt":"2018-09-12T08:47:08","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/09\/12\/hayvan-kaynakli-dokular-kullanilarak-imal-edilen-tibbi-cihazlara-dair-yonetmelik-taslagi-yayinlandi\/"},"modified":"2022-06-09T12:18:51","modified_gmt":"2022-06-09T12:18:51","slug":"hayvan-kaynakli-dokular-kullanilarak-imal-edilen-tibbi-cihazlara-dair-yonetmelik-taslagi-yayinlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/09\/12\/hayvan-kaynakli-dokular-kullanilarak-imal-edilen-tibbi-cihazlara-dair-yonetmelik-taslagi-yayinlandi\/","title":{"rendered":"Hayvan Kaynakl\u0131 Dokular Kullan\u0131larak \u0130mal Edilen T\u0131bbi Cihazlara Dair Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\u0131"},"content":{"rendered":"<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8221;) ge\u00e7ti\u011fimiz g\u00fcnlerde internet sitesinde taslak Hayvan Kaynakl\u0131 Dokular Kullan\u0131larak \u0130mal Edilen T\u0131bbi Cihazlara Dair Y\u00f6netmelik&#8217;i (&#8220;Y\u00f6netmelik&#8221;) yay\u0131mlad\u0131.<\/p>\n<p><strong>Y\u00f6netmelik Neler Getiriyor?<\/strong><br \/>\nTaslak Y\u00f6netmelik, AB mevzuat\u0131na uyum \u00e7al\u0131\u015fmalar\u0131 kapsam\u0131nda AB 722\/2012 say\u0131l\u0131 T\u00fcz\u00fck esas al\u0131narak haz\u0131rlanm\u0131\u015f olup temel itibariyle paralel olarak hayvan dokusu kullan\u0131larak imal edilen implante edilebilir aktif t\u0131bbi cihazlar da dahil t\u0131bbi cihazlar\u0131n piyasaya arz\u0131 ve\/veya hizmete sunulmas\u0131 ile ilgili \u00f6zel gereklilikleri d\u00fczenlemektedir.<\/p>\n<p>Taslak Y\u00f6netmelik uyar\u0131nca, imalat\u00e7\u0131lar, uygunluk de\u011ferlendirmesine y\u00f6nelik ba\u015fvurular\u0131n\u0131 yapmadan \u00f6nce Y\u00f6netmelik uyar\u0131nca risk analizi ve risk y\u00f6netimi plan\u0131n\u0131 uygulamal\u0131d\u0131r. Uygunluk de\u011ferlendirmesinde ayn\u0131 zamanda, hayvan dokular\u0131n\u0131n ya da t\u00fcrevlerinin kullan\u0131lmas\u0131n\u0131n gerek\u00e7esi, imalat\u00e7\u0131n\u0131n hammadde kaynaklar\u0131 ve bitmi\u015f \u00fcr\u00fcnler, \u00fcretim s\u00fcreci yap\u0131lan testler ve y\u00fcklenicilere ili\u015fkin kontrol\u00fc de g\u00f6z \u00f6n\u00fcnde bulundurulur.<\/p>\n<p>Hayvan Kaynakl\u0131 Dokular Kullan\u0131larak \u0130mal Edilen T\u0131bbi Cihazlara Dair Y\u00f6netmelik Tasla\u011f\u0131, Y\u00f6netmelik Tasla\u011f\u0131n\u0131n Kar\u015f\u0131la\u015ft\u0131rma Tablosu ve (AB) 722\/2012 say\u0131l\u0131 T\u00fcz\u00fck&#8217;e <u><a href=\"https:\/\/urldefense.proofpoint.com\/v2\/url?u=http-3A__esinxchange.com_collect_click.aspx-3Fu-3DjRYOrR8N39TT-2BtPEdI212fTDHd1GLccWY1tgPLL7nUpf8HLby3gcTd_KUyuFn4VDNuKRNpn5gBs-3D-26rh-3Dff004051af380b42d5c507d978498df81360ae9e&amp;d=DwMFaQ&amp;c=ptMoEJ5oTofwe4L9tBtGCQ&amp;r=G30VoJFPGz_Ir3aMyzsuwp-RUctbhKuQyecMIB0EBsk&amp;m=MuGnj5g27LEzonQSrXDkz249KMcY9dSH5O9EpGJJrbo&amp;s=HfrbxUV1FUxcyy11W5Ps9vRR425HTA-1WiULs65JsCY&amp;e=\" target=\"_blank\" rel=\"noopener noreferrer\">buradan<\/a><\/u> ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>T\u0130TCK, sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere d\u00fczenli olarak yol g\u00f6stermeye devam ediyor. Bu kapsamda yer alan \u015firketler, hayvan dokusu kullan\u0131larak imal edilen t\u0131bbi cihazlar\u0131n\u0131 piyasaya arz etmeden ve cihazlar\u0131n uygunluk de\u011ferlendirmesine y\u00f6nelik ba\u015fvurular\u0131n\u0131 yapmadan \u00f6nce taslak Y\u00f6netmelik&#8217;te yer alan gereklilikleri g\u00f6zden ge\u00e7irmeli, izlenmesi gereken usul ve esaslara uygun hareket etmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fme T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8221;) ge\u00e7ti\u011fimiz g\u00fcnlerde internet sitesinde taslak Hayvan Kaynakl\u0131 Dokular Kullan\u0131larak \u0130mal Edilen [&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-14588","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>Hayvan Kaynakl\u0131 Dokular Kullan\u0131larak \u0130mal Edilen T\u0131bbi Cihazlara Dair Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131nland\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 taslak Hayvan Kaynakl\u0131 Dokular Kullan\u0131larak \u0130mal Edilen\" \/>\n<meta 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