{"id":18231,"date":"2020-12-21T08:07:32","date_gmt":"2020-12-21T08:07:32","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=18231"},"modified":"2021-09-25T11:22:57","modified_gmt":"2021-09-25T11:22:57","slug":"saglik-sektorunde-guncel-gelismeler-aralik-2020","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2020\/12\/21\/saglik-sektorunde-guncel-gelismeler-aralik-2020\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; Aral\u0131k 2020"},"content":{"rendered":"<!--[if lt IE 9]><script>document.createElement('audio');<\/script><![endif]-->\n<audio class=\"wp-audio-shortcode\" id=\"audio-18231-1\" preload=\"none\" style=\"width: 100%;\" controls=\"controls\"><source type=\"audio\/mpeg\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2020\/12\/TUR-Saglik-Sektorunde-Guncel-Gelismeler-211220.mp3?_=1\" \/><a href=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2020\/12\/TUR-Saglik-Sektorunde-Guncel-Gelismeler-211220.mp3\">https:\/\/www.esin.av.tr\/wp-content\/uploads\/2020\/12\/TUR-Saglik-Sektorunde-Guncel-Gelismeler-211220.mp3<\/a><\/audio>\n<p>&nbsp;<\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>T\u0130TCK&#8221;<\/strong>), Klinik Ara\u015ft\u0131rmalara ili\u015fkin K\u0131lavuz&#8217;lar\u0131 g\u00fcncelledi.\u00a0 T\u0130TCK ayr\u0131ca T\u0131bbi Cihaz Teknik Servis Sa\u011flay\u0131c\u0131lar\u0131n\u0131n ve \u0130lgili Teknik Personelin Kayd\u0131na \u0130li\u015fkin yeni Genelge ve 11 Aral\u0131k 2020 tarihinde Eczanelerde Sat\u0131lan T\u0131bbi Cihazlarla ili\u015fkin yeni duyuru yay\u0131nlad\u0131. G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linkten ula\u015fabilirsiniz:<\/p>\n<p><a href=\"#1klinikaratrma\"><strong>T\u0130TCK Klinik Ara\u015ft\u0131rma Ba\u015fvurular\u0131na \u0130li\u015fkin K\u0131lavuzlar\u0131 G\u00fcncelledi<\/strong><\/a><br \/>\n<a href=\"#2teknikservissalayclar\"><strong>T\u0130TCK T\u0131bbi Cihaz Teknik Servis Sa\u011flay\u0131c\u0131lar\u0131n\u0131n ve \u0130lgili Teknik Personelin Kayd\u0131na \u0130li\u015fkin Genelge Yay\u0131nland\u0131<\/strong><\/a><br \/>\n<a href=\"#3eczanelerde\"><strong>T\u0130TCK&#8217;dan Eczanelerde Sat\u0131labilecek T\u0131bbi Cihazlara \u0130li\u015fkin Yeni Duyuru<\/strong><\/a><\/p>\n<p><strong>T\u0130TCK Klinik Ara\u015ft\u0131rma Ba\u015fvurular\u0131na \u0130li\u015fkin K\u0131lavuzlar\u0131 G\u00fcncelledi<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (\u201c<strong>Kurum<\/strong>\u201c) Klinik Ara\u015ft\u0131rmalar Daire Ba\u015fkanl\u0131\u011f\u0131na Yap\u0131lan Klinik Ara\u015ft\u0131rma Ba\u015fvurular\u0131na \u0130li\u015fkin K\u0131lavuz\u2019u ve Etik Kurullara Yap\u0131lan Klinik Ara\u015ft\u0131rma Ba\u015fvurular\u0131na \u0130li\u015fkin K\u0131lavuz\u2019u g\u00fcncelledi. G\u00fcncel K\u0131lavuzlar 4 Aral\u0131k 2020 tarihi itibari ile y\u00fcr\u00fcrl\u00fc\u011fe girmi\u015ftir.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Klinik ara\u015ft\u0131rmalar ile g\u00f6zlemsel ila\u00e7 \u00e7al\u0131\u015fmalar\u0131na ili\u015fkin Klinik Ara\u015ft\u0131rmalar Daire Ba\u015fkanl\u0131\u011f\u0131 ve klinik ara\u015ft\u0131rmalar etik kurulu nezdindeki ba\u015fvurular\u0131n Klinik Ara\u015ft\u0131rmalar Mod\u00fcl\u00fcne uygun \u015fekilde yap\u0131lmas\u0131 ad\u0131na klinik ara\u015ft\u0131rma ba\u015fvuru k\u0131lavuzlar\u0131 1 Aral\u0131k 2019 tarihinde g\u00fcncellenmi\u015fti. Kurum, al\u0131nan geri bildirimler ve yap\u0131lan de\u011ferlendirmeler do\u011frultusunda ilgili k\u0131lavuzlar\u0131 yeniden de\u011ferlendirdi ve g\u00fcncelledi.<\/p>\n<p>Klinik Ara\u015ft\u0131rmalar Daire Ba\u015fkanl\u0131\u011f\u0131na Yap\u0131lan Klinik Ara\u015ft\u0131rma Ba\u015fvurular\u0131na \u0130li\u015fkin K\u0131lavuz\u2019da yap\u0131lan de\u011fi\u015fikler kapsam\u0131nda;<\/p>\n<ul>\n<li>Etik kurul karar\u0131 fiziksel olarak veya elektronik imzal\u0131 olarak sunulabilecek.<\/li>\n<li>\u0130yi \u0130malat Uygulamalar\u0131 Sertifika Belgesi ilgili \u00fclkenin yetkili otoritesinin kamuya a\u00e7\u0131k olarak bu bilgileri yay\u0131mlamas\u0131 halinde bilgi eri\u015fim i\u00e7in kullan\u0131lan referans numaralar\u0131 Kurum&#8217;a sunulabilecek.<\/li>\n<li>Kurum taraf\u0131ndan izin verilmesine ra\u011fmen ara\u015ft\u0131rman\u0131n ba\u015flat\u0131lamamas\u0131 halinde K\u0131lavuz&#8217;da yer alan ad\u0131mlar takip edilecek.<\/li>\n<\/ul>\n<p>Etik Kurullara Yap\u0131lan Klinik Ara\u015ft\u0131rma Ba\u015fvurular\u0131na \u0130li\u015fkin K\u0131lavuz&#8217;da yap\u0131lan de\u011fi\u015fiklikler kapsam\u0131nda;<\/p>\n<ul>\n<li>\u0130yi \u0130malat Uygulamalar\u0131 Sertifika Belgesi ilgili \u00fclkenin yetkili otoritesinin kamuya a\u00e7\u0131k olarak bu bilgileri yay\u0131mlamas\u0131 halinde bilgi eri\u015fim i\u00e7in kullan\u0131lan referans numaralar\u0131 Kurum&#8217;a sunulabilecek.<\/li>\n<li>Kurum taraf\u0131ndan izin verilmesine ra\u011fmen ara\u015ft\u0131rman\u0131n ba\u015flat\u0131lamamas\u0131 halinde K\u0131lavuz&#8217;da yer alan ad\u0131mlar takip edilecek.<\/li>\n<li>G\u00fcvenlik bildirimleri kapsam\u0131nda yer alan SUSAR s\u0131ralama listeleri veri kilitlemesinden sonra 60 g\u00fcn i\u00e7erisinde raporlanabilecek.<\/li>\n<\/ul>\n<p>Kurum, Klinik Ara\u015ft\u0131rmalar Mod\u00fcl\u00fcne ili\u015fkin Bilgi Notlar\u0131n\u0131 da g\u00fcncelledi. G\u00fcncel Bilgi Notlar\u0131na ve K\u0131lavuzlara\u00a0<a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=S1RjaEkxN2t4V0xjNGFuU2tkTGVLMlIxMG5xN2xLcXNwZnVYZG5IYWtPTTFLbkI3NS8yUVpnTXRpY2U0aC91QWpMcmllTWF0RXZjQ0w1enBpcEVMN1VSTWh0ZzJFU2RDY1JjdE94WHVCTlFOL1NYT3JpaTNaNWxKOVpHQ0hsbjU=&amp;rh=ff006ffe48904b7a262bfff18344b113688c672d__;!!Hj9Y_P0nvg!Gi3aiue4WvBOYm0ZkFhszKgi1xvZs3ev6HZDf6nLd-PTi_10cYFmK_9JO7IgsJvvVWkllA$\"><strong>buradan<\/strong><\/a> ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum, klinik ara\u015ft\u0131rma faaliyetlerine ili\u015fkin olarak firmalara yol g\u00f6stermeye devam ediyor. Bu alandaki \u015firketler, ilgili ba\u015fvuru k\u0131lavuzlar\u0131n\u0131 incelemeli, duyurular\u0131 takip etmeli ve Kurum\u2019un y\u00f6nlendirmeleri do\u011frultusunda klinik ara\u015ft\u0131rma ba\u015fvurular\u0131n\u0131 yapmal\u0131d\u0131r.<\/p>\n<p><strong>T\u0130TCK T\u0131bbi Cihaz Teknik Servis Sa\u011flay\u0131c\u0131lar\u0131n\u0131n ve \u0130lgili Teknik Personelin Kayd\u0131na \u0130li\u015fkin Genelge Yay\u0131nland\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fmeler<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (<strong>T\u0130TCK<\/strong>) 9 Aral\u0131k 2020 tarihinde 2020\/5 say\u0131l\u0131 T\u0131bbi Cihaz Teknik Servis Sa\u011flay\u0131c\u0131lar\u0131n\u0131n ve \u0130lgili Teknik Personelin Kayd\u0131na \u0130li\u015fkin Genelge (<strong>\u201cGenelge\u201d<\/strong>) yay\u0131nlad\u0131. Genelge, t\u0131bbi teknik servis sa\u011flay\u0131c\u0131lar\u0131 ve ilgili teknik personelin \u00dcr\u00fcn Takip Sistemi\u2019ne (\u201c<strong>\u00dcTS<\/strong>\u201c) kay\u0131t i\u015flemlerine ili\u015fkin usul ve esaslar\u0131 belirliyor.<\/p>\n<p><strong>Ne De\u011fi\u015fecek? <\/strong><\/p>\n<p>T\u0130TCK taraf\u0131ndan ge\u00e7ti\u011fimiz y\u0131l yay\u0131nlanan 2019\/1 say\u0131l\u0131 Genelge ile sat\u0131\u015f sonras\u0131 bak\u0131m onar\u0131m i\u015flemine tabi t\u0131bbi cihazlar\u0131n teknik servis sa\u011flay\u0131c\u0131lar\u0131n\u0131n ve bu kurulu\u015flarda g\u00f6rev yapan ilgili teknik personelin \u00dcTS kay\u0131tlar\u0131n\u0131n yap\u0131lmas\u0131 zorunlu hale getirilmi\u015f ve sisteme kay\u0131tlar 1 Mart 2019 tarihi itibariyle ba\u015flam\u0131\u015ft\u0131r.<\/p>\n<p>Yeni Genelge kapsam\u0131nda hizmet al\u0131m\u0131 yapacak olan sa\u011fl\u0131k hizmet sunucular\u0131 taraf\u0131ndan t\u0131bb\u0131 servis sa\u011flay\u0131c\u0131lar\u0131n\u0131n ve ilgili teknik personelin \u00dcTS&#8217;de kay\u0131tl\u0131 olma \u015fart\u0131 aranacakt\u0131r. Teknik servis sa\u011flay\u0131c\u0131lar\u0131n\u0131n faaliyet kapsam\u0131na g\u00f6re T\u00fcrk Standartlar\u0131 Enstit\u00fcs\u00fc taraf\u0131ndan belirtilen standartlarda ge\u00e7erli Hizmet Yeri Yeterlilik Belgesi&#8217;ne sahip olmalar\u0131 gerekmektedir. Bu do\u011frultuda sa\u011fl\u0131k hizmet sunucular\u0131 Genelge kapsam\u0131nda yapacaklar\u0131 hizmet al\u0131mlar\u0131nda Hizmet Yeri Yeterlilik Belgesi \u015fart\u0131n\u0131 arayacakt\u0131r.<\/p>\n<p>Genelge&#8217;ye <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=S1RjaEkxN2t4V0xjNGFuU2tkTGVLMlIxMG5xN2xLcXNwZnVYZG5IYWtPTTFLbkI3NS8yUVpnTXRpY2U0aC91QWRCNUdHQk1FUnAyWE1ZU0JZUEx2aUJFN2NoOWs2Z3VNQ0lReVRRRFNhZFdCUERHLzFHV212OHcxdXRSR0JZNTM5eFhJL2EyL2crUTJOV01vZ2Y1UktidGRHQzd6L0pMcy9HMG5DZDl2b0NoYjgvcEJNY2I4clVVdzFVV2RkbmZRUjlBUkJjY0ZsVVFvVzVhWm5OK2JjejRQU2hCWXUvUmY2czMzYzRoaU1BWitxSllZMXg0alZnPT0=&amp;rh=ff006ffe48904b7a262bfff18344b113688c672d__;!!Hj9Y_P0nvg!Gi3aiue4WvBOYm0ZkFhszKgi1xvZs3ev6HZDf6nLd-PTi_10cYFmK_9JO7IgsJvs-BH6FQ$\"><strong>buradan<\/strong><\/a> ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>T\u0130TCK, t\u0131bbi cihaz firmalar\u0131na yol g\u00f6stermeye devam ediyor. Bu alanda faaliyet g\u00f6steren \u015firketler yay\u0131nlanan Genelge&#8217;yi dikkatlice incelemeli, T\u0130TCK duyurular\u0131n\u0131 takip etmeli, teknik servis sa\u011flay\u0131c\u0131lar\u0131na ve teknik personele ili\u015fkin \u00dcTS kay\u0131t i\u015flemlerini tamamlamal\u0131d\u0131rlar.<\/p>\n<p><strong>T\u0130TCK&#8217;dan Eczanelerde Sat\u0131labilecek T\u0131bbi Cihazlara \u0130li\u015fkin Yeni Duyuru<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu, (\u201cKurum\u201c) 11 Aral\u0131k 2020 tarihinde yapt\u0131\u011f\u0131 duyuruda T\u0131bbi Cihaz Sat\u0131\u015f, Reklam ve Tan\u0131t\u0131m Y\u00f6netmeli\u011fi uyar\u0131nca eczaneler taraf\u0131ndan sat\u0131labilecek t\u0131bbi cihazlar\u0131n listesini yay\u0131nlad\u0131.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Piyasaya arz edilen t\u0131bbi cihazlar\u0131n sat\u0131\u015f, reklam ve tan\u0131t\u0131m faaliyetlerine ili\u015fkin usul ve esaslar T\u0131bbi Cihaz Sat\u0131\u015f, Reklam Ve Tan\u0131t\u0131m Y\u00f6netmeli\u011fi ile d\u00fczenlenmektedir. Y\u00f6netmelik&#8217;te yap\u0131lan de\u011fi\u015fiklik ile istisna edilen cihazlar d\u0131\u015f\u0131ndaki t\u0131bbi cihazlar\u0131n herhangi bir yetki veya izin aranmaks\u0131z\u0131n eczanelerde sat\u0131labilece\u011fi belirtilmi\u015ftir.<\/p>\n<p>Bu kapsamda (i) yaln\u0131zca i\u015fitme cihaz\u0131 merkezlerinde, \u0131smarlama protez ve ortez merkezlerinde, optisyenlik m\u00fcesseselerinde veya di\u015f protez laboratuvarlar\u0131nda sat\u0131\u015f\u0131, uyarlamas\u0131 veya uygulamas\u0131 yap\u0131lan cihazlar; (ii) m\u00fcnhas\u0131ran sa\u011fl\u0131k profesyonelleri taraf\u0131ndan kullan\u0131lmas\u0131 veya uygulanmas\u0131 \u00f6ng\u00f6r\u00fclen ya da t\u0131bbi cihaz sat\u0131\u015f merkezlerinde uygulama gerektiren cihazlar hari\u00e7 olmak \u00fczere eczanelerde sat\u0131\u015fa sunulabilecek t\u0131bbi cihazlar a\u015fa\u011f\u0131daki \u015fekilde listelenmi\u015ftir:<\/p>\n<ul>\n<li>Farmas\u00f6tik formda piyasaya arz edilen t\u0131bbi cihazlar<\/li>\n<li>Be\u015feri t\u0131bbi \u00fcr\u00fcnlerin uygulanmas\u0131nda kullan\u0131lan t\u0131bbi cihazlar<\/li>\n<li>Y\u00f6netmelik Ek-3&#8217;te belirtilen t\u0131bbi cihazlar<\/li>\n<li>Bireysel kullan\u0131ma y\u00f6nelik cihazlar<\/li>\n<\/ul>\n<p>Duyuruya <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=S1RjaEkxN2t4V0xjNGFuU2tkTGVLMlIxMG5xN2xLcXNwZnVYZG5IYWtPTTFLbkI3NS8yUVpnTXRpY2U0aC91QWRCNUdHQk1FUnAzQ0c5VEloNkJMaXhXMUpIMzY3TFVPNFFwSFdXTDVtaXp0V2R4ZzFrVWJUUmk1cVNzODhXZEFGUXNaY1Rkb1pLZWl3U2RDL3BRNUl6djdtWE9WSVRXODlyTis4am5wc3BXM3MyMG5CbG82SlE9PQ==&amp;rh=ff006ffe48904b7a262bfff18344b113688c672d__;!!Hj9Y_P0nvg!Gi3aiue4WvBOYm0ZkFhszKgi1xvZs3ev6HZDf6nLd-PTi_10cYFmK_9JO7IgsJvg3HS9dg$\"><strong>buradan<\/strong><\/a> ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>T\u0130TCK, t\u0131bbi cihaz sekt\u00f6r\u00fcndeki firmalara yol g\u00f6stermeye devam ediyor. Bu alandaki \u015firketler T\u0130TCK duyurular\u0131n\u0131 takip etmeli, t\u0131bb\u0131 cihaz sat\u0131\u015f faaliyetlerini Y\u00f6netmelik\u2019teki usul ve esaslara uygun hareket etmek suretiyle ger\u00e7ekle\u015ftirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8221;), Klinik Ara\u015ft\u0131rmalara ili\u015fkin K\u0131lavuz&#8217;lar\u0131 g\u00fcncelledi.\u00a0 T\u0130TCK ayr\u0131ca T\u0131bbi Cihaz Teknik Servis Sa\u011flay\u0131c\u0131lar\u0131n\u0131n [&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-18231","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>Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler - Aral\u0131k 2020<\/title>\n<meta name=\"description\" content=\"&nbsp; 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