{"id":19290,"date":"2021-04-22T06:37:45","date_gmt":"2021-04-22T06:37:45","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=19290"},"modified":"2022-06-09T13:19:34","modified_gmt":"2022-06-09T13:19:34","slug":"saglik-sektorunde-guncel-gelismeler-22-nisan-2021","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2021\/04\/22\/saglik-sektorunde-guncel-gelismeler-22-nisan-2021\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; 22 Nisan 2021"},"content":{"rendered":"<p><strong>\u00a0 <a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC2410260243\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone wp-image-18799\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" alt=\"\" width=\"61\" height=\"61\" srcset=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png 186w, https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1-150x150.png 150w\" sizes=\"(max-width: 61px) 100vw, 61px\" \/><\/a>\u00a0 \u00a0 \u00a0Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8221;<strong>Kurum<\/strong>&#8221;) t\u0131bbi cihazlar\u0131n Brexit sonras\u0131 d\u00f6nemde kay\u0131t ve de\u011ferlendirme s\u00fcre\u00e7lerine ili\u015fkin yeni uygulamalar ve sa\u011fl\u0131k hizmetlerinde kullan\u0131lan t\u0131bbi cihazlara ili\u015fkin \u00dcr\u00fcn Takip Sistemi (&#8220;<strong>\u00dcTS<\/strong>&#8220;) kayd\u0131 ile t\u0131bbi hizmet sa\u011flay\u0131c\u0131lar\u0131n kayd\u0131 \u00dcTS kayd\u0131 gibi kritik konularda yeni duyurular yay\u0131mlad\u0131.<\/p>\n<p>G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n<p><u><a href=\"#1_Brexit_Sonras\u00c4\u00b1\"><strong>T\u0130TCK Brexit Sonras\u0131 T\u0131bbi Cihazlar\u0131n Kay\u0131t ve De\u011ferlendirme Uygulamalar\u0131nda De\u011fi\u015fiklik Yapt\u0131<\/strong><\/a><\/u> <u><br \/>\n<a href=\"#2_T\u00c4\u00b1bbi_Hizmet_Sa\u00c4\u009flay\u00c4\u00b1c\u00c4\u00b1lar\u00c4\u00b1na\"><strong>T\u0130TCK T\u0131bbi Hizmet Sa\u011flay\u0131c\u0131lar\u0131na Y\u00f6nelik Rehber Yay\u0131mlad\u0131<\/strong><\/a><\/u><\/p>\n<p><strong>T\u0130TCK Brexit Sonras\u0131 T\u0131bbi Cihazlar\u0131n Kay\u0131t ve De\u011ferlendirme Uygulamalar\u0131nda De\u011fi\u015fiklik Yapt\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8221;<strong>Kurum<\/strong>&#8221;), 12 Nisan 2021 tarihli duyurusunda, Brexit sonras\u0131 t\u0131bbi<br \/>\ncihazlar\u0131n kay\u0131t ve de\u011ferlendirme uygulamas\u0131na ili\u015fkin 15 Ocak 2021&#8217;de belirlemi\u015f oldu\u011fu esaslarda de\u011fi\u015fiklik yapt\u0131. Kurum&#8217;un tadil niteli\u011findeki duyurusuna <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YXNWMCt6NzVZM0hxUkFQODZmZnhCM3FTclFQOExhN3dMZXh0cno0NzV0S0NHOEROeStVQ3N0QXpkWjhJRlNKbDc4aWV5a0VYSWM3ZTRVNmtHZlZZSVptSVAxRWJadlBnWlowRGJjWWE5SmR6TXgrZlRBL2FJVDNrcm1KZldRTG5zTGM1a3RFYkpHTnlFVUdESWNjdGJDREo5a3JpV0IyQ3I3YTlZa3B0Tk0wYWVySUJzL1BFS0s0WE93Q3h4M1VOaFFDZ1J0TUN2b2U0K0p5bDhoL0EyUnlvbmw4ODJzNU0=&amp;rh=ff0077eae5932c6684ad7a3d5b4fb7581dcd4db1__;!!Hj9Y_P0nvg!ACjbtk0jm7EPa2-Lj9g_MrDboARAQqopEkn4ngvVrhdtAmvcB5LPnoHtuieOj9QXhS0DIg$\"><strong><u>buradan<\/u><\/strong> <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Kurum, duyurusunda Brexit s\u00fcrecinden etkilenen onaylanm\u0131\u015f kurulu\u015flar taraf\u0131ndan t\u0131bbi cihaz firmalar\u0131na<br \/>\nd\u00fczenlenen EC sertifikalar\u0131 ve bu belgelere ba\u011fl\u0131 t\u0131bbi cihaz kay\u0131tlar\u0131n\u0131n de\u011ferlendirilmesinde esas al\u0131nacak yeni uygulamalar\u0131 belirlemektedir.<\/p>\n<p>Kurum, duyurusunda a\u015fa\u011f\u0131daki hususlar\u0131n alt\u0131n\u0131 \u00e7izmi\u015ftir:<\/p>\n<ul>\n<li>08.04.2021 tarihine kadar, \u00dcr\u00fcn Takip Sistemi (&#8220;<strong>\u00dcTS<\/strong>&#8220;) \u00fczerinden \u00fcretim ya da ithalat bildirimi yap\u0131larak tekille\u015ftirilmi\u015f olan t\u0131bbi cihazlar\u0131n hareketlerinde herhangi bir k\u0131s\u0131tlamaya gidilmeyecek. Ancak, 08.04.2021 tarihi sonras\u0131nda yap\u0131lacak olan tekil \u00fcr\u00fcn bildirimleri \u00f6ncesinde, e\u011fer ilgili s\u00fcre i\u00e7erisinde g\u00fcncel ve ge\u00e7erli belge ile g\u00fcncelleme yap\u0131lmad\u0131\u011f\u0131ndan kay\u0131t ret durumuna d\u00fc\u015fm\u00fc\u015f ise, s\u00f6z konusu t\u0131bbi cihaz ve ba\u011fl\u0131 oldu\u011fu belge kay\u0131tlar\u0131n\u0131n g\u00fcncellenmesi ve kay\u0131tl\u0131 duruma getirilmesi gerekecektir.<\/li>\n<li>08.04.2021&#8217;den itibaren \u00dcTS&#8217;deki kayd\u0131 d\u00fc\u015fen t\u0131bbi cihazlar\u0131n 93\/42\/EEC veya 98\/79\/EEC veya 90\/385\/EEC (&#8220;T\u0131bbi Cihaz Y\u00f6netmelikleri&#8221;) kapsam\u0131nda farkl\u0131 bir onayl\u0131 kurulu\u015f taraf\u0131ndan d\u00fczenlenen g\u00fcncel EC sertifikas\u0131 ile sisteme kaydedilmesi halinde, ilgili t\u0131bbi cihazla ili\u015fkilendirilmi\u015f olan dok\u00fcmanlardaki bilgiler aras\u0131nda tutars\u0131zl\u0131k olmas\u0131 durumunda, bu uyumsuzluklar kayda esas de\u011ferlendirmeye al\u0131nmayacakt\u0131r. Dolay\u0131s\u0131yla t\u0131bbi cihaz ba\u015fvurusu \u00dcTS kayd\u0131na dayal\u0131 olarak reddedilmeyecek veya revizyon gerektirmeyecektir.<\/li>\n<\/ul>\n<p><strong>T\u0130TCK T\u0131bbi Hizmet Sa\u011flay\u0131c\u0131lar\u0131na Y\u00f6nelik Rehber Yay\u0131mlad\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8221;<strong>Kurum<\/strong>&#8221;), 12 Nisan 2021 tarihinde t\u0131bbi hizmet sa\u011flay\u0131c\u0131lar\u0131n\u0131n \u00dcr\u00fcn Takip Sistemi&#8217;ne (&#8220;<strong>\u00dcTS<\/strong>&#8220;) kayd\u0131 ve sa\u011fl\u0131k hizmet sunucular\u0131n\u0131n hizmet al\u0131m y\u00f6ntemi ile ger\u00e7ekle\u015ftirilen sa\u011fl\u0131k hizmetlerinde kullan\u0131lan t\u0131bbi cihazlara ili\u015fkin \u00dcTS&#8217;de ger\u00e7ekle\u015ftirilmesi gereken i\u015flemlere ili\u015fkin iki rehber yay\u0131mlad\u0131. T\u0131bbi hizmet sa\u011flay\u0131c\u0131lar\u0131n \u00dcTS&#8217;ye kayd\u0131na ili\u015fkin rehbere <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YXNWMCt6NzVZM0hxUkFQODZmZnhCM3FTclFQOExhN3dMZXh0cno0NzV0S0NHOEROeStVQ3N0QXpkWjhJRlNKbDc4aWV5a0VYSWM3ZTRVNmtHZlZZSVZselJPSDRodVNYNENKcmFMTnNrVHRLcHVaZzdVeGRQSVl4bjkxOWlyTXJEUy9DT0FJQzc5TE5VOVlqZGNXd0ZrT01wSHNBN2NzZGdnWTZ3Wk1RdzB4b0xiVHFxTEZiQkl6dGdlOWx4bkJKZk9rRmNvMEJOalRrVWtoZVc2cXc0MEV4dEdTcUMwSnM=&amp;rh=ff0077eae5932c6684ad7a3d5b4fb7581dcd4db1__;!!Hj9Y_P0nvg!ACjbtk0jm7EPa2-Lj9g_MrDboARAQqopEkn4ngvVrhdtAmvcB5LPnoHtuieOj9RP4t4u9Q$\">buradan<\/a><\/u><\/strong>, sa\u011fl\u0131k hizmet sunucular\u0131n\u0131n \u00dcTS i\u015flemlerine ili\u015fkin rehbere <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YXNWMCt6NzVZM0hxUkFQODZmZnhCM3FTclFQOExhN3dMZXh0cno0NzV0S0NHOEROeStVQ3N0QXpkWjhJRlNKbDc4aWV5a0VYSWM3ZTRVNmtHZlZZSVZselJPSDRodVNYNENKcmFMTnNrVHRPRTV5TnVDQ0Z4RE9vN1JsdUZkTkp2c1dmOUw5d3BHNDBhWkQxVVZqcEtTN1JldjVqZWFGY1NzeWgwQ3R6c3pyb1FlYTdCYlMyT01ISzc2aW4vckc5QVJHd0Z0akFIYU09&amp;rh=ff0077eae5932c6684ad7a3d5b4fb7581dcd4db1__;!!Hj9Y_P0nvg!ACjbtk0jm7EPa2-Lj9g_MrDboARAQqopEkn4ngvVrhdtAmvcB5LPnoHtuieOj9R48lPc3A$\">buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Sa\u011fl\u0131k hizmet sunucular\u0131, g\u00f6r\u00fcnt\u00fcleme, laboratuvar, diyaliz gibi alanlarda hizmet al\u0131m\u0131 yapabilmektedir. Sa\u011fl\u0131k hizmeti sunucular\u0131na bu alanda hizmet veren firmalar\u0131n \u00dcTS&#8217;de firma kayd\u0131n\u0131n bulunmas\u0131 gerekmektedir. Firma kay\u0131tlar\u0131, firman\u0131n imza yetkilisi taraf\u0131ndan <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YXNWMCt6NzVZM0hxUkFQODZmZnhCM3FTclFQOExhN3dMZXh0cno0NzV0SzVTM0grWlR3cEZSWWlDak9MOUk5MnlYNGI4dVovRkRIQmJoWHlrS1Ric2c9PQ==&amp;rh=ff0077eae5932c6684ad7a3d5b4fb7581dcd4db1__;!!Hj9Y_P0nvg!ACjbtk0jm7EPa2-Lj9g_MrDboARAQqopEkn4ngvVrhdtAmvcB5LPnoHtuieOj9RaG-iIWQ$\">https:\/\/utsuygulama.saglik.gov.tr\/<\/a> adresindeki &#8220;Ba\u015fvuru&#8221; mod\u00fcl\u00fc \u00fczerinden yap\u0131lmaktad\u0131r. \u0130lgili k\u0131lavuzda, MERS\u0130S kayd\u0131 olan firmalar, MERS\u0130S kayd\u0131 olmayan firmalar ve adi ortakl\u0131k firmalar\u0131n\u0131n \u00dcTS&#8217;ye kay\u0131t s\u0131ras\u0131nda izlemesi gereken ad\u0131mlar a\u00e7\u0131klanmaktad\u0131r.<\/p>\n<p>\u00dcTS kayd\u0131n\u0131 tamamlayan t\u0131bbi hizmet sa\u011flay\u0131c\u0131s\u0131, sa\u011fl\u0131k hizmet sa\u011flay\u0131c\u0131s\u0131 ile yapt\u0131\u011f\u0131 s\u00f6zle\u015fmeyi sisteme y\u00fcklemekle y\u00fck\u00fcml\u00fcd\u00fcr. Ard\u0131ndan, t\u0131bbi hizmet sa\u011flay\u0131c\u0131s\u0131 hizmetin sunumu s\u0131ras\u0131nda kullanm\u0131\u015f oldu\u011fu sarf malzemelerini &#8220;T\u00fcketim Bildirimi&#8221; ile sistemden \u00e7\u0131kmal\u0131d\u0131r. Buna ek olarak, hizmet sunumunda kullan\u0131lan demirba\u015f niteli\u011findeki t\u00fcm cihazlar\u0131n sistem \u00fczerinden &#8220;Hizmet Sunum Bildirimi&#8221; yoluyla ilgili hastaneler ile e\u015fle\u015ftirilmesi gerekmektedir. \u0130lgili k\u0131lavuzda bahsi ge\u00e7en s\u00fcrece ili\u015fkin g\u00f6rsel \u00f6rnekler kullanmak suretiyle detayl\u0131 a\u00e7\u0131klamalar i\u00e7ermektedir.<\/p>\n<p><strong>Sonu\u00e7 <\/strong><\/p>\n<p>Kurum, t\u0131bbi cihaz firmalar\u0131na yol g\u00f6stermeye devam ediyor. Bu alandaki \u015firketler, Kurum&#8217;un duyurular\u0131n\u0131 takip etmeli, Kurum&#8217;un rehberlerini dikkatle incelemeli ve mevzuat kapsam\u0131ndaki y\u00fck\u00fcml\u00fcl\u00fcklerini yerine getirmek i\u00e7in gerekli ad\u0131mlar\u0131 atmal\u0131d\u0131rlar.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8221;Kurum&#8221;) t\u0131bbi cihazlar\u0131n Brexit sonras\u0131 d\u00f6nemde kay\u0131t ve de\u011ferlendirme s\u00fcre\u00e7lerine ili\u015fkin yeni uygulamalar ve sa\u011fl\u0131k hizmetlerinde kullan\u0131lan t\u0131bbi cihazlara ili\u015fkin \u00dcr\u00fcn Takip Sistemi (&#8220;\u00dcTS&#8221;) kayd\u0131 ile t\u0131bbi hizmet sa\u011flay\u0131c\u0131lar\u0131n kayd\u0131 \u00dcTS kayd\u0131 gibi kritik konularda yeni duyurular yay\u0131mlad\u0131.<\/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-19290","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 - 22 Nisan 2021<\/title>\n<meta name=\"description\" content=\"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#039;&#039;Kurum&#039;&#039;) t\u0131bbi cihazlar\u0131n Brexit sonras\u0131 d\u00f6nemde kay\u0131t ve de\u011ferlendirme s\u00fcre\u00e7lerine ili\u015fkin yeni uygulamalar ve sa\u011fl\u0131k hizmetlerinde kullan\u0131lan t\u0131bbi cihazlara ili\u015fkin \u00dcr\u00fcn Takip Sistemi (&quot;\u00dcTS&quot;) kayd\u0131 ile t\u0131bbi hizmet sa\u011flay\u0131c\u0131lar\u0131n kayd\u0131 \u00dcTS kayd\u0131 gibi kritik konularda yeni duyurular yay\u0131mlad\u0131.\" \/>\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\/2021\/04\/22\/saglik-sektorunde-guncel-gelismeler-22-nisan-2021\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler - 22 Nisan 2021\" \/>\n<meta property=\"og:description\" content=\"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#039;&#039;Kurum&#039;&#039;) t\u0131bbi cihazlar\u0131n Brexit sonras\u0131 d\u00f6nemde kay\u0131t ve de\u011ferlendirme s\u00fcre\u00e7lerine ili\u015fkin yeni uygulamalar ve sa\u011fl\u0131k hizmetlerinde kullan\u0131lan t\u0131bbi cihazlara ili\u015fkin \u00dcr\u00fcn Takip Sistemi (&quot;\u00dcTS&quot;) kayd\u0131 ile t\u0131bbi hizmet sa\u011flay\u0131c\u0131lar\u0131n kayd\u0131 \u00dcTS kayd\u0131 gibi kritik konularda yeni duyurular yay\u0131mlad\u0131.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.esin.av.tr\/tr\/2021\/04\/22\/saglik-sektorunde-guncel-gelismeler-22-nisan-2021\/\" \/>\n<meta property=\"og:site_name\" content=\"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131\" \/>\n<meta property=\"article:published_time\" content=\"2021-04-22T06:37:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-06-09T13:19:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" \/>\n<meta name=\"author\" content=\"R\u0131dvan Konrat\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"R\u0131dvan Konrat\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2021\/04\/22\/saglik-sektorunde-guncel-gelismeler-22-nisan-2021\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2021\/04\/22\/saglik-sektorunde-guncel-gelismeler-22-nisan-2021\/\"},\"author\":{\"name\":\"R\u0131dvan Konrat\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/42c8e616aab56b8622fa365ad63282ae\"},\"headline\":\"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; 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