{"id":20064,"date":"2021-09-03T08:54:29","date_gmt":"2021-09-03T08:54:29","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=20064"},"modified":"2021-09-25T11:27:51","modified_gmt":"2021-09-25T11:27:51","slug":"saglik-sektorunde-guncel-gelismeler-3-eylul-2021","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2021\/09\/03\/saglik-sektorunde-guncel-gelismeler-3-eylul-2021\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; 3 Eyl\u00fcl 2021"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC9392450099?updated=1630652824\" 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=\"48\" height=\"48\" 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: 48px) 100vw, 48px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>Kurum<\/strong>&#8220;) ge\u00e7ti\u011fimiz hafta t\u0131bbi cihazlar\u0131n test kontrol ve kalibrasyonu ile klinik ara\u015ft\u0131rma ba\u015fvurular\u0131nda sunulan Ara\u015ft\u0131rma \u00dcr\u00fcn\u00fc Dosyas\u0131 hakk\u0131nda 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><strong><u><a href=\"#kalibrasyon\">Test, Kontrol ve Kalibrasyon Kurulu\u015flar\u0131na Y\u00f6nelik De\u011fi\u015fiklikler<\/a><\/u><\/strong><strong><u><br \/>\n<a href=\"#klinik\">Klinik Ara\u015ft\u0131rma \u00dcr\u00fcn Dosyas\u0131 Haz\u0131rlama Tasla\u011f\u0131 Yay\u0131mland\u0131<\/a><\/u><\/strong><\/p>\n<p><strong>Test, Kontrol ve Kalibrasyon Kurulu\u015flar\u0131na Y\u00f6nelik De\u011fi\u015fiklikler<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum 25.08.2021 tarihinde, 25.06.2015 tarihli ve 29397 say\u0131l\u0131 Resmi Gazete\u2019 de yay\u0131mlanarak y\u00fcr\u00fcrl\u00fc\u011fe giren T\u0131bbi Cihazlar\u0131n Test, Kontrol ve Kalibrasyonu Hakk\u0131nda Y\u00f6netmelik (&#8220;<strong>Y\u00f6netmelik<\/strong>&#8220;) kapsam\u0131nda yetkilendirdi\u011fi test, kontrol ve kalibrasyon kurulu\u015flar\u0131n\u0131n (&#8220;<strong>Kurulu\u015f<\/strong>&#8220;) g\u00f6rev alan\u0131na y\u00f6nelik bir duyuru yay\u0131mlad\u0131. \u0130lgili duyuruya <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=azNZeVhENHJCeC9TQnRQWWdxR1h1Q01SeEZITWc3RVg5bGsvTE04THFhVzJoZkVySzhlV3o1TGFQRWNNWUhVMUxRaFNZQ3ptOGNGalFwcDUvYWQ2QTFIeW5LT2hsamxZbTBkMUc5em9RcVR5bG10SmhMaXp5R29EeC9YVHQvQkVjc0ZtTEZSY1pxS01YemRrQit6VDRYYnRpek5xMlFod3E5eUlRdnFibnJQZXNwalFpc3hvK1UrbmJzWXNRZm80c3V0VkF2RWpZa2kxTmxTNkJpNENWbFJkbEJlbmttdVg2eXh0RWppbXdROD0=&amp;rh=ff0080a4cee59a3c1ba0294e1245ae0331461e14__;!!Hj9Y_P0nvg!GRKZ-e6v5sGfyLIgd8_LCNseG0-s313hQA1tWSeLQG3AVVipCf0HD_M7Bg-ToWzstpY$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Y\u00f6netmelik uyar\u0131nca t\u0131bbi cihazlar\u0131n test, kontrol ve kalibrasyonunu Kurum taraf\u0131ndan yetkilendirilmi\u015f Kurulu\u015flar&#8217;a yapt\u0131rmak zorunludur. Ancak Y\u00f6netmelik&#8217;in 10(3) Maddesi uyar\u0131nca yetkilendirilmi\u015f Kurulu\u015f say\u0131s\u0131n\u0131n uygulamada mevcut ihtiyac\u0131 kar\u015f\u0131lamamas\u0131 durumunda, Kurum bu zorunlulu\u011fu ge\u00e7ici olarak kald\u0131rma yetkisine sahiptir.<\/p>\n<p>Nitekim Kurum taraf\u0131ndan hali haz\u0131rda yetkilendirilmi\u015f iki Kurulu\u015f t\u0131bbi cihazlar\u0131n test, kontrol ve kalibrasyonunu yapmak konusunda say\u0131ca yetersiz kald\u0131\u011f\u0131ndan, Kurum tomografi, aspirat\u00f6r ya da kalp pili gibi birtak\u0131m t\u0131bbi cihazlara ili\u015fkin test, kontrol ve kalibrasyonlar\u0131 yetkilendirilmi\u015f Kurulu\u015flar&#8217;a yapt\u0131rma zorunlulu\u011funu kald\u0131rm\u0131\u015ft\u0131r. \u0130lgili t\u0131bbi cihazlar\u0131n tam listesine duyuru metninde yer verilmektedir.<\/p>\n<p><strong>Klinik Ara\u015ft\u0131rma \u00dcr\u00fcn Dosyas\u0131 Haz\u0131rlama Tasla\u011f\u0131 Yay\u0131mland\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme <\/strong><\/p>\n<p>Kurum 25.08.2021 tarihli duyurusu ile klinik ara\u015ft\u0131rma ba\u015fvurular\u0131nda sunulan Ara\u015ft\u0131rma \u00dcr\u00fcn\u00fc Dosyas\u0131n\u0131n (A\u00dcD) olu\u015fturulmas\u0131 a\u015famas\u0131nda ba\u015fvuru sahiplerine rehberlik etmek ve dosyan\u0131n haz\u0131rlanmas\u0131 a\u015famas\u0131nda kullan\u0131lmak \u00fczere haz\u0131rlad\u0131\u011f\u0131 taslak dosyay\u0131 yay\u0131mlam\u0131\u015ft\u0131r. Taslak A\u00dcD&#8217;ye <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=azNZeVhENHJCeC9TQnRQWWdxR1h1Q01SeEZITWc3RVg5bGsvTE04THFhVzJoZkVySzhlV3o1TGFQRWNNWUhVMUxRaFNZQ3ptOGNIRUJTdzhwRjlWWjNESTNHYktZdjhua1JSK2d6M1RKdzBwZEJQYTd1MmhxSFR1bWFFQ3ZSeXdkVllSQUQ1M1lzZXhhV3E3MGh3Z3o5bGFIQUliVitRUg==&amp;rh=ff0080a4cee59a3c1ba0294e1245ae0331461e14__;!!Hj9Y_P0nvg!GRKZ-e6v5sGfyLIgd8_LCNseG0-s313hQA1tWSeLQG3AVVipCf0HD_M7Bg-T3xWICWc$\">buradan<\/a>\u00a0ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>S\u00f6z konusu taslak, A\u00dcD i\u00e7eri\u011fine y\u00f6nelik klinik ara\u015ft\u0131rma gruplar\u0131na rehberlik etmektedir. Taslak i\u00e7erisinde, A\u00dcD&#8217;de makul olarak bulunmas\u0131 gereken b\u00f6l\u00fcm ba\u015fl\u0131klar\u0131na yer verilmi\u015f ve b\u00f6l\u00fcmlerin i\u00e7eri\u011fi klinik ara\u015ft\u0131rma gruplar\u0131 taraf\u0131ndan doldurulmak \u00fczere bo\u015f b\u0131rak\u0131lm\u0131\u015ft\u0131r. Ayr\u0131ca taslak, b\u00f6l\u00fcmlerin i\u00e7eri\u011finin hangi \u015fekilde olu\u015fturulmas\u0131 gerekti\u011fine y\u00f6nelik y\u00f6nlendirmeler i\u00e7ermektedir. Bunula birlikte taslak yaln\u0131zca \u00f6rnek niteli\u011finde olup, dosyan\u0131n tamamlanmas\u0131 i\u00e7in yeterli g\u00f6r\u00fclmeyece\u011fi unutulmamal\u0131d\u0131r. Benzer \u015fekilde, herhangi bir ba\u015fl\u0131\u011fa dair verinin sunulmas\u0131n\u0131n m\u00fcmk\u00fcn ya da ge\u00e7erli olmad\u0131\u011f\u0131 durumlarda, bu husus A\u00dcD&#8217;de bilimsel gerek\u00e7esiyle beraber mutlaka belirtilmelidir.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren ilgili \u015firketler, Kurum&#8217;un duyurular\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum&#8217;un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;Kurum&#8220;) [&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-20064","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 - 3 Eyl\u00fcl 2021<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Art\u0131k b\u00fcltenlerimizi sesli olarak da dinleyebilirsiniz! 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