{"id":21853,"date":"2022-02-09T06:21:15","date_gmt":"2022-02-09T06:21:15","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=21853"},"modified":"2022-06-09T13:38:16","modified_gmt":"2022-06-09T13:38:16","slug":"saglik-sektorunde-guncel-gelismeler-subat-2022","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/02\/09\/saglik-sektorunde-guncel-gelismeler-subat-2022\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler &#8211; \u015eubat 2022"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC9758699352?updated=1644370673\" 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=\"49\" height=\"49\" 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: 49px) 100vw, 49px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast 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 yay\u0131mlad\u0131\u011f\u0131 duyurular ile \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik&#8217;te (&#8220;<strong>Y\u00f6netmelik<\/strong>&#8220;) yap\u0131lacak de\u011fi\u015fiklikler ile Avrupa Birli\u011fi (AB) 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc&#8217;n\u00fcn Ek 16&#8217;s\u0131nda listelenen t\u0131bbi ama\u00e7l\u0131 olmayan \u00fcr\u00fcn gruplar\u0131na ili\u015fkin Avrupa Komisyonu Taslak Uygulama Tasarrufu&#8217;nun (&#8220;<strong>Taslak Uygulama Tasarrufu<\/strong>&#8220;) kamuoyu g\u00f6r\u00fc\u015f\u00fcne a\u00e7\u0131ld\u0131\u011f\u0131n\u0131 duyurdu.<\/p>\n<p>G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n<p><a href=\"#trke1\"><strong>\u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik De\u011fi\u015fiklikleri Neler Getiriyor?<\/strong><\/a><br \/>\n<a href=\"#trke2\"><strong>Avrupa Komisyonu Taslak Uygulama Tasarrufu G\u00f6r\u00fc\u015fe A\u00e7\u0131ld\u0131<\/strong><\/a><\/p>\n<p><strong>\u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik De\u011fi\u015fiklikleri Neler Getiriyor?<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum, 2 \u015eubat 2022 tarihinde Y\u00f6netmelik&#8217;te yap\u0131lacak de\u011fi\u015fikliklere ili\u015fkin \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik Tasla\u011f\u0131&#8217;n\u0131 (&#8220;<strong>Taslak Y\u00f6netmelik<\/strong>&#8220;) g\u00f6r\u00fc\u015fe a\u00e7t\u0131. Taslak Y\u00f6netmelik&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=RnBxOWNPQVpRRU1odE95c2FDR0REUFJIcThnKzZQckFQUnQ5VEQ4Z1BHQlk0bzM2cDk0N1NaZE51b0Nha1ZwQU5EUVc2cDhuSmthNHpIUUZySHcxa2lOWEsyUXdHRGFGbzl0a1J0N3FVaTFYV21ycjFhWmNoRjg0WVFiZ2Q5bHJsWXVmQUpaYkQ1UEJkSTFDb01jVnRvSnB5T1VlYUpBd2IvZHVYVHlLT1dPVnNuWjRLaklyRVh1MHFoMUFIbkswZUQwc2dCUXd0cDBEelIxRFdJcnpScW9HWXB3YkRzMXRnNm5aZkYzeUl6U2prZ2oyckZ0Zi9LL05NNDBUOW1GNUhOZDloMmRmV3RZPQ==&amp;rh=ff008a9f71d3b30b3625dee4614cbeb52abec70a__;!!Hj9Y_P0nvg!G11KLyyReOvDk4VgxH3gd6ZYof3x0_va47Ihl6-1I-YvLceREwOnbWJB8YUle0hhLG0$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Taslak Y\u00f6netmelik ile \u00f6ng\u00f6r\u00fclen ba\u015fl\u0131ca d\u00fczenlemeler a\u015fa\u011f\u0131daki gibidir:<\/p>\n<ul>\n<li>Klinik ara\u015ft\u0131rma destekleyicisinin yurt d\u0131\u015f\u0131nda oldu\u011fu durumlarda yurt i\u00e7inde yerle\u015fik bir ger\u00e7ek veya t\u00fczel ki\u015finin yasal temsilci olarak atanmas\u0131 gerekecektir. Yasal temsilci, destekleyicinin Y\u00f6netmelik&#8217;te \u00f6ng\u00f6r\u00fclen y\u00fck\u00fcml\u00fcl\u00fcklere uyumundan sorumlu ve t\u00fcm ileti\u015fimlerin muhatab\u0131d\u0131r.<\/li>\n<li>Klinik ara\u015ft\u0131rma g\u00f6n\u00fcll\u00fclerinin g\u00fcvenli\u011fini, haklar\u0131n\u0131 veya klinik ara\u015ft\u0131rma verilerinin g\u00fcvenilirli\u011fi ve kalitesini etkileyen; ayn\u0131 zamanda Y\u00f6netmelik veya onayl\u0131 ara\u015ft\u0131rma protokol\u00fcn\u00fcn ihlaline sebep olan durumun \u00f6\u011frenilmesinden itibaren en ge\u00e7 7 g\u00fcn i\u00e7inde etik kurul ve Kurum&#8217;a bilgi verilmesi gerekecektir.<\/li>\n<li>Ya\u015fam\u0131 tehdit eden hastal\u0131k tedavileri, D\u00fcnya Sa\u011fl\u0131k \u00d6rg\u00fct\u00fc veya T\u00fcrkiye taraf\u0131ndan halk sa\u011fl\u0131\u011f\u0131n\u0131 ciddi \u015fekilde tehdit eden durumlara ili\u015fkin ara\u015ft\u0131rmalar istisnai durumdaki ara\u015ft\u0131rmalar aras\u0131nda say\u0131larak daha k\u0131sa s\u00fcrede de\u011ferlendirilme gibi \u00f6zel usul ve esaslara tabi tutulmu\u015ftur.<\/li>\n<li>Ara\u015ft\u0131rman\u0131n t\u00fcm merkezlerde sona erdirilmesinden itibaren 1 y\u0131l i\u00e7inde ara\u015ft\u0131rma sonu\u00e7 raporu \u00f6zeti ve g\u00f6n\u00fcll\u00fclerin anlayabilece\u011fi hali etik kurul ve Kurum&#8217;a bildirilecektir.<\/li>\n<li>Ara\u015ft\u0131rma kay\u0131tlar\u0131n\u0131n ara\u015ft\u0131rman\u0131n tamamlanmas\u0131ndan itibaren saklanmas\u0131 gereken en k\u0131sa s\u00fcre 5 y\u0131ldan 25 y\u0131la \u00e7\u0131kar\u0131lm\u0131\u015ft\u0131r.<\/li>\n<li>Kurum&#8217;un ara\u015ft\u0131rmay\u0131 durdurabilece\u011fi, ara\u015ft\u0131rma iznini iptal edebilece\u011fi veya ara\u015ft\u0131rmada de\u011fi\u015fiklik talep edebilece\u011fi hallere y\u00f6nelik birtak\u0131m de\u011fi\u015fiklikler \u00f6ng\u00f6r\u00fclm\u00fc\u015ft\u00fcr. Bu kapsamda, ara\u015ft\u0131rmalar\u0131n onaylanm\u0131\u015f belgelere uygun y\u00fcr\u00fct\u00fclmemesi, ara\u015ft\u0131rmada elde edilen verilerin g\u00fcvenilirli\u011fi ve kalitesinin ara\u015ft\u0131rman\u0131n y\u00fcr\u00fct\u00fclmesini olumsuz etkilemesi ve ba\u015fvuru\/bildirim gerekliliklerinin yerine getirilmemesi bu hallere eklenmi\u015ftir.<\/li>\n<li>Y\u00f6netmelik kapsam\u0131ndaki ara\u015ft\u0131rmaya ait bilgiler ve ara\u015ft\u0131rma sonu\u00e7lar\u0131 ile gerekli g\u00f6r\u00fclmesi halinde \u00f6zet de\u011ferlendirme raporlar\u0131 ticari s\u0131r ve ki\u015fisel veriler g\u00f6z \u00f6n\u00fcnde bulundurulmak kayd\u0131yla kamuya a\u00e7\u0131k olarak Kurum taraf\u0131ndan yay\u0131mlanacakt\u0131r.<\/li>\n<\/ul>\n<p>\u0130lgililer, 10 \u015eubat 2022 tarihi sonuna kadar g\u00f6r\u00fc\u015flerini <a href=\"mailto:kainfo@titck.gov.tr\">kainfo@titck.gov.tr<\/a> adresine iletebilecektir.<\/p>\n<p><strong>Avrupa Komisyonu Taslak Uygulama Tasarrufu G\u00f6r\u00fc\u015fe A\u00e7\u0131ld\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum, 03 \u015eubat 2022 tarihinde, AB 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fcn\u00fcn Ek 16&#8217;s\u0131nda listelenen t\u0131bbi ama\u00e7l\u0131 olmayan \u00fcr\u00fcn gruplar\u0131na ili\u015fkin spesifikasyonlar\u0131 ortaya koyan Taslak Uygulama Tasarrufu&#8217;nun kamuoyu g\u00f6r\u00fc\u015f\u00fcne a\u00e7\u0131ld\u0131\u011f\u0131n\u0131 duyurdu. Taslak Uygulama Tasarrufu&#8217;na <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=RnBxOWNPQVpRRU1odE95c2FDR0REUFJIcThnKzZQckFQUnQ5VEQ4Z1BHRFZuWTNqK1I3SzJrWXFCc0p1bE0zRHE0aU1SbVVqNWp6RFAwbWdrQ3ZBZ2s1Q0hOemMrV0o1Q3lKYUdLcW5DcE5ndVpPbVQ3bURrS1FPbnlpNzYrYjUwNjVvSFhiNWJYU3BEYzU1TEJ5UDFwUkJwc09ocWhnT01kNE1nUjhocGplb1FWN29hMnNLM0VRdVlZUDFXNkkrZUxJV0xTTGs1dm5NaTBjdnpnQkw1VnZoeVZrVTArcDVwdU9nODlBT1RadEEzYmZnTkdqd1ZRPT0=&amp;rh=ff008a9f71d3b30b3625dee4614cbeb52abec70a__;!!Hj9Y_P0nvg!G11KLyyReOvDk4VgxH3gd6ZYof3x0_va47Ihl6-1I-YvLceREwOnbWJB8YUlsgxRzZ4$\">buradan<\/a> (\u0130ngilizce) ula\u015fabilir ve g\u00f6r\u00fc\u015f verebilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Taslak Uygulama Tasarrufu, T\u0131bbi Cihaz Y\u00f6netmeli\u011fi ile \u0130n Vitro Tan\u0131 Ama\u00e7l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi&#8217;nin tam uyumlu olarak haz\u0131rland\u0131\u011f\u0131 (AB) 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc&#8217;n\u00fcn uygulanmas\u0131na y\u00f6nelik olarak \u00e7\u0131kar\u0131lm\u0131\u015ft\u0131r. \u0130laveten, Taslak Uygulama Tasarrufu, kozmetik cerrahide kullan\u0131lan implantlar, dermal dolgu maddeleri, v\u00fccut \u015fekillendirme ekipmanlar\u0131 ile kontakt lensler, v\u00fccut t\u00fcy\u00fc almaya y\u00f6nelik lazer cihazlar\u0131 ve elektrikli beyin stim\u00fclat\u00f6rleri gibi t\u0131bbi ama\u00e7l\u0131 olmayan \u00fcr\u00fcn gruplar\u0131 i\u00e7in risk y\u00f6netimi ve g\u00fcvenlik gereklilikleri d\u00fczenlemektedir. Bu do\u011frultuda \u00fcr\u00fcnlerin da\u011f\u0131t\u0131m\u0131 ve kullan\u0131m\u0131 s\u0131ras\u0131nda ortaya \u00e7\u0131kabilecek riskler ve bunlar\u0131n kontrol alt\u0131na al\u0131nmas\u0131 i\u00e7in gereken \u00f6nlemler, ayr\u0131ca \u00fcr\u00fcn\u00fcn etiketi ve kullan\u0131m talimat\u0131nda yer almas\u0131 gereken unsurlara y\u00f6nelik kurallar d\u00fczenlenmektedir.<br \/>\n\u0130lgililer, 11 \u015eubat 2022 tarihine kadar Taslak Uygulama Tasarrufu&#8217;na y\u00f6nelik g\u00f6r\u00fc\u015flerini payla\u015fabilecektir.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum, sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlerin d\u00fczenleyici kurallara ili\u015fkin g\u00f6r\u00fc\u015flerini almaya y\u00f6nelik duyurular\u0131na devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, Kurum&#8217;un duyurular\u0131n\u0131 yak\u0131ndan takip ederek mevzuat de\u011fi\u015fikliklerine ili\u015fkin g\u00f6r\u00fc\u015f ve \u00f6nerilerini payla\u015fabilir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast 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-21853","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 - \u015eubat 2022<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! 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