
{"id":12618,"date":"2026-05-19T06:49:59","date_gmt":"2026-05-19T06:49:59","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/tibbi-cihaz-yonetmeligi-nedir\/"},"modified":"2026-07-17T06:35:47","modified_gmt":"2026-07-17T06:35:47","slug":"tibbi-cihaz-yonetmeligi-nedir","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/tibbi-cihaz-yonetmeligi-nedir\/","title":{"rendered":"T\u0131bbi cihaz y\u00f6netmeli\u011fi nedir?"},"content":{"rendered":"<p>Avrupa Birli\u011fi taraf\u0131nda ana d\u00fczenleme MDR 2017\/745 olup t\u0131bbi cihazlar\u0131n s\u0131n\u0131fland\u0131r\u0131lmas\u0131, teknik dok\u00fcmantasyonu, klinik de\u011ferlendirmesi, izlenebilirli\u011fi ve piyasa sonras\u0131 g\u00f6zetimi gibi alanlar\u0131 kapsar. T\u00fcrkiye\u2019de t\u0131bbi cihaz mevzuat\u0131 AB uyumu \u00e7er\u00e7evesinde de\u011ferlendirilir ve \u00dcTS kay\u0131t s\u00fcre\u00e7leriyle desteklenir. \u00dcretici, \u00fcr\u00fcn\u00fcn s\u0131n\u0131f\u0131n\u0131, uygunluk de\u011ferlendirme yolunu ve gerekli belgeleri \u00fcr\u00fcn \u00f6zelinde belirlemelidir.<\/p>","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi cihaz y\u00f6netmeli\u011fi, cihazlar\u0131n g\u00fcvenli ve performansl\u0131 \u015fekilde piyasaya arz edilmesi i\u00e7in \u00fcretici ve ekonomik operat\u00f6rlere kurallar getiren mevzuatt\u0131r.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"kkqa_category":[518],"kkqa_letter":[483],"class_list":["post-12618","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-genel-mevzuat","kkqa_letter-t"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/12618","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=12618"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/12618\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=12618"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=12618"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=12618"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}