{"id":18010,"date":"2026-09-14T11:31:06","date_gmt":"2026-09-14T08:31:06","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=18010"},"modified":"2026-09-14T11:31:11","modified_gmt":"2026-09-14T08:31:11","slug":"tibbi-cihaz-ithalati-nasil-yapilir","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/tibbi-cihaz-ithalati-nasil-yapilir\/","title":{"rendered":"T\u0131bbi Cihaz \u0130thalat\u0131 Nas\u0131l Yap\u0131l\u0131r? 2026 \u00dcTS, TAREKS ve T\u0130TCK Rehberi"},"content":{"rendered":"<style>\n.kk-import{\nmax-width:960px;margin:0 auto;color:#202124;font-size:17px;line-height:1.78\n}\n.kk-import h1{font-size:36px;line-height:1.25;color:#111;margin:0 0 22px}\n.kk-import h2{font-size:27px;line-height:1.35;color:#111;margin:44px 0 17px}\n.kk-import h3{font-size:21px;line-height:1.4;color:#222;margin:29px 0 12px}\n.kk-import p{margin:0 0 18px}\n.kk-import ul,.kk-import ol{margin:0 0 22px 23px}\n.kk-import li{margin-bottom:8px}\n.kk-import a{text-decoration:underline}\n.kk-summary,.kk-info,.kk-warning,.kk-update,.kk-check{\npadding:20px 23px;margin:25px 0;border-radius:6px\n}\n.kk-summary{background:#fafafa;border:1px solid #ddd;border-left:5px solid #111}\n.kk-info{background:#f5f7f9;border-left:4px solid #333}\n.kk-warning{background:#fff7e6;border-left:4px solid #d18b00}\n.kk-update{background:#f8f8f8;border:2px solid #111}\n.kk-check{background:#fafafa;border:1px solid #ddd}\n.kk-summary strong,.kk-update strong{font-size:19px}\n.kk-toc{\nbackground:#f7f7f7;border:1px solid #e1e1e1;\npadding:23px 26px;margin:30px 0;border-radius:7px\n}\n.kk-toc strong{display:block;font-size:20px;margin-bottom:12px}\n.kk-toc ol{margin-bottom:0}\n.kk-table{overflow-x:auto;margin:25px 0}\n.kk-import table{width:100%;border-collapse:collapse;min-width:680px}\n.kk-import th,.kk-import td{\nborder:1px solid #d7d7d7;padding:12px 14px;text-align:left;vertical-align:top\n}\n.kk-import th{background:#f3f4f5;font-weight:700}\n.kk-flow{\ndisplay:flex;flex-wrap:wrap;gap:7px;margin:25px 0\n}\n.kk-flow span{\nbackground:#f2f2f2;border:1px solid #ddd;padding:9px 12px;\nborder-radius:4px;font-weight:600\n}\n.kk-faq{border-top:1px solid #e4e4e4;padding:20px 0}\n.kk-faq h3{margin-top:0}\n.kk-cta{\nbackground:#111;color:#fff;padding:29px;margin:40px 0;border-radius:7px\n}\n.kk-cta h2{color:#fff;margin-top:0}\n.kk-cta a{\ndisplay:inline-block;background:#fff;color:#111;text-decoration:none;\nfont-weight:700;padding:11px 17px;margin:5px 7px 5px 0;border-radius:4px\n}\n.kk-source{font-size:15px;color:#555}\n@media(max-width:768px){\n.kk-import{font-size:16px}\n.kk-import h1{font-size:29px}\n.kk-import h2{font-size:24px}\n}\n<\/style>\n\n<article class=\"kk-import\">\n\n\n<p>\n<strong>T\u0131bbi cihaz ithalat\u0131<\/strong>, yurt d\u0131\u015f\u0131ndan bir \u00fcr\u00fcn sat\u0131n al\u0131p T\u00fcrkiye&#8217;ye\ngetirmekten ibaret de\u011fildir. \u0130thal edilecek \u00fcr\u00fcn\u00fcn ger\u00e7ekten t\u0131bbi cihaz olup olmad\u0131\u011f\u0131,\nuygunluk de\u011ferlendirmesi, CE i\u015fareti, \u00fcretici ve yetkili temsilci bilgileri, etiket ve\nkullan\u0131m k\u0131lavuzu, UDI, \u00dcTS ve gerekti\u011finde TAREKS s\u00fcre\u00e7leri birlikte de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\n\u00d6zellikle \u00c7in, ABD, G\u00fcney Kore veya di\u011fer \u00fc\u00e7\u00fcnc\u00fc \u00fclkelerden t\u0131bbi cihaz getirmeyi planlayan\nfirmalar\u0131n yaln\u0131zca \u00fcreticiden al\u0131nan \u201cCE Certificate\u201d belgesine g\u00fcvenerek sipari\u015f vermesi\n\u00f6nemli bir ticari ve mevzuat riski olu\u015fturabilir.\n<\/p>\n\n<div class=\"kk-summary\">\n<strong>K\u0131sa cevap: T\u0131bbi cihaz ithalat\u0131 nas\u0131l yap\u0131l\u0131r?<\/strong>\n<p>\n\u00d6nce \u00fcr\u00fcn\u00fcn T\u0131bbi Cihaz Y\u00f6netmeli\u011fi veya \u0130n Vitro Tan\u0131 Ama\u00e7l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi\nkapsam\u0131nda olup olmad\u0131\u011f\u0131 belirlenir. Ard\u0131ndan \u00fcreticinin mevzuata uygunlu\u011fu, CE i\u015fareti,\nAB Uygunluk Beyan\u0131, uygulanabiliyorsa Onaylanm\u0131\u015f Kurulu\u015f sertifikalar\u0131, yetkili temsilci,\nUDI, etiket ve kullan\u0131m k\u0131lavuzu kontrol edilir.\n<\/p>\n<p>\nT\u00fcrkiye taraf\u0131nda ithalat\u00e7\u0131 ve \u00fcr\u00fcn kay\u0131t s\u00fcre\u00e7leri de\u011ferlendirilir. \u00dcr\u00fcn\u00fcn GT\u0130P&#8217;i\n2026\/16 say\u0131l\u0131 T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Tebli\u011fi&#8217;nin Ek-1 kapsam\u0131ndaysa\nTAREKS s\u00fcreci ayr\u0131ca y\u00fcr\u00fct\u00fcl\u00fcr. \u00dcr\u00fcn fiili denetime y\u00f6nlendirildi\u011finde belge kontrol\u00fc,\ni\u015faret kontrol\u00fc, fiziki muayene veya gerekti\u011finde test yap\u0131labilir.\n<\/p>\n<\/div>\n\n<nav class=\"kk-toc\" aria-label=\"\u0130\u00e7indekiler\">\n<strong>\u0130\u00e7indekiler<\/strong>\n<ol>\n<li><a href=\"#ithalatci\">T\u0131bbi cihaz ithalat\u00e7\u0131s\u0131 kimdir?<\/a><\/li>\n<li><a href=\"#urun-kapsami\">\u0130lk ad\u0131m: \u00dcr\u00fcn ger\u00e7ekten t\u0131bbi cihaz m\u0131?<\/a><\/li>\n<li><a href=\"#ce\">CE belgesi ithalat i\u00e7in yeterli mi?<\/a><\/li>\n<li><a href=\"#uretici\">Yabanc\u0131 \u00fcretici kontrol\u00fc nas\u0131l yap\u0131l\u0131r?<\/a><\/li>\n<li><a href=\"#yetkili-temsilci\">Yetkili temsilci ne zaman gerekir?<\/a><\/li>\n<li><a href=\"#ithalatci-yukumluluk\">\u0130thalat\u00e7\u0131n\u0131n y\u00fck\u00fcml\u00fcl\u00fckleri nelerdir?<\/a><\/li>\n<li><a href=\"#etiket\">\u0130thalat\u00e7\u0131 bilgisi etikette bulunmal\u0131 m\u0131?<\/a><\/li>\n<li><a href=\"#turkce\">T\u00fcrk\u00e7e etiket ve kullan\u0131m k\u0131lavuzu gerekli mi?<\/a><\/li>\n<li><a href=\"#uts\">\u00dcTS kay\u0131tlar\u0131 hangi a\u015famada yap\u0131l\u0131r?<\/a><\/li>\n<li><a href=\"#gtip\">GT\u0130P neden \u00f6nemlidir?<\/a><\/li>\n<li><a href=\"#tareks\">TAREKS nedir?<\/a><\/li>\n<li><a href=\"#2026-16\">2026\/16 Tebli\u011fi ne getiriyor?<\/a><\/li>\n<li><a href=\"#tareks-belgeler\">TAREKS&#8217;te hangi belgeler gerekir?<\/a><\/li>\n<li><a href=\"#fiili-denetim\">Fiili denetim nas\u0131l yap\u0131l\u0131r?<\/a><\/li>\n<li><a href=\"#atr\">A.TR varsa TAREKS gerekir mi?<\/a><\/li>\n<li><a href=\"#ret\">TAREKS reddi olursa ne yap\u0131l\u0131r?<\/a><\/li>\n<li><a href=\"#cin\">\u00c7in&#8217;den t\u0131bbi cihaz ithal edilebilir mi?<\/a><\/li>\n<li><a href=\"#numune\">Numune \u00fcr\u00fcnlerde durum nedir?<\/a><\/li>\n<li><a href=\"#marka\">Kendi markamla \u00fcr\u00fcn ithal edebilir miyim?<\/a><\/li>\n<li><a href=\"#kontrol\">\u0130thalat \u00f6ncesi kontrol listesi<\/a><\/li>\n<li><a href=\"#sss\">S\u0131k sorulan sorular<\/a><\/li>\n<\/ol>\n<\/nav>\n\n<h2 id=\"ithalatci\">T\u0131bbi Cihaz \u0130thalat\u00e7\u0131s\u0131 Kimdir?<\/h2>\n\n<p>\nT\u0131bbi Cihaz Y\u00f6netmeli\u011fine g\u00f6re ithalat\u00e7\u0131;\n<strong>bir cihaz\u0131 \u00fc\u00e7\u00fcnc\u00fc bir \u00fclkeden T\u00fcrkiye&#8217;de piyasaya arz eden ve T\u00fcrkiye&#8217;de\nyerle\u015fik ger\u00e7ek veya t\u00fczel ki\u015fidir.<\/strong>\n<\/p>\n\n<p>\nBuradaki \u00f6nemli nokta \u015fudur:\n<\/p>\n\n<p>\nBir \u00fcr\u00fcn\u00fc yurt d\u0131\u015f\u0131ndan sat\u0131n almak sizi yaln\u0131zca ticari anlamda al\u0131c\u0131 yapmaz.\n\u00dcr\u00fcn\u00fc \u00fc\u00e7\u00fcnc\u00fc bir \u00fclkeden T\u00fcrkiye pazar\u0131na arz ediyorsan\u0131z t\u0131bbi cihaz mevzuat\u0131\na\u00e7\u0131s\u0131ndan da ithalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fckleri g\u00fcndeme gelir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>\u0130thalat\u00e7\u0131 yaln\u0131zca g\u00fcmr\u00fck i\u015flemini yapan firma de\u011fildir.<\/strong>\n<p>\nT\u0131bbi cihaz mevzuat\u0131 ithalat\u00e7\u0131ya; \u00fcr\u00fcn uygunlu\u011funu kontrol etme, belirli bilgileri\n\u00fcr\u00fcn\/ambalaj\/dok\u00fcmanda g\u00f6sterme, uygun depolama ve nakliye \u015fartlar\u0131n\u0131 sa\u011flama,\n\u015fik\u00e2yet ve geri \u00e7a\u011f\u0131rma kay\u0131tlar\u0131n\u0131 y\u00f6netme ve gerekti\u011finde yetkili otoriteyle\ni\u015f birli\u011fi yapma gibi y\u00fck\u00fcml\u00fcl\u00fckler de getirir.\n<\/p>\n<\/div>\n\n<h2 id=\"urun-kapsami\">1. \u0130lk Ad\u0131m: \u00dcr\u00fcn Ger\u00e7ekten T\u0131bbi Cihaz m\u0131?<\/h2>\n\n<p>\n\u0130thalat yap\u0131lmadan \u00f6nce cevaplanmas\u0131 gereken ilk soru:\n<strong>\u201cBu \u00fcr\u00fcn ger\u00e7ekten t\u0131bbi cihaz m\u0131?\u201d<\/strong>\n<\/p>\n\n<p>\nBir \u00fcr\u00fcn\u00fcn hastanede kullan\u0131lmas\u0131, medikal ma\u011fazada sat\u0131lmas\u0131 veya \u00fcreticisinin\n\u00fcr\u00fcne \u201cmedical\u201d demesi tek ba\u015f\u0131na t\u0131bbi cihaz stat\u00fcs\u00fcn\u00fc belirlemez.\n<\/p>\n\n<p>De\u011ferlendirmede \u00f6zellikle;<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn\u00fcn ama\u00e7lanan kullan\u0131m\u0131,<\/li>\n<li>etki mekanizmas\u0131,<\/li>\n<li>\u00fcreticinin sa\u011fl\u0131k iddialar\u0131,<\/li>\n<li>hedef kullan\u0131c\u0131 grubu,<\/li>\n<li>\u00fcr\u00fcn\u00fcn teknik \u00f6zellikleri ve<\/li>\n<li>uygulanabilir mevzuat<\/li>\n<\/ul>\n\n<p>\nbirlikte ele al\u0131nmal\u0131d\u0131r.\n<\/p>\n\n<p>\n\u00dcr\u00fcn\u00fcn t\u0131bbi cihaz oldu\u011fu belirlendikten sonra risk s\u0131n\u0131f\u0131 da uygunluk de\u011ferlendirme\nyolunun kontrol\u00fc a\u00e7\u0131s\u0131ndan \u00f6nemlidir.\n<\/p>\n\n<p>\n\u00d6n de\u011ferlendirme i\u00e7in\n<a href=\"\/en\/tibbi-cihaz-siniflandirma-araci\/\">\n<strong>KaliteKit T\u0131bbi Cihaz S\u0131n\u0131fland\u0131rma Arac\u0131n\u0131<\/strong>\n<\/a>\nkullanabilirsiniz.\n<\/p>\n\n<h2 id=\"ce\">2. CE Belgesi T\u0131bbi Cihaz \u0130thalat\u0131 \u0130\u00e7in Yeterli mi?<\/h2>\n\n<p>\n<strong>Hay\u0131r.<\/strong>\nBu, ithalat s\u00fcrecinde en s\u0131k kar\u015f\u0131la\u015f\u0131lan yanl\u0131\u015f kabullerden biridir.\n<\/p>\n\n<p>\nBir cihazda CE i\u015faretinin bulunmas\u0131 \u00f6nemlidir; ancak ithalat\u00e7\u0131n\u0131n kontrol y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc\nyaln\u0131zca etikette CE logosu olup olmad\u0131\u011f\u0131na bakmakla sona ermez.\n<\/p>\n\n<p>\n\u0130thalat\u00e7\u0131 cihaz\u0131 piyasaya arz etmeden \u00f6nce, uygulanabilir oldu\u011fu \u00f6l\u00e7\u00fcde;\n<\/p>\n\n<ul>\n<li>cihaz\u0131n CE i\u015faretli oldu\u011funu,<\/li>\n<li>AB Uygunluk Beyan\u0131n\u0131n d\u00fczenlendi\u011fini,<\/li>\n<li>\u00fcreticinin do\u011fru \u015fekilde tan\u0131mland\u0131\u011f\u0131n\u0131,<\/li>\n<li>gerekliyse yetkili temsilci atand\u0131\u011f\u0131n\u0131,<\/li>\n<li>cihaz etiketinin mevzuata uygun oldu\u011funu,<\/li>\n<li>gerekli kullan\u0131m talimat\u0131n\u0131n bulundu\u011funu,<\/li>\n<li>uygulanabilir oldu\u011funda UDI&#8217;nin tahsis edildi\u011fini<\/li>\n<\/ul>\n\n<p>\ndo\u011frulamal\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>\u201c\u00dcretici bana CE belgesi g\u00f6nderdi\u201d tek ba\u015f\u0131na yeterli bir uygunluk kontrol\u00fc de\u011fildir.<\/strong>\n<p>\nBelgenin hangi \u00fcr\u00fcn\u00fc kapsad\u0131\u011f\u0131, \u00fcretici ad\u0131, model bilgileri, risk s\u0131n\u0131f\u0131,\nuygunluk de\u011ferlendirme yolu, belgeyi d\u00fczenleyen kurulu\u015f ve belgenin g\u00fcncelli\u011fi\nbirlikte de\u011ferlendirilmelidir.\n<\/p>\n<\/div>\n\n<p>\nCE s\u00fcrecinin mant\u0131\u011f\u0131n\u0131 ayr\u0131nt\u0131l\u0131 incelemek i\u00e7in\n<a href=\"\/en\/tibbi-cihaz-ce-belgesi-nasil-alinir\/\">\n<strong>T\u0131bbi Cihaz CE Belgesi Nas\u0131l Al\u0131n\u0131r? 2026 MDR Rehberi<\/strong>\n<\/a>\nyaz\u0131m\u0131za bakabilirsiniz.\n<\/p>\n\n<h2 id=\"uretici\">3. Yabanc\u0131 \u00dcreticiyi Kontrol Etmeden Sipari\u015f Vermeyin<\/h2>\n\n<p>\n\u00d6zellikle b\u00fcy\u00fck sipari\u015flerde \u00fcr\u00fcn\u00fcn fiyat\u0131ndan \u00f6nce \u00fcreticinin mevzuat durumunun\nkontrol edilmesi daha g\u00fcvenli bir yakla\u015f\u0131md\u0131r.\n<\/p>\n\n<h3>\u00dcreticiden hangi bilgileri istemelisiniz?<\/h3>\n\n<ul>\n<li>\u00dcreticinin tam ticari ad\u0131 ve adresi,<\/li>\n<li>\u00fcr\u00fcn\u00fcn ticari ad\u0131 ve model\/varyant bilgileri,<\/li>\n<li>ama\u00e7lanan kullan\u0131m,<\/li>\n<li>cihaz risk s\u0131n\u0131f\u0131,<\/li>\n<li>AB Uygunluk Beyan\u0131,<\/li>\n<li>uygulanabiliyorsa Onaylanm\u0131\u015f Kurulu\u015f sertifikas\u0131,<\/li>\n<li>\u00fcr\u00fcn etiketi,<\/li>\n<li>kullan\u0131m k\u0131lavuzu,<\/li>\n<li>UDI-DI bilgileri,<\/li>\n<li>Basic UDI-DI bilgisi uygulan\u0131yorsa ilgili kay\u0131tlar,<\/li>\n<li>yetkili temsilci bilgileri,<\/li>\n<li>uygulanabilir test ve uygunluk kan\u0131tlar\u0131.<\/li>\n<\/ul>\n\n<div class=\"kk-info\">\n<strong>Sat\u0131n alma s\u00f6zle\u015fmesinden \u00f6nce belge kontrol\u00fc yap\u0131n.<\/strong>\n<p>\n10 veya 20 adet numune sipari\u015finde g\u00f6zden ka\u00e7an bir mevzuat problemi,\n5.000 veya 10.000 adetlik ticari sipari\u015fte ciddi maliyet olu\u015fturabilir.\n\u00dcr\u00fcn\u00fcn ithalat uygunlu\u011funu m\u00fcmk\u00fcn oldu\u011funca sipari\u015ften \u00f6nce de\u011ferlendirin.\n<\/p>\n<\/div>\n\n<h2 id=\"yetkili-temsilci\">4. Yabanc\u0131 \u00dcreticinin Yetkili Temsilcisi Olmal\u0131 m\u0131?<\/h2>\n\n<p>\n\u00dcretici T\u00fcrkiye&#8217;de veya Avrupa Birli\u011fi \u00fcyesi bir \u00fclkede yerle\u015fik de\u011filse,\nT\u0131bbi Cihaz Y\u00f6netmeli\u011fi kapsam\u0131nda cihaz\u0131n piyasaya arz\u0131 a\u00e7\u0131s\u0131ndan\n<strong>yetkili temsilci<\/strong> gereklili\u011fi g\u00fcndeme gelir.\n<\/p>\n\n<p>\n\u00d6rne\u011fin \u00fcreticinin \u00c7in, ABD veya T\u00fcrkiye\/AB d\u0131\u015f\u0131nda ba\u015fka bir \u00fclkede yerle\u015fik olmas\u0131\nhalinde, \u00fcreticinin yetkili temsilci yap\u0131s\u0131 mutlaka kontrol edilmelidir.\n<\/p>\n\n<p>\n\u0130thalat\u00e7\u0131 ile yetkili temsilci de ayn\u0131 kavram de\u011fildir.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Rol<\/th>\n<th>Temel i\u015flev<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u0130malat\u00e7\u0131<\/strong><\/td>\n<td>Cihaz\u0131n tasar\u0131m\u0131, \u00fcretimi ve mevzuata uygunlu\u011funun temel sorumlusudur.<\/td>\n<\/tr>\n<tr>\n<td><strong>Yetkili Temsilci<\/strong><\/td>\n<td>T\u00fcrkiye\/AB d\u0131\u015f\u0131nda yerle\u015fik imalat\u00e7\u0131 ad\u0131na mevzuatta tan\u0131mlanan g\u00f6revleri y\u00fcr\u00fct\u00fcr.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0130thalat\u00e7\u0131<\/strong><\/td>\n<td>\u00dc\u00e7\u00fcnc\u00fc \u00fclkeden cihaz\u0131 T\u00fcrkiye pazar\u0131na arz eden T\u00fcrkiye&#8217;de yerle\u015fik ekonomik i\u015fletmecidir.<\/td>\n<\/tr>\n<tr>\n<td><strong>Da\u011f\u0131t\u0131c\u0131<\/strong><\/td>\n<td>Tedarik zincirinde cihaz\u0131 piyasada bulunduran ekonomik i\u015fletmecidir.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<h2 id=\"ithalatci-yukumluluk\">5. T\u0131bbi Cihaz \u0130thalat\u00e7\u0131s\u0131n\u0131n Y\u00fck\u00fcml\u00fcl\u00fckleri Nelerdir?<\/h2>\n\n<p>\n\u0130thalat\u00e7\u0131 olmak yaln\u0131zca \u00fcr\u00fcn\u00fc T\u00fcrkiye&#8217;ye getirmek anlam\u0131na gelmez.\nT\u0131bbi Cihaz Y\u00f6netmeli\u011fi ithalat\u00e7\u0131ya \u00fcr\u00fcn piyasaya arz edilmeden \u00f6nce ve sonras\u0131nda\ndevam eden y\u00fck\u00fcml\u00fcl\u00fckler verir.\n<\/p>\n\n<h3>Piyasaya arzdan \u00f6nce<\/h3>\n\n<p>\u0130thalat\u00e7\u0131 temel olarak;<\/p>\n\n<ul>\n<li>CE i\u015faretini,<\/li>\n<li>AB Uygunluk Beyan\u0131n\u0131,<\/li>\n<li>\u00fcretici ve uygulan\u0131yorsa yetkili temsilci bilgilerini,<\/li>\n<li>etiket ve kullan\u0131m bilgilerini,<\/li>\n<li>uygulanabilir UDI yap\u0131s\u0131n\u0131,<\/li>\n<li>\u00fcr\u00fcn\u00fcn elektronik kay\u0131t durumunu<\/li>\n<\/ul>\n\n<p>\nkontrol etmelidir.\n<\/p>\n\n<h3>\u00dcr\u00fcn ithalat\u00e7\u0131n\u0131n sorumlulu\u011fundayken<\/h3>\n\n<p>\n\u0130thalat\u00e7\u0131, depolama ve ta\u015f\u0131ma ko\u015fullar\u0131n\u0131n cihaz\u0131n g\u00fcvenlilik ve performans\u0131n\u0131\ntehlikeye atmamas\u0131n\u0131 sa\u011flamal\u0131 ve \u00fcreticinin belirledi\u011fi ko\u015fullara uymal\u0131d\u0131r.\n<\/p>\n\n<h3>Piyasaya arzdan sonra<\/h3>\n\n<p>\n\u0130thalat\u00e7\u0131;\n<\/p>\n\n<ul>\n<li>\u015fik\u00e2yet kay\u0131tlar\u0131n\u0131,<\/li>\n<li>uygun olmayan cihazlar\u0131,<\/li>\n<li>geri \u00e7a\u011f\u0131rmalar\u0131,<\/li>\n<li>piyasadan \u00e7ekmeleri<\/li>\n<\/ul>\n\n<p>\nizlemeli ve gerekli durumlarda imalat\u00e7\u0131, yetkili temsilci, da\u011f\u0131t\u0131c\u0131 ve Kurum ile\ni\u015f birli\u011fi yapmal\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>\u0130thalat\u00e7\u0131 \u201csadece arac\u0131 firma\u201d de\u011fildir.<\/strong>\n\u0130thal edilen cihaz uygunsuzsa ithalat\u00e7\u0131n\u0131n da mevzuatta a\u00e7\u0131k\u00e7a tan\u0131mlanm\u0131\u015f sorumluluklar\u0131 vard\u0131r.\n<\/div>\n\n<h2 id=\"etiket\">6. \u0130thalat\u00e7\u0131n\u0131n Ad\u0131 ve Adresi Etikette Bulunmal\u0131 m\u0131?<\/h2>\n\n<p>\n\u0130thalat\u00e7\u0131n\u0131n kendi kimlik bilgilerine ili\u015fkin \u00f6zel bir y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc vard\u0131r.\n<\/p>\n\n<p>\n\u0130thalat\u00e7\u0131;\n<\/p>\n\n<ul>\n<li>ad\u0131n\u0131,<\/li>\n<li>kay\u0131tl\u0131 ticari unvan\u0131n\u0131 veya kay\u0131tl\u0131 ticari markas\u0131n\u0131,<\/li>\n<li>kendisine ula\u015f\u0131labilecek kay\u0131tl\u0131 i\u015f yerini ve adresini<\/li>\n<\/ul>\n\n<p>\ncihaz\u0131n veya ambalaj\u0131n\u0131n \u00fczerinde ya da cihaz\u0131n beraberindeki bir dok\u00fcmanda belirtmelidir.\n<\/p>\n\n<p>\nBu bilgi ilave bir etiket ile ekleniyorsa, ilave etiket \u00fcreticinin orijinal etiketindeki\nbilgileri kapatmamal\u0131d\u0131r.\n<\/p>\n\n<p>\nT\u0131bbi cihaz etiketi haz\u0131rl\u0131\u011f\u0131 i\u00e7in\n<a href=\"\/en\/tibbi-cihaz-etiket-olusturma-iso-15223\/\">\n<strong>KaliteKit T\u0131bbi Cihaz Etiket Olu\u015fturma Hizmetini<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"turkce\">7. T\u00fcrk\u00e7e Etiket ve Kullan\u0131m K\u0131lavuzu Gerekli mi?<\/h2>\n\n<p>\nT\u00fcrkiye piyasas\u0131na sunulacak t\u0131bbi cihazlarda dil gereklilikleri \u00fcr\u00fcn ve kullan\u0131c\u0131\ngrubuna g\u00f6re de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\n2026\/16 say\u0131l\u0131 T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Tebli\u011fi&#8217;nin Ek-2 b\u00f6l\u00fcm\u00fcnde,\nfiili denetim kapsam\u0131nda TAREKS&#8217;e sunulabilecek belgeler aras\u0131nda a\u00e7\u0131k \u015fekilde\n<strong>T\u00fcrk\u00e7e etiket ve kullan\u0131m k\u0131lavuzu<\/strong> say\u0131lmaktad\u0131r.\n<\/p>\n\n<p>\nBu nedenle ithalat yap\u0131lmadan \u00f6nce etiket ve IFU&#8217;nun T\u00fcrkiye piyasas\u0131 a\u00e7\u0131s\u0131ndan\nuygunlu\u011fu kontrol edilmelidir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>Sa\u011fl\u0131k profesyoneline y\u00f6nelik cihazlarda \u00f6zel dil uygulamas\u0131 bulunabilir.<\/strong>\n<p>\nT\u0130TCK&#8217;n\u0131n t\u0131bbi cihaz y\u00f6netmeliklerine ili\u015fkin uygulama d\u00fczenlemelerinde,\nson kullan\u0131c\u0131s\u0131 yaln\u0131zca sa\u011fl\u0131k profesyoneli olan belirli cihazlar a\u00e7\u0131s\u0131ndan etiket dili\nkonusunda \u00f6zel yakla\u015f\u0131m bulunmaktad\u0131r. Bununla birlikte \u00fcr\u00fcnle sa\u011flanan risk,\nmontaj, kullan\u0131m, bak\u0131m ve g\u00fcvenlik bilgilerinin T\u00fcrk\u00e7e sunulmas\u0131na ili\u015fkin \u015fartlar\nayr\u0131ca devam eder.\n<\/p>\n<p>\nBu nedenle \u201cprofesyonel cihazlarda T\u00fcrk\u00e7e hi\u00e7bir \u015fey gerekmez\u201d \u015feklinde genel bir\nsonu\u00e7 \u00e7\u0131kar\u0131lmamal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<h2 id=\"uts\">8. T\u0131bbi Cihaz \u0130thalat\u0131nda \u00dcTS Kayd\u0131<\/h2>\n\n<p>\nG\u00fcmr\u00fckten \u00fcr\u00fcn ge\u00e7irmek ile \u00fcr\u00fcn\u00fc T\u00fcrkiye&#8217;de mevzuata uygun \u015fekilde piyasaya arz etmek\nayn\u0131 i\u015flem de\u011fildir.\n<\/p>\n\n<p>\nT\u0131bbi cihaz ithalat\u00e7\u0131s\u0131 a\u00e7\u0131s\u0131ndan firma ve \u00fcr\u00fcn kay\u0131tlar\u0131n\u0131n \u00dcr\u00fcn Takip Sistemi\n\u00fczerindeki durumunun ayr\u0131ca de\u011ferlendirilmesi gerekir.\n<\/p>\n\n<p>\nFirma rol\u00fcne g\u00f6re \u00dcTS \u00f6ncesindeki s\u00fcre\u00e7ler de\u011fi\u015febilir.\n\u0130thalat\u00e7\u0131, da\u011f\u0131t\u0131c\u0131, sat\u0131\u015f merkezi veya \u00fcretici i\u00e7in ayn\u0131 kay\u0131t yolunun kullan\u0131laca\u011f\u0131n\u0131\nvarsaymak do\u011fru de\u011fildir.\n<\/p>\n\n<p>\n\u00dcTS firma kay\u0131t s\u00fcrecini ayr\u0131nt\u0131l\u0131 g\u00f6rmek i\u00e7in\n<a href=\"\/en\/uts-firma-kaydi-nasil-yapilir-sifirdan-tibbi-cihaz-firmasi-rehberi\/\">\n<strong>\u00dcTS Firma Kayd\u0131 Nas\u0131l Yap\u0131l\u0131r? 2026 Rehberi<\/strong>\n<\/a>\nyaz\u0131m\u0131z\u0131 inceleyebilirsiniz.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>\u00dcTS kayd\u0131 = ithalat izni de\u011fildir.<\/strong>\n<p>\n\u00dcTS \u00fcr\u00fcn\/firma kay\u0131tlar\u0131 ile Ticaret Bakanl\u0131\u011f\u0131n\u0131n TAREKS \u00fczerinden y\u00fcr\u00fctt\u00fc\u011f\u00fc\nithalat denetimi farkl\u0131 s\u00fcre\u00e7lerdir. Bir sistemde i\u015flem yap\u0131lm\u0131\u015f olmas\u0131 di\u011fer\ny\u00fck\u00fcml\u00fcl\u00fcklerin ortadan kalkt\u0131\u011f\u0131 anlam\u0131na gelmez.\n<\/p>\n<\/div>\n\n<h2 id=\"gtip\">9. T\u0131bbi Cihaz \u0130thalat\u0131nda GT\u0130P Neden \u00d6nemlidir?<\/h2>\n\n<p>\nGT\u0130P, ithalat denetimi a\u00e7\u0131s\u0131ndan \u00f6nemli bir ba\u015flang\u0131\u00e7 noktas\u0131d\u0131r.\n2026\/16 say\u0131l\u0131 Tebli\u011fin Ek-1 b\u00f6l\u00fcm\u00fcnde ithalatta denetime tabi \u00fcr\u00fcnlerin\nGT\u0130P listesi bulunmaktad\u0131r.\n<\/p>\n\n<p>\nAncak burada iki farkl\u0131 kavram kar\u0131\u015ft\u0131r\u0131lmamal\u0131d\u0131r:\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Kavram<\/th>\n<th>Anlam\u0131<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u00dcr\u00fcn\u00fcn t\u0131bbi cihaz olmas\u0131<\/td>\n<td>\u00dcr\u00fcn\u00fcn kullan\u0131m amac\u0131 ve ilgili t\u0131bbi cihaz mevzuat\u0131 \u00fczerinden belirlenir.<\/td>\n<\/tr>\n<tr>\n<td>TAREKS kapsam\u0131na girmesi<\/td>\n<td>2026\/16 Tebli\u011fi, Ek-1 GT\u0130P listesi ve Tebli\u011f kapsam\u0131 \u00fczerinden de\u011ferlendirilir.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<p>\nDolay\u0131s\u0131yla bir GT\u0130P numaras\u0131n\u0131n Ek-1&#8217;de bulunmas\u0131 tek ba\u015f\u0131na her \u00fcr\u00fcn\u00fcn t\u0131bbi cihaz\noldu\u011fu anlam\u0131na gelmez.\n<\/p>\n\n<p>\nAyn\u0131 GT\u0130P alt\u0131nda farkl\u0131 kullan\u0131m ama\u00e7lar\u0131na sahip \u00fcr\u00fcnler bulunabilir.\nGT\u0130P listesinde yer almakla birlikte t\u0131bbi cihaz y\u00f6netmelikleri kapsam\u0131na girmeyen\n\u00fcr\u00fcnler a\u00e7\u0131s\u0131ndan kapsam d\u0131\u015f\u0131 de\u011ferlendirmesi g\u00fcndeme gelebilir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>GT\u0130P&#8217;i \u00fcr\u00fcn geldikten sonra d\u00fc\u015f\u00fcnmeyin.<\/strong>\nYanl\u0131\u015f GT\u0130P veya yanl\u0131\u015f kapsam de\u011ferlendirmesi TAREKS ve g\u00fcmr\u00fck i\u015flemlerinin\nuzamas\u0131na neden olabilir. GT\u0130P tespiti g\u00fcmr\u00fck tekni\u011fi a\u00e7\u0131s\u0131ndan gerekti\u011finde\nyetkili g\u00fcmr\u00fck m\u00fc\u015faviriyle ayr\u0131ca de\u011ferlendirilmelidir.\n<\/div>\n\n<h2 id=\"tareks\">10. TAREKS Nedir?<\/h2>\n\n<p>\n<strong>TAREKS \u2013 D\u0131\u015f Ticarette Risk Esasl\u0131 Kontrol Sistemi<\/strong>,\nithalat ve ihracatta ger\u00e7ekle\u015ftirilen \u00fcr\u00fcn g\u00fcvenli\u011fi denetimlerinin elektronik\nve risk esasl\u0131 y\u00fcr\u00fct\u00fclmesini sa\u011flayan sistemdir.\n<\/p>\n\n<p>\nT\u0131bbi cihazlar\u0131n 2026 y\u0131l\u0131 ithalat denetimi,\n<strong>T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Tebli\u011fi\n(\u00dcr\u00fcn G\u00fcvenli\u011fi ve Denetimi: 2026\/16)<\/strong>\nkapsam\u0131nda TAREKS \u00fczerinden y\u00fcr\u00fct\u00fclmektedir.\n<\/p>\n\n<p>\nSistem b\u00fct\u00fcn ithalat partilerini otomatik olarak ayn\u0131 yo\u011funlukta fiziki denetime\ntabi tutmaz.\n<\/p>\n\n<p>\nRisk analizinde;\n<\/p>\n\n<ul>\n<li>firma bilgileri,<\/li>\n<li>ge\u00e7mi\u015f ithalat denetimleri,<\/li>\n<li>piyasa g\u00f6zetimi ve denetimi sonu\u00e7lar\u0131,<\/li>\n<li>\u00fcretici veya ithalat\u00e7\u0131,<\/li>\n<li>firma kullan\u0131c\u0131s\u0131,<\/li>\n<li>giri\u015f g\u00fcmr\u00fc\u011f\u00fc,<\/li>\n<li>\u00fcr\u00fcn\u00fcn cinsi,<\/li>\n<li>marka ve model,<\/li>\n<li>fiyat ve miktar,<\/li>\n<li>men\u015fe, \u00e7\u0131k\u0131\u015f ve sevk \u00fclkesi<\/li>\n<\/ul>\n\n<p>\ngibi \u00e7e\u015fitli kriterler dikkate al\u0131nabilir.\n<\/p>\n\n<h2 id=\"2026-16\">11. 2026\/16 T\u0131bbi Cihaz \u0130thalat Denetimi Tebli\u011fi<\/h2>\n\n<div class=\"kk-update\">\n<strong>2026 i\u00e7in esas al\u0131nacak d\u00fczenleme<\/strong>\n<p>\nT\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Tebli\u011fi\n(\u00dcr\u00fcn G\u00fcvenli\u011fi ve Denetimi: 2026\/16),\n31 Aral\u0131k 2025 tarihli Resm\u00ee Gazete&#8217;de yay\u0131mlanm\u0131\u015f ve\n<strong>1 Ocak 2026<\/strong> tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girmi\u015ftir.\n<\/p>\n<\/div>\n\n<p>\nTebli\u011f, Ek-1&#8217;de yer alan \u00fcr\u00fcnlerin;\n<\/p>\n\n<ul>\n<li>T\u0131bbi Cihaz Y\u00f6netmeli\u011fi ve<\/li>\n<li>\u0130n Vitro Tan\u0131 Ama\u00e7l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi<\/li>\n<\/ul>\n\n<p>\nkapsam\u0131ndaki uygunlu\u011funun ithalat a\u015famas\u0131nda denetlenmesine ili\u015fkin esaslar\u0131 d\u00fczenler.\n<\/p>\n\n<p>\n2026\/16 Tebli\u011fi, Serbest Dola\u015f\u0131ma Giri\u015f Rejiminin yan\u0131nda\n<strong>Ge\u00e7ici \u0130thalat Rejimine<\/strong> tabi tutulacak ilgili \u00fcr\u00fcnleri de kapsar.\nHari\u00e7te \u0130\u015fleme Rejimi kapsam\u0131nda ihra\u00e7 edilip geri gelen e\u015fya ise Tebli\u011fin kapsam\u0131\nd\u0131\u015f\u0131nda d\u00fczenlenmi\u015ftir.\n<\/p>\n\n<h2>TAREKS Ba\u015fvurusu Ne Zaman Yap\u0131l\u0131r?<\/h2>\n\n<p>\n2026\/16 kapsam\u0131ndaki ithalat denetimi ba\u015fvurusu,\n<strong>g\u00fcmr\u00fck beyannamesinin tescilinden \u00f6nce<\/strong> yap\u0131l\u0131r.\n<\/p>\n\n<p>\nTebli\u011f kapsam\u0131ndaki \u00fcr\u00fcnleri ithal etmek isteyen firman\u0131n TAREKS&#8217;te tan\u0131ml\u0131 olmas\u0131\nve firma ad\u0131na i\u015flem yapacak en az bir firma kullan\u0131c\u0131s\u0131n\u0131n yetkilendirilmi\u015f\nolmas\u0131 gerekir.\n<\/p>\n\n<p>\nYetkili firma kullan\u0131c\u0131s\u0131, ithal partisine ili\u015fkin bilgileri ve ilk a\u015famada\nistenen belgeleri TAREKS \u00fczerinden sisteme y\u00fckler.\n<\/p>\n\n<div class=\"kk-flow\">\n<span>\u00dcr\u00fcn<\/span>\n<span>\u2192<\/span>\n<span>GT\u0130P<\/span>\n<span>\u2192<\/span>\n<span>2026\/16 Kapsam Kontrol\u00fc<\/span>\n<span>\u2192<\/span>\n<span>TAREKS Ba\u015fvurusu<\/span>\n<span>\u2192<\/span>\n<span>Risk Analizi<\/span>\n<span>\u2192<\/span>\n<span>Referans No \/ Fiili Denetim<\/span>\n<span>\u2192<\/span>\n<span>G\u00fcmr\u00fck \u0130\u015flemleri<\/span>\n<\/div>\n\n<h2 id=\"tareks-belgeler\">12. TAREKS Ba\u015fvurusunda Hangi Belgeler \u0130stenir?<\/h2>\n\n<p>\n2026\/16 Tebli\u011fi Ek-2, TAREKS&#8217;e y\u00fcklenmesi gereken belgeleri iki a\u015famal\u0131 d\u00fc\u015f\u00fcnmeye\nimk\u00e2n verir.\n<\/p>\n\n<h3>\u0130lk ba\u015fvuru a\u015famas\u0131<\/h3>\n\n<p>E\u015fyan\u0131n durumuna g\u00f6re;<\/p>\n\n<ul>\n<li>\u00f6zet beyan,<\/li>\n<li>TIR karnesi,<\/li>\n<li>transit refakat belgesi,<\/li>\n<li>kon\u015fimento,<\/li>\n<li>CMR belgesi,<\/li>\n<li>CIM ta\u015f\u0131ma belgesi,<\/li>\n<li>serbest b\u00f6lge i\u015flem formu,<\/li>\n<li>\u00f6n stat\u00fc belgesi,<\/li>\n<li>\u00f6nceki g\u00fcmr\u00fck rejimine ili\u015fkin g\u00fcmr\u00fck beyannamesi<\/li>\n<\/ul>\n\n<p>\ngibi ilgili g\u00fcmr\u00fck\/ta\u015f\u0131ma belgelerinden e\u015fyan\u0131n durumuna uygun olanlar\u0131 ile\n<strong>fatura veya proforma fatura<\/strong> kullan\u0131l\u0131r.\n<\/p>\n\n<h3>Fiili denetime y\u00f6nlendirilirse<\/h3>\n\n<p>Ek olarak temel olarak;<\/p>\n\n<ul>\n<li><strong>AB Uygunluk Beyan\u0131,<\/strong><\/li>\n<li>\u00fcr\u00fcn\u00fcn uygunluk de\u011ferlendirme yoluna g\u00f6re uygulan\u0131yorsa Onaylanm\u0131\u015f Kurulu\u015f taraf\u0131ndan d\u00fczenlenmi\u015f ilgili AB sertifikalar\u0131,<\/li>\n<li><strong>T\u00fcrk\u00e7e etiket ve kullan\u0131m k\u0131lavuzu,<\/strong><\/li>\n<li><strong>g\u00fcmr\u00fckl\u00fc sahada \u00e7ekilmi\u015f \u00fcr\u00fcn g\u00f6rselleri<\/strong><\/li>\n<\/ul>\n\n<p>\nsisteme y\u00fcklenir.\n<\/p>\n\n<p>\nYabanc\u0131 dilde d\u00fczenlenen belirli uygunluk belgelerinin onayl\u0131 T\u00fcrk\u00e7e terc\u00fcmeleri\nde istenebilir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>Belge isimlerinin tutarl\u0131 olmas\u0131 kritik.<\/strong>\n<p>\nFaturadaki model, etiketteki model, Uygunluk Beyan\u0131ndaki \u00fcr\u00fcn tan\u0131m\u0131,\nsertifikadaki kapsam ve \u00fcr\u00fcn\u00fcn kendisi farkl\u0131 cihazlar\u0131 g\u00f6steriyorsa dosya\ndenetimde ciddi sorun ya\u015fayabilir.\n<\/p>\n<\/div>\n\n<h2 id=\"fiili-denetim\">13. TAREKS Fiili Denetimi Nas\u0131l Yap\u0131l\u0131r?<\/h2>\n\n<p>\nRisk analizi sonucunda b\u00fct\u00fcn ba\u015fvurular fiili denetime y\u00f6nlendirilmez.\nFiili denetime y\u00f6nlendirilmeyen \u00fcr\u00fcnler i\u00e7in ithalata ili\u015fkin TAREKS referans\nnumaras\u0131 sistem taraf\u0131ndan olu\u015fturulabilir.\n<\/p>\n\n<p>\nFiili denetime y\u00f6nlendirilmesi halinde denetim;\n<\/p>\n\n<ul>\n<li>belge kontrol\u00fc,<\/li>\n<li>i\u015faret kontrol\u00fc,<\/li>\n<li>fiziki muayene,<\/li>\n<li>laboratuvar testi<\/li>\n<\/ul>\n\n<p>\nunsurlar\u0131ndan birini veya birka\u00e7\u0131n\u0131 i\u00e7erebilir.\n<\/p>\n\n<h3>Belgeleri y\u00fcklemek i\u00e7in ne kadar s\u00fcre var?<\/h3>\n\n<p>\nFiili denetime y\u00f6nlendirilen \u00fcr\u00fcnlerde Tebli\u011fin Ek-2&#8217;sinin ilgili belgelerinin\n<strong>ba\u015fvuru g\u00fcn\u00fc d\u00e2hil 20 i\u015f g\u00fcn\u00fc i\u00e7erisinde<\/strong> elektronik ortamda\nTAREKS&#8217;e y\u00fcklenmesi gerekir.\n<\/p>\n\n<p>\nSistemin \u00f6ng\u00f6rd\u00fc\u011f\u00fc durumlarda ilave s\u00fcre verilebilir.\nBelgelerin belirtilen s\u00fcrede y\u00fcklenmemesi ba\u015fvurunun olumsuz sonu\u00e7lanmas\u0131na\nneden olabilir.\n<\/p>\n\n<h3>\u0130lave belge istenebilir mi?<\/h3>\n\n<p>\nEvet. Denetim birimi \u00fcr\u00fcn\u00fc de\u011ferlendirmek amac\u0131yla firmadan ilave bilgi\nve belge talep edebilir.\n<\/p>\n\n<h3>\u00dcr\u00fcn teste g\u00f6nderilebilir mi?<\/h3>\n\n<p>\nEvet. Fiili denetim gerekti\u011finde laboratuvar testini i\u00e7erebilir.\nNumune alma i\u015flemlerinde \u00fcr\u00fcn ve ba\u015fvuru bilgileri kay\u0131t alt\u0131na al\u0131n\u0131r.\n<\/p>\n\n<h2>TAREKS Referans Numaras\u0131 Ne \u0130\u015fe Yarar?<\/h2>\n\n<p>\nOlumlu sonu\u00e7lanan ilgili ba\u015fvurularda \u00fcr\u00fcn\u00fcn ithal edilebilece\u011fine ili\u015fkin\nTAREKS referans numaras\u0131 olu\u015fturulur.\n<\/p>\n\n<p>\nBu numaran\u0131n g\u00fcmr\u00fck beyannamesinin <strong>44 numaral\u0131 hanesine<\/strong>\nkaydedilmesi gerekir.\n<\/p>\n\n<p>\n2026\/16 Tebli\u011fine g\u00f6re TAREKS referans numaras\u0131 verildi\u011fi tarihten itibaren\n<strong>1 y\u0131l s\u00fcreyle ge\u00e7erlidir.<\/strong>\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>TAREKS referans numaras\u0131 \u201c\u00fcr\u00fcn uygundur\u201d sertifikas\u0131 de\u011fildir.<\/strong>\n<p>\nTebli\u011f a\u00e7\u0131k \u015fekilde, \u00fcr\u00fcn\u00fcn ithaline izin verilmesinin veya TAREKS referans numaras\u0131\nolu\u015fturulmas\u0131n\u0131n \u00fcr\u00fcn\u00fcn mevzuata uygun ve g\u00fcvenli oldu\u011fu anlam\u0131na gelmedi\u011fini belirtir.\n<\/p>\n<p>\n\u0130thalat\u00e7\u0131n\u0131n \u00fcr\u00fcn\u00fcn uygunlu\u011fu, g\u00fcvenli\u011fi ve \u00fcr\u00fcne e\u015flik eden belgelerin do\u011frulu\u011funa\nili\u015fkin sorumlulu\u011fu devam eder.\n<\/p>\n<\/div>\n\n<h2 id=\"atr\">14. A.TR Dola\u015f\u0131m Belgesi Varsa TAREKS Denetimi Yap\u0131l\u0131r m\u0131?<\/h2>\n\n<p>\n2026\/16 Tebli\u011fi A.TR Dola\u015f\u0131m Belgeli oldu\u011fu TAREKS&#8217;te beyan edilen \u00fcr\u00fcnler a\u00e7\u0131s\u0131ndan\n\u00f6zel bir uygulama \u00f6ng\u00f6rmektedir.\n<\/p>\n\n<p>\nBu \u00fcr\u00fcnlerde ithalata ili\u015fkin TAREKS referans numaras\u0131 do\u011frudan olu\u015fturulabilir.\n<\/p>\n\n<p>\nAncak bu durum <strong>mutlak denetim muafiyeti<\/strong> olarak yorumlanmamal\u0131d\u0131r.\nTebli\u011f, risk analizi sonucunda A.TR kapsam\u0131ndaki \u00fcr\u00fcnlerin de fiili denetime\ny\u00f6nlendirilebilmesine imk\u00e2n vermektedir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>A.TR ile CE ayn\u0131 belge de\u011fildir.<\/strong>\nA.TR, e\u015fyan\u0131n g\u00fcmr\u00fck stat\u00fcs\u00fc ve serbest dola\u015f\u0131mla ili\u015fkili bir belgedir.\n\u00dcr\u00fcn\u00fcn t\u0131bbi cihaz mevzuat\u0131na uygunlu\u011funu g\u00f6steren CE\/uygunluk belgelerinin\nyerine ge\u00e7mez.\n<\/div>\n\n<h2 id=\"ret\">15. TAREKS Ba\u015fvurusu Reddedilirse Ne Olur?<\/h2>\n\n<p>\nFiili denetim sonucunda mevzuata ayk\u0131r\u0131l\u0131k tespit edilmesi veya istenen belgelerin\ns\u00fcresi i\u00e7inde sunulmamas\u0131 halinde ba\u015fvuru olumsuz sonu\u00e7lanabilir.\n<\/p>\n\n<p>\n\u00d6zellikle;\n<\/p>\n\n<ul>\n<li>belge eksikli\u011fi,<\/li>\n<li>i\u015faretleme eksikli\u011fi,<\/li>\n<li>uygunsuz test sonucu,<\/li>\n<li>yanl\u0131\u015f veya yan\u0131lt\u0131c\u0131 belge,<\/li>\n<li>belgenin ilgili ki\u015fi veya kurulu\u015f taraf\u0131ndan d\u00fczenlenmedi\u011finin tespiti<\/li>\n<\/ul>\n\n<p>\nfarkl\u0131 sonu\u00e7lar do\u011furabilir.\n<\/p>\n\n<h3>Ret karar\u0131na itiraz edilebilir mi?<\/h3>\n\n<p>\nTicaret Bakanl\u0131\u011f\u0131n\u0131n 2026 T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Rehberinde,\nbelirli ret t\u00fcrlerinde TAREKS \u00fczerinden yeniden de\u011ferlendirme\/itiraz mekanizmas\u0131\n\u00f6ng\u00f6r\u00fclmektedir.\n<\/p>\n\n<p>\nAncak b\u00fct\u00fcn ret t\u00fcrleri ayn\u0131 \u015fekilde itiraza a\u00e7\u0131k de\u011fildir.\n\u00d6rne\u011fin yan\u0131lt\u0131c\u0131 i\u015flem veya ilgilisince d\u00fczenlenmemi\u015f belge gibi durumlarda\nfarkl\u0131 h\u00fck\u00fcmler uygulanabilir.\n<\/p>\n\n<p>\nTest sonu\u00e7lar\u0131na itiraz i\u00e7in ise rehberde\n<strong>15 i\u015f g\u00fcnl\u00fck s\u00fcre<\/strong> \u00f6ng\u00f6r\u00fclmektedir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Ret ald\u0131ktan sonra belge \u00fcretmeye \u00e7al\u0131\u015fmak yerine ithalat \u00f6ncesi dosyay\u0131 kontrol edin.<\/strong>\n\u00d6zellikle Uygunluk Beyan\u0131, sertifika, etiket, IFU ve \u00fcr\u00fcn model e\u015fle\u015fmesini\nsipari\u015f verilmeden \u00f6nce kontrol etmek \u00e7o\u011fu sorunu daha \u00fcr\u00fcn yola \u00e7\u0131kmadan \u00f6nleyebilir.\n<\/div>\n\n<h2 id=\"cin\">16. \u00c7in&#8217;den T\u0131bbi Cihaz \u0130thal Edilebilir mi?<\/h2>\n\n<p>\nEvet. Bir t\u0131bbi cihaz\u0131n \u00c7in&#8217;de \u00fcretilmi\u015f olmas\u0131 tek ba\u015f\u0131na T\u00fcrkiye&#8217;ye ithal edilmesine\nengel de\u011fildir.\n<\/p>\n\n<p>\nAncak \u00c7in&#8217;deki \u00fcreticinin \u00fcr\u00fcn\u00fc i\u00e7in T\u00fcrkiye&#8217;de ge\u00e7erli t\u0131bbi cihaz mevzuat\u0131n\u0131n\ngerekliliklerini kar\u015f\u0131lamas\u0131 gerekir.\n<\/p>\n\n<h3>\u00c7in&#8217;deki \u00fcreticide ne kontrol edilmeli?<\/h3>\n\n<ol>\n<li>\u00dcr\u00fcn\u00fcn ger\u00e7ekten t\u0131bbi cihaz olup olmad\u0131\u011f\u0131,<\/li>\n<li>ama\u00e7lanan kullan\u0131m\u0131,<\/li>\n<li>risk s\u0131n\u0131f\u0131,<\/li>\n<li>CE i\u015fareti,<\/li>\n<li>AB Uygunluk Beyan\u0131,<\/li>\n<li>gerekiyorsa Onaylanm\u0131\u015f Kurulu\u015f sertifikas\u0131,<\/li>\n<li>yetkili temsilci yap\u0131s\u0131,<\/li>\n<li>UDI bilgileri,<\/li>\n<li>etiket ve kullan\u0131m k\u0131lavuzu,<\/li>\n<li>\u00fcr\u00fcn ve belge model bilgilerinin uyumu,<\/li>\n<li>T\u00fcrkiye&#8217;deki \u00dcTS ve ithalat s\u00fcre\u00e7lerine uygunluk<\/li>\n<\/ol>\n\n<p>\nkontrol edilmelidir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Alibaba&#8217;da \u201cCE Certified\u201d yazmas\u0131 mevzuat kan\u0131t\u0131 de\u011fildir.<\/strong>\n<p>\n\u00dcr\u00fcn ilan\u0131ndaki CE logosu veya sat\u0131c\u0131n\u0131n size g\u00f6nderdi\u011fi tek sayfal\u0131k bir\n\u201ccertificate\u201d yerine cihaz\u0131n b\u00fct\u00fcn uygunluk yap\u0131s\u0131 kontrol edilmelidir.\n<\/p>\n<\/div>\n\n<h2>Amazon, Alibaba veya AliExpress&#8217;ten Medikal \u00dcr\u00fcn Getirip Satabilir miyim?<\/h2>\n\n<p>\n\u00dcr\u00fcn\u00fcn internet \u00fczerinden sat\u0131n al\u0131nm\u0131\u015f olmas\u0131 ticari piyasaya arz y\u00fck\u00fcml\u00fcl\u00fcklerini\nortadan kald\u0131rmaz.\n<\/p>\n\n<p>\nT\u00fcrkiye&#8217;de sat\u0131\u015f amac\u0131yla getirilen t\u0131bbi cihaz a\u00e7\u0131s\u0131ndan;\n<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn uygunlu\u011fu,<\/li>\n<li>ithalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fckleri,<\/li>\n<li>\u00dcTS,<\/li>\n<li>uygulanabilir TAREKS s\u00fcreci,<\/li>\n<li>sat\u0131\u015f merkezi h\u00fck\u00fcmleri ve<\/li>\n<li>sat\u0131\u015f\/reklam kurallar\u0131<\/li>\n<\/ul>\n\n<p>\nayr\u0131ca de\u011ferlendirilir.\n<\/p>\n\n<p>\nT\u00fcrkiye&#8217;de cihaz\u0131n sat\u0131\u015f taraf\u0131n\u0131 planl\u0131yorsan\u0131z\n<a href=\"\/en\/tibbi-cihaz-satis-merkezi-nasil-acilir\/\">\n<strong>T\u0131bbi Cihaz Sat\u0131\u015f Merkezi Nas\u0131l A\u00e7\u0131l\u0131r? 2026 Rehberimizi<\/strong>\n<\/a>\nve\n<a href=\"\/en\/tibbi-cihaz-internetten-satilir-mi\/\">\n<strong>T\u0131bbi Cihaz \u0130nternetten Sat\u0131l\u0131r m\u0131? 2026 Rehberimizi<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"numune\">17. T\u0131bbi Cihaz Numunesi \u0130thal Edilebilir mi?<\/h2>\n\n<p>\n\u201cNumune\u201d ifadesinin kullan\u0131lmas\u0131 \u00fcr\u00fcn\u00fcn otomatik olarak t\u0131bbi cihaz mevzuat\u0131 veya\ng\u00fcmr\u00fck mevzuat\u0131 d\u0131\u015f\u0131na \u00e7\u0131kt\u0131\u011f\u0131 anlam\u0131na gelmez.\n<\/p>\n\n<p>\n\u00dcr\u00fcn\u00fcn;\n<\/p>\n\n<ul>\n<li>ticari sat\u0131\u015f amac\u0131,<\/li>\n<li>test veya de\u011ferlendirme amac\u0131,<\/li>\n<li>klinik ara\u015ft\u0131rma amac\u0131,<\/li>\n<li>fuar\/sergi amac\u0131 veya<\/li>\n<li>ba\u015fka bir \u00f6zel kullan\u0131m<\/li>\n<\/ul>\n\n<p>\ni\u00e7in getiriliyor olmas\u0131 farkl\u0131 mevzuat sonu\u00e7lar\u0131 do\u011furabilir.\n<\/p>\n\n<p>\nBu nedenle numune ithalat\u0131nda \u00fcr\u00fcn\u00fcn amac\u0131, miktar\u0131 ve uygulanacak g\u00fcmr\u00fck rejimi\nsomut olay \u00fczerinden de\u011ferlendirilmelidir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>\u201cSadece bir tane getiriyorum\u201d tek ba\u015f\u0131na muafiyet gerek\u00e7esi de\u011fildir.<\/strong>\n\u00dcr\u00fcn\u00fcn hangi ama\u00e7la getirildi\u011fi ve piyasaya arz edilip edilmeyece\u011fi \u00f6nemlidir.\n<\/div>\n\n<h2 id=\"marka\">18. \u00c7in&#8217;deki \u00dcr\u00fcn\u00fc Kendi Markamla T\u00fcrkiye&#8217;de Satabilir miyim?<\/h2>\n\n<p>\nBu konu basit bir \u201cprivate label\u201d i\u015flemi olarak g\u00f6r\u00fclmemelidir.\nT\u0131bbi cihaz mevzuat\u0131nda \u00fcr\u00fcn\u00fc kendi ad\u0131n\u0131z veya ticari markan\u0131z alt\u0131nda piyasaya sunman\u0131z,\nbelirli durumlarda <strong>imalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerini \u00fcstlenmenize<\/strong> neden olabilir.\n<\/p>\n\n<p>\nAyn\u0131 \u015fekilde;\n<\/p>\n\n<ul>\n<li>cihaz\u0131n kullan\u0131m amac\u0131n\u0131n de\u011fi\u015ftirilmesi veya<\/li>\n<li>\u00fcr\u00fcn\u00fcn mevzuata uygunlu\u011funu etkileyebilecek bi\u00e7imde modifiye edilmesi<\/li>\n<\/ul>\n\n<p>\nde ithalat\u00e7\u0131 veya da\u011f\u0131t\u0131c\u0131n\u0131n imalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerini \u00fcstlenmesine yol a\u00e7abilir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Marka basmadan \u00f6nce mevzuat rol\u00fcn\u00fcz\u00fc belirleyin.<\/strong>\n<p>\nHaz\u0131r \u00fcr\u00fcn\u00fc \u00c7in&#8217;den getirip \u00fczerine kendi markan\u0131z\u0131 koymak yaln\u0131zca bir pazarlama\nkarar\u0131 de\u011fildir. T\u0131bbi cihaz mevzuat\u0131ndaki \u201cimalat\u00e7\u0131\u201d tan\u0131m\u0131n\u0131 ve Madde 16 h\u00fck\u00fcmlerini\ndo\u011frudan etkileyebilir.\n<\/p>\n<\/div>\n\n<h2>19. UDI \u0130thalat\u00e7\u0131 \u0130\u00e7in Neden \u00d6nemlidir?<\/h2>\n\n<p>\n\u0130thalat\u00e7\u0131, uygulanabilir oldu\u011funda \u00fcretici taraf\u0131ndan UDI tahsis edildi\u011fini do\u011frulamakla\ny\u00fck\u00fcml\u00fcd\u00fcr.\n<\/p>\n\n<p>\nUDI bilgilerinin;\n<\/p>\n\n<ul>\n<li>\u00fcr\u00fcn etiketi,<\/li>\n<li>teknik dok\u00fcmantasyon,<\/li>\n<li>\u00dcTS\/EUDAMED kay\u0131tlar\u0131 ve<\/li>\n<li>ithal edilen ger\u00e7ek \u00fcr\u00fcn<\/li>\n<\/ul>\n\n<p>\naras\u0131nda tutarl\u0131 olmas\u0131 \u00f6nemlidir.\n<\/p>\n\n<p>\nUDI yap\u0131s\u0131 hakk\u0131nda ayr\u0131nt\u0131l\u0131 bilgi i\u00e7in\n<a href=\"\/en\/udi-di-ve-udi-pi-olusturma-rehberi-tum-adimlar-ve-ornekler\/\">\n<strong>UDI-DI, UDI-PI ve Basic UDI-DI Olu\u015fturma Rehberimizi<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2>20. EUDAMED Kayd\u0131 \u0130thalat A\u00e7\u0131s\u0131ndan \u00d6nemli mi?<\/h2>\n\n<p>\nT\u0131bbi cihazlar\u0131n Avrupa d\u00fczenleyici kay\u0131t yap\u0131s\u0131 ile T\u00fcrkiye&#8217;deki \u00fcr\u00fcn kay\u0131t ve ithalat\ni\u015flemleri birbirinden tamamen ba\u011f\u0131ms\u0131z d\u00fc\u015f\u00fcn\u00fclmemelidir.\n<\/p>\n\n<p>\n\u00d6zellikle \u00fcretici, yetkili temsilci, UDI-DI, Basic UDI-DI, cihaz ad\u0131, model,\nrisk s\u0131n\u0131f\u0131 ve sertifika bilgilerindeki tutars\u0131zl\u0131klar farkl\u0131 kay\u0131t sistemlerinde\nsorun olu\u015fturabilir.\n<\/p>\n\n<p>\nEUDAMED taraf\u0131ndaki kay\u0131t s\u00fcre\u00e7leri i\u00e7in\n<a href=\"\/en\/service\/eudamed-urun-kayit\/\">\n<strong>KaliteKit EUDAMED \u00dcr\u00fcn Kay\u0131t Deste\u011fini<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2>21. T\u0131bbi Cihaz \u0130thalat S\u00fcreci Ad\u0131m Ad\u0131m<\/h2>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Ad\u0131m<\/th>\n<th>Kontrol<\/th>\n<th>Temel \u00e7\u0131kt\u0131<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>\u00dcr\u00fcn kapsam\u0131<\/td>\n<td>T\u0131bbi cihaz \/ IVD \/ ba\u015fka mevzuat<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>Ama\u00e7lanan kullan\u0131m ve s\u0131n\u0131fland\u0131rma<\/td>\n<td>Risk s\u0131n\u0131f\u0131 ve mevzuat yolu<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>\u00dcretici kontrol\u00fc<\/td>\n<td>Do\u011fru \u00fcretici ve \u00fcr\u00fcn e\u015fle\u015fmesi<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>CE ve uygunluk belgeleri<\/td>\n<td>AB Uygunluk Beyan\u0131 + uygulanabilir sertifikalar<\/td>\n<\/tr>\n<tr>\n<td>5<\/td>\n<td>Yetkili temsilci<\/td>\n<td>Gerekliyse ge\u00e7erli temsilci yap\u0131s\u0131<\/td>\n<\/tr>\n<tr>\n<td>6<\/td>\n<td>UDI<\/td>\n<td>UDI-DI \/ uygulanabilir \u00fcr\u00fcn tan\u0131mlamalar\u0131<\/td>\n<\/tr>\n<tr>\n<td>7<\/td>\n<td>Etiket ve IFU<\/td>\n<td>T\u00fcrkiye piyasas\u0131na uygun \u00fcr\u00fcn bilgileri<\/td>\n<\/tr>\n<tr>\n<td>8<\/td>\n<td>\u0130thalat\u00e7\u0131 bilgileri<\/td>\n<td>\u0130thalat\u00e7\u0131 ad\u0131\/adresi<\/td>\n<\/tr>\n<tr>\n<td>9<\/td>\n<td>\u00dcTS<\/td>\n<td>Firma ve \u00fcr\u00fcn kay\u0131tlar\u0131n\u0131n de\u011ferlendirilmesi<\/td>\n<\/tr>\n<tr>\n<td>10<\/td>\n<td>GT\u0130P<\/td>\n<td>Do\u011fru g\u00fcmr\u00fck s\u0131n\u0131fland\u0131rmas\u0131<\/td>\n<\/tr>\n<tr>\n<td>11<\/td>\n<td>2026\/16 kapsam kontrol\u00fc<\/td>\n<td>TAREKS gereklili\u011fi<\/td>\n<\/tr>\n<tr>\n<td>12<\/td>\n<td>TAREKS<\/td>\n<td>Ba\u015fvuru \/ risk analizi<\/td>\n<\/tr>\n<tr>\n<td>13<\/td>\n<td>Fiili denetim gerekiyorsa<\/td>\n<td>Belge, i\u015faret, fiziki kontrol ve\/veya test<\/td>\n<\/tr>\n<tr>\n<td>14<\/td>\n<td>TAREKS referans numaras\u0131<\/td>\n<td>G\u00fcmr\u00fck beyannamesi i\u015flemi<\/td>\n<\/tr>\n<tr>\n<td>15<\/td>\n<td>Piyasaya arz<\/td>\n<td>Sat\u0131\u015f ve izlenebilirlik s\u00fcreci<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<h2 id=\"kontrol\">T\u0131bbi Cihaz \u0130thal Etmeden \u00d6nce 20 Soruluk Kontrol Listesi<\/h2>\n\n<div class=\"kk-check\">\n<ol>\n<li>\u00dcr\u00fcn ger\u00e7ekten t\u0131bbi cihaz m\u0131?<\/li>\n<li>\u00dcr\u00fcn\u00fcn ama\u00e7lanan kullan\u0131m\u0131 a\u00e7\u0131k m\u0131?<\/li>\n<li>Risk s\u0131n\u0131f\u0131 do\u011fru belirlenmi\u015f mi?<\/li>\n<li>\u00dcreticinin tam ticari unvan\u0131 ve adresi mevcut mu?<\/li>\n<li>CE i\u015fareti uygun mu?<\/li>\n<li>AB Uygunluk Beyan\u0131 \u00fcr\u00fcn\u00fc ger\u00e7ekten kaps\u0131yor mu?<\/li>\n<li>Onaylanm\u0131\u015f Kurulu\u015f gerekiyorsa sertifika ge\u00e7erli mi?<\/li>\n<li>\u00dcretici T\u00fcrkiye\/AB d\u0131\u015f\u0131ndaysa yetkili temsilci yap\u0131s\u0131 uygun mu?<\/li>\n<li>UDI-DI bilgileri mevcut ve tutarl\u0131 m\u0131?<\/li>\n<li>Etiket \u00fcr\u00fcn ve belgelerle ayn\u0131 modeli g\u00f6steriyor mu?<\/li>\n<li>T\u00fcrkiye&#8217;deki dil gereklilikleri kar\u015f\u0131lan\u0131yor mu?<\/li>\n<li>\u0130thalat\u00e7\u0131 ad\u0131 ve adresinin g\u00f6sterimi planland\u0131 m\u0131?<\/li>\n<li>Firman\u0131n \u00dcTS rol\u00fc\/kay\u0131t durumu uygun mu?<\/li>\n<li>\u00dcr\u00fcn kay\u0131t s\u00fcreci tamamlanabilir durumda m\u0131?<\/li>\n<li>GT\u0130P do\u011fru belirlendi mi?<\/li>\n<li>GT\u0130P 2026\/16 Tebli\u011fi Ek-1 kapsam\u0131nda m\u0131?<\/li>\n<li>TAREKS firma kullan\u0131c\u0131s\u0131 yetkilendirilmi\u015f mi?<\/li>\n<li>Fatura\/proforma bilgileri belgelerle uyumlu mu?<\/li>\n<li>Fiili denetime girerse gerekli uygunluk belgeleri haz\u0131r m\u0131?<\/li>\n<li>\u00dcr\u00fcn geldikten sonraki depolama, \u015fik\u00e2yet ve geri \u00e7a\u011f\u0131rma s\u00fcre\u00e7leri planland\u0131 m\u0131?<\/li>\n<\/ol>\n<\/div>\n\n<div class=\"kk-cta\">\n<h2>T\u0131bbi Cihaz \u0130thalat\u0131nda \u0130lk Kontrol\u00fc Sipari\u015ften \u00d6nce Yap\u0131n<\/h2>\n\n<p>\nYurt d\u0131\u015f\u0131ndan t\u0131bbi cihaz sat\u0131n almadan \u00f6nce \u00fcr\u00fcn\u00fcn CE, \u00fcretici,\nyetkili temsilci, UDI, etiket, \u00dcTS ve TAREKS a\u00e7\u0131s\u0131ndan \u00f6n de\u011ferlendirmesinin\nyap\u0131lmas\u0131 sonradan olu\u015fabilecek kay\u0131t ve ithalat sorunlar\u0131n\u0131 azaltabilir.\n<\/p>\n\n<a href=\"\/en\/tibbi-cihaz-siniflandirma-araci\/\">Cihaz S\u0131n\u0131f\u0131n\u0131 Kontrol Et<\/a>\n<a href=\"\/en\/tibbi-cihaz-ce-belgesi-nasil-alinir\/\">CE S\u00fcrecini \u0130ncele<\/a>\n<a href=\"\/en\/uts-firma-kaydi-nasil-yapilir-sifirdan-tibbi-cihaz-firmasi-rehberi\/\">\u00dcTS Firma Kayd\u0131<\/a>\n<a href=\"\/en\/iletisim\/\">KaliteKit ile \u0130leti\u015fime Ge\u00e7<\/a>\n<\/div>\n\n<h2 id=\"sss\">T\u0131bbi Cihaz \u0130thalat\u0131 Hakk\u0131nda S\u0131k Sorulan Sorular<\/h2>\n\n<div class=\"kk-faq\">\n<h3>CE belgeli her t\u0131bbi cihaz T\u00fcrkiye&#8217;ye ithal edilebilir mi?<\/h3>\n<p>\nHay\u0131r. CE i\u015fareti \u00f6nemli bir uygunluk unsurudur ancak tek ba\u015f\u0131na ithalat\u0131n b\u00fct\u00fcn\ngerekliliklerinin kar\u015f\u0131land\u0131\u011f\u0131n\u0131 g\u00f6stermez. \u00dcretici, Uygunluk Beyan\u0131, sertifikalar,\nyetkili temsilci, etiket, IFU, UDI, \u00dcTS ve uygulanabilir TAREKS gereklilikleri\nayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>T\u0131bbi cihaz ithalat\u0131nda TAREKS zorunlu mu?<\/h3>\n<p>\n2026\/16 say\u0131l\u0131 Tebli\u011fin Ek-1 kapsam\u0131na giren ilgili \u00fcr\u00fcnlerin ithalat denetimi\nTAREKS \u00fczerinden y\u00fcr\u00fct\u00fcl\u00fcr. \u00dcr\u00fcn ve GT\u0130P \u00f6zelinde kapsam kontrol\u00fc yap\u0131lmal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>TAREKS ba\u015fvurusu ne zaman yap\u0131l\u0131r?<\/h3>\n<p>\n2026\/16 kapsam\u0131ndaki denetimler g\u00fcmr\u00fck beyannamesinin tescilinden \u00f6nce y\u00fcr\u00fct\u00fcl\u00fcr.\nFirma kullan\u0131c\u0131s\u0131 ba\u015fvuruyu TAREKS \u00fczerinden ger\u00e7ekle\u015ftirir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>TAREKS i\u00e7in hangi belgeler gerekir?<\/h3>\n<p>\n\u0130lk a\u015famada e\u015fyan\u0131n durumuna uygun g\u00fcmr\u00fck\/ta\u015f\u0131ma belgeleri ile fatura veya proforma\nfatura kullan\u0131l\u0131r. Fiili denetime y\u00f6nlendirilmesi halinde AB Uygunluk Beyan\u0131,\nuygulanabilir sertifikalar, T\u00fcrk\u00e7e etiket ve kullan\u0131m k\u0131lavuzu ile g\u00fcmr\u00fckl\u00fc\nsahada \u00e7ekilen \u00fcr\u00fcn g\u00f6rselleri istenir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>TAREKS referans numaras\u0131 \u00fcr\u00fcn\u00fcn uygun oldu\u011funu g\u00f6sterir mi?<\/h3>\n<p>\nHay\u0131r. 2026\/16 Tebli\u011fi TAREKS referans numaras\u0131n\u0131n \u00fcr\u00fcn\u00fcn mevzuata uygun veya\ng\u00fcvenli oldu\u011funun ispat\u0131 olarak kullan\u0131lamayaca\u011f\u0131n\u0131 a\u00e7\u0131k\u00e7a d\u00fczenler.\n\u0130thalat\u00e7\u0131n\u0131n sorumlulu\u011fu devam eder.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>\u00c7in&#8217;den t\u0131bbi cihaz getirilebilir mi?<\/h3>\n<p>\nEvet. Men\u015fe \u00fclkenin \u00c7in olmas\u0131 tek ba\u015f\u0131na ithalata engel de\u011fildir.\nAncak \u00fcr\u00fcn\u00fcn T\u00fcrkiye&#8217;de uygulanabilir t\u0131bbi cihaz mevzuat\u0131na uygun olmas\u0131,\n\u00fcretici ve yetkili temsilci yap\u0131s\u0131n\u0131n do\u011fru olmas\u0131 ve \u00dcTS\/TAREKS dahil ilgili\nithalat ve piyasaya arz y\u00fck\u00fcml\u00fcl\u00fcklerinin kar\u015f\u0131lanmas\u0131 gerekir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>\u0130thalat\u00e7\u0131n\u0131n ad\u0131 \u00fcr\u00fcn \u00fczerinde bulunmal\u0131 m\u0131?<\/h3>\n<p>\n\u0130thalat\u00e7\u0131 kendi ad\u0131n\u0131, kay\u0131tl\u0131 ticari unvan\u0131n\u0131 veya markas\u0131n\u0131 ve ula\u015f\u0131labilecek\nadresini cihaz\u0131n, ambalaj\u0131n veya cihaz\u0131n beraberindeki bir dok\u00fcman\u0131n \u00fczerinde\nbelirtmelidir. Kullan\u0131lan ilave etiket \u00fcreticinin sa\u011flad\u0131\u011f\u0131 bilgileri kapatmamal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>T\u0131bbi cihaz ithalat\u0131nda T\u00fcrk\u00e7e kullan\u0131m k\u0131lavuzu gerekli mi?<\/h3>\n<p>\nT\u00fcrkiye piyasas\u0131 a\u00e7\u0131s\u0131ndan uygulanabilir dil gereklilikleri kar\u015f\u0131lanmal\u0131d\u0131r.\n2026\/16 Tebli\u011fi Ek-2, fiili denetim belgeleri aras\u0131nda T\u00fcrk\u00e7e etiket ve kullan\u0131m\nk\u0131lavuzunu a\u00e7\u0131k\u00e7a saymaktad\u0131r. Yaln\u0131zca sa\u011fl\u0131k profesyonellerine y\u00f6nelik belirli\ncihazlarda T\u0130TCK uygulamalar\u0131ndaki \u00f6zel dil h\u00fck\u00fcmleri ayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>A.TR belgesi olan t\u0131bbi cihaz denetlenmez mi?<\/h3>\n<p>\nA.TR beyan edilen ilgili \u00fcr\u00fcnler i\u00e7in TAREKS referans numaras\u0131n\u0131n do\u011frudan\nolu\u015fturulmas\u0131na ili\u015fkin h\u00fck\u00fcm vard\u0131r. Ancak risk analizi sonucunda bu \u00fcr\u00fcnlerin de\nfiili denetime y\u00f6nlendirilmesi m\u00fcmk\u00fcnd\u00fcr.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>\u00dcTS kayd\u0131 varsa TAREKS&#8217;e gerek yok mu?<\/h3>\n<p>\nHay\u0131r. \u00dcTS ve TAREKS farkl\u0131 s\u00fcre\u00e7lerdir. \u00dcTS kayd\u0131 \u00fcr\u00fcn\u00fcn TAREKS kapsam\u0131ndaki\nithalat denetimi y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn\u00fc otomatik olarak ortadan kald\u0131rmaz.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Kendi markamla yabanc\u0131 \u00fcreticiden t\u0131bbi cihaz getirebilir miyim?<\/h3>\n<p>\nBu m\u00fcmk\u00fcnd\u00fcr ancak kendi ad\u0131n\u0131z veya markan\u0131z alt\u0131nda cihaz\u0131 piyasada bulundurman\u0131z\nbelirli durumlarda mevzuat a\u00e7\u0131s\u0131ndan imalat\u00e7\u0131 y\u00fck\u00fcml\u00fcl\u00fcklerini \u00fcstlenmenize neden\nolabilir. Bu nedenle private-label modeline ge\u00e7meden \u00f6nce Madde 16 kapsam\u0131nda\nrol analizi yap\u0131lmal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>TAREKS&#8217;te test sonucuna itiraz edilebilir mi?<\/h3>\n<p>\n2026 T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Rehberinde test sonu\u00e7lar\u0131na itiraz i\u00e7in\n15 i\u015f g\u00fcnl\u00fck s\u00fcre bulunmaktad\u0131r. Di\u011fer ret t\u00fcrlerinde uygulanacak itiraz yolu\nret nedenine g\u00f6re de\u011fi\u015febilir.\n<\/p>\n<\/div>\n\n<h2>Sonu\u00e7: T\u0131bbi Cihaz \u0130thalat\u0131 Sipari\u015fle De\u011fil, Mevzuat Kontrol\u00fcyle Ba\u015flamal\u0131<\/h2>\n\n<p>\n<strong>T\u0131bbi cihaz ithalat\u0131 nas\u0131l yap\u0131l\u0131r?<\/strong> sorusunun do\u011fru cevab\u0131\n\u201c\u00fcr\u00fcn\u00fc sat\u0131n al, g\u00fcmr\u00fc\u011fe geldi\u011finde TAREKS i\u015flemini yap\u201d de\u011fildir.\n<\/p>\n\n<p>\nSa\u011fl\u0131kl\u0131 bir ithalat s\u00fcreci;\n<\/p>\n\n<p>\n<strong>\n\u00dcr\u00fcn kapsam\u0131 \u2192 S\u0131n\u0131fland\u0131rma \u2192 \u00dcretici \u2192 CE\/Uygunluk Beyan\u0131 \u2192\nYetkili Temsilci \u2192 UDI \u2192 Etiket\/IFU \u2192 \u0130thalat\u00e7\u0131 \u2192\n\u00dcTS \u2192 GT\u0130P \u2192 TAREKS \u2192 G\u00fcmr\u00fck \u2192 Piyasaya Arz\n<\/strong>\n<\/p>\n\n<p>\n\u015feklinde planlanmal\u0131d\u0131r.\n<\/p>\n\n<p>\n\u00d6zellikle y\u00fcksek adetli sipari\u015flerde mevzuat kontrol\u00fcn\u00fcn \u00fcr\u00fcn T\u00fcrkiye&#8217;ye geldikten\nsonra de\u011fil, sat\u0131n alma karar\u0131 verilmeden \u00f6nce yap\u0131lmas\u0131 b\u00fcy\u00fck \u00f6nem ta\u015f\u0131r.\n<\/p>\n\n<hr>\n\n<section class=\"kk-source\">\n\n<h2>Mevzuat ve Resm\u00ee Kaynaklar<\/h2>\n\n<p>\nBu rehber haz\u0131rlan\u0131rken ba\u015fta a\u015fa\u011f\u0131daki g\u00fcncel d\u00fczenlemeler esas al\u0131nm\u0131\u015ft\u0131r:\n<\/p>\n\n<ul>\n<li>T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Tebli\u011fi (\u00dcr\u00fcn G\u00fcvenli\u011fi ve Denetimi: 2026\/16),<\/li>\n<li>Ticaret Bakanl\u0131\u011f\u0131 T\u0131bbi Cihazlar\u0131n \u0130thalat Denetimi Rehberi \u2013 Uygulama Esaslar\u0131na \u0130li\u015fkin El Kitab\u0131 2026,<\/li>\n<li>T\u0131bbi Cihaz Y\u00f6netmeli\u011fi, \u00f6zellikle Madde 11, Madde 13 ve Madde 16,<\/li>\n<li>\u0130n Vitro Tan\u0131 Ama\u00e7l\u0131 T\u0131bbi Cihaz Y\u00f6netmeli\u011fi,<\/li>\n<li>T\u0130TCK T\u0131bbi Cihaz Y\u00f6netmeliklerine \u0130li\u015fkin Genelge 2024\/2,<\/li>\n<li>7223 say\u0131l\u0131 \u00dcr\u00fcn G\u00fcvenli\u011fi ve Teknik D\u00fczenlemeler Kanunu.<\/li>\n<\/ul>\n\n<p>\n<strong>Son g\u00f6zden ge\u00e7irme:<\/strong> 14 Eyl\u00fcl 2026\n<\/p>\n\n<p>\n<strong>Bilgilendirme:<\/strong>\nBu i\u00e7erik genel t\u0131bbi cihaz mevzuat\u0131 ve \u00fcr\u00fcn g\u00fcvenli\u011fi bilgilendirmesi amac\u0131yla\nhaz\u0131rlanm\u0131\u015ft\u0131r. GT\u0130P s\u0131n\u0131fland\u0131rmas\u0131, g\u00fcmr\u00fck vergileri, g\u00fcmr\u00fck rejimleri ve\ng\u00fcmr\u00fck beyannamesine ili\u015fkin i\u015flemler somut \u00fcr\u00fcn ve ithalat i\u015flemine g\u00f6re\nyetkili g\u00fcmr\u00fck m\u00fc\u015faviriyle ayr\u0131ca de\u011ferlendirilmelidir.\n<\/p>\n\n<\/section>\n\n<\/article>","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi cihaz ithalat\u0131, yurt d\u0131\u015f\u0131ndan bir \u00fcr\u00fcn sat\u0131n al\u0131p T\u00fcrkiye&#8217;ye getirmekten ibaret de\u011fildir. \u0130thal edilecek \u00fcr\u00fcn\u00fcn ger\u00e7ekten t\u0131bbi cihaz olup [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","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":""},"categories":[],"tags":[],"class_list":["post-18010","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/18010","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"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=18010"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/18010\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=18010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=18010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=18010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}