{"id":15898,"date":"2020-04-10T12:17:12","date_gmt":"2020-04-10T12:17:12","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=15898"},"modified":"2022-06-09T12:48:44","modified_gmt":"2022-06-09T12:48:44","slug":"covid-19-tedbirleri-tibbi-tani-kitlerinin-ithalati-izne-tabi-olacak","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2020\/04\/10\/covid-19-tedbirleri-tibbi-tani-kitlerinin-ithalati-izne-tabi-olacak\/","title":{"rendered":"COVID-19 Tedbirleri: T\u0131bbi Tan\u0131 Kitlerinin \u0130thalat\u0131 \u0130zne Tabi Olacak"},"content":{"rendered":"<p><strong>Yeni Geli\u015fmeler<\/strong><\/p>\n<p>T\u0131bbi Tan\u0131 Kitlerinin \u0130thaline \u0130li\u015fkin Tebli\u011f (&#8220;<strong>Tebli\u011f<\/strong>&#8220;) 2 Nisan 2020 tarihli 31087 say\u0131l\u0131 Resmi Gazete&#8217;de yay\u0131mland\u0131. Tebli\u011f uyar\u0131nca COVID-19 te\u015fhislerinde kullan\u0131labilen reaktifler, standart (referans maddeleri) ve belirli ba\u011f\u0131\u015f\u0131kl\u0131k \u00fcr\u00fcnlerinin (birlikte &#8220;t\u0131bbi tan\u0131 kitleri&#8221;) ithalat\u0131 i\u00e7in T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu&#8217;nun (&#8220;<strong>Kurum<\/strong>&#8220;) uygunluk yaz\u0131s\u0131 aranacak. Kurum, ge\u00e7ti\u011fimiz g\u00fcnlerde yapt\u0131\u011f\u0131 duyurularda Tebli\u011f&#8217;e istinaden yap\u0131lacak ithalat izni ba\u015fvuru usul\u00fcne ili\u015fkin a\u00e7\u0131klamalarda bulundu.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>\u00d6n izin belgeleri V\u00fccut D\u0131\u015f\u0131nda Kullan\u0131lan (In-vitro) T\u0131bbi Tan\u0131 Cihazlar\u0131 Y\u00f6netmeli\u011fi (&#8220;<strong>Y\u00f6netmelik<\/strong>&#8220;) kapsam\u0131nda piyasaya arz edilen \u00fcr\u00fcnler i\u00e7in d\u00fczenlenecek. \u0130thalat \u00f6n izin ba\u015fvurusu verilecek \u00fcr\u00fcnlerin \u00dcr\u00fcn Takip Sistemi&#8217;ne (\u00dcTS) kay\u0131tl\u0131 olmas\u0131 gerekecek.<\/p>\n<p>Y\u00f6netmelik kapsam\u0131nda olan ve COVID-19 tan\u0131 kiti olarak \u00dcTS&#8217;de kay\u0131tl\u0131 olan \u00fcr\u00fcnler i\u00e7in bu \u00fcr\u00fcnlerin Y\u00f6netmelik&#8217;te \u00f6ng\u00f6r\u00fclen \u015fartlar\u0131 sa\u011flad\u0131\u011f\u0131na y\u00f6nelik Halk Sa\u011fl\u0131\u011f\u0131 Genel M\u00fcd\u00fcrl\u00fc\u011f\u00fc&#8217;n\u00fcn g\u00f6r\u00fc\u015f\u00fc al\u0131nacak. \u00dcTS kayd\u0131 tamamlanmam\u0131\u015f COVID-19 tan\u0131 kitlerinin \u00dcTS kayd\u0131 i\u00e7in ise \u00f6ncelikle Halk Sa\u011fl\u0131\u011f\u0131 Genel M\u00fcd\u00fcrl\u00fc\u011f\u00fc&#8217;n\u00fcn uygunluk yaz\u0131s\u0131 aranacak. COVID-19 t\u0131bbi tan\u0131 kitlerinin \u00dcTS kayd\u0131 ve ithalat izinlerine ili\u015fkin detayl\u0131 bilgiye <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=WmdKTnhsdjFqSVhQRUpCOEhIMmdsM1dJbk82M1NkVGRTVzhhOTdnd1drT2lTQk9pcTEvZGlDK2ZQd081UmlCb0wzTlQreU8yYVpSRkdwTnJxb0JWU0VtSjVqSlQ1dzllSUsvMHV6dVB5K3BzUVJrd0drcWtJcVQ0WXVKT1JuT0NMbXphVFdLQ0Q3a2ErUVNGK1MwUXpWUDJibHJRTGppU05YeFJPQTBGNFNMVFF3QjI3cGxadWU5aHNkUThCYm1NUExVWEtubVVBaVJoNGlkMWVaMEdMdkdobHRnUExTSnBkVGdpazZOeE5Ebz0=&amp;rh=ff005eacef62952780e3201aaa41b767c74758e5__;!!Hj9Y_P0nvg!DIP5PcFWqngJO04lYTFsgTZNQc49X0XgOaqmnYaY4DPr7C618KQ98ScrIUTz4L2gfgZJ4Q$\">buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz.<\/p>\n<p>Ba\u015fvurular Elektronik Ba\u015fvuru Sistemindeki (EBS) T\u0131bbi Tan\u0131 Kiti \u0130thalat Ba\u015fvurusu sekmesinden yap\u0131lacak. \u0130thalat\u0131 yap\u0131lacak \u00fcr\u00fcne ait \u00fcr\u00fcn numaras\u0131 girilerek ilgili \u00fcr\u00fcn sisteme eklenecek ve \u00fcr\u00fcn\u00fcn ithalat\u0131n\u0131n yap\u0131laca\u011f\u0131 \u00fclke bilgisi girilecek. G\u00fcmr\u00fck beyannameleri her \u00fclke i\u00e7in ayr\u0131 olu\u015fturuldu\u011fundan ba\u015fvurular da her \u00fclke i\u00e7in ayr\u0131 ayr\u0131 yap\u0131lmal\u0131d\u0131r. Devam\u0131nda, Kurum&#8217;un sitesinde belirtilen ba\u015fvuru dilek\u00e7esinin doldurulup elektronik imza ile imzalanarak sisteme eklenmesi gerekiyor.<\/p>\n<p>Ba\u015fvurunun onaylanmas\u0131 durumunda Ticaret Bakanl\u0131\u011f\u0131&#8217;ndan Tek Pencere Sistemi (TPS) numaras\u0131 al\u0131narak ba\u015fvuruyu yapan firma kayd\u0131 s\u0131ras\u0131nda belirtti\u011fi kay\u0131tl\u0131 elektronik posta adresine g\u00f6nderilecek. TPS numaras\u0131 yaln\u0131zca 6 ay ge\u00e7erli olacak. EBS \u00fczerinden yap\u0131lan ithalat izin ba\u015fvurular\u0131na ili\u015fkin detayl\u0131 bilgiye <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=WmdKTnhsdjFqSVhQRUpCOEhIMmdsM1dJbk82M1NkVGRTVzhhOTdnd1drT2lTQk9pcTEvZGlDK2ZQd081UmlCb0wzTlQreU8yYVpTZjZ2MisvcTE4NEZpZENZMzZxNkx3SStUc29XVGd2QXhBM0ZGUmxDTGJudUhuYWZXZS9tMlI4bVphbC9SUXR5R3kvLzlhYWpXZGQ5U3RjZlVBWkFhT05Eck0yUFlpUzIyTUNwajRCNEsybGc9PQ==&amp;rh=ff005eacef62952780e3201aaa41b767c74758e5__;!!Hj9Y_P0nvg!DIP5PcFWqngJO04lYTFsgTZNQc49X0XgOaqmnYaY4DPr7C618KQ98ScrIUTz4L3RN-FuPA$\">buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum, COVID-19 salg\u0131n\u0131n\u0131n \u00f6nlenmesine ili\u015fkin \u00e7al\u0131\u015fmalar\u0131n\u0131 s\u00fcrd\u00fcr\u00fcyor. COVID-19 tan\u0131 kiti ithal etmek isteyen t\u0131bbi cihaz \u015firketlerinin ve kurulu\u015flar\u0131n, Kurum&#8217;a ba\u015fvuruda bulunmas\u0131 ve ithalat \u00f6n izni almas\u0131 gerekecek. Bu kapsamda t\u00fcm ilgililer, Kurum&#8217;un \u00f6n izin ba\u015fvuru s\u00fcre\u00e7lerine ili\u015fkin y\u00f6nlendirmelerine uygun hareket etmeli, Kurum&#8217;un bu konudaki duyuru ve a\u00e7\u0131klamalar\u0131n\u0131 takip etmelidir.<\/p>\n<p><strong>COVID-19\u2019un hukuki etkilerine y\u00f6nelik mevzuat b\u00fcltenlerimize\u00a0\u00a0<\/strong><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=K1d0Sk81VjhQU3g3R1dPRXlGTDJxOU5WREY2MEo4Tzl0M3F6T3NEQUFFdHVFYWJLUjlHZk0vOFhBcmk0WGtaNSt3a0NFKzV1MDY1SWk4dkdCejl6OXpXUkxyVjgwaHJV&amp;rh=ff005d3612b7cb104102d66711459731454aadcb__;!!Hj9Y_P0nvg!DrGnikyNw68s3tVd_hiPqfDZsBFFY_g_yCv7YqWDJY1kyEL1BloeEKhTul1k2zYNa4_ZeA$\"><strong>https:\/\/www.esin.av.tr\/tr\/coronavirus-desk\/<\/strong><\/a><strong>\u00a0adresinden ula\u015fabilirsiniz.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fmeler T\u0131bbi Tan\u0131 Kitlerinin \u0130thaline \u0130li\u015fkin Tebli\u011f (&#8220;Tebli\u011f&#8220;) 2 Nisan 2020 tarihli 31087 say\u0131l\u0131 Resmi Gazete&#8217;de yay\u0131mland\u0131. Tebli\u011f uyar\u0131nca [&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":[120,149],"tags":[92],"class_list":["post-15898","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","category-covid-19-tr","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>COVID-19 Tedbirleri: T\u0131bbi Tan\u0131 Kitlerinin \u0130thalat\u0131 \u0130zne Tabi Olacak<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u0131bbi Tan\u0131 Kitlerinin \u0130thaline \u0130li\u015fkin Tebli\u011f (&quot;Tebli\u011f&quot;) 2 Nisan 2020 tarihli 31087 say\u0131l\u0131 Resmi Gazete&#039;de yay\u0131mland\u0131. 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