{"id":15972,"date":"2020-04-16T08:01:08","date_gmt":"2020-04-16T08:01:08","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=15972"},"modified":"2022-06-09T13:01:34","modified_gmt":"2022-06-09T13:01:34","slug":"covid-19-tedbirleri-titck-on-izne-tabi-tibbi-cihazlar-icin-basvuru-kilavuzunu-yayimladi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2020\/04\/16\/covid-19-tedbirleri-titck-on-izne-tabi-tibbi-cihazlar-icin-basvuru-kilavuzunu-yayimladi\/","title":{"rendered":"COVID-19 Tedbirleri: T\u0130TCK, \u00d6n \u0130zne Tabi T\u0131bbi Cihazlar i\u00e7in Ba\u015fvuru K\u0131lavuzu&#8217;nu Yay\u0131mlad\u0131"},"content":{"rendered":"<p><strong>Yeni Geli\u015fmeler<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu, (&#8220;<strong>Kurum<\/strong>&#8220;) 14 Nisan 2020 tarihli duyurusunda COVID-19 Salg\u0131n\u0131 Sebebiyle \u0130hracat\u0131nda ve \u0130thalat\u0131nda \u00d6n \u0130zne Ba\u011flanan T\u0131bbi Cihazlar i\u00e7in \u00d6n \u0130zin Ba\u015fvuru K\u0131lavuzu&#8217;nu yay\u0131mlad\u0131. Kurum, \u00f6n izin s\u00fcrecine dair yay\u0131mlad\u0131\u011f\u0131 t\u00fcm duyurular\u0131 g\u00fcncelleyerek tek bir k\u0131lavuzda birle\u015ftirdi. K\u0131lavuz&#8217;a <strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=aTJpeXlOcEtSTnRESmNiR2Nla28xWXhtWWQ1VXVmZXR3YzROQXdEVkwzZDB1ejVjVjAzd3ZHeHFZVVEwSlRxTS9PSjhrTUFHVEFTQWVMTEZKU3JNN295NlJpOWhCcDFLRU5XSWc1WGdqeXd5U1VHb0tHbmFjSUdjMGI5UkZkd01NeG5UNFRwL0syZ2V1TFVUbHNGRkJqZVc4NlhoRUU2L3dVb3RJTGtxWkpDZ2R0K1BrdXJjOFE9PQ==&amp;rh=ff005ef14d2ec24a84bd567b8344a2890ba90fa3__;!!Hj9Y_P0nvg!FKUOXBrUIyercVH582c61BJstV8tq6gpccpgratr7KbT8ou4UqKMtj-boAcbULIw5DFMZA$\">buradan<\/a><\/u><\/strong> ula\u015fabilirsiniz<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Bilindi\u011fi \u00fczere COVID-19 ile m\u00fccadele s\u00fcrecinde g\u00fcvenli \u00fcr\u00fcn eri\u015filebilirli\u011finin temin edilmesi, tedavide kullan\u0131lan kritik \u00fcr\u00fcnlerin stok ve tedarik y\u00f6netiminin etkin \u015fekilde yap\u0131lmas\u0131, sa\u011fl\u0131k hizmeti sunumunun aksamamas\u0131 ve kamu sa\u011fl\u0131\u011f\u0131n\u0131n korunmas\u0131 ama\u00e7lar\u0131yla belirli \u00fcr\u00fcnlerin ihracat\u0131 ve ithalat\u0131 Kurum&#8217;un \u00f6n iznine ba\u011fland\u0131.<\/p>\n<p>Bu kapsamda koruyucu maske, s\u0131z\u0131 ge\u00e7irmez \u00f6nl\u00fck ve g\u00f6zl\u00fck gibi ki\u015fisel koruyucu donan\u0131m \u00fcr\u00fcnleri ile t\u0131bbi ve cerrahi maskeler, t\u0131bbi steril eldivenler, ent\u00fcbasyon t\u00fcp\u00fc ve yo\u011fun bak\u0131m monit\u00f6r\u00fc gibi T\u0131bbi Cihaz Y\u00f6netmeli\u011fi uyar\u0131nca piyasaya arz edilen \u00fcr\u00fcnlerin ihracat\u0131; t\u0131bbi tan\u0131 kitlerinin ise ithalat\u0131 i\u00e7in Kurum&#8217;dan \u00f6n izin al\u0131nmas\u0131 gerekecek.<\/p>\n<p>\u0130lgili \u00fcr\u00fcnlerin ithalat\u0131 ve ihracat\u0131 i\u00e7in \u00f6n izin ba\u015fvurular\u0131 Kurum&#8217;un Elektronik Bilgi Sistemi (EBS) \u00fczerinden yap\u0131lacak. T\u0131bbi cihaz y\u00f6netmelikleri kapsam\u0131nda piyasaya arz edilen \u00fcr\u00fcnlerin ithalat\u0131 i\u00e7in \u00f6n izin ba\u015fvurusu verilecek \u00fcr\u00fcnlerin \u00dcr\u00fcn Takip Sistemi&#8217;ne (\u00dcTS) kay\u0131tl\u0131 olmas\u0131 gerekecek. 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\u0131lacak. 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 firman\u0131n kay\u0131t s\u0131ras\u0131nda belirtti\u011fi kay\u0131tl\u0131 elektronik posta adresine g\u00f6nderilecek. \u0130thalat ba\u015fvurular\u0131 i\u00e7in g\u00f6nderilen TPS numaras\u0131 6 ay, ihracat ba\u015fvurular\u0131 i\u00e7in g\u00f6nderilen TPS numaras\u0131 ise 15 g\u00fcn s\u00fcre ile ge\u00e7erli olacak.<\/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. \u00d6n izne tabi tutulan ki\u015fisel koruyucu donan\u0131m \u00fcr\u00fcnleri ve t\u0131bbi malzemeleri ithal ve ihra\u00e7 etmek isteyen \u015firketlerin ve kurulu\u015flar\u0131n, Kurum&#8217;a ba\u015fvuruda bulunmas\u0131 ve ihracat\/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\u00fcltenlerimiz ve di\u011fer b\u00fcltenlerimize <\/strong><u><a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=aTJpeXlOcEtSTnRESmNiR2Nla28xWXhtWWQ1VXVmZXR3YzROQXdEVkwzZkhBbU9hTFowNUUxRXg0aFZRdm1CcGtnVHBmL0s3VnZib21kQk1jY0lxSkR6RS9lU0ZSNWR2&amp;rh=ff005ef14d2ec24a84bd567b8344a2890ba90fa3__;!!Hj9Y_P0nvg!FKUOXBrUIyercVH582c61BJstV8tq6gpccpgratr7KbT8ou4UqKMtj-boAcbULLzUuAbkg$\"><strong>Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131 Koronavir\u00fcs<\/strong><\/a><\/u><strong> Masas\u0131 adresinden ula\u015fabilirsiniz.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu, (&#8220;Kurum&#8220;) 14 Nisan 2020 tarihli duyurusunda COVID-19 Salg\u0131n\u0131 Sebebiyle \u0130hracat\u0131nda ve \u0130thalat\u0131nda [&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-15972","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\u0130TCK, \u00d6n \u0130zne Tabi T\u0131bbi Cihazlar i\u00e7in Ba\u015fvuru K\u0131lavuzu&#039;nu Yay\u0131mlad\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve 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