{"id":14666,"date":"2017-09-18T07:18:55","date_gmt":"2017-09-18T07:18:55","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2017\/09\/18\/beseri-tibbi-urun-uretim-yeri-izin-sahiplerinin-bildirmesi-gereken-degisikliklere-dair-yeni-bir-kilavuz-yayinlandi\/"},"modified":"2022-06-09T12:08:43","modified_gmt":"2022-06-09T12:08:43","slug":"beseri-tibbi-urun-uretim-yeri-izin-sahiplerinin-bildirmesi-gereken-degisikliklere-dair-yeni-bir-kilavuz-yayinlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2017\/09\/18\/beseri-tibbi-urun-uretim-yeri-izin-sahiplerinin-bildirmesi-gereken-degisikliklere-dair-yeni-bir-kilavuz-yayinlandi\/","title":{"rendered":"Be\u015feri T\u0131bbi \u00dcr\u00fcn \u00dcretim Yeri \u0130zin Sahiplerinin Bildirmesi Gereken De\u011fi\u015fikliklere Dair Yeni Bir K\u0131lavuz Yay\u0131nland\u0131"},"content":{"rendered":"<p><strong>Yeni Geli\u015fmeler<\/strong><\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>T\u0130TCK<\/strong>&#8220;), internet sitesinde be\u015feri t\u0131bbi \u00fcr\u00fcn imalat\u00e7\u0131lar\u0131 i\u00e7in \u00dcretim Yeri \u0130zin Sahiplerinin Bildirmesi Gereken De\u011fi\u015fikliklere Ait K\u0131lavuz\u2019u (\u201c<strong>K\u0131lavuz<\/strong>\u201d) yay\u0131nlad\u0131.<\/p>\n<p><strong>K\u0131lavuz Neler Getiriyor? <\/strong><\/p>\n<p>T\u0130TCK\u2019n\u0131n internet sitesinde yay\u0131nlanan K\u0131lavuz, be\u015feri t\u0131bbi \u00fcr\u00fcn imalat\u00e7\u0131lar\u0131n\u0131n veya ithalat\u00e7\u0131lar\u0131n\u0131n \u00fcretim yeri veya kontratl\u0131 laboratuvar gibi \u00fcr\u00fcn\u00fcn ruhsat\u0131 ile ilgili dosyada veya imalat yerinde bir de\u011fi\u015fiklik olmas\u0131 halinde T\u0130TCK\u2019ya bildirimde bulunulmas\u0131n\u0131 \u00f6ng\u00f6ren Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin \u0130malathaneleri Hakk\u0131nda Y\u00f6netmelik\u2019in 10. maddesi esas al\u0131narak haz\u0131rland\u0131. T\u0130TCK, K\u0131lavuz arac\u0131l\u0131\u011f\u0131yla be\u015feri t\u0131bbi \u00fcr\u00fcn imalat\u00e7\u0131lar\u0131na veya ithalat\u00e7\u0131lar\u0131na T\u0130TCK\u2019ya de\u011fi\u015fiklik bildiriminde bulunurken uyulmas\u0131 gereken usullere dair rehberlik etmeyi ama\u00e7lamaktad\u0131r.<\/p>\n<p>K\u0131lavuz, T\u0130TCK\u2019ya bildirilmesi gereken de\u011fi\u015fikliklerin t\u00fcrleri ile belgelendirme gereklilikleri ve bildirim s\u00fcreleri gibi usullere detayl\u0131 olarak yer vermektedir. K\u0131lavuz\u2019a <u><a href=\"http:\/\/bakerxchange.com\/collect\/click.aspx?u=\/G1GTPto3VUljU2pbwAd4vKw4jvpliqJUzTakKd4JYk6bOvWLaH2bQDrYwBsldylZFmHyBR4dqli37npUDf5RpDlT88HC5V5ABVpEJkwFTE=&amp;rh=ff00336ae5b997eddc927cca8841a363f5f870b0\">buradan<\/a><\/u> ula\u015fabilirsiniz.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>T\u0130TCK, d\u00fczenli olarak be\u015feri t\u0131bbi \u00fcr\u00fcn \u015firketlerine yol g\u00f6stermeye devam ediyor. \u00a0Bu kapsamda yer alan \u015firketler, yeni yay\u0131nlanan K\u0131lavuz\u2019da yer alan gereklilikleri g\u00f6zden ge\u00e7irmeli ve bildirimde bulunurken izlenmesi gereken usul ve esaslara uygun hareket etmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;T\u0130TCK&#8220;), internet sitesinde be\u015feri t\u0131bbi \u00fcr\u00fcn imalat\u00e7\u0131lar\u0131 i\u00e7in \u00dcretim Yeri \u0130zin Sahiplerinin [&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-14666","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>Be\u015feri T\u0131bbi \u00dcr\u00fcn \u00dcretim Yeri \u0130zin Sahiplerinin Bildirmesi Gereken De\u011fi\u015fikliklere Dair Yeni Bir K\u0131lavuz Yay\u0131nland\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&quot;T\u0130TCK&quot;), internet sitesinde be\u015feri t\u0131bbi \u00fcr\u00fcn imalat\u00e7\u0131lar\u0131 i\u00e7in \u00dcretim Yeri \u0130zin Sahiplerinin\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.esin.av.tr\/tr\/2017\/09\/18\/beseri-tibbi-urun-uretim-yeri-izin-sahiplerinin-bildirmesi-gereken-degisikliklere-dair-yeni-bir-kilavuz-yayinlandi\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Be\u015feri T\u0131bbi \u00dcr\u00fcn \u00dcretim Yeri \u0130zin Sahiplerinin Bildirmesi Gereken De\u011fi\u015fikliklere Dair Yeni Bir K\u0131lavuz Yay\u0131nland\u0131\" \/>\n<meta property=\"og:description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&quot;T\u0130TCK&quot;), internet sitesinde be\u015feri t\u0131bbi \u00fcr\u00fcn imalat\u00e7\u0131lar\u0131 i\u00e7in \u00dcretim Yeri \u0130zin Sahiplerinin\" \/>\n<meta property=\"og:url\" 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