{"id":14559,"date":"2018-10-18T08:52:20","date_gmt":"2018-10-18T08:52:20","guid":{"rendered":"http:\/\/upt.esin.av.tr\/2018\/10\/18\/tibbi-cihaz-yonetmelik-taslagi-yayimlandi\/"},"modified":"2022-06-09T12:21:22","modified_gmt":"2022-06-09T12:21:22","slug":"tibbi-cihaz-yonetmelik-taslagi-yayimlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2018\/10\/18\/tibbi-cihaz-yonetmelik-taslagi-yayimlandi\/","title":{"rendered":"T\u0131bbi Cihaz Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131mland\u0131"},"content":{"rendered":"

Yeni Geli\u015fmeler<\/strong><\/p>\n

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK<\/strong>“), internet sitesinde T\u0131bbi Cihaz Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Y\u00f6netmelik<\/strong>“) yay\u0131mlad\u0131. Taslak Y\u00f6netmelik, AB mevzuat\u0131na uyum \u00e7al\u0131\u015fmalar\u0131 kapsam\u0131nda AB 2017\/745 say\u0131l\u0131 T\u00fcz\u00fck (“T\u00fcz\u00fck<\/strong>“) dikkate al\u0131narak haz\u0131rland\u0131. Y\u00f6netmelik’e ili\u015fkin g\u00f6r\u00fc\u015flerin 16 Aral\u0131k 2018 tarihine kadar T\u0130TCK’ya yaz\u0131 ile veya md.reg@titck.gov.tr<\/a> adresine iletilmesi gerekiyor.<\/p>\n

Y\u00f6netmelik Neler Getiriyor?<\/strong>
\nY\u00f6netmelik kapsam\u0131nda, hastalar, cihaz\u0131 kullanan ki\u015filer ve sa\u011fl\u0131k \u00e7al\u0131\u015fanlar\u0131 i\u00e7in sa\u011fl\u0131\u011f\u0131n ve g\u00fcvenli\u011fin y\u00fcksek seviyede korunmas\u0131 amac\u0131yla, t\u0131bbi cihazlar i\u00e7in y\u00fcksek kalite ve g\u00fcvenlik standartlar\u0131 belirleniyor. Bununla beraber, insan kullan\u0131m\u0131na y\u00f6nelik t\u0131bbi cihazlar ve bunlar\u0131n yard\u0131mc\u0131 par\u00e7alar\u0131n\u0131n (t\u0131bbi cihaz aksesuarlar\u0131) piyasaya arz edilmesi, piyasada bulundurulmas\u0131 veya hizmete sunulmas\u0131 ile ilgili usul ve esaslar ayr\u0131nt\u0131l\u0131 \u015fekilde d\u00fczenleniyor.<\/p>\n

Y\u00f6netmelik’te belirtilen gereklilikleri kar\u015f\u0131lamayan cihazlar piyasaya s\u00fcr\u00fclemeyecek. Y\u00f6netmelik kapsam\u0131ndaki t\u0131bbi cihazlar\u0131n, kullan\u0131m ama\u00e7lar\u0131 dikkate al\u0131nmak suretiyle, Y\u00f6netmelik’te belirtilen genel g\u00fcvenlik ve performans gerekliliklerine uygun oldu\u011funun ispat edilmesi gerekiyor. Bununla beraber Y\u00f6netmelik, cihazlar\u0131n g\u00fcvenli\u011fi ve performans\u0131yla ilgili kullan\u0131c\u0131 veya hastay\u0131 yanl\u0131\u015f y\u00f6nlendirebilecek her t\u00fcrl\u00fc metin, isim, ticari marka, resim ve di\u011fer i\u015faretlerin kullan\u0131m\u0131n\u0131 yasakl\u0131yor.<\/p>\n

Y\u00f6netmelik t\u0131bbi cihaz imalat\u00e7\u0131lar\u0131 ve ithalat\u00e7\u0131lar\u0131na \u00f6nemli y\u00fck\u00fcml\u00fcl\u00fckler getiriyor. \u0130malat\u00e7\u0131lar, cihazlar\u0131n\u0131 piyasaya arz ederken cihazlar\u0131n Y\u00f6netmelik gerekliliklerince uygun olarak tasarlan\u0131p imal edilmi\u015f olmas\u0131n\u0131 sa\u011flamak zorunda olacak. \u0130thalat\u00e7\u0131lar ise cihazlar\u0131n\u0131 piyasaya arz etmeden \u00f6nce cihaza ili\u015fkin AB uygunluk beyan\u0131n\u0131n d\u00fczenlenmi\u015f oldu\u011funu ve gerekli kullan\u0131m k\u0131lavuzunun cihaz\u0131n beraberinde bulundu\u011funu do\u011frulamakla y\u00fck\u00fcml\u00fc k\u0131l\u0131n\u0131yor.<\/p>\n

Y\u00f6netmelik Tasla\u011f\u0131’na, T\u00fcz\u00fck’e ve T\u00fcz\u00fck ile Y\u00f6netmelik tasla\u011f\u0131n\u0131n kar\u015f\u0131la\u015ft\u0131rma tablolar\u0131na buradan<\/a><\/u> ula\u015fabilirsiniz.<\/p>\n

Sonu\u00e7<\/strong><\/p>\n

T\u0130TCK, d\u00fczenli olarak t\u0131bbi cihaz \u015firketlerine yol g\u00f6stermeye devam ediyor. Bu kapsamda yer alan \u015firketler, taslak Y\u00f6netmelik’in geli\u015ftirilmesi i\u00e7in T\u0130TCK ile i\u015fbirli\u011fi i\u00e7erisinde hareket etmeli ve \u00fcr\u00fcnlerini piyasaya s\u00fcrmeden \u00f6nce Y\u00f6netmelik’te \u00f6ng\u00f6r\u00fclen gereklilikleri g\u00f6zden ge\u00e7irmeli, izlenmesi gereken usul ve esaslara uygun hareket etmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“T\u0130TCK“), internet sitesinde T\u0131bbi Cihaz Y\u00f6netmelik Tasla\u011f\u0131’n\u0131 (“Y\u00f6netmelik“) yay\u0131mlad\u0131. Taslak Y\u00f6netmelik, AB […]<\/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-14559","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\nT\u0131bbi Cihaz Y\u00f6netmelik Tasla\u011f\u0131 Yay\u0131mland\u0131<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("T\u0130TCK"), internet sitesinde T\u0131bbi Cihaz Y\u00f6netmelik Tasla\u011f\u0131'n\u0131 ("Y\u00f6netmelik") yay\u0131mlad\u0131. 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