{"id":26014,"date":"2023-06-22T07:38:38","date_gmt":"2023-06-22T07:38:38","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=26014"},"modified":"2023-06-22T07:38:38","modified_gmt":"2023-06-22T07:38:38","slug":"saglik-sektorunde-guncel-gelismeler-9","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2023\/06\/22\/saglik-sektorunde-guncel-gelismeler-9\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler"},"content":{"rendered":"

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum<\/strong>“) ge\u00e7ti\u011fimiz haftalarda Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik, \u0130leri Tedavi T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi ve Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmelik’i yay\u0131nlam\u0131\u015ft\u0131r.
\nG\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n

Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik<\/strong><\/p>\n

Yeni Geli\u015fme<\/strong><\/p>\n

Kurum, 27 May\u0131s 2023 tarihinde Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik’i yay\u0131mlad\u0131. \u00a0Y\u00f6netmelik, Avrupa Birli\u011fi mevzuat\u0131na uyum \u00e7er\u00e7evesinde 16 Nisan 2014 tarihli ve (AB) 536\/2014 say\u0131l\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Avrupa Parlamentosu ve Konsey T\u00fcz\u00fc\u011f\u00fc ile 8 Nisan 2005 tarihli ve 2005\/28\/AT say\u0131l\u0131 Ara\u015ft\u0131rmalarda Kullan\u0131lan Be\u015feri T\u0131bbi \u00dcr\u00fcnler ve Bu \u00dcr\u00fcnlerin \u00dcretim veya \u0130thalat\u0131na Dair \u0130yi Klinik Uygulamalar\u0131n\u0131 Belirleyen Komisyon Direktifi dikkate al\u0131narak haz\u0131rlanm\u0131\u015ft\u0131r. Ek olarak, Y\u00f6netmelik ile 13 Nisan 2013 tarihli \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lm\u0131\u015ft\u0131r.<\/p>\n

Y\u00f6netmelik’e buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Ne De\u011fi\u015fecek?<\/strong><\/p>\n

Biyoyararlan\u0131m ve biyoe\u015fde\u011ferlik \u00e7al\u0131\u015fmalar\u0131 kapsam\u0131nda yap\u0131lacak ba\u015fvurular, usul\u00fcne uygun olarak yap\u0131lmas\u0131 ve ba\u015fvuruda bulunmas\u0131 gereken bilgi ve belgelerde eksiklik bulunmamas\u0131 halinde etik kurul taraf\u0131ndan 7 i\u015f g\u00fcn\u00fc i\u00e7inde, Kurum taraf\u0131ndan ise 12 i\u015f g\u00fcn\u00fc i\u00e7inde incelenecektir.<\/p>\n

\u0130lk uygunluk ba\u015fvurusunun reddedilmesi, iptal edilmesi veya geri \u00e7ekilmesi durumunda ilgili ba\u015fvuru \u00fcst yaz\u0131da belirtilerek tekrar yeni bir ba\u015fvuru olarak Kurum’a sunulabilir.<\/p>\n

Klinik ara\u015ft\u0131rmalar\u0131n ara sonu\u00e7lar\u0131 ve ara\u015ft\u0131rma s\u00fcresince ger\u00e7ekle\u015ftirilen analizler uyar\u0131nca yap\u0131lan de\u011ferlendirmelere ili\u015fkin haz\u0131rlanan ara rapor etik kurul ile Kurum’a bildirilmelidir.<\/p>\n

Ki\u015fisel Verilerin Korunmas\u0131 Kanunu h\u00fck\u00fcmlerine uymak \u015fart\u0131yla klinik ara\u015ft\u0131rma protokol\u00fc kapsam\u0131nda g\u00f6n\u00fcll\u00fclerden elde edilen veriler gelecekteki bilimsel ara\u015ft\u0131rmalarda kullan\u0131labilir. Bu kapsamda veri toplamak i\u00e7in, g\u00f6n\u00fcll\u00fcden kendisine ait verilerin klinik ara\u015ft\u0131rma protokol\u00fc d\u0131\u015f\u0131nda da kullan\u0131lmas\u0131na ili\u015fkin olur al\u0131nmal\u0131 ve bu oluru istedi\u011fi zaman geri \u00e7ekme hakk\u0131 olmal\u0131d\u0131r. Olurun geri \u00e7ekilmesi, halihaz\u0131rda y\u00fcr\u00fct\u00fclm\u00fc\u015f faaliyetleri ve geri \u00e7ekilmeden \u00f6nce olura dayal\u0131 olarak elde edilen verilerin kullan\u0131m\u0131n\u0131 etkilemeyecektir.<\/p>\n

Bilgilendirilmi\u015f g\u00f6n\u00fcll\u00fc oluru al\u0131n\u0131rken ara\u015ft\u0131rman\u0131n ayr\u0131nt\u0131lar\u0131 hakk\u0131nda soru sorabilmesi ve ara\u015ft\u0131rmaya kat\u0131l\u0131p kat\u0131lmama karar\u0131n\u0131 verebilmesi i\u00e7in g\u00f6n\u00fcll\u00fc veya kanuni temsilcisine yeterli zaman verilmelidir. Ayr\u0131ca, g\u00f6n\u00fcll\u00fc veya kanuni temsilcinin okuma yazma bilmemesi veya g\u00f6rme engeli gibi t\u0131bbi veya sosyal bir neden ile olur formunu imzalayamayacak durumda olmas\u0131 halinde bilgilendirilmi\u015f g\u00f6n\u00fcll\u00fc oluru g\u00f6r\u00fc\u015fmesi ara\u015ft\u0131rma ekibinden olmayan ba\u011f\u0131ms\u0131z bir tan\u0131k huzurunda yap\u0131lmal\u0131d\u0131r.<\/p>\n

Ara\u015ft\u0131rman\u0131n y\u00fcr\u00fct\u00fclmesi esnas\u0131nda ara\u015ft\u0131rmaya i\u015ftirak eden \u00e7ocu\u011fun olur verecek ya\u015fa gelmesi durumunda \u00e7ocuktan bilgilendirilmi\u015f g\u00f6n\u00fcll\u00fc oluru al\u0131nmal\u0131d\u0131r.<\/p>\n

\u0130znin bildirim tarihinden itibaren 2 y\u0131l i\u00e7erisinde T\u00fcrkiye’de klinik ara\u015ft\u0131rmaya herhangi bir g\u00f6n\u00fcll\u00fc dahil edilmemi\u015fse, ba\u015fvuru sahibinin talebi \u00fczerine bir uzatma onaylanmad\u0131\u011f\u0131 takdirde, Kurum taraf\u0131ndan verilen izin iptal edilecektir. Benzer \u015fekilde, ge\u00e7ici olarak durdurulmu\u015f bir klinik ara\u015ft\u0131rma 2 y\u0131l i\u00e7erisinde yeniden ba\u015flat\u0131lmazsa, bu s\u00fcrenin sona erdi\u011fi tarih ya da destekleyicinin klinik ara\u015ft\u0131rmay\u0131 yeniden ba\u015flatmama karar\u0131n\u0131 verdi\u011fi tarihten hangisi daha \u00f6nce ise, bu tarih klinik ara\u015ft\u0131rman\u0131n sona erme tarihi olarak kabul edilecektir. Klinik ara\u015ft\u0131rman\u0131n erken sonland\u0131r\u0131lmas\u0131 halinde ise bu tarih klinik ara\u015ft\u0131rman\u0131n sona erme tarihi olarak kabul edilecektir.<\/p>\n

Destekleyici, T\u00fcrkiye’de ara\u015ft\u0131rman\u0131n tamamlanmas\u0131ndan itibaren 15 g\u00fcn i\u00e7erisinde ara\u015ft\u0131rman\u0131n tamamland\u0131\u011f\u0131n\u0131 Kurum’a ve etik kurula bildirmelidir. Ek olarak, ara\u015ft\u0131rma, y\u00fcr\u00fct\u00fcld\u00fc\u011f\u00fc t\u00fcm \u00fclkelerde tamamlanmas\u0131n\u0131n ard\u0131ndan 30 g\u00fcn i\u00e7erisinde Kurum’a ve etik kurula bildirilmelidir.<\/p>\n

Ba\u015flat\u0131ld\u0131ktan sonra destekleyici taraf\u0131ndan ge\u00e7ici olarak durdurulmu\u015f veya erken sonland\u0131r\u0131lm\u0131\u015f ara\u015ft\u0131rmalar Kurum taraf\u0131ndan izin verilmedik\u00e7e yeniden ba\u015flat\u0131lamaz. Ara\u015ft\u0131rman\u0131n yeniden ba\u015flat\u0131labilmesi i\u00e7in risk ve yarar de\u011ferlendirmesi, ge\u00e7ici olarak durdurma sonras\u0131nda al\u0131nan \u00f6nlemler ve sonu\u00e7lar\u0131n\u0131 da i\u00e7eren ba\u015flatma gerek\u00e7esi ile birlikte Kurum’a ba\u015fvuru yap\u0131lmal\u0131d\u0131r.<\/p>\n

Destekleyici, sorumlu ara\u015ft\u0131rmac\u0131 ve ara\u015ft\u0131rmac\u0131lara ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fc temin etmeli ve y\u0131lda en az bir kez ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fcn\u00fc g\u00f6zden ge\u00e7irmelidir. Ayr\u0131ca, g\u00fcvenlili\u011fe ili\u015fkin bilgiler de dahil olmak \u00fczere anlaml\u0131 yeni bilgiler temin edildik\u00e7e ara\u015ft\u0131rmac\u0131 bro\u015f\u00fcr\u00fc g\u00fcncellenmelidir.
\nAra\u015ft\u0131rmalarda kullan\u0131lacak yard\u0131mc\u0131 be\u015feri t\u0131bbi \u00fcr\u00fcnlerin ithali i\u00e7in gerekti\u011finde Kurum’dan izin al\u0131nabilir.<\/p>\n

Destekleyicinin T\u00fcrkiye i\u00e7inde yerle\u015fik olmad\u0131\u011f\u0131 durumlarda destekleyici T\u00fcrkiye’de yerle\u015fik ger\u00e7ek veya t\u00fczel bir ki\u015fiyi yasal temsilcisi olarak atamal\u0131d\u0131r. Yasal temsilci, destekleyicinin y\u00fck\u00fcml\u00fcl\u00fcklerine uygunlu\u011fun sa\u011flanmas\u0131nda sorumlu olacak ve destekleyici ile yap\u0131lacak ileti\u015fimlerin muhatab\u0131 olacakt\u0131r.
\nKlinik ara\u015ft\u0131rmalar\u0131n her t\u00fcrl\u00fc mali sorumlulu\u011fu destekleyici ve mevcutsa yasal temsilcisi, g\u00f6rev devri yap\u0131lan di\u011fer taraflar ile ara\u015ft\u0131rma ekibine aittir.<\/p>\n

Y\u00f6netmelik kapsam\u0131nda, klinik ara\u015ft\u0131rmalara ait ba\u015fvuru ve bildirimlerin al\u0131nmas\u0131, ara\u015ft\u0131rmalara ait verilerin elektronik olarak ar\u015fivlenmesi ve analiz edilmesi i\u00e7in ve g\u00f6rev ve yetkilerini yerine getirirken kullan\u0131lmak \u00fczere Klinik Ara\u015ft\u0131rmalar Mod\u00fcl\u00fc ve ara\u015ft\u0131rmalara ait bilgiler ve ara\u015ft\u0131rma sonu\u00e7lar\u0131n\u0131n \u015feffaf olarak kamuya a\u00e7\u0131klanmas\u0131 amac\u0131yla Klinik Ara\u015ft\u0131rmalar Portal\u0131 kurulacakt\u0131r.<\/p>\n

\u0130leri Tedavi T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi<\/strong><\/p>\n

Yeni Geli\u015fme<\/strong><\/p>\n

Kurum, 27 May\u0131s 2023 tarihinde \u0130leri Tedavi T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi’ni yay\u0131mlad\u0131. Y\u00f6netmelik, ileri tedavi t\u0131bbi \u00fcr\u00fcnlerin ruhsatland\u0131rma ve farmakovijilans\u0131na ili\u015fkin i\u015f ve i\u015flemlerde uygulanacak usul ve esaslar ile ruhsatland\u0131r\u0131lm\u0131\u015f ileri tedavi t\u0131bbi \u00fcr\u00fcnlere ili\u015fkin uygulamalar\u0131 d\u00fczenlemektedir.<\/p>\n

Y\u00f6netmelik’e buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Ne De\u011fi\u015fecek?<\/strong><\/p>\n

\u0130leri tedavi t\u0131bbi \u00fcr\u00fcnlerin piyasaya s\u00fcr\u00fclebilmesi i\u00e7in ruhsatland\u0131r\u0131lmas\u0131 gerekmektedir. Ruhsat ba\u015fvurular\u0131 Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi’ne uygun olarak yap\u0131lmal\u0131d\u0131r.
\nAyn\u0131 ger\u00e7ek veya t\u00fczel ki\u015fi ayn\u0131 etkin maddelere ve endikasyona sahip ileri tedavi t\u0131bbi \u00fcr\u00fcnlerinin, farkl\u0131 yitilik veya uygulama yolu veya farmas\u00f6tik \u015fekilleri i\u00e7in farkl\u0131 bir ticari isim kullanamaz. Ayr\u0131ca, bir ileri tedavi t\u0131bbi \u00fcr\u00fcne, be\u015feri t\u0131bbi \u00fcr\u00fcn, geleneksel bitkisel t\u0131bbi \u00fcr\u00fcn, t\u0131bbi cihaz veya homeopatik t\u0131bbi \u00fcr\u00fcn ile ayn\u0131 isimli ruhsat verilemez.<\/p>\n

Ruhsat, verildi\u011fi tarihten 5 y\u0131l sonra Kurum taraf\u0131ndan yarar ve risk dengesi dikkate al\u0131narak yenilebilir. Bir kez yenilenen ruhsatlar bak\u0131m\u0131ndan Kurum, farmakovijilans ile ilgili nedenlerle ek bir 5 y\u0131ll\u0131k yenileme de\u011ferlendirmesi yap\u0131lmas\u0131na karar vermedi\u011fi s\u00fcrece ruhsat s\u00fcresiz olarak ge\u00e7erli olacakt\u0131r.<\/p>\n

Normal kullan\u0131m \u015fartlar\u0131nda zararl\u0131 etkilerin ortaya \u00e7\u0131kmas\u0131, terap\u00f6tik etkinin olmad\u0131\u011f\u0131n\u0131n veya az oldu\u011funun tespiti, ruhsata esas olan form\u00fclden farkl\u0131 bir form\u00fcl ile \u00fcretim gibi uygunsuzluklar\u0131n varl\u0131\u011f\u0131 halinde Kurum ruhsat\u0131 ask\u0131ya alabilir.<\/p>\n

Ruhsat sahibi ileri tedavi t\u0131bbi \u00fcr\u00fcn\u00fcn piyasada bulunabilirli\u011finin sa\u011flanmas\u0131 ile y\u00fck\u00fcml\u00fcd\u00fcr. Ancak ruhsat sahibi piyasada olan \u00fcr\u00fcn\u00fc bak\u0131m\u0131ndan piyasaya veremeyece\u011fi bir durumun olu\u015fmas\u0131 halinde Kurum’a durumun olu\u015fmas\u0131 halinden 30 g\u00fcn \u00f6nce \u00fcr\u00fcn\u00fc piyasaya veremeyece\u011fi bilgisini vermelidir.
\nRuhsatland\u0131r\u0131lm\u0131\u015f bir ileri tedavi t\u0131bbi \u00fcr\u00fcn\u00fcn\u00fcn ruhsat devri i\u00e7in Kurum’a devir i\u015flemleri ile ilgili istenilen belgeler ile ba\u015fvurulmal\u0131d\u0131r. Ayr\u0131ca ruhsat ba\u015fvurusunun devri de m\u00fcmk\u00fcnd\u00fcr.<\/p>\n

Kurum taraf\u0131ndan ruhsatland\u0131r\u0131lan ve ilk kez piyasaya sunulacak ileri tedavi t\u0131bbi \u00fcr\u00fcnleri i\u00e7in sat\u0131\u015f izni al\u0131nmas\u0131 gerekmektedir.<\/p>\n

\u0130leri tedavi t\u0131bbi \u00fcr\u00fcnlerinin k\u0131sa \u00fcr\u00fcn bilgisi, kullanma talimat\u0131, d\u0131\u015f ve i\u00e7 ambalaj\u0131 Y\u00f6netmelik’te belirtilen \u015fartlar\u0131 i\u00e7erecek \u015fekilde haz\u0131rlanmal\u0131d\u0131r.<\/p>\n

Ruhsat sahibi \u00fcr\u00fcn\u00fcn izlenebilirli\u011finin sa\u011flanabilmesi ad\u0131na \u0130nsan Doku ve H\u00fccreleri ile Bunlarla \u0130lgili Merkezlerin Kalite ve G\u00fcvenli\u011fi Hakk\u0131nda Y\u00f6netmelik do\u011frultusunda sistem olu\u015fturmal\u0131d\u0131r. Ruhsat sahibi sistem \u00fczerindeki verileri \u00fcr\u00fcn\u00fcn son kullanma tarihinden sonra en az 30 y\u0131l s\u00fcreyle saklamal\u0131d\u0131r.<\/p>\n

Y\u00f6netmeli\u011fin yay\u0131nlanmas\u0131ndan \u00f6nce Kurum’a ileri tedavi t\u0131bbi \u00fcr\u00fcnleri i\u00e7in ruhsat ba\u015fvurusunda bulunan ki\u015filer 27 A\u011fustos 2023 tarihine kadar Y\u00f6netmelik’e uygun olarak g\u00fcncel dosyalar\u0131n\u0131 sunmal\u0131d\u0131r.<\/p>\n

Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmelik<\/strong><\/p>\n

Yeni Geli\u015fme<\/strong><\/p>\n

Kurum, 27 May\u0131s 2023 tarihinde, Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011finde De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmelik’i yay\u0131mlad\u0131.<\/p>\n

Y\u00f6netmelik’e buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Ne De\u011fi\u015fecek?<\/strong><\/p>\n

Ruhsat ba\u015fvurular\u0131nda, uygulanabilir oldu\u011fu durumlarda, etkin maddenin \u00fcretim i\u015fleminde kullan\u0131lan ara \u00fcr\u00fcn\/\u00fcr\u00fcnlerin uluslararas\u0131 kabul g\u00f6rm\u00fc\u015f iyi imalat uygulamalar\u0131na uygun \u00fcretildi\u011fini g\u00f6steren belge ve Kurum taraf\u0131ndan talep edildi\u011fi takdirde buna dair bir denetim raporu sunulmal\u0131d\u0131r.<\/p>\n

\u00d6n de\u011ferlendirme s\u00fcreci haricinde Kurum taraf\u0131ndan talep edilen bilgi ve belgelerin veya sunulaca\u011f\u0131 tarih bilgisiyle birlikte, bu bilgi ve belgelerin sunulamad\u0131\u011f\u0131na ili\u015fkin gerekli a\u00e7\u0131klaman\u0131n en ge\u00e7 30 g\u00fcn i\u00e7inde Kuruma sunulmamas\u0131 durumunda ba\u015fvuru usulden reddedilecektir. Yeniden ruhsatland\u0131rma ba\u015fvurusunda bulunulan bu \u00fcr\u00fcnler i\u00e7in Kurum taraf\u0131ndan onaylanan de\u011fi\u015fikliklerin yans\u0131t\u0131lm\u0131\u015f oldu\u011fu g\u00fcncel dosya ve de\u011fi\u015fikliklerin yans\u0131t\u0131ld\u0131\u011f\u0131na dair taahh\u00fct dosyada sunulmal\u0131d\u0131r.<\/p>\n

Ruhsat devir ba\u015fvurular\u0131nda ruhsata esas \u00fcretim yeri\/yerlerinin iyi imalat uygulamalar\u0131 k\u0131lavuzlar\u0131na uygun \u00fcretim yap\u0131ld\u0131\u011f\u0131n\u0131 g\u00f6steren belgenin ve T\u00fcrkiye\u2019de faaliyet g\u00f6steren etkin madde \u00fcretim yeri\/yerleri i\u00e7in \u00dcretim Yeri \u0130zin Belgesinin de Kurum’a sunulmas\u0131 gerekmektedir. S\u00f6z konusu belgelerin ruhsat sahibi taraf\u0131ndan sunulmamas\u0131 durumunda ruhsat Kurum taraf\u0131ndan ask\u0131ya al\u0131nabilir.<\/p>\n

Ko\u015fullu olarak ruhsatland\u0131r\u0131lan bir be\u015feri t\u0131bbi \u00fcr\u00fcn i\u00e7in y\u0131ll\u0131k olarak de\u011ferlendirme sonucunda Kurum taraf\u0131ndan ko\u015fullu ruhsat\u0131n iptal edilme karar\u0131 al\u0131nmas\u0131 halinde s\u00f6z konusu \u00fcr\u00fcnlerin ruhsat iptal i\u015flemleri ruhsat ask\u0131ya al\u0131nmas\u0131 i\u015flemi yap\u0131lmaks\u0131z\u0131n ger\u00e7ekle\u015ftirilecektir.<\/p>\n

Ruhsat sahibi, ruhsat ba\u015fvurusunda bulunulan di\u011fer \u00fclkelerde ruhsat ba\u015fvurusunun reddedilmesi veya ba\u015fvurunun geri \u00e7ekilmesi durumlar\u0131n\u0131 Kurum’a bildirmekle y\u00fck\u00fcml\u00fcd\u00fcr.<\/p>\n

Ruhsat ba\u015fvurusunda bulunulan veya ruhsatland\u0131r\u0131lan b\u00fct\u00fcnle\u015fik bir t\u0131bbi cihaz ihtiva eden be\u015feri t\u0131bbi \u00fcr\u00fcnler i\u00e7in 31 Aral\u0131k 2028 tarihine kadar onaylanm\u0131\u015f kurulu\u015f g\u00f6r\u00fc\u015f\u00fc veya CE belgesi sunulmas\u0131 gereklidir ve belirtilen tarihe kadar yap\u0131lan ruhsat ba\u015fvurular\u0131 ilgili k\u0131lavuz h\u00fck\u00fcmlerine uygun olarak yap\u0131lmal\u0131d\u0131r.<\/p>\n

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

Kurum sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, Kurum’un duyurular\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum’un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum“) ge\u00e7ti\u011fimiz haftalarda Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik, \u0130leri Tedavi T\u0131bbi \u00dcr\u00fcnler […]<\/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-26014","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"\nSa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler<\/title>\n<meta name=\"description\" content=\"T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("Kurum") ge\u00e7ti\u011fimiz haftalarda Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda 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