{"id":15781,"date":"2020-04-03T14:54:49","date_gmt":"2020-04-03T14:54:49","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=15781"},"modified":"2022-06-09T12:48:18","modified_gmt":"2022-06-09T12:48:18","slug":"titckdan-covid-19-ile-mucadeleye-iliskin-yeni-tedbirler","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2020\/04\/03\/titckdan-covid-19-ile-mucadeleye-iliskin-yeni-tedbirler\/","title":{"rendered":"T\u0130TCK’dan COVID-19 ile M\u00fccadeleye \u0130li\u015fkin Yeni Tedbirler"},"content":{"rendered":"

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

T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum<\/strong>“), COVID-19 ile m\u00fccadele kapsam\u0131nda al\u0131nan yeni tedbirleri duyurdu. Kurum, okunabilirlik testleri, \u00fcr\u00fcn sertifikaland\u0131rma ba\u015fvurular\u0131, kronik hastalar taraf\u0131ndan kullan\u0131lan ila\u00e7lar ve bilimsel toplant\u0131 izinlerine ili\u015fkin a\u00e7\u0131klamalarda bulundu.<\/p>\n

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

Okunabilirlik Testleri<\/em><\/p>\n

Be\u015feri T\u0131bbi \u00dcr\u00fcnlerin Ambalaj Bilgileri, Kullanma Talimat\u0131 ve Takibi Y\u00f6netmeli\u011fi uyar\u0131nca, be\u015feri t\u0131bbi \u00fcr\u00fcnlerin kullanma talimatlar\u0131n\u0131n kolayl\u0131kla okunabilir, a\u00e7\u0131k\u00e7a anla\u015f\u0131labilir olmas\u0131 ve bu kapsamda hedef hasta gruplar\u0131yla Okunabilirlik Testinin sonu\u00e7lar\u0131n\u0131n Kurum’a sunulmas\u0131 gerekmektedir.<\/p>\n

Kurum, okunabilirlik testlerinin y\u00fcz y\u00fcze ger\u00e7ekle\u015ftirilmesi esnas\u0131nda olu\u015fabilecek riskleri g\u00f6z \u00f6n\u00fcnde bulundurarak ruhsatland\u0131rma i\u015flemlerinin tamamlanmas\u0131 i\u00e7in sunulmas\u0131 zorunlu olan okunabilirlik testlerinin, sat\u0131\u015f izni ba\u015fvurusundan \u00f6nce de sunulabilece\u011fini duyurdu. Kurum’un ilgili duyurusuna buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Farmas\u00f6tik \u00dcr\u00fcn Sertifikaland\u0131rma Birimine Yap\u0131lan Ba\u015fvurular<\/em><\/p>\n

Kurum, Farmas\u00f6tik \u00dcr\u00fcn Sertifikaland\u0131rma Birimine yap\u0131lan ba\u015fvurular\u0131n fiziksel evrak gerektirmesi ve belge \u00fccretli olmas\u0131 nedeniyle, sertifika onay s\u00fcresi olan 10 i\u015f g\u00fcn\u00fcn\u00fcn g\u00f6z \u00f6n\u00fcnde bulundurularak bu s\u00fcre sonunda \u00f6deme yap\u0131lmas\u0131 gereken belgeler i\u00e7in ba\u015fvuru yap\u0131lmas\u0131 gerekti\u011fini duyurdu. Bu kapsamda ilgili birime yap\u0131lan ba\u015fvurular\u0131n, de\u011ferlendirme ve onay s\u00fcresi hesaplanarak \u00f6deme yap\u0131lacak tarihe ertelenmesi gerekecek.<\/p>\n

Kurum ayr\u0131ca incelemelerini elektronik olarak ger\u00e7ekle\u015ftirilece\u011fini, bu sebeple ba\u015fvurularda fiziksel olarak g\u00f6nderilen sertifikalar\u0131n \u00f6rneklerinin Elektronik S\u00fcre\u00e7 Y\u00f6netim sistemine y\u00fcklenmesi gerekti\u011fini duyurdu. Duyuruya buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Kronik Hastalar Taraf\u0131ndan Kullan\u0131lan \u0130la\u00e7lar\u0131n Temini <\/em><\/p>\n

Kurum, 16 Mart 2020 tarihli duyurusunda COVID-19 s\u00fcrecinde hastalar\u0131n kronik olarak kulland\u0131klar\u0131 ila\u00e7lar\u0131na eri\u015fimlerine kolayla\u015ft\u0131rmak i\u00e7in ge\u00e7ici tedbirler alm\u0131\u015ft\u0131. Bu do\u011frultuda Kurum, ge\u00e7ti\u011fimiz g\u00fcnlerde yapt\u0131\u011f\u0131 duyuruda, riskleri nedeniyle takip edilen ila\u00e7 g\u00fcvenlik izlem formu ile kullan\u0131lan ila\u00e7lar ve k\u0131s\u0131tl\u0131 da\u011f\u0131t\u0131mda olan ila\u00e7lar\u0131n temini i\u00e7in hastalar\u0131n ve eczanelerin ne \u015fekilde hareket etmesi gerekti\u011fine dair bir yol haritas\u0131 haz\u0131rlad\u0131. Kurum’un haz\u0131rlad\u0131\u011f\u0131 belgeye buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

Bilimsel Toplant\u0131 \u0130zinleri<\/em><\/p>\n

Kurum, 2020\/3 say\u0131l\u0131 Cumhurba\u015fkanl\u0131\u011f\u0131 Genelgesi ile ertelenen organizasyon ve etkinliklere ili\u015fkin olarak ruhsat\/izin sahibi ila\u00e7 firmalar\u0131 taraf\u0131ndan d\u00fczenlenen web tabanl\u0131 toplant\u0131lar\u0131n bu kapsamda de\u011ferlendirilmeyece\u011fini duyurdu. Bu kapsamda, ila\u00e7 firmalar\u0131 taraf\u0131ndan d\u00fczenlenecek veya destek verilecek web tabanl\u0131 toplant\u0131lar i\u00e7in Kurum’a ba\u015fvuru yap\u0131lmas\u0131 gerekmektedir. Kurum’un ilgili yaz\u0131s\u0131na buradan<\/a> ula\u015fabilirsiniz.<\/p>\n

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

Kurum, COVID-19 salg\u0131n\u0131n\u0131n \u00f6nlenmesine ili\u015fkin \u00e7al\u0131\u015fmalar\u0131n\u0131 s\u00fcrd\u00fcr\u00fcyor. T\u00fcm ila\u00e7 firmalar\u0131, Kurum’un ba\u015fvuru s\u00fcre\u00e7lerine ili\u015fkin y\u00f6nlendirmelerine uygun hareket etmeli, Kurum’un bu konudaki duyuru ve a\u00e7\u0131klamalar\u0131n\u0131 takip etmelidir.<\/p>\n

COVID-19\u2019un hukuki etkilerine y\u00f6nelik mevzuat b\u00fcltenlerimiz ve di\u011fer b\u00fcltenlerimize\u00a0<\/strong>https:\/\/www.esin.av.tr\/tr\/coronavirus-desk\/<\/strong><\/a>\u00a0adresinden ula\u015fabilirsiniz.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (“Kurum“), COVID-19 ile m\u00fccadele kapsam\u0131nda al\u0131nan yeni tedbirleri duyurdu. Kurum, okunabilirlik testleri, […]<\/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-15781","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","category-covid-19-tr","tag-healthcare-tr"],"acf":[],"yoast_head":"\nT\u0130TCK'dan COVID-19 ile M\u00fccadeleye \u0130li\u015fkin Yeni Tedbirler<\/title>\n<meta name=\"description\" content=\"Yeni Geli\u015fmeler T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ("Kurum"), COVID-19 ile m\u00fccadele kapsam\u0131nda al\u0131nan yeni tedbirleri duyurdu. 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