{"id":61763,"date":"2023-12-04T11:22:59","date_gmt":"2023-12-04T02:22:59","guid":{"rendered":"https:\/\/monolith.law\/tr\/?p=61763"},"modified":"2024-01-17T16:14:27","modified_gmt":"2024-01-17T07:14:27","slug":"medical-equipment-regulation","status":"publish","type":"post","link":"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation","title":{"rendered":"Medyal Cihazlar\u0131n Reklam Yay\u0131nlamas\u0131na Y\u00f6nelik D\u00fczenlemeler - Japon 'Yakkih\u014d' Yasas\u0131 Nedir?"},"content":{"rendered":"\n<p>T\u0131bbi cihazlar \u00e7e\u015fitli t\u00fcrlerde bulunmaktad\u0131r. Bunlar\u0131n aras\u0131nda, v\u00fccudumuz ve sa\u011fl\u0131\u011f\u0131m\u0131z \u00fczerinde b\u00fcy\u00fck etkisi olan t\u0131bbi cihazlar da bulunmaktad\u0131r.<\/p>\n\n\n\n<p>Bu t\u00fcr t\u0131bbi cihazlar hakk\u0131nda, uygunsuz reklam yay\u0131mlanmas\u0131 durumunda, bu uygunsuz reklam\u0131n i\u00e7eri\u011fine inanan ki\u015filerin t\u0131bbi cihaz\u0131 sat\u0131n al\u0131p kullanmas\u0131 sonucunda, b\u00fcy\u00fck sa\u011fl\u0131k zararlar\u0131 meydana gelebilir.<\/p>\n\n\n\n<p>Bu nedenle, t\u0131bbi cihazlar\u0131n reklam yay\u0131mlanmas\u0131, \u0130la\u00e7lar, T\u0131bbi Cihazlar vb. Kalite, Etkinlik ve G\u00fcvenlik Sa\u011flama Yasas\u0131 (Bundan sonra &#8216;\u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217; olarak an\u0131lacakt\u0131r.) ile d\u00fczenlenmi\u015ftir.<\/p>\n\n\n\n<p>\u0130\u015fte bu makalede, t\u0131bbi cihaz reklamlar\u0131n\u0131 d\u00fc\u015f\u00fcnen i\u015fletme sahiplerine y\u00f6nelik olarak, t\u0131bbi cihaz reklamlar\u0131 hakk\u0131ndaki yasal d\u00fczenlemeleri tan\u0131taca\u011f\u0131z.<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/medical-supplies-law\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/medical-supplies-law [ja]<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/corporate\/cbd-ad-pmd-restriction\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/monolith.law\/corporate\/cbd-ad-pmd-restriction [ja]<\/a><\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Ilac_Makinesi_Yasasi_Japanese_Pharmaceutical_and_Medical_Device_Act_ile_Belirlenen_Tibbi_Cihazlarla_Ilgili_Reklam_Duzenlemeleri\" title=\"\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) ile Belirlenen T\u0131bbi Cihazlarla \u0130lgili Reklam D\u00fczenlemeleri\">\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) ile Belirlenen T\u0131bbi Cihazlarla \u0130lgili Reklam D\u00fczenlemeleri<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Tibbi_Cihazlarin_Hukuki_Tanimi_Nedir\" title=\"T\u0131bbi Cihazlar\u0131n Hukuki Tan\u0131m\u0131 Nedir?\">T\u0131bbi Cihazlar\u0131n Hukuki Tan\u0131m\u0131 Nedir?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Tibbi_Cihazlarin_Reklam_Ifadelerinin_Duzenlenmesi\" title=\"T\u0131bbi Cihazlar\u0131n Reklam \u0130fadelerinin D\u00fczenlenmesi\">T\u0131bbi Cihazlar\u0131n Reklam \u0130fadelerinin D\u00fczenlenmesi<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#%E2%80%9CReklam%E2%80%9Din_Uygunlugu\" title=\"&#8220;Reklam&#8221;\u0131n Uygunlu\u011fu\">&#8220;Reklam&#8221;\u0131n Uygunlu\u011fu<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Tibbi_Cihaz_Reklam_Duzenlemelerinin_Hedefi_Olan_Kisiler_Hakkinda\" title=\"T\u0131bbi Cihaz Reklam D\u00fczenlemelerinin Hedefi Olan Ki\u015filer Hakk\u0131nda\">T\u0131bbi Cihaz Reklam D\u00fczenlemelerinin Hedefi Olan Ki\u015filer Hakk\u0131nda<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Hangi_Ifadelerin_Duzenlemeye_Tabi_Oldugu\" title=\"Hangi \u0130fadelerin D\u00fczenlemeye Tabi Oldu\u011fu\">Hangi \u0130fadelerin D\u00fczenlemeye Tabi Oldu\u011fu<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Tibbi_Cihazlarla_Ilgili_Abartili_Reklamlarin_Yasaklanmasi_Madde_66\" title=\"T\u0131bbi Cihazlarla \u0130lgili Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)\">T\u0131bbi Cihazlarla \u0130lgili Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Onay_Alinmamis_Tibbi_Cihazlarin_Reklaminin_Yasaklanmasi_Madde_68\" title=\"Onay Al\u0131nmam\u0131\u015f T\u0131bbi Cihazlar\u0131n Reklam\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)\">Onay Al\u0131nmam\u0131\u015f T\u0131bbi Cihazlar\u0131n Reklam\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Ozet\" title=\"\u00d6zet\">\u00d6zet<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/tr\/general-corporate\/medical-equipment-regulation\/#Buromuz_Tarafindan_Alinan_Onlemler\" title=\"B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler\">B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ilac_Makinesi_Yasasi_Japanese_Pharmaceutical_and_Medical_Device_Act_ile_Belirlenen_Tibbi_Cihazlarla_Ilgili_Reklam_Duzenlemeleri\"><\/span>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) ile Belirlenen T\u0131bbi Cihazlarla \u0130lgili Reklam D\u00fczenlemeleri<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131, t\u0131bbi cihazlar\u0131n kalitesi, etkinli\u011fi ve g\u00fcvenli\u011finin sa\u011flanmas\u0131 ve t\u0131bbi cihazlar\u0131n kullan\u0131m\u0131ndan kaynaklanan sa\u011fl\u0131k ve hijyen tehlikelerinin olu\u015fumunu ve yay\u0131lmas\u0131n\u0131 \u00f6nlemek amac\u0131yla, t\u0131bbi cihazlar\u0131n reklam yay\u0131nlamalar\u0131 konusunda a\u015fa\u011f\u0131daki gibi d\u00fczenlemeler yapmaktad\u0131r.<\/p>\n\n\n\n<ul>\n<li>A\u015f\u0131r\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)<\/li>\n\n\n\n<li>Onay Al\u0131nmadan T\u0131bbi Cihaz Reklamlar\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)<\/li>\n<\/ul>\n\n\n\n<p>A\u015fa\u011f\u0131da, \u0130la\u00e7 Makinesi Yasas\u0131 ile belirlenen t\u0131bbi cihazlarla ilgili reklam d\u00fczenlemeleri hakk\u0131nda daha ayr\u0131nt\u0131l\u0131 bilgi verilmektedir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tibbi_Cihazlarin_Hukuki_Tanimi_Nedir\"><\/span>T\u0131bbi Cihazlar\u0131n Hukuki Tan\u0131m\u0131 Nedir?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation4.jpg\" alt=\"\" class=\"wp-image-45031\" \/><\/figure><\/div>\n\n\n<p>&#8220;T\u0131bbi cihaz&#8221; tan\u0131m\u0131, a\u015fa\u011f\u0131daki Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n (Pharmaceuticals and Medical Devices Act) 2. maddesinin 4. f\u0131kras\u0131nda belirtilmi\u015ftir.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Tan\u0131m)<br> Bu yasada &#8220;t\u0131bbi cihaz&#8221;, insan veya hayvan hastal\u0131klar\u0131n\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi i\u00e7in kullan\u0131lmas\u0131 veya insan veya hayvan v\u00fccudunun yap\u0131s\u0131 veya i\u015flevine etki etme amac\u0131 g\u00fcden makineler, aletler vb. (Rejeneratif t\u0131p \u00fcr\u00fcnleri hari\u00e7.) anlam\u0131na gelir ve bunlar h\u00fck\u00fcmet kararnamesi ile belirlenir.<\/p>\n<\/blockquote>\n\n\n\n<p>Yukar\u0131daki tan\u0131mdan, bir \u00fcr\u00fcn\u00fcn &#8220;t\u0131bbi cihaz&#8221; olarak kabul edilebilmesi i\u00e7in a\u015fa\u011f\u0131dakilerden birine uymas\u0131 gerekmektedir:<\/p>\n\n\n\n<ul>\n<li>\u0130nsan veya hayvan hastal\u0131klar\u0131n\u0131n te\u015fhisi, tedavisi veya \u00f6nlenmesi i\u00e7in kullan\u0131lmas\u0131<\/li>\n\n\n\n<li>\u0130nsan veya hayvan v\u00fccudunun yap\u0131s\u0131 veya i\u015flevine etki etme amac\u0131 g\u00fcd\u00fclmesi<\/li>\n<\/ul>\n\n\n\n<p>Not: &#8220;T\u0131bbi cihaz&#8221; tan\u0131m\u0131ndan, rejeneratif t\u0131p \u00fcr\u00fcnleri hari\u00e7 tutulmu\u015ftur, bu nedenle rejeneratif t\u0131p \u00fcr\u00fcnleri, t\u0131bbi cihazlara dahil de\u011fildir.<\/p>\n\n\n\n<p>T\u0131bbi cihazlar hakk\u0131nda, g\u00fcnl\u00fck ya\u015fam\u0131m\u0131zda s\u0131k\u00e7a kar\u015f\u0131la\u015ft\u0131\u011f\u0131m\u0131z somut \u00f6rnekler aras\u0131nda termometre, tansiyon aleti, kontakt lensler bulunmaktad\u0131r.<\/p>\n\n\n\n<p>Ayr\u0131ca, AED (Otomatik Eksternal Defibrilat\u00f6r) gibi cihazlar da t\u0131bbi cihazlara dahildir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tibbi_Cihazlarin_Reklam_Ifadelerinin_Duzenlenmesi\"><\/span>T\u0131bbi Cihazlar\u0131n Reklam \u0130fadelerinin D\u00fczenlenmesi<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation2.jpg\" alt=\"\" class=\"wp-image-45028\" \/><\/figure><\/div>\n\n\n<p>T\u0131bbi cihazlarla ilgili reklam ifadelerinin d\u00fczenlenmesi konusunda, daha \u00f6nce belirtildi\u011fi gibi, abart\u0131l\u0131 reklamlar ve onay al\u0131nmam\u0131\u015f t\u0131bbi cihazlar\u0131n reklamlar\u0131 hedef al\u0131nmaktad\u0131r.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%9CReklam%E2%80%9Din_Uygunlugu\"><\/span>&#8220;Reklam&#8221;\u0131n Uygunlu\u011fu<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131 (Japanese Pharmaceutical and Medical Device Act) \u00e7er\u00e7evesinde, &#8220;t\u0131bbi cihaz&#8221; gibi, &#8220;reklam&#8221; ile ilgili bir tan\u0131m belirlenmemi\u015ftir.<\/p>\n\n\n\n<p>Ancak, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n h\u00fck\u00fcmleri aras\u0131nda &#8220;reklam&#8221; terimi kullan\u0131lm\u0131\u015ft\u0131r ve neyin &#8220;reklam&#8221; olarak kabul edilece\u011fini bilmeden, \u0130la\u00e7 Makinesi Yasas\u0131&#8217;n\u0131n uygulanabilirli\u011fini belirlemek m\u00fcmk\u00fcn olmaz.<\/p>\n\n\n\n<p>Bu nedenle, &#8220;reklam&#8221;\u0131n anlam\u0131n\u0131 d\u00fc\u015f\u00fcnmek gerekmektedir.<\/p>\n\n\n\n<p>\u0130la\u00e7 Makinesi Yasas\u0131&#8217;na g\u00f6re &#8220;reklam&#8221;, a\u015fa\u011f\u0131daki &#8220;\u0130la\u00e7 Yasas\u0131&#8217;nda (Japanese Pharmaceutical Affairs Law) \u0130la\u00e7lar vb. Reklamlar\u0131n\u0131n Uygunlu\u011fu Hakk\u0131nda&#8221; (Heisei 10 y\u0131l\u0131nda (1998) 29 Eyl\u00fcl tarihli \u0130la\u00e7 Denetim No. 148, \u0130l Sa\u011fl\u0131k M\u00fcd\u00fcrl\u00fc\u011f\u00fcne (B\u00fcro) Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 \u0130la\u00e7 G\u00fcvenli\u011fi B\u00fcrosu Denetim ve Y\u00f6nlendirme B\u00f6l\u00fcm Ba\u015fkan\u0131 bildirisi) ile, gereklilikler yay\u0131nlanm\u0131\u015ft\u0131r.<\/p>\n\n\n\n<p>\u00d6zellikle, a\u015fa\u011f\u0131daki 3 gereklili\u011fi kar\u015f\u0131layan durumlar &#8220;reklam&#8221; olarak kabul edilir.<\/p>\n\n\n\n<ul>\n<li>M\u00fc\u015fteriyi \u00e7ekme (m\u00fc\u015fterinin sat\u0131n alma iste\u011fini art\u0131rma) niyetinin a\u00e7\u0131k olmas\u0131<\/li>\n\n\n\n<li>T\u0131bbi cihaz\u0131n \u00fcr\u00fcn ad\u0131n\u0131n a\u00e7\u0131k\u00e7a belirtilmi\u015f olmas\u0131<\/li>\n\n\n\n<li>Genel halk\u0131n fark edebilece\u011fi bir durumda olmas\u0131<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf [ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tibbi_Cihaz_Reklam_Duzenlemelerinin_Hedefi_Olan_Kisiler_Hakkinda\"><\/span>T\u0131bbi Cihaz Reklam D\u00fczenlemelerinin Hedefi Olan Ki\u015filer Hakk\u0131nda<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>T\u0131bbi cihaz reklam d\u00fczenlemelerinin hedefi olan ki\u015filer hakk\u0131nda dikkat edilmesi gereken nokta, hedefin herhangi bir ki\u015fi olabilece\u011fi ve k\u0131s\u0131tlaman\u0131n olmad\u0131\u011f\u0131d\u0131r.<\/p>\n\n\n\n<p>Bu nedenle, t\u0131bbi cihaz satan bir i\u015fletme olmasa bile, t\u0131bbi cihazlar hakk\u0131nda reklam yaparsan\u0131z, Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;n\u0131n (Japon ~) d\u00fczenlemelerine tabi olacaks\u0131n\u0131z.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Hangi_Ifadelerin_Duzenlemeye_Tabi_Oldugu\"><\/span>Hangi \u0130fadelerin D\u00fczenlemeye Tabi Oldu\u011fu<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Daha \u00f6nce belirtildi\u011fi gibi, Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131 (Pharmaceuticals and Medical Devices Act) kapsam\u0131nda d\u00fczenlemeye tabi olanlar, abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 (Madde 66) ve onay al\u0131nmam\u0131\u015f t\u0131bbi cihazlar\u0131n reklam\u0131n\u0131n yasaklanmas\u0131d\u0131r (Madde 68).<\/p>\n\n\n\n<p>Bu nedenle, a\u015fa\u011f\u0131da, her bir reklam d\u00fczenlemesi hakk\u0131nda ayr\u0131nt\u0131l\u0131 bir a\u00e7\u0131klama yapaca\u011f\u0131z.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tibbi_Cihazlarla_Ilgili_Abartili_Reklamlarin_Yasaklanmasi_Madde_66\"><\/span>T\u0131bbi Cihazlarla \u0130lgili Abart\u0131l\u0131 Reklamlar\u0131n Yasaklanmas\u0131 (Madde 66)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n 66. maddesinde, t\u0131bbi cihazlarla ilgili abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 a\u015fa\u011f\u0131daki gibi belirtilmi\u015ftir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Abart\u0131l\u0131 Reklamlar vb.)<br>Madde 66: Kimse, ila\u00e7lar, t\u0131bbi cihazlar veya rejeneratif t\u0131p \u00fcr\u00fcnlerinin ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda, a\u00e7\u0131k veya ima yoluyla, yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 ifadeleri reklam yapmak, yazmak veya yaymak i\u00e7in kullanamaz.<br>2. Bir doktor veya ba\u015fka bir ki\u015finin, bir ila\u00e7, t\u0131bbi cihaz veya rejeneratif t\u0131p \u00fcr\u00fcn\u00fcn\u00fcn etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadelerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak, birinci f\u0131kra h\u00fckm\u00fcne ayk\u0131r\u0131d\u0131r.<br>3. Kimse, bir ila\u00e7, t\u0131bbi cihaz veya rejeneratif t\u0131p \u00fcr\u00fcn\u00fc hakk\u0131nda k\u00fcrtaj\u0131 ima etmek veya m\u00fcstehcen belgeler veya \u00e7izimler kullanmak i\u00e7in kullanamaz.<\/p>\n<\/blockquote>\n\n\n\n<p>T\u0131bbi cihazlarla ilgili abart\u0131l\u0131 reklamlar\u0131n yasaklanmas\u0131 hakk\u0131nda genel bir \u00f6zet a\u015fa\u011f\u0131daki gibidir:<\/p>\n\n\n\n<ul>\n<li>T\u0131bbi cihazlar\u0131n ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda yan\u0131lt\u0131c\u0131 veya abart\u0131l\u0131 ifadelerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak yasakt\u0131r.<\/li>\n\n\n\n<li>Bir doktorun veya ba\u015fka bir ki\u015finin, bir t\u0131bbi cihaz\u0131n etkinli\u011fini, etkisini veya performans\u0131n\u0131 garanti etti\u011fi yan\u0131lg\u0131s\u0131na yol a\u00e7abilecek ifadelerin reklam\u0131n\u0131 yapmak, yazmak veya yaymak yasakt\u0131r.<\/li>\n\n\n\n<li>T\u0131bbi cihazlar hakk\u0131nda k\u00fcrtaj\u0131 ima etmek veya m\u00fcstehcen belgeler veya \u00e7izimler kullanmak yasakt\u0131r.<\/li>\n<\/ul>\n\n\n\n<p>T\u0131bbi cihazlarla ilgili abart\u0131l\u0131 reklamlar\u0131n tipik \u00f6rnekleri, t\u0131bbi cihaz\u0131n hi\u00e7bir etkisi olmad\u0131\u011f\u0131 veya \u00e7ok az etkisi oldu\u011fu halde, b\u00fcy\u00fck bir etkisi oldu\u011fu gibi reklam yap\u0131lmas\u0131d\u0131r. Ayr\u0131ca, somut veriler g\u00f6stererek t\u0131bbi cihaz\u0131n etkisi hakk\u0131nda bir temel oldu\u011fu gibi reklam yap\u0131l\u0131rken, somut verilerin sahte verilerle de\u011fi\u015ftirildi\u011fi durumlar da d\u00fc\u015f\u00fcn\u00fclebilir.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Onay_Alinmamis_Tibbi_Cihazlarin_Reklaminin_Yasaklanmasi_Madde_68\"><\/span>Onay Al\u0131nmam\u0131\u015f T\u0131bbi Cihazlar\u0131n Reklam\u0131n\u0131n Yasaklanmas\u0131 (Madde 68)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Japon \u0130la\u00e7 ve T\u0131bbi Cihaz Yasas\u0131&#8217;n\u0131n 68. maddesinde, onay al\u0131nmam\u0131\u015f t\u0131bbi cihazlar\u0131n reklam\u0131n\u0131n yasaklanmas\u0131 a\u015fa\u011f\u0131daki gibi belirtilmi\u015ftir:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>(Onay Al\u0131nmam\u0131\u015f \u0130la\u00e7lar\u0131n, T\u0131bbi Cihazlar\u0131n ve Rejeneratif T\u0131p \u00dcr\u00fcnlerinin Reklam\u0131n\u0131n Yasaklanmas\u0131)<br>Madde 68: Kimse, hen\u00fcz onay veya sertifikasyon al\u0131nmam\u0131\u015f bir ila\u00e7, t\u0131bbi cihaz veya rejeneratif t\u0131p \u00fcr\u00fcn\u00fc hakk\u0131nda, ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda reklam yapamaz.<\/p>\n<\/blockquote>\n\n\n\n<p>Onay al\u0131nmam\u0131\u015f t\u0131bbi cihazlar\u0131n reklam\u0131n\u0131n yasaklanmas\u0131 hakk\u0131nda, onay (veya sertifikasyon) al\u0131nmam\u0131\u015f t\u0131bbi cihazlar hakk\u0131nda, ad\u0131, \u00fcretim y\u00f6ntemi, etkinli\u011fi, etkisi veya performans\u0131 hakk\u0131nda reklam yapmak yasakt\u0131r.<\/p>\n\n\n\n<p>Onay al\u0131nmam\u0131\u015f t\u0131bbi cihazlar\u0131n reklam\u0131n\u0131n yasaklanmas\u0131 hakk\u0131nda, bir cihaz\u0131n yabanc\u0131 bir \u00fclkede onaylanm\u0131\u015f olmas\u0131 durumunda bile, Japonya&#8217;da hen\u00fcz onaylanmam\u0131\u015fsa, reklam yapmak, onay al\u0131nmam\u0131\u015f t\u0131bbi cihazlar\u0131n reklam\u0131n\u0131n yasaklanmas\u0131na ayk\u0131r\u0131 olaca\u011f\u0131ndan, dikkatli olunmal\u0131d\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ozet\"><\/span>\u00d6zet<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/monolith.law\/wp-content\/uploads\/2022\/05\/medical-equipment-regulation3.jpg\" alt=\"\" class=\"wp-image-45030\" \/><\/figure><\/div>\n\n\n<p>Yukar\u0131da, t\u0131bbi cihaz reklamlar\u0131n\u0131 d\u00fc\u015f\u00fcnen i\u015fletmeler i\u00e7in t\u0131bbi cihaz reklamlar\u0131 hakk\u0131ndaki yasal d\u00fczenlemeleri tan\u0131tt\u0131k.<\/p>\n\n\n\n<p>T\u0131bbi cihaz reklamlar\u0131 s\u00f6z konusu oldu\u011funda, reklam i\u00e7eri\u011fini dikkatlice incelemeden reklam yay\u0131nlarsan\u0131z, Japon \u0130la\u00e7 ve T\u0131bbi Cihazlar Yasas\u0131&#8217;na (JPMDL) ayk\u0131r\u0131 olabilir.<\/p>\n\n\n\n<p>Bu nedenle, t\u0131bbi cihaz reklamlar\u0131 d\u00fc\u015f\u00fcnen i\u015fletmelerin dikkatli olmas\u0131 gerekmektedir.<\/p>\n\n\n\n<p>T\u0131bbi cihaz reklamlar\u0131n\u0131n JPMDL&#8217;ye ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131, t\u0131bbi cihaz\u0131n ger\u00e7ek etkisi ve d\u00fc\u015f\u00fcn\u00fclen reklam i\u00e7eri\u011fi gibi fakt\u00f6rlere ba\u011fl\u0131 olarak belirlenir.<\/p>\n\n\n\n<p>T\u0131bbi cihaz reklamlar\u0131n\u0131n JPMDL&#8217;ye ayk\u0131r\u0131 olup olmad\u0131\u011f\u0131n\u0131 belirlemek i\u00e7in uzman bir de\u011ferlendirme gereklidir.<\/p>\n\n\n\n<p>Bu nedenle, t\u0131bbi cihaz reklamlar\u0131 d\u00fc\u015f\u00fcnen i\u015fletmelere, uzman bilgisi olan bir avukata dan\u0131\u015fmalar\u0131n\u0131 \u00f6neririz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Buromuz_Tarafindan_Alinan_Onlemler\"><\/span>B\u00fcromuz Taraf\u0131ndan Al\u0131nan \u00d6nlemler<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Monolith Hukuk B\u00fcrosu, \u00f6zellikle internet ve hukuk olmak \u00fczere IT alan\u0131nda y\u00fcksek uzmanl\u0131\u011fa sahip bir hukuk firmas\u0131d\u0131r. Son y\u0131llarda, internet reklamc\u0131l\u0131\u011f\u0131 gibi alanlarda &#8216;Japon \u0130la\u00e7 Makinesi Yasas\u0131&#8217; ihlalleri b\u00fcy\u00fck bir sorun haline gelmi\u015ftir ve hukuki denetim ihtiyac\u0131 giderek artmaktad\u0131r. B\u00fcromuz, \u00e7e\u015fitli yasal d\u00fczenlemeleri g\u00f6z \u00f6n\u00fcnde bulundurarak, mevcut veya ba\u015flatmay\u0131 planlad\u0131\u011f\u0131n\u0131z i\u015fletmelerle ilgili hukuki riskleri analiz eder ve i\u015fletmeyi durdurmadan m\u00fcmk\u00fcn oldu\u011funca yasalla\u015ft\u0131rmay\u0131 hedefler. Ayr\u0131nt\u0131lar a\u015fa\u011f\u0131daki makalede belirtilmi\u015ftir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi cihazlar \u00e7e\u015fitli t\u00fcrlerde bulunmaktad\u0131r. Bunlar\u0131n aras\u0131nda, v\u00fccudumuz ve sa\u011fl\u0131\u011f\u0131m\u0131z \u00fczerinde b\u00fcy\u00fck etkisi olan t\u0131bbi cihazlar da bulunmaktad\u0131r. Bu t\u00fcr t\u0131bbi cihazlar hakk\u0131nda, uygunsuz reklam ya [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":62722,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[30,24],"acf":[],"_links":{"self":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61763"}],"collection":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/comments?post=61763"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61763\/revisions"}],"predecessor-version":[{"id":62724,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/posts\/61763\/revisions\/62724"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media\/62722"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/media?parent=61763"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/categories?post=61763"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/tr\/wp-json\/wp\/v2\/tags?post=61763"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}