{"id":10382,"date":"2026-06-30T10:48:41","date_gmt":"2026-06-30T02:48:41","guid":{"rendered":"https:\/\/regask.com\/?p=10382"},"modified":"2026-06-30T10:48:41","modified_gmt":"2026-06-30T02:48:41","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e7%9b%a3%e7%9d%a3-2026%e5%b9%b46%e6%9c%88","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/medical-device-oversight-june-2026\/","title":{"rendered":"EUDAMED\u304c\u7fa9\u52d9\u5316\u3078\uff1a\u533b\u7642\u6a5f\u5668\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u53b3\u683c\u5316\u2026"},"content":{"rendered":"<p id=\"ember1956\" class=\"ember-view reader-text-block__paragraph\"><span class=\"TextRun SCXW231934779 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW231934779 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EU\u306f\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u7fa9\u52d9\u5316\u3092\u63a8\u9032\u3057\u3001\u7c73\u56fdFDA\u306f\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u3092\u5f37\u5316\u3057\u3001\u4e2d\u56fd\u306f\u767b\u9332\u5236\u5ea6\u306e\u8abf\u6574\u3092\u7d9a\u3051\u305f\u3002\u3069\u308c\u3082\u5358\u72ec\u3067\u306f\u5287\u7684\u306a\u5909\u5316\u3067\u306f\u306a\u3044\u304c\u3001\u3053\u308c\u3089\u304c\u5408\u308f\u3055\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u3092\u5e02\u5834\u306b\u51fa\u56de\u3089\u305b\u308b\u305f\u3081\u306e\u57fa\u6e96\u304c\u5f15\u304d\u4e0a\u3052\u3089\u308c\u305f\u3002<\/span><span class=\"NormalTextRun SCXW231934779 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW231934779 BCX0\">\u305d\u3057\u3066\u3001\u7fa9\u52d9\u306f\u30c7\u30fc\u30bf\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u767b\u9332\u898f\u5f8b\u3078\u3068\u53ce\u675f\u3057\u3064\u3064\u3042\u308b\u3002.<\/span><\/span><span class=\"EOP Selected SCXW231934779 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-461873139\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-461873139 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW61593356 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW61593356 BCX0\">EUDAMED\u306fEU\u5168\u57df\u3067\u7fa9\u52d9\u5316\u3055\u308c\u307e\u3057\u305f<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1565271320\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1565271320 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW224198092 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW224198092 BCX0\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u306fEUDAMED\u306e\u6700\u521d\u306e4\u3064\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u4f7f\u7528\u3092\u7fa9\u52d9\u4ed8\u3051\u3001\u5404\u56fd\u306e\u6a5f\u95a2\u306f\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">(<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">\u30a8\u30b9\u30c8\u30cb\u30a2\u533b\u85ac\u54c1\u5e81\u3082\u305d\u306e\u4e00\u3064<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u304c\u4e8b\u5b9f\u4e0a\u7fa9\u52d9\u5316\u3055\u308c\u305f\u3053\u3068\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002EUDAMED\u306f\u4f55\u5e74\u3082\u524d\u304b\u3089\u300c\u5c0e\u5165\u304c\u8fd1\u3065\u3044\u3066\u3044\u308b\u300d\u3068\u8a00\u308f\u308c\u3066\u304a\u308a\u3001\u6cb9\u65ad\u304c\u751f\u3058\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u7fa9\u52d9\u5316\u3078\u306e\u79fb\u884c\u306f\u6cb9\u65ad\u304c\u88cf\u76ee\u306b\u51fa\u308b\u77ac\u9593\u3067\u3059\u3002\u88fd\u9020\u696d\u8005\u3068\u8f38\u5165\u696d\u8005\u306f\u3001\u95a2\u4fc2\u8005\u306e\u767b\u9332\u3001\u6a5f\u5668\u306e\u8b58\u5225\u3001\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u63d0\u51fa\u66f8\u985e\u3092\u304d\u3061\u3093\u3068\u63c3\u3048\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001EUDAMED\u30c7\u30fc\u30bf\u304c\u4e0d\u5b8c\u5168\u306a\u5834\u5408\u3001\u7ba1\u7406\u4e0a\u306e\u554f\u984c\u3067\u306f\u306a\u304f\u3001\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u4e0a\u306e\u554f\u984c\u3068\u306a\u308b\u30b1\u30fc\u30b9\u304c\u5897\u3048\u3066\u3044\u308b\u304b\u3089\u3067\u3059\u3002\u3053\u306e\u4f5c\u696d\u306f\u5730\u5473\u3067\u3059\u304c\u3001\u4eca\u3084\u5e02\u5834\u53c2\u5165\u306e\u969c\u58c1\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">\u305d\u3057\u3066\u3001\u6642\u9593\u7684\u5236\u7d04\u306e\u4e2d\u3067\u57cb\u3081\u623b\u3057\u3092\u884c\u3046\u306e\u306f\u3001\u6700\u521d\u304b\u3089\u69cb\u7bc9\u3059\u308b\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u96e3\u3057\u3044\u3002.<\/span><\/span><span class=\"EOP SCXW224198092 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW166143349 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW166143349 BCX0\">FDA\u306e\u8b66\u544a\u66f8\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u6a19\u7684\u3068\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1198388351\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1198388351 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW143045283 BCX0\">FDA\u306f\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3068\u533b\u7642\u6a5f\u5668\u5831\u544a\u306e\u4e0d\u5099\u306b\u95a2\u3057\u3066ZOLL Medical\u306b\u8b66\u544a\u66f8\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u3088\u3046\u306a\u8b66\u544a\u66f8\u306f\u3001\u5e02\u8ca9\u5f8c\u306e\u7fa9\u52d9\u3092\u6539\u3081\u3066\u8a8d\u8b58\u3055\u305b\u308b\u3082\u306e\u3067\u3059\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">(<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">\u82e6\u60c5\u51e6\u7406\u3001\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u3001\u6709\u5bb3\u4e8b\u8c61\u5831\u544a<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u627f\u8a8d\u6642\u306b\u30af\u30ea\u30a2\u3055\u308c\u308b\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3060\u3051\u3067\u306a\u304f\u3001\u7a4d\u6975\u7684\u306b\u76e3\u8996\u3055\u308c\u307e\u3059\u3002\u5185\u90e8\u6587\u66f8\u306e\u3088\u3046\u306b\u898b\u3048\u308b\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u4e0d\u5099\u306f\u3001\u3059\u3050\u306b\u516c\u7684\u306a\u57f7\u884c\u8a18\u9332\u3068\u306a\u308a\u3001\u540c\u3058\u6587\u66f8\u3092\u8aad\u3080\u9867\u5ba2\u3001\u30d1\u30fc\u30c8\u30ca\u30fc\u3001\u305d\u306e\u4ed6\u306e\u898f\u5236\u5f53\u5c40\u306e\u76e3\u8996\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002\u8b66\u544a\u66f8\u306b\u57fa\u3065\u3044\u3066\u662f\u6b63\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u3088\u308a\u3082\u3001\u6700\u521d\u304b\u3089\u30b7\u30b9\u30c6\u30e0\u3092\u6b63\u3057\u304f\u69cb\u7bc9\u3059\u308b\u65b9\u304c\u3001\u6642\u9593\u3068\u30b3\u30b9\u30c8\u304c\u304b\u304b\u308a\u307e\u305b\u3093\u3002.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW59049111 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW59049111 BCX0\">\u4e2d\u56fd\u306f\u6a5f\u5668\u306e\u767b\u9332\u3068\u5206\u985e\u3092\u66f4\u65b0\u3057\u7d9a\u3051\u3066\u3044\u308b\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-2100990970\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2100990970 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW215322073 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW215322073 BCX0\">\u4e2d\u56fd\u306eNMPA\u306f\u5206\u985e\u8abf\u6574\u3092\u53d7\u3051\u3066\u6a5f\u5668\u767b\u9332\u3068\u7533\u8acb\u8981\u4ef6\u3092\u66f4\u65b0\u3057\u3001CMDE\u306f\u8907\u6570\u306e\u6280\u8853\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u6848\u306b\u3064\u3044\u3066\u5354\u8b70\u3092\u884c\u3063\u305f\u3002\u4e2d\u56fd\u306e\u6a5f\u5668\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306f\u307b\u307c\u7d76\u3048\u305a\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u5206\u985e\u5909\u66f4\u306f\u898b\u304b\u3051\u306b\u3088\u3089\u305a\u6df7\u4e71\u3092\u62db\u304f\u3002\u518d\u5206\u985e\u3055\u308c\u305f\u6a5f\u5668\u306f\u3001\u7570\u306a\u308b\u8a3c\u62e0\u57fa\u6e96\u3001\u7533\u8acb\u7d4c\u8def\u3001\u307e\u305f\u306f\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306b\u76f4\u9762\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u6642\u306b\u306f\u9014\u4e2d\u3067<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW215322073 BCX0\">\u30d7\u30ed\u30b0\u30e9\u30e0<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\">. \u4e2d\u56fd\u306b\u8ca9\u58f2\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306f\u00a0<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\">\u30e2\u30cb\u30bf\u30fc<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\"> \u5206\u985e\u3068\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u7d99\u7d9a\u7684\u306b\u5909\u66f4\u3055\u308c\u308b\u305f\u3081\u3001\u767b\u9332\u306f\u4e00\u5ea6\u9650\u308a\u306e\u30a4\u30d9\u30f3\u30c8\u3067\u306f\u306a\u304f\u3001\u5909\u5316\u3059\u308b\u67a0\u7d44\u307f\u3068\u306e\u7d99\u7d9a\u7684\u306a\u95a2\u4fc2\u3068\u3057\u3066\u6349\u3048\u308b\u3079\u304d\u3067\u3059\u3002.<\/span><\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW56844195 BCX0\">\u4f55\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u3053\u308c\u306f<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u5e73\u5747<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u00a0\u306e\u305f\u3081\u306b\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u88fd\u9020\u696d\u8005\uff1f<\/span><\/strong><\/h3>\n\t<div id=\"gap-1552604966\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1552604966 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW103495034 BCX0\">EU\u3001\u7c73\u56fd\u3001\u4e2d\u56fd\u306f\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u624b\u6bb5\u3067\u7de0\u3081\u4ed8\u3051\u3092\u5f37\u5316\u3057\u3066\u3044\u308b\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">(<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u5b8c\u5168\u6027\u3001\u5e02\u8ca9\u5f8c\u306e\u54c1\u8cea\u7ba1\u7406\u3001\u304a\u3088\u3073\u767b\u9332\u8981\u4ef6<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 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