{"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 BCX0\"><strong>2026\u5e74\u534a\u3070\u3001\u4e16\u754c\u6700\u5927\u306e\u5e02\u58343\u3064\u3067\u540c\u6642\u306b\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u304c\u5f37\u5316\u3055\u308c\u3001\u533b\u7642\u6a5f\u5668\u3068\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306f\u3001\u5f53\u793e\u304c\u8ffd\u8de1\u3057\u3066\u3044\u308b\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u898f\u5236\u306e\u4e2d\u3067\u6700\u3082\u6d3b\u767a\u306a\u5206\u91ce\u3068\u306a\u3063\u305f\u3002.<\/strong> 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-455489411\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-455489411 {\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-990916122\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-990916122 {\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-895784272\" class=\"gap-element clearfix\" style=\"display:block; 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The EU pushed its device database toward mandatory use, the US FDA enforced on device quality, and China kept adjusting its registration machinery. None is dramatic alone, but together they raise the baseline for keeping products on the market,\u00a0and the obligations are converging on data, quality systems, and registration discipline.\u00a0 EUDAMED has become mandatory across the EU The European Commission set mandatory use of the first four EUDAMED modules, and national agencies\u00a0(Estonia&#8217;s Medicines Agency among them)\u00a0confirmed the database is now obligatory in&#8230;<\/p>","protected":false},"author":46,"featured_media":10383,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10382","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Medical 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