{"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%96%97%e5%99%a8%e6%a2%b0%e7%9b%91%e7%ae%a1-2026%e5%b9%b46%e6%9c%88","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/medical-device-oversight-june-2026\/","title":{"rendered":"EUDAMED\u5f3a\u5236\u5b9e\u65bd\uff1a\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\u8981\u6c42\u4e25\u683c\u2026\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\u5e74\u4e2d\uff0c\u5168\u7403\u4e09\u5927\u5e02\u573a\u540c\u65f6\u6536\u7d27\u4e86\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\uff0c\u4f7f\u5f97\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6210\u4e3a\u6211\u4eec\u8ffd\u8e2a\u7684\u751f\u547d\u79d1\u5b66\u76d1\u7ba1\u9886\u57df\u4e2d\u6700\u7e41\u5fd9\u7684\u9886\u57df\u3002.<\/strong> \u6b27\u76df\u63a8\u52a8\u5176\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\u5f3a\u5236\u4f7f\u7528\uff0c\u7f8e\u56fdFDA\u52a0\u5f3a\u4e86\u5bf9\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7684\u76d1\u7ba1\uff0c\u4e2d\u56fd\u5219\u4e0d\u65ad\u8c03\u6574\u5176\u6ce8\u518c\u673a\u5236\u3002\u8fd9\u4e9b\u63aa\u65bd\u5355\u72ec\u6765\u770b\u6216\u8bb8\u5e76\u4e0d\u5f15\u4eba\u6ce8\u76ee\uff0c\u4f46\u5b83\u4eec\u5171\u540c\u63d0\u9ad8\u4e86\u4ea7\u54c1\u5728\u5e02\u573a\u4e0a\u9500\u552e\u7684\u95e8\u69db\u3002<\/span><span class=\"NormalTextRun SCXW231934779 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW231934779 BCX0\">\u5404\u9879\u4e49\u52a1\u6b63\u8d8b\u5411\u4e8e\u6570\u636e\u3001\u8d28\u91cf\u4f53\u7cfb\u548c\u6ce8\u518c\u89c4\u8303\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-1098657342\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1098657342 {\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 \u5df2\u6210\u4e3a\u6b27\u76df\u8303\u56f4\u5185\u7684\u5f3a\u5236\u6027\u8981\u6c42<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-2117886314\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2117886314 {\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\u76df\u59d4\u5458\u4f1a\u89c4\u5b9a\u5f3a\u5236\u4f7f\u7528\u524d\u56db\u4e2a EUDAMED \u6a21\u5757\uff0c\u5404\u56fd\u673a\u6784\u4e5f\u5e94\u5982\u6b64\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">(<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">\u5176\u4e2d\u5305\u62ec\u7231\u6c99\u5c3c\u4e9a\u836f\u54c1\u7ba1\u7406\u5c40<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">\u5df2\u786e\u8ba4\u8be5\u6570\u636e\u5e93\u5728\u5b9e\u8df5\u4e2d\u5df2\u6210\u4e3a\u5f3a\u5236\u6027\u8981\u6c42\u3002EUDAMED \u7684\u5b9e\u65bd\u915d\u917f\u591a\u5e74\uff0c\u5bfc\u81f4\u4eba\u4eec\u4ea7\u751f\u61c8\u6020\u60c5\u7eea\uff1b\u800c\u5982\u4eca\uff0c\u4e00\u65e6\u8f6c\u4e3a\u5f3a\u5236\u6027\u8981\u6c42\uff0c\u8fd9\u79cd\u61c8\u6020\u5c31\u4f1a\u53d8\u6210\u4e00\u79cd\u8d1f\u62c5\u3002\u5236\u9020\u5546\u548c\u8fdb\u53e3\u5546\u9700\u8981\u5b8c\u6210\u53c2\u4e0e\u8005\u6ce8\u518c\u3001\u8bbe\u5907\u8bc6\u522b\u4ee5\u53ca\u76f8\u5173\u7533\u62a5\uff0c\u56e0\u4e3a EUDAMED \u6570\u636e\u4e0d\u5b8c\u6574\u8d8a\u6765\u8d8a\u610f\u5473\u7740\u5e02\u573a\u51c6\u5165\u95ee\u9898\uff0c\u800c\u975e\u884c\u653f\u95ee\u9898\u3002\u8fd9\u9879\u5de5\u4f5c\u5e76\u4e0d\u5149\u9c9c\u4eae\u4e3d\uff0c\u4f46\u5b83\u6b63\u5728\u6210\u4e3a\u51c6\u5165\u7684\u95e8\u69db\u3002<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW224198092 BCX0\">\u5728\u65f6\u95f4\u538b\u529b\u4e0b\u8fdb\u884c\u540e\u671f\u586b\u8865\u6bd4\u4e00\u5f00\u59cb\u5c31\u5efa\u9020\u8981\u56f0\u96be\u5f97\u591a\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\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u8b66\u544a\u4fe1\u9488\u5bf9\u533b\u7597\u5668\u68b0\u8d28\u91cf\u4f53\u7cfb\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1690230676\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1690230676 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW143045283 BCX0\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5c31\u8d28\u91cf\u4f53\u7cfb\u548c\u533b\u7597\u5668\u68b0\u62a5\u544a\u65b9\u9762\u7684\u7f3a\u9677\u5411ZOLL Medical\u516c\u53f8\u53d1\u51fa\u8b66\u544a\u4fe1\u3002\u6b64\u7c7b\u8b66\u544a\u4fe1\u65e8\u5728\u63d0\u9192\u4f01\u4e1a\u5c65\u884c\u4e0a\u5e02\u540e\u4e49\u52a1\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">(<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">\u6295\u8bc9\u5904\u7406\u3001\u7ea0\u6b63\u548c\u9884\u9632\u63aa\u65bd\u3001\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW143045283 BCX0\">\u8d28\u91cf\u4f53\u7cfb\u7684\u7f3a\u9677\u4f1a\u53d7\u5230\u79ef\u6781\u76d1\u7ba1\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u5ba1\u6279\u65f6\u901a\u8fc7\u7684\u95e8\u69db\u8981\u6c42\u3002\u770b\u4f3c\u5185\u90e8\u6587\u4ef6\u8bb0\u5f55\u7684\u8d28\u91cf\u4f53\u7cfb\u7f3a\u9677\u5f88\u5feb\u5c31\u4f1a\u6210\u4e3a\u516c\u5f00\u7684\u6267\u6cd5\u8bb0\u5f55\uff0c\u5f15\u8d77\u5ba2\u6237\u3001\u5408\u4f5c\u4f19\u4f34\u548c\u5176\u4ed6\u76d1\u7ba1\u673a\u6784\u7684\u5bc6\u5207\u5173\u6ce8\uff0c\u56e0\u4e3a\u4ed6\u4eec\u90fd\u4f1a\u9605\u8bfb\u540c\u6837\u7684\u8b66\u544a\u4fe1\u3002\u6839\u636e\u8b66\u544a\u4fe1\u8fdb\u884c\u6574\u6539\u6bd4\u4e00\u5f00\u59cb\u5c31\u5efa\u7acb\u5b8c\u5584\u7684\u4f53\u7cfb\u66f4\u8017\u65f6\u8017\u529b\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\u4e0d\u65ad\u66f4\u65b0\u533b\u7597\u5668\u68b0\u6ce8\u518c\u548c\u5206\u7c7b\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-907208898\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-907208898 {\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\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u5728\u8c03\u6574\u533b\u7597\u5668\u68b0\u5206\u7c7b\u540e\u66f4\u65b0\u4e86\u6ce8\u518c\u548c\u5907\u6848\u8981\u6c42\uff0c\u800c\u533b\u7597\u5668\u68b0\u534f\u8c03\u59d4\u5458\u4f1a\uff08CMDE\uff09\u5219\u5c31\u591a\u9879\u6280\u672f\u6307\u5357\u8349\u6848\u8fdb\u884c\u4e86\u78cb\u5546\u3002\u4e2d\u56fd\u7684\u533b\u7597\u5668\u68b0\u6846\u67b6\u51e0\u4e4e\u4e00\u76f4\u5728\u4e0d\u65ad\u53d8\u5316\uff0c\u5206\u7c7b\u53d8\u66f4\u7684\u5f71\u54cd\u4e5f\u5f80\u5f80\u51fa\u4eba\u610f\u6599\uff1a\u91cd\u65b0\u5206\u7c7b\u7684\u533b\u7597\u5668\u68b0\u53ef\u80fd\u9762\u4e34\u4e0d\u540c\u7684\u8bc1\u636e\u8981\u6c42\u3001\u5907\u6848\u9014\u5f84\u6216\u65f6\u95f4\u9650\u5236\uff0c\u6709\u65f6\u751a\u81f3\u5728\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u4e5f\u4f1a\u53d1\u751f\u53d8\u5316\u3002<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW215322073 BCX0\">\u7a0b\u5e8f<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\">. \u5411\u4e2d\u56fd\u9500\u552e\u4ea7\u54c1\u7684\u5236\u9020\u5546\u5e94\u8be5\u00a0<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\">\u76d1\u89c6\u5668<\/span><span class=\"NormalTextRun SCXW215322073 BCX0\"> \u5206\u7c7b\u548c\u6307\u5bfc\u4e0d\u65ad\u53d8\u5316\uff0c\u6ce8\u518c\u5e94\u88ab\u89c6\u4e3a\u4e0e\u4e0d\u65ad\u53d8\u5316\u7684\u6846\u67b6\u5efa\u7acb\u6301\u7eed\u7684\u5173\u7cfb\uff0c\u800c\u4e0d\u662f\u4e00\u6b21\u6027\u4e8b\u4ef6\u3002.<\/span><\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW56844195 BCX0\">\u4ec0\u4e48\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u8fd9\u6837\u505a<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u610f\u601d\u662f<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u00a0\u4e3a\u4e86\u00a0<\/span><span class=\"NormalTextRun SCXW56844195 BCX0\">\u5236\u9020\u5546\uff1f<\/span><\/strong><\/h3>\n\t<div id=\"gap-1918261605\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1918261605 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW103495034 BCX0\">\u6b27\u76df\u3001\u7f8e\u56fd\u548c\u4e2d\u56fd\u6b63\u5728\u6536\u7d27\u4e0d\u540c\u7684\u653f\u7b56\u624b\u6bb5\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">(<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">\u6570\u636e\u5e93\u5b8c\u6574\u6027\u3001\u4e0a\u5e02\u540e\u8d28\u91cf\u76d1\u7ba1\u548c\u6ce8\u518c\u8981\u6c42<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">\u4f46\u7efc\u5408\u6765\u770b\uff0c\u8fd9\u4f1a\u5e26\u6765\u66f4\u9ad8\u3001\u66f4\u5bc6\u96c6\u7684\u6570\u636e\u57fa\u7ebf\u3002\u5e94\u5c06 EUDAMED \u6ce8\u518c\u3001\u8d28\u91cf\u4f53\u7cfb\u51c6\u5907\u60c5\u51b5\u548c\u4e2d\u56fd\u5206\u7c7b\u72b6\u6001\u89c6\u4e3a\u9010\u4e2a\u5e02\u573a\u3001\u5b9e\u65f6\u5c65\u884c\u7684\u4e49\u52a1\uff0c\u800c\u4e0d\u662f\u4e0a\u5e02\u540e\u4e00\u6b21\u6027\u5b8c\u6210\u7684\u91cc\u7a0b\u7891\u3002\u5728\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u65b9\u9762\uff0c\u4ee3\u4ef7\u9ad8\u6602\u7684\u610f\u5916\u60c5\u51b5\u2026\u2026\u00a0<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">\u51e0\u4e4e\u603b\u662f<\/span><span class=\"NormalTextRun SCXW103495034 BCX0\">\u00a0\u6e90\u4e8e\u67d0\u79cd\u5728\u5ba1\u6279\u65f6\u7b26\u5408\u89c4\u5b9a\uff0c\u4f46\u540e\u6765\u6084\u7136\u4e0d\u518d\u7b26\u5408\u89c4\u5b9a\u7684\u60c5\u51b5\u3002.\u00a0<\/span><a href=\"http:\/\/regask.com\/zh\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW103495034 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW103495034 BCX0\">\u00a0\u8ffd\u8e2a 160 \u591a\u4e2a\u5e02\u573a\u7684\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff0c\u5e2e\u52a9\u5236\u9020\u5546\u53ca\u65e9\u4e86\u89e3\u5206\u7c7b\u3001\u6570\u636e\u5e93\u548c\u6267\u6cd5\u65b9\u9762\u7684\u53d8\u5316\uff0c\u4ee5\u4fbf\u91c7\u53d6\u884c\u52a8\u3002.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Medical device compliance tightened across three of the world&#8217;s largest markets at once in mid-2026, making devices and IVDs the busiest area of Life Sciences regulation we tracked. 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,&#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 Device Compliance 2026: Key Changes Ahead<\/title>\n<meta name=\"description\" content=\"Stay informed on medical device compliance 2026 as regulations tighten in major markets and EUDAMED becomes mandatory.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/\u533b\u7597\u5668\u68b0\u76d1\u7ba1-2026\u5e746\u6708\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUDAMED Goes Mandatory: Medical Device Compliance Tightens Across EU, US &amp; China\" \/>\n<meta property=\"og:description\" content=\"Stay informed on medical device compliance 2026 as regulations tighten in major markets and EUDAMED becomes mandatory.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u533b\u7597\u5668\u68b0\u76d1\u7ba1-2026\u5e746\u6708\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-30T02:48:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/6d86c29c9123b2b67a3ea8e259cdb925\"},\"headline\":\"EUDAMED Goes Mandatory: Medical Device Compliance Tight&hellip;\",\"datePublished\":\"2026-06-30T02:48:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/\"},\"wordCount\":508,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png\",\"articleSection\":[\"Blogs\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/\",\"name\":\"Medical Device Compliance 2026: Key Changes Ahead\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png\",\"datePublished\":\"2026-06-30T02:48:41+00:00\",\"description\":\"Stay informed on medical device compliance 2026 as regulations tighten in major markets and EUDAMED becomes mandatory.\",\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/medical-device-oversight-june-2026\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png\",\"width\":800,\"height\":600,\"caption\":\"Eudamed Goes Mandatory Medical Device Compliance Tightens Across Eu Us China\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/6d86c29c9123b2b67a3ea8e259cdb925\",\"name\":\"Shaffa Renaningtyas\",\"sameAs\":[\"https:\\\/\\\/regask.com\\\/\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"2026\u5e74\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\uff1a\u672a\u6765\u5173\u952e\u53d8\u5316","description":"\u968f\u7740\u4e3b\u8981\u5e02\u573a\u7684\u76d1\u7ba1\u65e5\u76ca\u4e25\u683c\uff0cEUDAMED \u6210\u4e3a\u5f3a\u5236\u6027\u8981\u6c42\uff0c\u8bf7\u968f\u65f6\u4e86\u89e3 2026 \u5e74\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\u65b9\u9762\u7684\u4fe1\u606f\u3002.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/zh\/\u533b\u7597\u5668\u68b0\u76d1\u7ba1-2026\u5e746\u6708\/","og_locale":"zh_CN","og_type":"article","og_title":"EUDAMED Goes Mandatory: Medical Device Compliance Tightens Across EU, US & China","og_description":"Stay informed on medical device compliance 2026 as regulations tighten in major markets and EUDAMED becomes mandatory.","og_url":"https:\/\/regask.com\/zh\/\u533b\u7597\u5668\u68b0\u76d1\u7ba1-2026\u5e746\u6708\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-06-30T02:48:41+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png","type":"image\/png"}],"author":"Shaffa Renaningtyas","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"\u4f5c\u8005":"Shaffa Renaningtyas","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"3 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/#article","isPartOf":{"@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/"},"author":{"name":"Shaffa Renaningtyas","@id":"https:\/\/regask.com\/#\/schema\/person\/6d86c29c9123b2b67a3ea8e259cdb925"},"headline":"EUDAMED Goes Mandatory: Medical Device Compliance Tight&hellip;","datePublished":"2026-06-30T02:48:41+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/"},"wordCount":508,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png","articleSection":["Blogs"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/","url":"https:\/\/regask.com\/medical-device-oversight-june-2026\/","name":"2026\u5e74\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\uff1a\u672a\u6765\u5173\u952e\u53d8\u5316","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png","datePublished":"2026-06-30T02:48:41+00:00","description":"\u968f\u7740\u4e3b\u8981\u5e02\u573a\u7684\u76d1\u7ba1\u65e5\u76ca\u4e25\u683c\uff0cEUDAMED \u6210\u4e3a\u5f3a\u5236\u6027\u8981\u6c42\uff0c\u8bf7\u968f\u65f6\u4e86\u89e3 2026 \u5e74\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\u65b9\u9762\u7684\u4fe1\u606f\u3002.","inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/medical-device-oversight-june-2026\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/medical-device-oversight-june-2026\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/06\/eudamed-goes-mandatory-medical-device-compliance-tightens-across-eu-us-china.png","width":800,"height":600,"caption":"Eudamed Goes Mandatory Medical Device Compliance Tightens Across Eu Us China"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"\u9762\u5411\u9ad8\u6548\u56e2\u961f\u7684\u76d1\u7ba1\u4eba\u5de5\u667a\u80fd\u64cd\u4f5c\u7cfb\u7edf","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/6d86c29c9123b2b67a3ea8e259cdb925","name":"\u6c99\u6cd5\u00b7\u96f7\u7eb3\u5b81\u8482\u4e9a\u65af","sameAs":["https:\/\/regask.com\/"]}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/10382","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/users\/46"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/comments?post=10382"}],"version-history":[{"count":3,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/10382\/revisions"}],"predecessor-version":[{"id":10386,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/10382\/revisions\/10386"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media\/10383"}],"wp:attachment":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media?parent=10382"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/categories?post=10382"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/tags?post=10382"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}