{"id":613,"date":"2026-08-14T09:00:00","date_gmt":"2026-08-13T21:00:00","guid":{"rendered":"https:\/\/www.bbm.co.nz\/zh\/insights\/nmpa-cer-without-sota\/"},"modified":"2026-11-01T22:46:52","modified_gmt":"2026-11-01T09:46:52","slug":"nmpa-cer-without-sota","status":"publish","type":"page","link":"https:\/\/www.bbm.co.nz\/zh\/insights\/nmpa-cer-without-sota\/","title":{"rendered":"\u4e3a\u4ec0\u4e48 NMPA \u4e34\u5e8a\u8bc4\u4ef7\u4e0d\u8981\u6c42\u73b0\u6709\u6280\u672f\u6c34\u5e73\uff08SOTA\uff09\u5206\u6790\uff1f"},"content":{"rendered":"<div class=\"bbm-home bbm-page bbm-article\">\n<section class=\"bbm-hero bbm-hero-sm\">\n<p class=\"bbm-eyebrow\">\u4e13\u4e1a\u89c2\u70b9 \u00b7 \u4e34\u5e8a\u8bc4\u4ef7<\/p>\n<h1>\u4e3a\u4ec0\u4e48 NMPA \u4e34\u5e8a\u8bc4\u4ef7\u4e0d\u8981\u6c42\u73b0\u6709\u6280\u672f\u6c34\u5e73\uff08SOTA\uff09\u5206\u6790\uff1f<\/h1>\n<p class=\"bbm-lead\">\u6b27\u76df MDR \u4e0e NMPA \u91c7\u7528\u4e24\u5957\u7ed3\u6784\u4e0d\u540c\u7684\u8bc1\u636e\u903b\u8f91\u3002SOTA \u5728 MDR \u4e0b\u56de\u7b54\u7684\u95ee\u9898\u5728\u4e2d\u56fd\u4f9d\u7136\u5b58\u5728\uff0cNMPA \u901a\u8fc7\u540c\u54c1\u79cd\u5bf9\u6bd4\u5668\u68b0\u7684\u9009\u62e9\u6765\u56de\u7b54\u5b83\u3002<\/p>\n<\/section>\n<div class=\"bbm-body\">\n<p class=\"bbm-article-meta\">BBM \u00b7 2026 \u5e74 8 \u6708 14 \u65e5<\/p>\n<section class=\"bbm-block\" id=\"question\">\n<h2>\u53ea\u505a\u8fc7 MDR CER \u7684\u56e2\u961f\u5e38\u95ee\u7684\u95ee\u9898<\/h2>\n<p>\u53ea\u505a\u8fc7 MDR \u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\uff08CER\uff09\u7684\u5382\u5546\uff0c\u5f80\u5f80\u9ed8\u8ba4\u201c\u73b0\u6709\u6280\u672f\u6c34\u5e73\u5206\u6790\u201d\uff08State of the Art\uff0cSOTA\uff09\u662f\u4efb\u4f55\u4e00\u4efd\u5408\u683c\u4e34\u5e8a\u8bc4\u4ef7\u90fd\u5e94\u6709\u7684\u901a\u7528\u6b65\u9aa4\u3002\u8fdb\u5165 NMPA \u7533\u62a5\u540e\uff0c\u4ed6\u4eec\u4f1a\u53d1\u73b0\u5e76\u6ca1\u6709\u5bf9\u5e94\u8981\u6c42\u3002\u7b2c\u4e00\u53cd\u5e94\u5f80\u5f80\u662f\uff1a\u662f\u4e0d\u662f\u9057\u6f0f\u4e86\u4ec0\u4e48\uff1f<\/p>\n<p>\u5e76\u6ca1\u6709\u9057\u6f0f\u3002\u4e24\u4e2a\u76d1\u7ba1\u4f53\u7cfb\u4f7f\u7528\u7684\u662f\u4e24\u5957\u7ed3\u6784\u4e0d\u540c\u7684\u8bc1\u636e\u903b\u8f91\u3002<\/p>\n<\/section>\n<section class=\"bbm-block\" id=\"mdr\">\n<h2>SOTA \u5728 MDR CER \u4e2d\u505a\u4ec0\u4e48<\/h2>\n<p>\u6309 MEDDEV 2.7\/1 Rev. 4 \u7684\u8981\u6c42\uff0cSOTA \u7ae0\u8282\u4e0d\u662f\u4e00\u822c\u610f\u4e49\u4e0a\u7684\u6587\u732e\u7efc\u8ff0\uff0c\u800c\u662f\u5bf9\u6574\u4e2a\u6cbb\u7597\u9886\u57df\u7684\u7cfb\u7edf\u68c0\u7d22\uff1a\u53ef\u6bd4\u5668\u68b0\u3001\u66ff\u4ee3\u6cbb\u7597\u65b9\u5f0f\u548c\u76f8\u5173\u4e34\u5e8a\u7814\u7a76\u90fd\u8981\u7eb3\u5165\uff0c\u5e76\u6c47\u603b\u6210\u6027\u80fd\u548c\u5b89\u5168\u6027\u7684\u57fa\u51c6\u6570\u636e\uff08benchmark\uff09\u3002<\/p>\n<p>\u8fd9\u4e9b\u57fa\u51c6\u6570\u636e\u968f\u540e\u6210\u4e3a\u7533\u62a5\u4ea7\u54c1\u81ea\u8eab\u4e34\u5e8a\u6570\u636e\u7684\u9a8c\u6536\u6807\u51c6\u3002\u56e0\u6b64\uff0cSOTA \u4e3a CER \u5efa\u7acb\u7684\u662f\u5168\u9886\u57df\u7684\u9a8c\u6536\u5c3a\u5ea6\uff0c\u4e0d\u4f9d\u8d56\u4efb\u4f55\u5355\u4e00\u5bf9\u7167\u4ea7\u54c1\u3002\u5b83\u65e2\u8981\u6c42\u8be6\u7ec6\u7684\u5206\u6790\uff0c\u4e5f\u8981\u6c42\u9644\u4e0a\u7eb3\u5165\u548c\u6392\u9664\u6587\u732e\u7684\u5b8c\u6574\u6e05\u5355\u3002<\/p>\n<\/section>\n<section class=\"bbm-block\" id=\"nmpa\">\n<h2>NMPA \u8981\u6c42\u4ec0\u4e48<\/h2>\n<p>NMPA \u7684\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u5efa\u7acb\u5728\u540c\u54c1\u79cd\u533b\u7597\u5668\u68b0\u5bf9\u6bd4\u4e4b\u4e0a\uff0c\u5373\u628a\u7533\u62a5\u4ea7\u54c1\u4e0e\u4e00\u6b3e\u5df2\u5728\u4e2d\u56fd\u5408\u6cd5\u4e0a\u5e02\u7684\u540c\u54c1\u79cd\u4ea7\u54c1\u8fdb\u884c\u6bd4\u8f83\u3002\u8fd9\u91cc\u8981\u56de\u7b54\u7684\u4e0d\u662f\u201c\u6574\u4e2a\u9886\u57df\u73b0\u5728\u662f\u4ec0\u4e48\u6c34\u5e73\u201d\uff0c\u800c\u662f\u201c\u8fd9\u6b3e\u4ea7\u54c1\u4e0e\u90a3\u6b3e\u4ea7\u54c1\u6709\u4ec0\u4e48\u4e0d\u540c\uff0c\u8fd9\u4e9b\u4e0d\u540c\u662f\u5426\u53ef\u63a7\u201d\u3002<\/p>\n<p>\u6bcf\u4e00\u5904\u5dee\u5f02\u90fd\u8981\u9010\u6761\u5206\u6790\uff0c\u5305\u62ec\u5df2\u77e5\u4e0d\u826f\u4e8b\u4ef6\u3001\u6750\u6599\u3001\u4f5c\u7528\u673a\u7406\u548c\u53ef\u9884\u89c1\u7684\u8bef\u7528\u3002\u5982\u679c\u8bc4\u4f30\u7ed3\u679c\u662f\u8fd9\u4e9b\u5dee\u5f02\u4e0d\u5f71\u54cd\u5b89\u5168\u6709\u6548\u6027\uff0c\u6216\u53ef\u4ee5\u901a\u8fc7\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u52a0\u4ee5\u7ba1\u7406\uff0c\u5c31\u53ef\u4ee5\u5f97\u51fa\u7b49\u540c\u6216\u76f8\u4f3c\u7684\u7ed3\u8bba\u3002<\/p>\n<p>\u8fd9\u662f\u4ea7\u54c1\u5bf9\u4ea7\u54c1\u7684\u6bd4\u8f83\uff0c\u4e0d\u662f\u4ea7\u54c1\u5bf9\u6574\u4e2a\u9886\u57df\u7684\u6bd4\u8f83\u3002\u9a8c\u6536\u6807\u51c6\u4e0d\u662f\u4ece\u6c47\u603b\u57fa\u51c6\u4e2d\u63a8\u5bfc\uff0c\u800c\u662f\u76f4\u63a5\u53c2\u7167\u5bf9\u7167\u4ea7\u54c1\u5df2\u7ecf\u5efa\u7acb\u7684\u5b89\u5168\u6709\u6548\u6027\u8bb0\u5f55\u3002<\/p>\n<\/section>\n<section class=\"bbm-block\" id=\"why\">\n<h2>SOTA \u56de\u7b54\u7684\u95ee\u9898\u53bb\u4e86\u54ea\u91cc<\/h2>\n<p>\u5728 MDR \u4e0b\uff0cSOTA \u56de\u7b54\u7684\u662f\uff1a\u4e0e\u5f53\u524d\u80fd\u8fbe\u5230\u7684\u6c34\u5e73\u76f8\u6bd4\uff0c\u7533\u62a5\u4ea7\u54c1\u662f\u5426\u8db3\u591f\u597d\u3002\u5728 NMPA \u4f53\u7cfb\u4e0b\uff0c\u8fd9\u4e2a\u95ee\u9898\u5728\u9009\u62e9\u5bf9\u6bd4\u5668\u68b0\u65f6\u5c31\u5df2\u7ecf\u56de\u7b54\u4e86\u3002\u4e00\u6b3e\u5df2\u83b7\u6279\u3001\u5b89\u5168\u8bb0\u5f55\u6210\u719f\u7684\u540c\u54c1\u79cd\u4ea7\u54c1\uff0c\u4ee3\u8868\u7740\u4e2d\u56fd\u5e02\u573a\u5df2\u7ecf\u8ba4\u53ef\u7684\u6c34\u5e73\u3002\u8bc1\u660e\u7533\u62a5\u4ea7\u54c1\u4e0e\u5b83\u7b49\u540c\uff0c\u4e5f\u5c31\u8bc1\u660e\u4e86\u7533\u62a5\u4ea7\u54c1\u8fbe\u5230\u8fd9\u4e00\u6c34\u5e73\u3002<\/p>\n<p>\u8fd9\u4e00\u5dee\u522b\u53cd\u6620\u4e86\u4e24\u4e2a\u4f53\u7cfb\u4e0d\u540c\u7684\u76d1\u7ba1\u601d\u8def\u3002MDR \u7684\u83b7\u76ca\u2013\u98ce\u9669\u6846\u67b6\u8981\u6c42\u81ea\u6210\u4f53\u7cfb\u3001\u8bc1\u636e\u7a77\u5c3d\uff1bNMPA \u7684\u6846\u67b6\u8ffd\u6c42\u6548\u7387\uff0c\u4ee5\u4e2d\u56fd\u5df2\u7ecf\u5ba1\u8bc4\u8fc7\u7684\u4ea7\u54c1\u4e3a\u951a\u70b9\u3002<\/p>\n<\/section>\n<section class=\"bbm-block\" id=\"practice\">\n<h2>\u5bf9\u5df2\u6709 MDR CER \u610f\u5473\u7740\u4ec0\u4e48<\/h2>\n<p>\u6309 MDR \u7f16\u5199\u7684 CER \u901a\u5e38\u5df2\u6709\u76f8\u5f53\u5b8c\u6574\u7684 SOTA \u5206\u6790\uff0c\u4f46\u5176\u4e2d\u5927\u90e8\u5206\u4e0d\u80fd\u76f4\u63a5\u642c\u8fdb NMPA \u7533\u62a5\uff0c\u56e0\u4e3a NMPA \u91c7\u7528\u4e0d\u540c\u7684\u8bc1\u636e\u903b\u8f91\u3002NMPA \u9700\u8981\u7684\u662f\u5728\u5145\u5206\u7406\u89e3\u5bf9\u6bd4\u5668\u68b0\u7684\u57fa\u7840\u4e0a\uff0c\u63d0\u4f9b\u5b8c\u6574\u3001\u6709\u4f9d\u636e\u7684\u5dee\u5f02\u5206\u6790\u3002<\/p>\n<\/section>\n<p class=\"bbm-article-meta\"><a href=\"\/zh\/insights\/\">\u2190 \u8fd4\u56de\u4e13\u4e1a\u89c2\u70b9<\/a><\/p>\n<\/div>\n<div class=\"bbm-body\">\n<div class=\"bbm-wp-callout\"><a class=\"bbm-wp-cover\" href=\"\/zh\/insights\/white-paper-nmpa-clinical-evaluation\/\"><img src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/wp-cover-thumb.avif\" alt=\"\u767d\u76ae\u4e66\u5c01\u9762\uff1a\u5883\u5916\u533b\u7597\u5668\u68b0NMPA\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u6307\u5357\" width=\"440\" height=\"621\" loading=\"lazy\" decoding=\"async\"\/><\/a><\/p>\n<p class=\"bbm-wp-label\">\u514d\u8d39\u767d\u76ae\u4e66<\/p>\n<h3><a href=\"\/zh\/insights\/white-paper-nmpa-clinical-evaluation\/\">\u5883\u5916\u533b\u7597\u5668\u68b0NMPA\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u6307\u5357<\/a><\/h3>\n<p>NMPA \u4e09\u6761\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u3001\u8def\u5f84\u51b3\u7b56\u56fe\uff0c\u4ee5\u53ca\u4e2d\u56fd\u3001\u6fb3\u5927\u5229\u4e9a\u548c\u65b0\u897f\u5170\u76d1\u7ba1\u89c4\u5219\u6bd4\u8f83\u3002\u5171 14 \u9875\uff0c\u4e2d\u82f1\u53cc\u8bed\u3002<\/p>\n<p class=\"bbm-trust-more\"><a href=\"\/zh\/insights\/white-paper-nmpa-clinical-evaluation\/\">\u7d22\u53d6\u767d\u76ae\u4e66 \u2192<\/a><\/p>\n<\/div>\n<\/div>\n<section class=\"bbm-cta\">\n<h2>\u9700\u8981\u628a\u6b27\u76df MDR \u7684 CER \u8f6c\u7528\u4e8e\u4e2d\u56fd\u7533\u62a5\uff1f<\/h2>\n<p>\u6211\u4eec\u4ee5\u5df2\u5728\u4e2d\u56fd\u6ce8\u518c\u7684\u540c\u54c1\u79cd\u5668\u68b0\u4e3a\u5bf9\u7167\u91cd\u65b0\u7ec4\u7ec7\u4e34\u5e8a\u8bc4\u4ef7\uff0c\u5e76\u590d\u7528\u5df2\u6709\u7684\u6587\u732e\u5de5\u4f5c\u3002<\/p>\n<p class=\"bbm-actions\"><a class=\"bbm-btn bbm-btn-primary\" href=\"\/zh\/regulatory-consulting\/#clinical-evidence\">\u4e86\u89e3\u4e34\u5e8a\u8bc4\u4ef7\u670d\u52a1<\/a><\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u4e13\u4e1a\u89c2\u70b9 \u00b7 \u4e34\u5e8a\u8bc4\u4ef7 \u4e3a\u4ec0\u4e48 NMPA \u4e34\u5e8a\u8bc4\u4ef7\u4e0d\u8981\u6c42\u73b0\u6709\u6280\u672f\u6c34\u5e73\uff08SOTA\uff09\u5206\u6790\uff1f \u6b27\u76df MDR \u4e0e NM [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":608,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-613","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/comments?post=613"}],"version-history":[{"count":5,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/613\/revisions"}],"predecessor-version":[{"id":716,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/613\/revisions\/716"}],"up":[{"embeddable":true,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/608"}],"wp:attachment":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/media?parent=613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}