{"id":391,"date":"2026-10-29T00:36:40","date_gmt":"2026-10-28T11:36:40","guid":{"rendered":"https:\/\/www.bbm.co.nz\/zh\/medtech-china-entry\/"},"modified":"2026-10-29T16:24:27","modified_gmt":"2026-10-29T03:24:27","slug":"regulatory-consulting","status":"publish","type":"page","link":"https:\/\/www.bbm.co.nz\/zh\/regulatory-consulting\/","title":{"rendered":"\u6cd5\u89c4\u54a8\u8be2"},"content":{"rendered":"<div class=\"bbm-home bbm-page\">\n<section class=\"bbm-hero bbm-hero-sm\">\n<p class=\"bbm-eyebrow\">\u6cd5\u89c4\u54a8\u8be2<\/p>\n<h1>\u6ce8\u518c\u7533\u62a5\u7684\u4e34\u5e8a\u8bc1\u636e\u4e0e\u6cd5\u89c4\u652f\u6301<\/h1>\n<p class=\"bbm-lead\">\u6ce8\u518c\u7533\u62a5\u6240\u9700\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u7531\u6211\u4eec\u7684\u54a8\u8be2\u56e2\u961f\u8d1f\u8d23\u5206\u6790\u548c\u64b0\u5199\u3002\u6211\u4eec\u5224\u65ad\u73b0\u6709\u8bc1\u636e\u80fd\u8bc1\u660e\u4ec0\u4e48\u3001\u8fd8\u7f3a\u4ec0\u4e48\uff0c\u5e76\u6309\u5ba1\u8bc4\u673a\u6784\u671f\u671b\u7684\u65b9\u5f0f\u7ec4\u7ec7\u8bba\u8bc1\u3002\u56fd\u5185\u6ce8\u518c\u6309 NMPA \u8981\u6c42\u51c6\u5907\uff1b\u4ea7\u54c1\u51fa\u6d77\uff0c\u6309\u6b27\u76df\u3001\u7f8e\u56fd\u3001\u6fb3\u65b0\u7b49\u76ee\u6807\u5e02\u573a\u7684\u8981\u6c42\u51c6\u5907\u3002<\/p>\n<\/section>\n<div class=\"bbm-body\">\n<section class=\"bbm-block\" id=\"clinical-evidence\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-c1-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>1. \u4e34\u5e8a\u8bc4\u4ef7\u4e0e\u8bc1\u636e\u8bc4\u4ef7<\/h2>\n<\/div>\n<\/div>\n<div class=\"bbm-cards bbm-cards-2\">\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-nmpa-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>NMPA \u4e34\u5e8a\u8bc4\u4ef7<\/h3>\n<p>\u6309 NMPA \u4e34\u5e8a\u8bc4\u4ef7\u76f8\u5173\u6307\u5bfc\u539f\u5219\u7f16\u5199\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599\uff0c\u5305\u62ec\u540c\u54c1\u79cd\u6bd4\u5bf9\u3001\u6587\u732e\u8d44\u6599\u548c\u4e34\u5e8a\u6570\u636e\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sota-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u6700\u65b0\u6280\u672f\u6c34\u5e73\uff08SOTA\uff09\u5206\u6790<\/h3>\n<p>\u68b3\u7406\u8be5\u7c7b\u5668\u68b0\u7684\u73b0\u884c\u6807\u51c6\u6cbb\u7597\u3001\u66ff\u4ee3\u65b9\u6848\u548c\u6027\u80fd\u57fa\u51c6\uff0c\u4f5c\u4e3a\u83b7\u76ca\u98ce\u9669\u5206\u6790\u548c\u7b49\u540c\u6027\u8bba\u8bc1\u7684\u4f9d\u636e\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-lit-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u7cfb\u7edf\u6587\u732e\u68c0\u7d22\u4e0e\u7efc\u8ff0<\/h3>\n<p>\u5728 PubMed\u3001Embase \u548c\u4e07\u65b9\u4e2d\u68c0\u7d22\uff0c\u6309\u9884\u8bbe\u6807\u51c6\u7b5b\u9009\uff0c\u63d0\u53d6\u6570\u636e\u5e76\u9010\u7bc7\u8bc4\u4ef7\u3002\u6211\u4eec\u540c\u65f6\u63d0\u4f9b\u6587\u732e\u68c0\u7d22\u65b9\u6848\u548c\u7efc\u8ff0\u62a5\u544a\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-globe-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u51fa\u6d77\u6ce8\u518c\u7684\u4e34\u5e8a\u8bc4\u4ef7<\/h3>\n<p>\u6309\u76ee\u6807\u5e02\u573a\u8981\u6c42\u7f16\u5199\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u548c\u6587\u732e\u90e8\u5206\uff0c\u8986\u76d6\u6b27\u76df MDR\u3001\u7f8e\u56fd FDA\u3001\u6fb3\u5927\u5229\u4e9a\u548c\u65b0\u897f\u5170\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-gap-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u8bc1\u636e\u5dee\u8ddd\u5206\u6790<\/h3>\n<p>\u73b0\u6709\u8bc1\u636e\u591f\u4e0d\u591f\uff1f\u6211\u4eec\u5bf9\u7167\u5ba1\u8bc4\u8981\u6c42\uff0c\u5217\u51fa\u7f3a\u53e3\uff0c\u5e76\u9010\u9879\u63d0\u51fa\u8865\u5145\u8bc1\u636e\u7684\u5efa\u8bae\u3002<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"bbm-block\" id=\"nmpa-support\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-c2-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>2. \u4e2d\u56fd\u6ce8\u518c\u4e0e NMPA \u652f\u6301<\/h2>\n<\/div>\n<\/div>\n<div class=\"bbm-cards bbm-cards-2\">\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-transfer-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u6d77\u5916\u6570\u636e\u7528\u4e8e\u4e2d\u56fd\u6ce8\u518c<\/h3>\n<p>\u8bc4\u4f30 FDA \u6216\u6b27\u76df\u7684\u4e34\u5e8a\u6570\u636e\u80fd\u5426\u652f\u6301 NMPA \u7533\u62a5\uff0c\u4ee5\u53ca\u4e2d\u56fd\u8fd8\u9700\u8981\u54ea\u4e9b\u8865\u5145\u5206\u6790\u6216\u6570\u636e\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-reply-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>NMPA \u53d1\u8865\u56de\u590d<\/h3>\n<p>\u9010\u6761\u5206\u6790\u53d1\u8865\u610f\u89c1\u4e2d\u4e0e\u4e34\u5e8a\u8bc4\u4ef7\u76f8\u5173\u7684\u95ee\u9898\uff0c\u5224\u65ad\u54ea\u4e9b\u9700\u8981\u8865\u5145\u8bc1\u636e\u3001\u54ea\u4e9b\u9700\u8981\u628a\u8bba\u8bc1\u8bb2\u6e05\u695a\uff0c\u5e76\u8d77\u8349\u5f15\u7528\u8bf4\u660e\u4e66\u3001\u6807\u7b7e\u548c\u68c0\u6d4b\u62a5\u544a\u7684\u56de\u590d\u3002\u8fd1\u671f\u6848\u4f8b\uff1a\u4e00\u6b3e\u5fc3\u8840\u7ba1\u5916\u79d1\u5668\u68b0\u6269\u5927\u9002\u5e94\u8bc1\u65f6\u7684\u4ee3\u8868\u6027\u8bba\u8bc1\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-route-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u54a8\u8be2<\/h3>\n<p>\u4e0e\u5317\u4eac\u6ce8\u518c\u4e8b\u52a1\u5408\u4f5c\u4f19\u4f34 Best-Road (Beijing) \u5171\u540c\u63d0\u4f9b NMPA \u4e34\u5e8a\u8bc4\u4ef7\u8def\u5f84\u548c\u8bc1\u636e\u8981\u6c42\u65b9\u9762\u7684\u54a8\u8be2\u3002<\/p>\n<\/div>\n<div class=\"bbm-card bbm-card-photo\"><img class=\"bbm-card-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-review-768x432.avif\" alt=\"\" width=\"768\" height=\"432\" loading=\"lazy\" decoding=\"async\"><\/p>\n<h3>\u9012\u4ea4\u524d\u5ba1\u9605<\/h3>\n<p>\u5ba1\u9605\u8d35\u53f8\u81ea\u884c\u8d77\u8349\u7684\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599\uff0c\u5728\u9012\u4ea4\u524d\u5c31\u7ed3\u6784\u3001\u8bc1\u636e\u548c\u8bba\u8bc1\u63d0\u51fa\u4fee\u6539\u610f\u89c1\u3002<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"bbm-block\" id=\"manuscript-review\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-c3-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>3. SCI \u8bba\u6587\u5ba1\u9605\u4e0e\u6da6\u8272<\/h2>\n<p>\u9762\u5411\u51c6\u5907\u6295\u7a3f SCI \u671f\u520a\u7684\u4e34\u5e8a\u7814\u7a76\u8005\u548c\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u3002\u6211\u4eec\u5728\u540c\u884c\u8bc4\u5ba1\u4e4b\u524d\uff0c\u5148\u505a\u4e00\u4f4d\u4e25\u683c\u7684\u5ba1\u7a3f\u4eba\u3002<\/p>\n<\/div>\n<\/div>\n<ul class=\"bbm-checklist\">\n<li><strong>\u8bba\u8bc1\u4e0e\u7ed3\u6784\uff1a<\/strong>\u7814\u7a76\u95ee\u9898\u3001\u65b9\u6cd5\u3001\u7ed3\u679c\u548c\u7ed3\u8bba\u662f\u5426\u76f8\u4e92\u652f\u6491<\/li>\n<li><strong>\u7edf\u8ba1\u8fb9\u754c\uff1a<\/strong>\u6570\u636e\u80fd\u652f\u6301\u4ec0\u4e48\u7ed3\u8bba\u3001\u4e0d\u80fd\u652f\u6301\u4ec0\u4e48\uff0c\u4ee5\u53ca\u5982\u4f55\u8868\u8ff0<\/li>\n<li><strong>\u671f\u520a\u8981\u6c42\uff1a<\/strong>\u62a5\u544a\u89c4\u8303\uff0c\u4ee5\u53ca\u5ba1\u7a3f\u4eba\u53ef\u80fd\u63d0\u51fa\u7684\u8d28\u7591<\/li>\n<li><strong>\u8bed\u8a00\u6da6\u8272\uff1a<\/strong>\u6e05\u6670\u3001\u51c6\u786e\u7684\u5b66\u672f\u82f1\u6587<\/li>\n<li><strong>\u4fee\u56de\u652f\u6301\uff1a<\/strong>\u534f\u52a9\u56de\u590d\u5ba1\u7a3f\u610f\u89c1<\/li>\n<\/ul>\n<\/section>\n<section class=\"bbm-block\" id=\"method\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-how-768x432.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>\u6211\u4eec\u7684\u5de5\u4f5c\u65b9\u6cd5<\/h2>\n<p>\u4e34\u5e8a\u8bc4\u4ef7\u662f\u57fa\u4e8e\u8bc1\u636e\u7684\u8bba\u8bc1\uff0c\u4e0d\u662f\u6587\u732e\u6458\u8981\u7684\u6c47\u603b\u3002\u6bcf\u4e2a\u9879\u76ee\u90fd\u6309\u4ee5\u4e0b\u6b65\u9aa4\u8fdb\u884c\u3002<\/p>\n<\/div>\n<\/div>\n<ol class=\"bbm-numbered\">\n<li><strong>\u786e\u5b9a\u8def\u5f84\u3002<\/strong>\u660e\u786e\u9002\u7528\u4e8e\u8be5\u5668\u68b0\u53ca\u5176\u58f0\u79f0\u7528\u9014\u7684\u6cd5\u89c4\u3001\u6307\u5bfc\u539f\u5219\u548c\u8bc4\u4ef7\u8def\u5f84\u3002<\/li>\n<li><strong>\u8bbe\u8ba1\u68c0\u7d22\u3002<\/strong>\u786e\u5b9a\u6570\u636e\u5e93\u3001\u68c0\u7d22\u5f0f\u548c\u7eb3\u5165\u6392\u9664\u6807\u51c6\uff0c\u5e76\u5b8c\u6574\u8bb0\u5f55\uff0c\u786e\u4fdd\u68c0\u7d22\u53ef\u4ee5\u590d\u73b0\u3002<\/li>\n<li><strong>\u533a\u5206\u8bc1\u636e\u3002<\/strong>\u672c\u5668\u68b0\u81ea\u8eab\u7684\u6570\u636e\u3001\u7b49\u540c\u6216\u540c\u54c1\u79cd\u5668\u68b0\u7684\u6570\u636e\u3001\u4e00\u822c\u652f\u6301\u6027\u6587\u732e\u5206\u5f00\u6574\u7406\uff0c\u5206\u522b\u8d4b\u4e88\u4e0d\u540c\u6743\u91cd\u3002<\/li>\n<li><strong>\u8bc4\u4ef7\u76f8\u5173\u6027\u3002<\/strong>\u9010\u7bc7\u6838\u5bf9\u6587\u732e\u4e0e\u76ee\u6807\u5668\u68b0\u5728\u9002\u5e94\u8bc1\u3001\u8bbe\u8ba1\u3001\u6027\u80fd\u548c\u98ce\u9669\u65b9\u9762\u7684\u76f8\u5173\u7a0b\u5ea6\u3002<\/li>\n<li><strong>\u627e\u51fa\u7f3a\u53e3\u3002<\/strong>\u5bf9\u7167\u5ba1\u8bc4\u8981\u6c42\uff0c\u5199\u660e\u8fd8\u7f3a\u54ea\u4e9b\u8bc1\u636e\uff0c\u4ee5\u53ca\u5982\u4f55\u8865\u5145\u3002<\/li>\n<\/ol>\n<p>\u62a5\u544a\u4e2d\u7684\u6bcf\u4e00\u9879\u9648\u8ff0\u90fd\u6ce8\u660e\u51fa\u5904\uff0c\u5e76\u5728\u4ea4\u4ed8\u524d\u9010\u6761\u6838\u5bf9\u539f\u6587\uff1b\u6bcf\u4efd\u62a5\u544a\u90fd\u7531\u7b2c\u4e8c\u4e2a\u4eba\u5ba1\u6838\u3002<\/p>\n<\/section>\n<section class=\"bbm-block\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-cfor-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>\u9002\u7528\u60c5\u5f62<\/h2>\n<\/div>\n<\/div>\n<ul class=\"bbm-checklist\">\n<li>\u4ea7\u54c1\u5df2\u5728\u6b27\u76df\u3001\u7f8e\u56fd\u6216\u6fb3\u5927\u5229\u4e9a\u4e0a\u5e02\uff0c\u6b63\u5728\u51c6\u5907\u9996\u6b21 NMPA \u6ce8\u518c<\/li>\n<li>\u6536\u5230\u4e86 NMPA \u5173\u4e8e\u4e34\u5e8a\u8bc4\u4ef7\u7684\u53d1\u8865\u610f\u89c1<\/li>\n<li>\u4ea7\u54c1\u51c6\u5907\u51fa\u6d77\uff0c\u9700\u8981\u7f16\u5199\u6b27\u76df MDR \u7b49\u76ee\u6807\u5e02\u573a\u7684\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a<\/li>\n<li>\u9700\u8981 SOTA \u5206\u6790\u6216\u6587\u732e\u7efc\u8ff0\uff0c\u7528\u4e8e CER \u66f4\u65b0\u6216\u4ea7\u54c1\u51b3\u7b56<\/li>\n<li>\u4e0d\u786e\u5b9a\u73b0\u6709\u4e34\u5e8a\u8bc1\u636e\u80fd\u5426\u652f\u6301\u65b0\u5e02\u573a\u6216\u65b0\u9002\u5e94\u8bc1<\/li>\n<li>\u6b63\u5728\u51c6\u5907\u6295\u7a3f SCI \u671f\u520a\u7684\u8bba\u6587<\/li>\n<\/ul>\n<\/section>\n<section class=\"bbm-block\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-cneed-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>\u9700\u8981\u60a8\u63d0\u4f9b<\/h2>\n<\/div>\n<\/div>\n<ul class=\"bbm-checklist\">\n<li>\u4ea7\u54c1\u63cf\u8ff0\u3001\u9884\u671f\u7528\u9014\u3001\u8bf4\u660e\u4e66\u548c\u6807\u7b7e<\/li>\n<li>\u5df2\u6709\u7684\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u53ca\u5176\u6587\u732e\u9644\u4ef6<\/li>\n<li>\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\u6216\u4e34\u5e8a\u6570\u636e\u6c47\u603b\uff08\u5982\u6709\uff09<\/li>\n<li>\u5728\u5176\u4ed6\u5e02\u573a\u7684\u6ce8\u518c\u60c5\u51b5\u548c\u76ee\u6807\u65f6\u95f4\u8868<\/li>\n<li>\u53d1\u8865\u56de\u590d\uff1aNMPA \u53d1\u8865\u901a\u77e5\u548c\u5df2\u9012\u4ea4\u7684\u4e34\u5e8a\u8bc4\u4ef7\u8d44\u6599<\/li>\n<li>\u8bba\u6587\u5ba1\u9605\uff1a\u8bba\u6587\u7a3f\u4ef6\u3001\u76ee\u6807\u671f\u520a\u548c\u5ba1\u7a3f\u610f\u89c1\uff08\u5982\u6709\uff09<\/li>\n<\/ul>\n<\/section>\n<section class=\"bbm-block\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-cscope-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>\u670d\u52a1\u8fb9\u754c<\/h2>\n<\/div>\n<\/div>\n<div class=\"bbm-cards bbm-cards-2\">\n<div class=\"bbm-card\">\n<h3>\u4e2d\u56fd\uff08NMPA\uff09<\/h3>\n<p>\u4e34\u5e8a\u8bc4\u4ef7\u5206\u6790\u548c\u53d1\u8865\u56de\u590d\u7531\u6211\u4eec\u76f4\u63a5\u5b8c\u6210\uff1b\u9012\u4ea4\u4ee5\u53ca\u4e0e NMPA \u7684\u6c9f\u901a\uff0c\u7531\u8d35\u53f8\u6ce8\u518c\u56e2\u961f\u6216\u4ee3\u7406\u673a\u6784\u8d1f\u8d23\u3002<\/p>\n<\/div>\n<div class=\"bbm-card\">\n<h3>\u6b27\u76df MDR\u3001\u7f8e\u56fd FDA\u3001\u6fb3\u5927\u5229\u4e9a\u548c\u65b0\u897f\u5170<\/h3>\n<p>\u6211\u4eec\u8d1f\u8d23\u4e34\u5e8a\u8bc4\u4ef7\u548c\u6587\u732e\u5de5\u4f5c\uff0c\u4e0d\u62c5\u4efb\u8fd9\u4e9b\u5e02\u573a\u7684\u6388\u6743\u4ee3\u8868\u3001\u7533\u529e\u65b9\u6216\u6ce8\u518c\u4ee3\u7406\u3002<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"bbm-block\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-cstart-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>\u5982\u4f55\u5f00\u59cb<\/h2>\n<\/div>\n<\/div>\n<ol class=\"bbm-numbered\">\n<li><strong>\u8bc4\u4f30\u3002<\/strong>\u53d1\u6765\u5668\u68b0\u7b80\u4ecb\u3001\u76ee\u6807\u5e02\u573a\u548c\u73b0\u6709\u8d44\u6599\u6e05\u5355\uff0c\u6211\u4eec\u56de\u590d\u5de5\u4f5c\u8303\u56f4\u3001\u65f6\u95f4\u548c\u8d39\u7528\u3002<\/li>\n<li><strong>\u8ba1\u5212\u3002<\/strong>\u52a8\u7b14\u524d\u4e0e\u60a8\u786e\u8ba4\u68c0\u7d22\u7b56\u7565\u3001\u8bc4\u4ef7\u8def\u5f84\u548c\u62a5\u544a\u5927\u7eb2\u3002<\/li>\n<li><strong>\u64b0\u5199\u4e0e\u5ba1\u6838\u3002<\/strong>\u64b0\u5199\u3001\u9010\u6761\u6838\u5bf9\u6587\u732e\u3001\u7b2c\u4e8c\u4eba\u5ba1\u6838\u3002<\/li>\n<li><strong>\u4ea4\u4ed8\u3002<\/strong>\u63d0\u4f9b Word \u548c PDF \u62a5\u544a\u3001\u5b8c\u6574\u53c2\u8003\u6587\u732e\u5217\u8868\u548c EndNote \u6587\u732e\u5e93\uff0c\u5e76\u652f\u6301\u4fee\u6539\u76f4\u81f3\u9012\u4ea4\u3002<\/li>\n<\/ol>\n<\/section>\n<section class=\"bbm-block\">\n<div class=\"bbm-sec-head\"><img class=\"bbm-sec-img\" src=\"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-card-sec-cq-300x225.avif\" alt=\"\" width=\"300\" height=\"225\" loading=\"lazy\" decoding=\"async\"><\/p>\n<div class=\"bbm-sec-text\">\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<\/div>\n<\/div>\n<div class=\"bbm-cards bbm-cards-2\">\n<div class=\"bbm-card\">\n<h3>\u4f60\u4eec\u80fd\u4ee3\u4e3a\u9012\u4ea4\u5417\uff1f<\/h3>\n<p>\u4e0d\u80fd\u3002\u6211\u4eec\u51c6\u5907\u4e34\u5e8a\u8bc1\u636e\u548c\u56de\u590d\uff0c\u9012\u4ea4\u7531\u8d35\u53f8\u6ce8\u518c\u56e2\u961f\u6216\u4ee3\u7406\u673a\u6784\u8d1f\u8d23\u3002<\/p>\n<\/div>\n<div class=\"bbm-card\">\n<h3>\u53ef\u4ee5\u5728\u5df2\u6709\u7684\u6d77\u5916\u4e34\u5e8a\u8bc4\u4ef7\u62a5\u544a\u57fa\u7840\u4e0a\u505a\u5417\uff1f<\/h3>\n<p>\u53ef\u4ee5\u3002\u6b27\u76df MDR \u6216 FDA \u7684\u4e34\u5e8a\u8bc4\u4ef7\u901a\u5e38\u662f\u4e3b\u8981\u4f9d\u636e\u3002\u6211\u4eec\u627e\u51fa NMPA \u8fd8\u9700\u8981\u54ea\u4e9b\u5185\u5bb9\uff0c\u5e76\u91cd\u65b0\u7ec4\u7ec7\u8bba\u8bc1\u3002<\/p>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<section class=\"bbm-cta\">\n<h2>\u6b63\u5728\u51c6\u5907\u6ce8\u518c\u7533\u62a5\u6216\u8bba\u6587\u6295\u7a3f\uff1f<\/h2>\n<p>\u544a\u8bc9\u6211\u4eec\u5668\u68b0\u6216\u8bba\u6587\u60c5\u51b5\u548c\u65f6\u95f4\u8981\u6c42\uff0c\u6211\u4eec\u4f1a\u63d0\u51fa\u5de5\u4f5c\u8303\u56f4\u548c\u8d39\u7528\u3002<\/p>\n<p class=\"bbm-actions\"><a class=\"bbm-btn bbm-btn-primary\" href=\"\/zh\/contact-us\/\">\u8054\u7cfb\u54a8\u8be2\u56e2\u961f<\/a><\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6cd5\u89c4\u54a8\u8be2 \u6ce8\u518c\u7533\u62a5\u7684\u4e34\u5e8a\u8bc1\u636e\u4e0e\u6cd5\u89c4\u652f\u6301 \u6ce8\u518c\u7533\u62a5\u6240\u9700\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u7531\u6211\u4eec\u7684\u54a8\u8be2\u56e2\u961f\u8d1f\u8d23\u5206\u6790\u548c\u64b0\u5199\u3002\u6211\u4eec\u5224\u65ad\u73b0\u6709\u8bc1 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_titles_title":"\u6cd5\u89c4\u54a8\u8be2\uff1aNMPA \u4e34\u5e8a\u8bc4\u4ef7\u3001\u8bc1\u636e\u5dee\u8ddd\u5206\u6790\u3001\u53d1\u8865\u56de\u590d\u4e0e\u8bba\u6587\u6da6\u8272\uff5cBBM","_seopress_titles_desc":"NMPA \u4e34\u5e8a\u8bc4\u4ef7\u4e0e\u53d1\u8865\u56de\u590d\uff0c\u51fa\u6d77\u4e34\u5e8a\u8bc4\u4ef7\uff0c\u7cfb\u7edf\u6587\u732e\u68c0\u7d22\u3001SOTA \u4e0e\u8bc1\u636e\u5dee\u8ddd\u5206\u6790\uff0c\u4ee5\u53caSCI \u8bba\u6587\u5ba1\u9605\u4e0e\u6da6\u8272\u3002","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-hero-lake-pukaki.jpg","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":1920,"_seopress_social_fb_img_height":1280,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"https:\/\/www.bbm.co.nz\/wp-content\/uploads\/bbm-hero-lake-pukaki.jpg","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"","_seopress_redirections_param":"","_seopress_redirections_type":0,"_seopress_analysis_target_kw":"","footnotes":""},"class_list":["post-391","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/391","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=391"}],"version-history":[{"count":7,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/391\/revisions"}],"predecessor-version":[{"id":529,"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/pages\/391\/revisions\/529"}],"wp:attachment":[{"href":"https:\/\/www.bbm.co.nz\/zh\/wp-json\/wp\/v2\/media?parent=391"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}