{"id":7589,"date":"2024-09-10T12:45:50","date_gmt":"2024-09-10T04:45:50","guid":{"rendered":"https:\/\/regask.com\/?p=7589"},"modified":"2024-11-22T05:06:31","modified_gmt":"2024-11-21T21:06:31","slug":"%e9%a3%9f%e8%8d%af%e7%9b%91%e9%83%a8%e4%bf%ae%e8%ae%a2%e5%88%9b%e6%96%b0%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%bf%ab%e9%80%9f%e5%ae%a1%e8%af%84%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/ministry-of-food-and-drug-safety-revises-guidelines-for-expedited-review-of-innovative-medical-devices\/","title":{"rendered":"\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\u4fee\u8ba2\u2026\u6307\u5357"},"content":{"rendered":"<p>\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\u4e8e2024\u5e749\u67086\u65e5\u4fee\u8ba2\u4e86\u300a\u521b\u65b0\u533b\u7597\u5668\u68b0\u4f18\u5148\u5ba1\u67e5\u6307\u5357\uff08\u7533\u8bf7\u4eba\u6307\u5357\uff09\u300b\u3002\u8fd9\u4e9b\u4fee\u8ba2\u7b80\u5316\u4e86\u4e0e\u521b\u65b0\u533b\u7597\u5668\u68b0\u4f18\u5148\u5ba1\u67e5\u76f8\u5173\u7684\u7acb\u6cd5\uff0c\u5e76\u66f4\u65b0\u4e86\u7ec4\u7ec7\u7ed3\u6784\u4ee5\u7b26\u5408\u5f53\u524d\u505a\u6cd5\u3002\u8fd9\u9879\u66f4\u65b0\u7684\u6307\u5357\u5bf9\u4e8e\u5728\u533b\u7597\u4fdd\u5065\u65b9\u9762\u63d0\u4f9b\u91cd\u5927\u8fdb\u6b65\u7684\u533b\u7597\u5668\u68b0\u81f3\u5173\u91cd\u8981\uff0c\u53ef\u786e\u4fdd\u5b83\u4eec\u80fd\u591f\u901a\u8fc7\u66f4\u5feb\u7684\u5ba1\u67e5\u6d41\u7a0b\u5e76\u66f4\u5feb\u5730\u8fdb\u5165\u5e02\u573a\u3002<\/p>\n<p>\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u4f01\u4e1a\u6765\u8bf4\uff0c\u65b0\u6307\u5357\u4ee3\u8868\u7740\u52a0\u5feb\u7a81\u7834\u6027\u4ea7\u54c1\u8fdb\u5165\u5e02\u573a\u7684\u673a\u4f1a\u3002\u5bf9\u4e8e\u5e0c\u671b\u8fc5\u901f\u5c06\u521b\u65b0\u533b\u7597\u5668\u68b0\u63a8\u5411\u5e02\u573a\u7684\u516c\u53f8\u6765\u8bf4\uff0c\u4e86\u89e3\u66f4\u65b0\u7684\u6807\u51c6\u548c\u6d41\u7a0b\u81f3\u5173\u91cd\u8981\u3002\u73b0\u5728\uff0c\u90a3\u4e9b\u5728\u533b\u7597\u4fdd\u5065\u6548\u679c\u65b9\u9762\u6709\u663e\u8457\u6539\u5584\u7684\u4ea7\u54c1\u66f4\u9002\u5408\u8fdb\u884c\u7cbe\u7b80\u7684\u5ba1\u67e5\u3002<\/p>\n<p>\u8bf7\u8054\u7cfb RegAsk \u4ee5\u5e2e\u52a9\u4e86\u89e3\u66f4\u65b0\u540e\u7684\u6307\u5357\u5e76\u52a0\u5feb\u60a8\u7684\u521b\u65b0\u533b\u7597\u8bbe\u5907\u8fdb\u5165\u5e02\u573a\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>The Ministry of Food and Drug Safety revised the &#8220;Innovative Medical Devices Priority Review Guidelines (Guide for Applicants)&#8221; on September 6, 2024. These revisions simplify the legislation related to priority reviews for innovative medical devices and update the organizational structure to align with current practices. This updated guideline is essential for medical devices that provide&#8230;<\/p>","protected":false},"author":43,"featured_media":7607,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[593],"class_list":["post-7589","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-innovative-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Ministry of Food and Drug Safety Revises Guidelines for Expedited Review of Innovative Medical Devices | RegASK<\/title>\n<meta name=\"description\" content=\"Check the updated guidelines published by the Ministry of Food and Drug Safety for faster market access of innovative medical devices and how it might impact regulatory 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