{"id":40845,"date":"2015-12-29T10:00:40","date_gmt":"2015-12-29T15:00:40","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-drug-device-regulations-in-2015-a-year-in-review\/"},"modified":"2020-02-10T14:45:59","modified_gmt":"2020-02-10T14:45:59","slug":"fda-drug-device-regulations-in-2015-a-year-in-review","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-drug-device-regulations-in-2015-a-year-in-review\/","title":{"rendered":"FDA 2015\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff1a\u5e74\u5ea6\u56de\u987e"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>2015\u5e74\uff0c\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6570\u5b57\u5316\u8d8b\u52bf\u663e\u73b0\u3002\u7f8e\u56fd\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(U.S. Food and Drug Administration, FDA)\u65b0\u6cd5\u89c4\u8981\u6c42\u7279\u5b9a\u6587\u4ef6\u901a\u8fc7\u7535\u5b50\u65b9\u5f0f\u9012\u4ea4\uff0c\u5982\u533b\u7597\u836f\u54c1\u4e34\u5e8a\u5e94\u7528\u548c\u5668\u68b0\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\u3002\u6b64\u5916\uff0cFDA\u8fd8\u5f00\u653e\u4e86\u5728\u7ebf\u6570\u636e\u5e93\u4f9b\u516c\u4f17\u67e5\u8be2\u5668\u68b0\u4fe1\u606f\u3002FDA 2015\u5e74\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u5e74\u5ea6\u56de\u987e\u5982\u4e0b\uff1a<\/p>\n<ul>\n<li>4\u670820\u65e5\uff1aFDA\u5f00\u59cb\u4fee\u8ba2\u987a\u52bf\u7597\u6cd5\u836f\u7269\u6cd5\u89c4\u5e76\u4e3e\u884c\u4e86\u4e3a\u671f\u4e24\u5929\u7684\u542c\u8bc1\u4f1a\u4ee5\u5411\u5229\u76ca\u76f8\u5173\u8005\u5f81\u96c6\u610f\u89c1\u30028\u6708\uff0c\u8054\u90a6\u8d38\u6613\u59d4\u5458\u4f1a\u5c31\u6b64\u4e8b\u53d1\u8868\u4e86\u610f\u89c1\u3002<\/li>\n<li>5\u67084\u65e5\uff1aFDA\u5411\u516c\u4f17\u5f00\u653e\u5168\u7403\u552f\u4e00\u8bbe\u5907\u8bc6\u522b\u6570\u636e\u5e93(Global Unique Device Identification Database, GUDID)\uff0c\u8be5\u6570\u636e\u5e93\u6839\u636e\u5668\u68b0\u7c7b\u522b\u5411\u7528\u6237\u63d0\u4f9b\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\u7b26(Unique Device Identifier, UDI)\u3002<\/li>\n<li>5\u67087\u65e5\uff1aFDA\u53d1\u5e03\u6700\u7ec8\u6307\u5357\u6587\u4ef6\u8981\u6c42INDs, NDAs, ANDAs, \u548c BLAs\u901a\u8fc7\u7535\u5b50\u516c\u5171\u6280\u672f\u6587\u6863(Electronic Common Technical Document, eCTD)\u65b9\u5f0f\u9012\u4ea4\u3002<\/li>\n<li>6\u67086\u65e5\uff1aFDA\u53d1\u5e03\u6700\u7ec8\u6307\u4ee4\u5bf9\u592a\u9633\u706f\u548cUV\u706f\u8fdb\u884c\u91cd\u65b0\u5206\u7c7b\uff0c\u56e0\u4e8c\u7c7b\u4ea7\u54c1\u9700\u5b8c\u6210510(k)\u6ce8\u518c\u3002<\/li>\n<li>6\u670824\u65e5\uff1aFDA\u53d1\u5e03UDI\u8bbe\u5907\u96f6\u552e\u5e02\u573a\u6307\u5357\u8349\u6848\u3002<\/li>\n<li>FDA\u4fee\u8ba2510(k)\u7533\u8bf7\u53d7\u7406\u8981\u6c42\u3002<\/li>\n<li>8\u670814\u65e5\uff1aFDA\u7535\u5b50\u533b\u7597\u8bbe\u5907\u62a5\u544a(electronic medical device reporting, eMDR)\u8981\u6c42\u751f\u6548\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u8981\u6c42\u901a\u8fc7\u7535\u5b50\u65b9\u5f0f\u9012\u4ea4\u5f3a\u5236\u6027\u4e0d\u826f\u53cd\u5e94\u4e8b\u4ef6\u62a5\u544a\u3002<\/li>\n<li>8\u670818\u65e5\uff1aFDA\u63d0\u5347\u533b\u7597\u5668\u68b0\u51fa\u53e3\u8bc1\u4e66\u8d39\u7528\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; 2015\u5e74\uff0c\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6570\u5b57\u5316\u8d8b\u52bf\u663e\u73b0\u3002\u7f8e\u56fd\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(U.S. Food and Drug Administration, FDA)\u65b0\u6cd5\u89c4\u8981\u6c42\u7279\u5b9a\u6587\u4ef6\u901a\u8fc7\u7535\u5b50\u65b9\u5f0f\u9012\u4ea4\uff0c\u5982\u533b\u7597\u836f\u54c1\u4e34\u5e8a\u5e94\u7528\u548c\u5668\u68b0\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\u3002\u6b64\u5916\uff0cFDA\u8fd8\u5f00\u653e\u4e86\u5728\u7ebf\u6570\u636e\u5e93\u4f9b\u516c\u4f17\u67e5\u8be2\u5668\u68b0\u4fe1\u606f\u3002FDA 2015\u5e74\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u5e74\u5ea6\u56de\u987e\u5982\u4e0b\uff1a 4\u670820\u65e5\uff1aFDA\u5f00\u59cb\u4fee\u8ba2\u987a\u52bf\u7597\u6cd5\u836f\u7269\u6cd5\u89c4\u5e76\u4e3e\u884c\u4e86\u4e3a\u671f\u4e24\u5929\u7684\u542c\u8bc1\u4f1a\u4ee5\u5411\u5229\u76ca\u76f8\u5173\u8005\u5f81\u96c6\u610f\u89c1\u30028\u6708\uff0c\u8054\u90a6\u8d38\u6613\u59d4\u5458\u4f1a\u5c31\u6b64\u4e8b\u53d1\u8868\u4e86\u610f\u89c1\u3002 5\u67084\u65e5\uff1aFDA\u5411\u516c\u4f17\u5f00\u653e\u5168\u7403\u552f\u4e00\u8bbe\u5907\u8bc6\u522b\u6570\u636e\u5e93(Global Unique Device Identification Database, GUDID)\uff0c\u8be5\u6570\u636e\u5e93\u6839\u636e\u5668\u68b0\u7c7b\u522b\u5411\u7528\u6237\u63d0\u4f9b\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\u7b26(Unique Device Identifier, UDI)\u3002 5\u67087\u65e5\uff1aFDA\u53d1\u5e03\u6700\u7ec8\u6307\u5357\u6587\u4ef6\u8981\u6c42INDs, NDAs, ANDAs, \u548c BLAs\u901a\u8fc7\u7535\u5b50\u516c\u5171\u6280\u672f\u6587\u6863(Electronic Common Technical Document, eCTD)\u65b9\u5f0f\u9012\u4ea4\u3002 6\u67086\u65e5\uff1aFDA\u53d1\u5e03\u6700\u7ec8\u6307\u4ee4\u5bf9\u592a\u9633\u706f\u548cUV\u706f\u8fdb\u884c\u91cd\u65b0\u5206\u7c7b\uff0c\u56e0\u4e8c\u7c7b\u4ea7\u54c1\u9700\u5b8c\u6210510(k)\u6ce8\u518c\u3002 6\u670824\u65e5\uff1aFDA\u53d1\u5e03UDI\u8bbe\u5907\u96f6\u552e\u5e02\u573a\u6307\u5357\u8349\u6848\u3002 FDA\u4fee\u8ba2510(k)\u7533\u8bf7\u53d7\u7406\u8981\u6c42\u3002 8\u670814\u65e5\uff1aFDA\u7535\u5b50\u533b\u7597\u8bbe\u5907\u62a5\u544a(electronic medical device reporting, eMDR)\u8981\u6c42\u751f\u6548\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u8981\u6c42\u901a\u8fc7\u7535\u5b50\u65b9\u5f0f\u9012\u4ea4\u5f3a\u5236\u6027\u4e0d\u826f\u53cd\u5e94\u4e8b\u4ef6\u62a5\u544a\u3002 8\u670818\u65e5\uff1aFDA\u63d0\u5347\u533b\u7597\u5668\u68b0\u51fa\u53e3\u8bc1\u4e66\u8d39\u7528\u3002 &nbsp;<\/p>\n","protected":false},"author":30,"featured_media":39533,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[69,68],"tags":[],"class_list":["post-40845","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-devices-zh","category-drugs-zh","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA 2015\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff1a\u5e74\u5ea6\u56de\u987e - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA 2015\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff1a\u5e74\u5ea6\u56de\u987e\" \/>\n<meta property=\"og:description\" content=\"&nbsp; 2015\u5e74\uff0c\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6570\u5b57\u5316\u8d8b\u52bf\u663e\u73b0\u3002\u7f8e\u56fd\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(U.S. Food and Drug Administration, FDA)\u65b0\u6cd5\u89c4\u8981\u6c42\u7279\u5b9a\u6587\u4ef6\u901a\u8fc7\u7535\u5b50\u65b9\u5f0f\u9012\u4ea4\uff0c\u5982\u533b\u7597\u836f\u54c1\u4e34\u5e8a\u5e94\u7528\u548c\u5668\u68b0\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\u3002\u6b64\u5916\uff0cFDA\u8fd8\u5f00\u653e\u4e86\u5728\u7ebf\u6570\u636e\u5e93\u4f9b\u516c\u4f17\u67e5\u8be2\u5668\u68b0\u4fe1\u606f\u3002FDA 2015\u5e74\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u5e74\u5ea6\u56de\u987e\u5982\u4e0b\uff1a 4\u670820\u65e5\uff1aFDA\u5f00\u59cb\u4fee\u8ba2\u987a\u52bf\u7597\u6cd5\u836f\u7269\u6cd5\u89c4\u5e76\u4e3e\u884c\u4e86\u4e3a\u671f\u4e24\u5929\u7684\u542c\u8bc1\u4f1a\u4ee5\u5411\u5229\u76ca\u76f8\u5173\u8005\u5f81\u96c6\u610f\u89c1\u30028\u6708\uff0c\u8054\u90a6\u8d38\u6613\u59d4\u5458\u4f1a\u5c31\u6b64\u4e8b\u53d1\u8868\u4e86\u610f\u89c1\u3002 5\u67084\u65e5\uff1aFDA\u5411\u516c\u4f17\u5f00\u653e\u5168\u7403\u552f\u4e00\u8bbe\u5907\u8bc6\u522b\u6570\u636e\u5e93(Global Unique Device Identification Database, GUDID)\uff0c\u8be5\u6570\u636e\u5e93\u6839\u636e\u5668\u68b0\u7c7b\u522b\u5411\u7528\u6237\u63d0\u4f9b\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\u7b26(Unique Device Identifier, UDI)\u3002 5\u67087\u65e5\uff1aFDA\u53d1\u5e03\u6700\u7ec8\u6307\u5357\u6587\u4ef6\u8981\u6c42INDs, NDAs, ANDAs, \u548c BLAs\u901a\u8fc7\u7535\u5b50\u516c\u5171\u6280\u672f\u6587\u6863(Electronic Common Technical Document, eCTD)\u65b9\u5f0f\u9012\u4ea4\u3002 6\u67086\u65e5\uff1aFDA\u53d1\u5e03\u6700\u7ec8\u6307\u4ee4\u5bf9\u592a\u9633\u706f\u548cUV\u706f\u8fdb\u884c\u91cd\u65b0\u5206\u7c7b\uff0c\u56e0\u4e8c\u7c7b\u4ea7\u54c1\u9700\u5b8c\u6210510(k)\u6ce8\u518c\u3002 6\u670824\u65e5\uff1aFDA\u53d1\u5e03UDI\u8bbe\u5907\u96f6\u552e\u5e02\u573a\u6307\u5357\u8349\u6848\u3002 FDA\u4fee\u8ba2510(k)\u7533\u8bf7\u53d7\u7406\u8981\u6c42\u3002 8\u670814\u65e5\uff1aFDA\u7535\u5b50\u533b\u7597\u8bbe\u5907\u62a5\u544a(electronic medical device reporting, eMDR)\u8981\u6c42\u751f\u6548\u3002\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u8981\u6c42\u901a\u8fc7\u7535\u5b50\u65b9\u5f0f\u9012\u4ea4\u5f3a\u5236\u6027\u4e0d\u826f\u53cd\u5e94\u4e8b\u4ef6\u62a5\u544a\u3002 8\u670818\u65e5\uff1aFDA\u63d0\u5347\u533b\u7597\u5668\u68b0\u51fa\u53e3\u8bc1\u4e66\u8d39\u7528\u3002 &nbsp;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/zh\/fda-drug-device-regulations-in-2015-a-year-in-review\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2015-12-29T15:00:40+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-02-10T14:45:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1650\" \/>\n\t<meta property=\"og:image:height\" content=\"500\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mason Grandusky\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n<script type=\"application\/ld+json\" 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