{"id":497,"date":"2025-11-14T14:29:53","date_gmt":"2025-11-14T06:29:53","guid":{"rendered":"https:\/\/www.fda-registered.com\/?p=497"},"modified":"2025-11-14T14:29:54","modified_gmt":"2025-11-14T06:29:54","slug":"2025-pharma-medical-device-summary","status":"publish","type":"post","link":"https:\/\/www.fda-registered.com\/en\/2025-pharma-medical-device-summary\/","title":{"rendered":"2025 Annual Summary of Registration Services for Pharmaceutical and Medical Device Enterprises"},"content":{"rendered":"<h2 class=\"wp-block-heading\"><strong>\u4e00\u3001\u533b\u7597\u5668\u68b0\u4f01\u4e1aFDA\u6ce8\u518c\u4e0e510(k)\u670d\u52a1<\/strong><\/h2>\n\n\n\n<p>2025\u5e74\u5ea6\uff0c\u516c\u53f8\u5171\u670d\u52a1<strong>171\u5bb6\u533b\u7597\u5668\u68b0\u4f01\u4e1a<\/strong>\uff0c\u63d0\u4f9b\u4ece\u4f01\u4e1a\u6ce8\u518c\u5230\u5e02\u573a\u51c6\u5165\u7684\u5168\u6d41\u7a0b\u4e13\u4e1a\u670d\u52a1\uff0c\u6db5\u76d6\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>US Agent Service<\/strong>\uff1a\u4e3a\u672a\u5728\u7f8e\u56fd\u8bbe\u7acb\u5b9e\u4f53\u7684\u4f01\u4e1a\u63d0\u4f9b\u5408\u89c4\u4ee3\u7406\uff0c\u786e\u4fdd\u4e0eFDA\u987a\u5229\u6c9f\u901a\u3002<\/li>\n\n\n\n<li><strong>510(k)\u8c41\u514d\u4ea7\u54c1\u4f01\u4e1a\u6ce8\u518c<\/strong>\uff1a\u534f\u52a9\u4f01\u4e1a\u5b8c\u6210FDA\u6ce8\u518c\u53ca\u5e74\u5ea6\u66f4\u65b0\u3002<\/li>\n\n\n\n<li><strong>510(k)\u4ea7\u54c1\u6ce8\u518c\u7533\u62a5\u8f85\u5bfc<\/strong>\uff1a\u63d0\u4f9b\u8d44\u6599\u51c6\u5907\u3001\u63d0\u4ea4\u53ca\u5ba1\u6838\u5168\u6d41\u7a0b\u8f85\u5bfc\u3002<\/li>\n\n\n\n<li><strong>QSR 820\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8f85\u5bfc<\/strong>\uff1a\u534f\u52a9\u4f01\u4e1a\u5efa\u7acb\u5e76\u4f18\u5316\u7b26\u5408FDA\u8981\u6c42\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3002<\/li>\n\n\n\n<li><strong>CFG\u53caCFG-NE\u51fa\u53e3\u8bc1\u4e66\u7533\u8bf7<\/strong>\uff1a\u5e2e\u52a9\u4f01\u4e1a\u987a\u5229\u7533\u8bf7\u4ea7\u54c1\u51fa\u53e3\u76f8\u5173\u8bc1\u4e66\u3002<\/li>\n\n\n\n<li><strong>GUDID\u7533\u62a5<\/strong>\uff1a\u534f\u52a9\u4f01\u4e1a\u5b8c\u6210\u552f\u4e00\u8bbe\u5907\u8bc6\u522b\u53f7\uff08UDI\uff09\u7684\u6ce8\u518c\u4e0e\u7ba1\u7406\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u901a\u8fc7\u8fd9\u4e9b\u4e13\u4e1a\u670d\u52a1\uff0c\u516c\u53f8\u5e2e\u52a9\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u63d0\u5347\u6ce8\u518c\u6548\u7387\u3001\u5408\u89c4\u6c34\u5e73\uff0c\u5e76\u987a\u5229\u8fdb\u5165\u7f8e\u56fd\u53ca\u56fd\u9645\u5e02\u573a\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4e8c\u3001\u836f\u54c1\u4f01\u4e1aFDA\u6ce8\u518c\u4e0eDMF\u670d\u52a1<\/strong><\/h2>\n\n\n\n<p>\u672c\u5e74\u5ea6\uff0c\u516c\u53f8\u5171\u670d\u52a1<strong>56\u5bb6\u836f\u54c1\u4f01\u4e1a<\/strong>\uff0c\u670d\u52a1\u8303\u56f4\u8986\u76d6<strong>\u539f\u6599\u836f\u3001\u975e\u5904\u65b9\u836f\u3001\u4eff\u5236\u836f\u3001\u836f\u5305\u6750\u3001\u8f85\u6599<\/strong>\u3002\u4e3b\u8981\u670d\u52a1\u5185\u5bb9\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FDA\u4f01\u4e1a\u6ce8\u518c\u4e0e\u5e74\u5ea6\u7eed\u8d39<\/strong>\uff1a\u786e\u4fdd\u4f01\u4e1a\u987a\u5229\u5b8c\u6210\u6ce8\u518c\u548c\u66f4\u65b0\uff0c\u7ef4\u6301\u5408\u89c4\u72b6\u6001\u3002<\/li>\n\n\n\n<li><strong>DMF\uff08\u836f\u54c1\u4e3b\u6587\u4ef6\uff09\u7ba1\u7406<\/strong>\uff1a\u534f\u52a9\u4f01\u4e1a\u51c6\u5907\u3001\u63d0\u4ea4\u53ca\u7ef4\u62a4DMF\u6587\u4ef6\uff0c\u652f\u6301\u539f\u6599\u836f\u53ca\u8f85\u6599\u5728\u7f8e\u56fd\u5e02\u573a\u7684\u6d41\u901a\u3002<\/li>\n\n\n\n<li><strong>US Agent 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class=\"wp-block-list\">\n<li><strong>\u8986\u76d6\u5e7f\u6cdb<\/strong>\uff1a\u670d\u52a1\u4f01\u4e1a\u6db5\u76d6\u539f\u6599\u836f\u3001\u975e\u5904\u65b9\u836f\u3001\u4eff\u5236\u836f\u3001\u836f\u5305\u6750\u3001\u8f85\u6599\u53ca\u5404\u7c7b\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u3002<\/li>\n\n\n\n<li><strong>\u4e13\u4e1a\u9ad8\u6548<\/strong>\uff1a\u4f9d\u6258\u4e13\u4e1a\u56e2\u961f\u548c\u6807\u51c6\u5316\u6d41\u7a0b\uff0c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u7cbe\u51c6\u3001\u53ca\u65f6\u7684\u6ce8\u518c\u53ca\u5408\u89c4\u670d\u52a1\u3002<\/li>\n\n\n\n<li><strong>\u5b9a\u5236\u5316\u89e3\u51b3\u65b9\u6848<\/strong>\uff1a\u6839\u636e\u4f01\u4e1a\u9700\u6c42\u63d0\u4f9bDMF\u3001510(k)\u7533\u62a5\u8f85\u5bfc\u3001QSR820\u8f85\u5bfc\u3001\u51fa\u53e3\u8bc1\u4e66\u7533\u8bf7\u53ca\u7f8e\u56fd\u4ee3\u7406\u4eba\u670d\u52a1\uff0c\u5b9e\u73b0\u5dee\u5f02\u5316\u670d\u52a1\u3002<\/li>\n\n\n\n<li><strong>\u5ba2\u6237\u6ee1\u610f\u5ea6\u63d0\u5347<\/strong>\uff1a\u672c\u5e74\u5ea6\u5ba2\u6237\u7eed\u8d39\u7387\u4e0e\u63a8\u8350\u7387\u5747\u8f83\u5f80\u5e74\u663e\u8457\u63d0\u5347\uff0c\u670d\u52a1\u53e3\u7891\u6301\u7eed\u7a33\u56fa\u3002<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u56db\u3001\u5c55\u671b2026\u5e74\u5ea6<\/strong><\/h2>\n\n\n\n<p>\u5c55\u671b2026\u5e74\u5ea6\uff0c\u516c\u53f8\u5c06\u7ee7\u7eed\u6df1\u8015\u836f\u54c1\u53ca\u533b\u7597\u5668\u68b0\u6ce8\u518c\u670d\u52a1\u9886\u57df\uff0c\u62d3\u5c55\u521b\u65b0\u578b\u4f01\u4e1a\u5408\u4f5c\uff0c\u63d0\u5347\u670d\u52a1\u8d28\u91cf\u4e0e\u6548\u7387\uff0c\u52a9\u529b\u5ba2\u6237\u5728\u56fd\u5185\u5916\u5e02\u573a\u7a33\u5065\u53d1\u5c55\uff0c\u5b9e\u73b0\u5408\u89c4\u4e0e\u5546\u4e1a\u4ef7\u503c\u53cc\u8d62\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>2025 Company Service Summary: Provided FDA registration for 171 medical device companies and 56 pharmaceutical companies<\/p>","protected":false},"author":1,"featured_media":498,"comment_status":"open","ping_status":"open","sticky":false,"template":"template-single-sidebar","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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