{"id":18191,"date":"2025-05-17T18:15:40","date_gmt":"2025-05-17T10:15:40","guid":{"rendered":"https:\/\/greenoo.tw\/?p=18191"},"modified":"2026-01-24T22:02:43","modified_gmt":"2026-01-24T14:02:43","slug":"fda-us-agent-responsibilities-taiwan-sellers-guide-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/fda-us-agent-responsibilities-taiwan-sellers-guide-2026\/","title":{"rendered":"You'd never guess! 5 Important Responsibilities of FDA's U.S. Agents, a must-see for Taiwan's cross-border sellers!"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-20005\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-responsibilities-guide-feature-2026.png\" alt=\"FDA\u7f8e\u570b\u4ee3\u7406\u4eba5\u5927\u8077\u8cac\u5b8c\u6574\u89e3\u6790\u5c01\u9762\uff0c\u986f\u793a\u7f8e\u570b\u5730\u5716\u8207\u63e1\u624b\u5716\u793a\uff0c2026\u6700\u65b0\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u6307\u5357\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-responsibilities-guide-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-responsibilities-guide-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-responsibilities-guide-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-responsibilities-guide-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-responsibilities-guide-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>FDA\u7f8e\u570b\u4ee3\u7406\u4eba\u4e0d\u53ea\u662f\u300c\u806f\u7d61\u7a97\u53e3\u300d<\/h2>\n<p>According to <a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\/how-register-food-facility-what-us-agent\" target=\"_blank\" rel=\"noopener\">FDA\u5b98\u65b9\u5b9a\u7fa9<\/a>{:target=&#8221;_blank&#8221;}\uff0c\u7f8e\u570b\u4ee3\u7406\u4eba(US Agent)\u662f\u300c\u4f4d\u65bc\u7f8e\u570b\u5883\u5167\uff0c\u7d93\u8a2d\u65bd\u64c1\u6709\u8005\u6307\u5b9a\uff0c\u4f5c\u70baFDA\u8207\u570b\u5916\u8a2d\u65bd\u6e9d\u901a\u6a4b\u6a11\u7684\u500b\u4eba\u6216\u4f01\u696d\u300d\u3002\u8a31\u591a\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u8aa4\u4ee5\u70ba\u7f8e\u570b\u4ee3\u7406\u4eba\u53ea\u662f\u300c\u6536\u4fe1\u8f49\u9054\u300d\u7684\u89d2\u8272\uff0c\u5be6\u969b\u4e0a\u5176\u8077\u8cac\u7bc4\u570d\u9060\u8d85\u904e\u4e00\u822c\u60f3\u50cf\uff0c\u6db5\u84cb\u6cd5\u5f8b\u8cac\u4efb\u3001\u7dca\u6025\u61c9\u8b8a\u3001\u6587\u4ef6\u7ba1\u7406\u7b49\u95dc\u9375\u74b0\u7bc0\u3002<\/p>\n<p><strong>\u6838\u5fc3\u91cd\u9ede<\/strong>:<\/p>\n<ul>\n<li>\u7f8e\u570b\u4ee3\u7406\u4eba\u5177\u5099\u6cd5\u5f8b\u4ee3\u8868\u6b0a\uff0c\u4e26\u975e\u55ae\u7d14\u806f\u7d61\u7a97\u53e3<\/li>\n<li>\u5fc5\u980824\u5c0f\u6642\u5167\u56de\u61c9FDA\u6240\u6709\u901a\u8a0a(\u5305\u542b\u7dca\u6025\u4e8b\u4ef6)<\/li>\n<li>\u9700\u5354\u52a9\u8655\u7406\u6263\u95dc\u3001\u67e5\u9a57\u3001\u53ec\u56de\u7b49\u91cd\u5927\u4e8b\u4ef6<\/li>\n<li>\u9078\u932f\u4ee3\u7406\u4eba\u53ef\u80fd\u5c0e\u81f4\u8a2d\u65bd\u8a3b\u518a\u7121\u6548\u6216\u7522\u54c1\u88ab\u6263<\/li>\n<\/ul>\n<hr \/>\n<h2>\u70ba\u4f55\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u5fc5\u9808\u6df1\u5165\u4e86\u89e3\u7f8e\u570b\u4ee3\u7406\u4eba\u8077\u8cac\uff1f<\/h2>\n<p>\u53f0\u7063\u98df\u54c1\u696d\u8005\u51fa\u53e3\u7f8e\u570b\u6642\uff0c\u5e38\u56e0\u5c0d\u7f8e\u570b\u4ee3\u7406\u4eba\u8077\u8cac\u7406\u89e3\u4e0d\u8db3\uff0c\u5c0e\u81f4\u4ee5\u4e0b\u554f\u984c\uff1a<\/p>\n<p><strong>Common Misconceptions<\/strong>:<\/p>\n<ul>\n<li>\u8aa4\u4ee5\u70ba\u300c\u96a8\u4fbf\u627e\u500b\u7f8e\u570b\u5730\u5740\u300d\u5c31\u80fd\u7576\u4ee3\u7406\u4eba<\/li>\n<li>\u4e0d\u6e05\u695a\u4ee3\u7406\u4eba\u9700\u627f\u64d4\u7684\u6cd5\u5f8b\u8cac\u4efb\u7bc4\u570d<\/li>\n<li>\u5ffd\u7565\u4ee3\u7406\u4eba\u5728\u7dca\u6025\u4e8b\u4ef6\u4e2d\u7684\u95dc\u9375\u89d2\u8272<\/li>\n<li>\u672a\u78ba\u8a8d\u4ee3\u7406\u4eba\u662f\u5426\u5177\u5099\u5be6\u969b\u8655\u7406\u80fd\u529b<\/li>\n<\/ul>\n<p>rely on <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\" target=\"_blank\" rel=\"noopener\">FSMA\u6cd5\u6848<\/a>{:target=&#8221;_blank&#8221;} \u5be6\u65bd\u5f8c\uff0cFDA\u5c0d\u570b\u5916\u8a2d\u65bd\u7684\u76e3\u7ba1\u529b\u5ea6\u5927\u5e45\u63d0\u5347\uff0c\u7f8e\u570b\u4ee3\u7406\u4eba\u7684\u89d2\u8272\u66f4\u52a0\u91cd\u8981\u3002\u82e5\u4ee3\u7406\u4eba\u7121\u6cd5\u6709\u6548\u5c65\u884c\u8077\u8cac\uff0c\u53ef\u80fd\u5c0e\u81f4\u8a2d\u65bd\u8a3b\u518a\u88ab\u64a4\u92b7\u3001\u7522\u54c1\u88ab\u6263\u95dc\uff0c\u751a\u81f3\u9762\u81e8\u6cd5\u5f8b\u8a34\u8a1f\u3002<\/p>\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0dFDA\u98df\u54c1\u8a3b\u518a\u5236\u5ea6\u7684\u6574\u9ad4\u7406\u89e3\uff0c\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7e3d\u89bd\u5165\u624b\uff0c\u6709\u52a9\u65bc\u5f8c\u7e8c\u5224\u65b7\u4e0d\u540c\u60c5\u5883\u8207\u57f7\u884c\u5dee\u7570\u3002<\/p>\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u5b8c\u6574\u6307\u5357|\u53f0\u7063\u98df\u54c1\u51fa\u53e3\u7f8e\u570b\u5fc5\u8b80(2026 \u6700\u65b0)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/en\/fda-food-registration\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration\/<\/a><\/p>\n<hr \/>\n<h2>FDA\u7f8e\u570b\u4ee3\u7406\u4eba\u76845\u5927\u6838\u5fc3\u8077\u8cac<\/h2>\n<h3>\u8077\u8cac\u4e00\uff1a\u4f5c\u70baFDA\u8207\u570b\u5916\u8a2d\u65bd\u7684\u6b63\u5f0f\u6e9d\u901a\u7ba1\u9053(Communication Hub)<\/h3>\n<p>\u7f8e\u570b\u4ee3\u7406\u4eba\u5fc5\u9808\u78ba\u4fddFDA\u6240\u6709\u901a\u8a0a\u80fd\u5373\u6642\u50b3\u9054\u7d66\u8a2d\u65bd\u64c1\u6709\u8005\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u65e5\u5e38\u67e5\u8a62<\/strong>: FDA\u95dc\u65bc\u7522\u54c1\u6210\u5206\u3001\u6a19\u7c64\u3001\u88fd\u7a0b\u7684\u554f\u8a62<\/li>\n<li><strong>\u6cd5\u898f\u901a\u77e5<\/strong>: \u65b0\u6cd5\u898f\u5be6\u65bd\u3001\u5408\u898f\u8981\u6c42\u8b8a\u66f4\u901a\u77e5<\/li>\n<li><strong>\u6aa2\u67e5\u9810\u544a<\/strong>: FDA\u73fe\u5834\u6aa2\u67e5(Foreign Facility Inspection)\u901a\u77e5<\/li>\n<li><strong>\u7dca\u6025\u901a\u8a0a<\/strong>: \u7522\u54c1\u5b89\u5168\u7591\u616e\u3001\u53ec\u56de\u6307\u4ee4<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u5fc5\u9808\u63d0\u4f9b\u53ef\u96a8\u6642\u806f\u7e6b\u7684\u96fb\u8a71\u8207\u96fb\u5b50\u90f5\u4ef6<\/li>\n<li>\u9700\u572824\u5c0f\u6642\u5167\u56de\u61c9FDA\u6240\u6709\u901a\u8a0a<\/li>\n<li>\u9700\u5efa\u7acb\u4e2d\u82f1\u6587\u96d9\u8a9e\u6e9d\u901a\u6a5f\u5236(\u82e5\u8a2d\u65bd\u64c1\u6709\u8005\u4e0d\u8af3\u82f1\u6587)<\/li>\n<\/ul>\n<p>\u274c <strong>Common Errors<\/strong>: \u4f7f\u7528\u865b\u64ec\u8fa6\u516c\u5ba4\u6216\u7121\u4eba\u63a5\u807d\u7684\u96fb\u8a71\u865f\u78bc\uff0c\u5c0e\u81f4FDA\u7121\u6cd5\u806f\u7e6b\uff0c\u8a2d\u65bd\u8a3b\u518a\u53ef\u80fd\u88ab\u64a4\u92b7\u3002<\/p>\n<hr \/>\n<h3>\u8077\u8cac\u4e8c\uff1a\u5354\u52a9\u8655\u7406\u7dca\u6025\u4e8b\u4ef6\u8207\u7522\u54c1\u53ec\u56de(Emergency Response)<\/h3>\n<p>\u7576\u767c\u751f\u98df\u54c1\u5b89\u5168\u4e8b\u4ef6\u6642\uff0c\u7f8e\u570b\u4ee3\u7406\u4eba\u9700\u5354\u52a9\u8a2d\u65bd\u64c1\u6709\u8005\u5feb\u901f\u61c9\u5c0d\uff1a<\/p>\n<p><strong>\u7dca\u6025\u4e8b\u4ef6\u985e\u578b<\/strong>:<\/p>\n<ul>\n<li>FDA\u767c\u51fa\u9032\u53e3\u8b66\u793a(Import Alert)<\/li>\n<li>\u7522\u54c1\u88ab\u6d77\u95dc\u6263\u7559(Detention)<\/li>\n<li>\u5f37\u5236\u53ec\u56de(Mandatory Recall)\u901a\u77e5<\/li>\n<li>\u98df\u54c1\u5b89\u5168\u5371\u5bb3\u901a\u5831<\/li>\n<\/ul>\n<p><strong>\u4ee3\u7406\u4eba\u8077\u8cac<\/strong>:<\/p>\n<ul>\n<li>\u7acb\u5373\u901a\u77e5\u8a2d\u65bd\u64c1\u6709\u8005<\/li>\n<li>\u5354\u52a9\u6e96\u5099\u56de\u61c9\u6587\u4ef6(\u82f1\u6587\u7248)<\/li>\n<li>\u5354\u8abfFDA\u8207\u8a2d\u65bd\u4e4b\u9593\u7684\u6e9d\u901a<\/li>\n<li>\u63d0\u4f9b\u53ec\u56de\u57f7\u884c\u5efa\u8b70(\u82e5\u9069\u7528)<\/li>\n<\/ul>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>: \u9078\u64c7\u5177\u5099\u98df\u54c1\u6cd5\u898f\u5c08\u696d\u80cc\u666f\u7684\u4ee3\u7406\u4eba\uff0c\u80fd\u5728\u7dca\u6025\u4e8b\u4ef6\u4e2d\u63d0\u4f9b\u66f4\u6709\u6548\u7684\u652f\u63f4\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: FDA\u7f8e\u570b\u4ee3\u7406\u4eba5\u5927\u8077\u8cac\u6d41\u7a0b\u5716<\/h3>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20006\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-five-responsibilities-flowchart-2026.png\" alt=\"FDA\u7f8e\u570b\u4ee3\u7406\u4eba5\u5927\u8077\u8cac\u6d41\u7a0b\u5716\uff0c\u986f\u793a\u5f9e\u6e9d\u901a\u7ba1\u9053\u5230\u8a3b\u518a\u66f4\u65b0\u7684\u5b8c\u6574\u8077\u8cac\u7bc4\u570d\uff0c\u5305\u542b24\u5c0f\u6642\u56de\u61c9\u8207\u7dca\u6025\u8655\u7406\u8981\u6c42\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-five-responsibilities-flowchart-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-five-responsibilities-flowchart-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-five-responsibilities-flowchart-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-five-responsibilities-flowchart-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-five-responsibilities-flowchart-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<hr \/>\n<h3>\u8077\u8cac\u4e09\uff1a\u4fdd\u5b58\u8207\u63d0\u4f9b\u8a2d\u65bd\u8a3b\u518a\u6587\u4ef6(Document Management)<\/h3>\n<p>rely on <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-1.232\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 1.232<\/a>{:target=&#8221;_blank&#8221;}\uff0c\u7f8e\u570b\u4ee3\u7406\u4eba\u9700\u5354\u52a9\u4fdd\u5b58\u4ee5\u4e0b\u6587\u4ef6\uff1a<\/p>\n<p><strong>\u5fc5\u9808\u4fdd\u5b58\u7684\u6587\u4ef6<\/strong>:<\/p>\n<ul>\n<li>\u8a2d\u65bd\u8a3b\u518a\u78ba\u8a8d\u6587\u4ef6(Registration Confirmation)<\/li>\n<li>\u7522\u54c1\u985e\u5225\u6e05\u55ae(Product Category List)<\/li>\n<li>\u8a2d\u65bd\u8cc7\u8a0a\u8b8a\u66f4\u7d00\u9304<\/li>\n<li>FDA\u901a\u8a0a\u5f80\u4f86\u7d00\u9304<\/li>\n<\/ul>\n<p><strong>\u6587\u4ef6\u63d0\u4f9b\u7fa9\u52d9<\/strong>:<\/p>\n<ul>\n<li>FDA\u8981\u6c42\u6642\u9700\u572824\u5c0f\u6642\u5167\u63d0\u4f9b\u76f8\u95dc\u6587\u4ef6<\/li>\n<li>\u9700\u5354\u52a9\u8a2d\u65bd\u64c1\u6709\u8005\u6e96\u5099\u82f1\u6587\u7248\u6587\u4ef6<\/li>\n<li>\u9700\u78ba\u4fdd\u6587\u4ef6\u7b26\u5408FDA\u683c\u5f0f\u8981\u6c42<\/li>\n<\/ul>\n<p>\u26a0\ufe0f <strong>important reminder<\/strong>: \u4ee3\u7406\u4eba\u7121\u6cd5\u63d0\u4f9b\u6587\u4ef6\u53ef\u80fd\u5c0e\u81f4FDA\u8a8d\u5b9a\u8a2d\u65bd\u4e0d\u5408\u898f\uff0c\u9032\u800c\u64a4\u92b7\u8a3b\u518a\u3002<\/p>\n<hr \/>\n<h3>\u8077\u8cac\u56db\uff1a\u4ee3\u8868\u8a2d\u65bd\u627f\u64d4\u7279\u5b9a\u6cd5\u5f8b\u8cac\u4efb(Legal Representation)<\/h3>\n<p>\u7f8e\u570b\u4ee3\u7406\u4eba\u5728\u6cd5\u5f8b\u4e0a\u5177\u5099\u4ee3\u8868\u8a2d\u65bd\u7684\u6b0a\u529b\uff0c\u5305\u62ec\uff1a<\/p>\n<p><strong>\u6cd5\u5f8b\u8cac\u4efb\u7bc4\u570d<\/strong>:<\/p>\n<ul>\n<li>\u63a5\u53d7FDA\u6cd5\u5f8b\u6587\u4ef6\u9001\u9054(Service of Process)<\/li>\n<li>\u4ee3\u8868\u8a2d\u65bd\u56de\u61c9FDA\u6cd5\u5f8b\u8a62\u554f<\/li>\n<li>\u5354\u52a9\u8655\u7406\u884c\u653f\u8a34\u8a1f\u76f8\u95dc\u4e8b\u5b9c<\/li>\n<li>\u5728\u7279\u5b9a\u60c5\u6cc1\u4e0b\u4ee3\u8868\u8a2d\u65bd\u7c3d\u7f72\u6587\u4ef6<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u5f71\u97ff<\/strong>:<\/p>\n<ul>\n<li>\u4ee3\u7406\u4eba\u7684\u884c\u70ba\u53ef\u80fd\u5c0d\u8a2d\u65bd\u7522\u751f\u6cd5\u5f8b\u7d04\u675f\u529b<\/li>\n<li>\u9078\u64c7\u4e0d\u9069\u4efb\u7684\u4ee3\u7406\u4eba\u53ef\u80fd\u5c0e\u81f4\u8a2d\u65bd\u9762\u81e8\u6cd5\u5f8b\u98a8\u96aa<\/li>\n<li>\u9700\u78ba\u8a8d\u4ee3\u7406\u5354\u8b70\u4e2d\u660e\u78ba\u898f\u7bc4\u8cac\u4efb\u7bc4\u570d<\/li>\n<\/ul>\n<p>\u274c <strong>Common Misconceptions<\/strong>: \u8aa4\u4ee5\u70ba\u4ee3\u7406\u4eba\u50c5\u662f\u300c\u540d\u7fa9\u4e0a\u300d\u7684\u89d2\u8272\uff0c\u5be6\u969b\u4e0a\u4ee3\u7406\u4eba\u5177\u5099\u5be6\u8cea\u6cd5\u5f8b\u4ee3\u8868\u6b0a\u3002<\/p>\n<hr \/>\n<h3>\u8077\u8cac\u4e94\uff1a\u5354\u52a9\u8a2d\u65bd\u8a3b\u518a\u8cc7\u8a0a\u66f4\u65b0(Registration Updates)<\/h3>\n<p>\u8a2d\u65bd\u8cc7\u8a0a\u8b8a\u66f4\u6642\uff0c\u7f8e\u570b\u4ee3\u7406\u4eba\u9700\u5354\u52a9\u5b8c\u6210\u4ee5\u4e0b\u66f4\u65b0\uff1a<\/p>\n<p><strong>\u9700\u66f4\u65b0\u7684\u60c5\u5883<\/strong>:<\/p>\n<ul>\n<li>\u8a2d\u65bd\u5730\u5740\u3001\u806f\u7d61\u8cc7\u8a0a\u8b8a\u66f4<\/li>\n<li>\u7522\u54c1\u985e\u5225\u65b0\u589e\u6216\u522a\u9664<\/li>\n<li>Change of Facility Owner<\/li>\n<li>\u6bcf\u5169\u5e74\u4e00\u6b21\u7684\u5b9a\u671f\u66f4\u65b0(Biennial Registration Renewal)<\/li>\n<\/ul>\n<p><strong>\u4ee3\u7406\u4eba\u5354\u52a9\u4e8b\u9805<\/strong>:<\/p>\n<ul>\n<li>\u901a\u77e5\u8a2d\u65bd\u64c1\u6709\u8005\u66f4\u65b0\u671f\u9650<\/li>\n<li>\u5354\u52a9\u6e96\u5099\u66f4\u65b0\u6240\u9700\u8cc7\u6599<\/li>\n<li>\u78ba\u8a8d\u66f4\u65b0\u5b8c\u6210\u4e26\u53d6\u5f97\u65b0\u7684\u78ba\u8a8d\u6587\u4ef6<\/li>\n<li>\u4fdd\u5b58\u66f4\u65b0\u7d00\u9304<\/li>\n<\/ul>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>: \u9078\u64c7\u63d0\u4f9b\u300c\u4e3b\u52d5\u63d0\u9192\u670d\u52d9\u300d\u7684\u4ee3\u7406\u4eba\uff0c\u907f\u514d\u56e0\u903e\u671f\u672a\u66f4\u65b0\u5c0e\u81f4\u8a3b\u518a\u5931\u6548\u3002<\/p>\n<hr \/>\n<h3>\u5716 3: \u9078\u64c7FDA\u7f8e\u570b\u4ee3\u7406\u4eba\u6aa2\u6838\u8868<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20007\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-selection-checklist-taiwan-sellers-2026.png\" alt=\"FDA\u7f8e\u570b\u4ee3\u7406\u4eba\u9078\u64c7\u6aa2\u6838\u8868\uff0c\u5217\u51fa8\u9805\u5fc5\u9808\u78ba\u8a8d\u7684\u689d\u4ef6\uff0c\u5305\u542b\u5be6\u9ad4\u8fa6\u516c\u5ba4\u300124\u5c0f\u6642\u806f\u7d61\u3001\u5c08\u696d\u80cc\u666f\u7b49\u95dc\u9375\u8981\u6c42\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-selection-checklist-taiwan-sellers-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-selection-checklist-taiwan-sellers-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-selection-checklist-taiwan-sellers-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-selection-checklist-taiwan-sellers-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-us-agent-selection-checklist-taiwan-sellers-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<hr \/>\n<h2>\u5982\u4f55\u9078\u64c7\u9069\u4efb\u7684FDA\u7f8e\u570b\u4ee3\u7406\u4eba\uff1f<\/h2>\n<p>\u9078\u64c7\u7f8e\u570b\u4ee3\u7406\u4eba\u6642\uff0c\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u9700\u8003\u91cf\u4ee5\u4e0b\u6a19\u6e96\uff1a<\/p>\n<p><strong>\u6838\u5fc3\u8a55\u4f30\u6a19\u6e96<\/strong>:<\/p>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>Evaluation Items<\/th>\n<th>\u5fc5\u5099\u689d\u4ef6<\/th>\n<th>\u52a0\u5206\u689d\u4ef6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u5be6\u9ad4\u71df\u904b<\/strong><\/td>\n<td>\u7f8e\u570b\u5883\u5167\u5be6\u9ad4\u8fa6\u516c\u5ba4<\/td>\n<td>\u591a\u5dde\u8fa6\u516c\u5ba4\u7db2\u7d61<\/td>\n<\/tr>\n<tr>\n<td><strong>Professional Competence<\/strong><\/td>\n<td>\u719f\u6089FDA\u98df\u54c1\u6cd5\u898f<\/td>\n<td>\u5177\u5099FSMA\u5be6\u52d9\u7d93\u9a57<\/td>\n<\/tr>\n<tr>\n<td><strong>\u6e9d\u901a\u80fd\u529b<\/strong><\/td>\n<td>\u63d0\u4f9b\u82f1\u6587\u6e9d\u901a<\/td>\n<td>\u63d0\u4f9b\u4e2d\u82f1\u96d9\u8a9e\u670d\u52d9<\/td>\n<\/tr>\n<tr>\n<td><strong>\u56de\u61c9\u901f\u5ea6<\/strong><\/td>\n<td>24\u5c0f\u6642\u5167\u56de\u61c9<\/td>\n<td>\u5373\u6642\u901a\u8a0a\u7ba1\u9053<\/td>\n<\/tr>\n<tr>\n<td><strong>Scope of Services<\/strong><\/td>\n<td>\u57fa\u672c\u4ee3\u7406\u8077\u8cac<\/td>\n<td>\u7dca\u6025\u4e8b\u4ef6\u61c9\u8b8a\u3001\u6cd5\u898f\u8aee\u8a62<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p><strong>\u9078\u64c7\u6d41\u7a0b\u5efa\u8b70<\/strong>:<\/p>\n<ol>\n<li>\u78ba\u8a8d\u4ee3\u7406\u4eba\u5177\u5099\u7f8e\u570b\u5883\u5167\u5be6\u9ad4\u5730\u5740<\/li>\n<li>\u8981\u6c42\u63d0\u4f9b\u904e\u5f80\u670d\u52d9\u6848\u4f8b\u6216\u5ba2\u6236\u63a8\u85a6<\/li>\n<li>\u660e\u78ba\u8a62\u554f\u7dca\u6025\u4e8b\u4ef6\u8655\u7406\u6a5f\u5236<\/li>\n<li>\u78ba\u8a8d\u4ee3\u7406\u5354\u8b70\u4e2d\u7684\u8cac\u4efb\u7bc4\u570d\u8207\u9650\u5236<\/li>\n<li>\u8a55\u4f30\u8cbb\u7528\u5408\u7406\u6027(\u904e\u4f4e\u53ef\u80fd\u670d\u52d9\u54c1\u8cea\u4e0d\u4f73)<\/li>\n<\/ol>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u76843\u500b\u5e38\u898b\u9677\u9631<\/h2>\n<h3>\u9677\u9631\u4e00\uff1a\u4f7f\u7528\u865b\u64ec\u8fa6\u516c\u5ba4\u6216\u4ee3\u6536\u4fe1\u4ef6\u670d\u52d9<\/h3>\n<p>\u8a31\u591a\u53f0\u7063\u8ce3\u5bb6\u70ba\u7bc0\u7701\u6210\u672c\uff0c\u9078\u64c7\u865b\u64ec\u8fa6\u516c\u5ba4\u6216\u4ee3\u6536\u4fe1\u4ef6\u670d\u52d9\u4f5c\u70ba\u7f8e\u570b\u4ee3\u7406\u4eba\uff0c\u4f46\u9019\u985e\u670d\u52d9\u901a\u5e38\uff1a<\/p>\n<ul>\n<li>\u7121\u6cd5\u63d0\u4f9b24\u5c0f\u6642\u5373\u6642\u56de\u61c9<\/li>\n<li>\u4e0d\u5177\u5099\u8655\u7406\u7dca\u6025\u4e8b\u4ef6\u7684\u80fd\u529b<\/li>\n<li>\u53ef\u80fd\u5c0e\u81f4FDA\u8a8d\u5b9a\u8a2d\u65bd\u8a3b\u518a\u7121\u6548<\/li>\n<\/ul>\n<h3>\u9677\u9631\u4e8c\uff1a\u672a\u78ba\u8a8d\u4ee3\u7406\u4eba\u7684\u6cd5\u5f8b\u8cac\u4efb\u7bc4\u570d<\/h3>\n<p>\u90e8\u5206\u4ee3\u7406\u4eba\u50c5\u63d0\u4f9b\u300c\u540d\u7fa9\u4ee3\u7406\u300d\uff0c\u4e0d\u9858\u627f\u64d4\u5be6\u8cea\u6cd5\u5f8b\u8cac\u4efb\uff0c\u5c0e\u81f4\uff1a<\/p>\n<ul>\n<li>\u7dca\u6025\u4e8b\u4ef6\u767c\u751f\u6642\u7121\u4eba\u8655\u7406<\/li>\n<li>FDA\u6cd5\u5f8b\u6587\u4ef6\u7121\u6cd5\u6709\u6548\u9001\u9054<\/li>\n<li>\u8a2d\u65bd\u64c1\u6709\u8005\u9700\u81ea\u884c\u9762\u5c0d\u6cd5\u5f8b\u554f\u984c<\/li>\n<\/ul>\n<h3>\u9677\u9631\u4e09\uff1a\u5ffd\u7565\u4ee3\u7406\u5354\u8b70\u7684\u7e8c\u7d04\u8207\u7d42\u6b62\u689d\u6b3e<\/h3>\n<p>\u672a\u4ed4\u7d30\u95b1\u8b80\u4ee3\u7406\u5354\u8b70\u53ef\u80fd\u5c0e\u81f4\uff1a<\/p>\n<ul>\n<li>\u4ee3\u7406\u4eba\u55ae\u65b9\u9762\u7d42\u6b62\u670d\u52d9\uff0c\u8a2d\u65bd\u8a3b\u518a\u5931\u6548<\/li>\n<li>\u66f4\u63db\u4ee3\u7406\u4eba\u6642\u7522\u751f\u9ad8\u984d\u9055\u7d04\u91d1<\/li>\n<li>\u670d\u52d9\u7bc4\u570d\u8207\u671f\u671b\u4e0d\u7b26\u537b\u7121\u6cd5\u89e3\u7d04<\/li>\n<\/ul>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3FDA\u98df\u54c1\u8a3b\u518a\u7684\u7533\u8acb\u6d41\u7a0b\u8207\u6240\u9700\u6587\u4ef6\uff0c\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762\uff0c\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u6d41\u7a0b\u8207\u6587\u4ef6\u5b8c\u6574\u8aaa\u660e|\u53f0\u7063\u7533\u8acb\u91cd\u9ede\u6574\u7406(2026)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/en\/fda-food-registration-fda-food-registration-process-and-documents-taiwan\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration-fda-food-registration-process-and-documents-taiwan\/<\/a><\/p>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3\u53f0\u7063\u8ce3\u5bb6\u5728FDA\u98df\u54c1\u8a3b\u518a\u4e0a\u7684\u8cac\u4efb\u6b78\u5c6c\u8207\u5e38\u898b\u8aa4\u5340\uff0c\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762\uff0c\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\n<p>\ud83d\udc49 <strong>\u53f0\u7063\u8ce3\u5bb6 FDA \u98df\u54c1\u8a3b\u518a\u6307\u5357|\u8cac\u4efb\u6b78\u5c6c\u8207\u5e38\u898b\u8aa4\u5340\u4e00\u6b21\u8aaa\u6e05(2026)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/en\/fda-food-registration-fda-food-registration-responsibility-taiwan-sellers\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration-fda-food-registration-responsibility-taiwan-sellers\/<\/a><\/p>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p>FDA\u7f8e\u570b\u4ee3\u7406\u4eba\u76845\u5927\u6838\u5fc3\u8077\u8cac\u9060\u8d85\u904e\u4e00\u822c\u60f3\u50cf\uff1a<\/p>\n<ul>\n<li><strong>\u8077\u8cac\u4e00<\/strong>: \u4f5c\u70baFDA\u8207\u8a2d\u65bd\u7684\u6b63\u5f0f\u6e9d\u901a\u7ba1\u9053\uff0c\u970024\u5c0f\u6642\u5167\u56de\u61c9<\/li>\n<li><strong>\u8077\u8cac\u4e8c<\/strong>: \u5354\u52a9\u8655\u7406\u7dca\u6025\u4e8b\u4ef6\u8207\u7522\u54c1\u53ec\u56de<\/li>\n<li><strong>\u8077\u8cac\u4e09<\/strong>: \u4fdd\u5b58\u8207\u63d0\u4f9b\u8a2d\u65bd\u8a3b\u518a\u6587\u4ef6<\/li>\n<li><strong>\u8077\u8cac\u56db<\/strong>: \u4ee3\u8868\u8a2d\u65bd\u627f\u64d4\u7279\u5b9a\u6cd5\u5f8b\u8cac\u4efb<\/li>\n<li><strong>\u8077\u8cac\u4e94<\/strong>: \u5354\u52a9\u8a2d\u65bd\u8a3b\u518a\u8cc7\u8a0a\u66f4\u65b0<\/li>\n<\/ul>\n<p>\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u61c9\u5be9\u614e\u9078\u64c7\u5177\u5099\u5be6\u9ad4\u71df\u904b\u80fd\u529b\u3001\u5c08\u696d\u80cc\u666f\u8207\u5b8c\u6574\u670d\u52d9\u7684\u7f8e\u570b\u4ee3\u7406\u4eba\uff0c\u907f\u514d\u56e0\u4ee3\u7406\u4eba\u4e0d\u9069\u4efb\u5c0e\u81f4\u8a2d\u65bd\u8a3b\u518a\u5931\u6548\u6216\u7522\u54c1\u88ab\u6263\u3002\u5efa\u8b70\u5728\u7c3d\u8a02\u4ee3\u7406\u5354\u8b70\u524d\uff0c\u8a73\u7d30\u78ba\u8a8d\u670d\u52d9\u7bc4\u570d\u3001\u6cd5\u5f8b\u8cac\u4efb\u8207\u7dca\u6025\u61c9\u8b8a\u6a5f\u5236\u3002<\/p>\n<p>\u82e5\u5c0dFDA\u98df\u54c1\u5408\u898f\u4ecd\u6709\u7591\u554f\uff0c\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/en\/\" target=\"_blank\" rel=\"noopener\">Green Circle Official Website<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\u3002<\/p>\n<hr \/>\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0bFDA\u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f32026\u5e741\u6708):<\/p>\n<ol>\n<li>U.S. Food and Drug Administration. &#8220;How to Register Your Food Facility: What is a U.S. Agent?&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\/how-register-food-facility-what-us-agent\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/food-facility-registration\/how-register-food-facility-what-us-agent<\/a><\/li>\n<li>U.S. Food and Drug Administration. &#8220;Food Safety Modernization Act (FSMA).&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma<\/a><\/li>\n<li>Code of Federal Regulations Title 21, \u00a7 1.232. &#8220;What is the role of a U.S. agent?&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-1.232\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/section-1.232<\/a><\/li>\n<\/ol>\n<p><em>\u8a3b: FDA\u6cd5\u898f\u53ef\u80fd\u66f4\u65b0\uff0c\u5efa\u8b70\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u7f8e\u570b\u4ee3\u7406\u4eba\u4e0d\u53ea\u662f\u300c\u806f\u7d61\u7a97\u53e3\u300d \u6839\u64da FDA\u5b98\u65b9\u5b9a\u7fa9{:target=&#8221;_blank&#038;#822 [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"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":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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