{"id":18077,"date":"2025-05-16T21:34:03","date_gmt":"2025-05-16T13:34:03","guid":{"rendered":"https:\/\/greenoo.tw\/?p=18077"},"modified":"2026-01-23T19:07:32","modified_gmt":"2026-01-23T11:07:32","slug":"taiwan-sellers-fda-certification-required-documents-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/taiwan-sellers-fda-certification-required-documents-2026\/","title":{"rendered":"\u53f0\u7063\u8ce3\u5bb6\u6ce8\u610f\uff01FDA\u8a8d\u8b49\u7533\u8acb6\u5927\u5fc5\u5099\u8cc7\u6599\u5b8c\u6574\u89e3\u6790(2026\u6700\u65b0)"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19931\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/taiwan-sellers-fda-certification-required-documents-feature-2026.png\" alt=\"\u53f0\u7063\u8ce3\u5bb6FDA\u8a8d\u8b49\u7533\u8acb\u5fc5\u5099\u8cc7\u6599\u5c01\u9762,\u986f\u793a6\u5927\u6587\u4ef6\u5b8c\u6574\u89e3\u6790\u82072026\u6700\u65b0\u8981\u6c42\u8aaa\u660e\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/taiwan-sellers-fda-certification-required-documents-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/taiwan-sellers-fda-certification-required-documents-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/taiwan-sellers-fda-certification-required-documents-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/taiwan-sellers-fda-certification-required-documents-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/taiwan-sellers-fda-certification-required-documents-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>\u53f0\u7063\u8ce3\u5bb6\u7533\u8acbFDA\u8a8d\u8b49\u9700\u8981\u6e96\u5099\u54ea\u4e9b\u8cc7\u6599?<\/h2>\n<p>\u6839\u64da <a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\" target=\"_blank\" rel=\"noopener\">FDA\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u898f\u5b9a<\/a>,\u53f0\u7063\u98df\u54c1\u8ce3\u5bb6\u7533\u8acbFDA\u8a8d\u8b49(\u6b63\u5f0f\u540d\u7a31\u70ba\u300c\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u300d)\u9700\u6e96\u5099<strong>6\u5927\u985e\u5fc5\u5099\u8cc7\u6599<\/strong>:\u8a2d\u65bd\u57fa\u672c\u8cc7\u6599\u3001\u7f8e\u570b\u4ee3\u7406\u4eba\u8cc7\u8a0a\u3001\u7522\u54c1\u985e\u5225\u6e05\u55ae\u3001DUNS\u865f\u78bc(\u8996\u60c5\u6cc1)\u3001\u98df\u54c1\u5b89\u5168\u8a08\u756b(\u82e5\u9069\u7528FSMA)\u53ca\u71df\u696d\u8b49\u660e\u6587\u4ef6\u3002\u8cc7\u6599\u4e0d\u5b8c\u6574\u662f\u5c0e\u81f4\u8a3b\u518a\u5931\u6557\u6216\u5f8c\u7e8c\u6263\u95dc\u7684\u4e3b\u8981\u539f\u56e0,\u5efa\u8b70\u63d0\u524d4-6\u9031\u958b\u59cb\u6e96\u5099\u3002<\/p>\n<p>\u5fc5\u5099\u8cc7\u6599\u6db5\u84cb\u8a2d\u65bd\u8eab\u4efd\u3001\u6cd5\u898f\u9075\u5faa\u80fd\u529b\u53ca\u7522\u54c1\u5b89\u5168\u6027\u4e09\u5927\u9762\u5411\u3002\u53f0\u7063\u8ce3\u5bb6\u5e38\u56e0\u8aa4\u89e3\u300cFDA\u8a8d\u8b49\u300d\u8207\u300cFDA\u8a3b\u518a\u300d\u5dee\u7570,\u6216\u672a\u78ba\u8a8d\u81ea\u8eab\u662f\u5426\u70ba\u8a2d\u65bd\u64c1\u6709\u8005\u800c\u6e96\u5099\u932f\u8aa4\u6587\u4ef6\u3002\u5be6\u52d9\u4e0a,<strong>90%\u7684\u8cc7\u6599\u554f\u984c\u96c6\u4e2d\u5728\u7f8e\u570b\u4ee3\u7406\u4eba\u6307\u5b9a\u8207\u7522\u54c1\u5206\u985e\u5169\u9805<\/strong>,\u9700\u7279\u5225\u7559\u610f\u3002<\/p>\n<h2>\u70ba\u4f55\u53f0\u7063\u8ce3\u5bb6\u9700\u8981\u4e86\u89e3\u9019\u500b\u554f\u984c?<\/h2>\n<p>\u53f0\u7063\u98df\u54c1\u696d\u8005\u51fa\u53e3\u7f8e\u570b\u6642,\u5e38\u5c07\u300cFDA\u8a8d\u8b49\u300d\u8207\u300cFDA\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u300d\u6df7\u6dc6\u3002\u5be6\u969b\u4e0a,FDA\u4e0d\u63d0\u4f9b\u300c\u8a8d\u8b49\u300d\u670d\u52d9,\u800c\u662f\u8981\u6c42\u98df\u54c1\u8a2d\u65bd\u5b8c\u6210\u300c\u8a3b\u518a\u300d\u4e26\u9075\u5faa <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food\" target=\"_blank\" rel=\"noopener\">FSMA\u9810\u9632\u6027\u63a7\u5236\u898f\u5247<\/a>{:target=&#8221;_blank&#8221;}\u3002\u8cc7\u6599\u6e96\u5099\u4e0d\u5168\u6703\u5c0e\u81f4\u8a3b\u518a\u7121\u6cd5\u5b8c\u6210,\u5f71\u97ff\u51fa\u53e3\u6642\u7a0b,\u751a\u81f3\u9762\u81e8\u6d77\u95dc\u6263\u7559\u98a8\u96aa\u3002<\/p>\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0dFDA\u98df\u54c1\u8a3b\u518a\u5236\u5ea6\u7684\u6574\u9ad4\u7406\u89e3,\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7e3d\u89bd\u5165\u624b,\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\/zh\/fda-food-registration\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration\/<\/a><\/p>\n<h2>6\u5927\u5fc5\u5099\u8cc7\u6599\u5b8c\u6574\u89e3\u6790<\/h2>\n<h3>\u8cc7\u65991: \u8a2d\u65bd\u57fa\u672c\u8cc7\u6599<\/h3>\n<p><strong>\u5fc5\u9808\u63d0\u4f9b\u7684\u8cc7\u8a0a<\/strong>:<\/p>\n<ul>\n<li>\u8a2d\u65bd\u5b8c\u6574\u540d\u7a31(\u4e2d\u82f1\u6587)<\/li>\n<li>\u8a2d\u65bd\u5be6\u969b\u5730\u5740(\u5de5\u5ee0\/\u5009\u5132\/\u52a0\u5de5\u5ee0\u6240\u5728\u5730)<\/li>\n<li>\u90f5\u5bc4\u5730\u5740(\u82e5\u8207\u5be6\u969b\u5730\u5740\u4e0d\u540c)<\/li>\n<li>\u8a2d\u65bd\u985e\u578b(\u88fd\u9020\/\u52a0\u5de5\/\u5305\u88dd\/\u5009\u5132,\u53ef\u8907\u9078)<\/li>\n<li>\u8ca0\u8cac\u4eba\u59d3\u540d\u8207\u8077\u7a31<\/li>\n<li>\u806f\u7d61\u96fb\u8a71\u8207Email<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u932f\u8aa4<\/strong>:<\/p>\n<ul>\n<li>\u274c \u50c5\u63d0\u4f9b\u516c\u53f8\u767b\u8a18\u5730\u5740,\u672a\u63d0\u4f9b\u5be6\u969b\u751f\u7522\u5730\u5740<\/li>\n<li>\u274c \u8a2d\u65bd\u985e\u578b\u9078\u64c7\u932f\u8aa4(\u4f8b\u5982\u50c5\u505a\u5305\u88dd\u537b\u52fe\u9078\u88fd\u9020)<\/li>\n<li>\u274c \u806f\u7d61\u8cc7\u8a0a\u4f7f\u7528\u500b\u4ebaEmail,\u5f8c\u7e8c\u7121\u6cd5\u63a5\u6536FDA\u901a\u77e5<\/li>\n<\/ul>\n<p><strong>\u6e96\u5099\u6280\u5de7<\/strong>:<br \/>\n\u8a2d\u65bd\u5730\u5740\u5fc5\u9808\u8207\u5be6\u969b\u98df\u54c1\u8655\u7406\u5834\u6240\u4e00\u81f4\u3002\u82e5\u53f0\u7063\u5de5\u5ee0\u540c\u6642\u8ca0\u8cac\u88fd\u9020\u8207\u5305\u88dd,\u9700\u5728\u8a2d\u65bd\u985e\u578b\u4e2d<strong>\u540c\u6642\u52fe\u9078Manufacturing\u548cPacking<\/strong>\u3002\u5efa\u8b70\u4f7f\u7528\u516c\u53f8\u5b98\u65b9Email\u4f5c\u70ba\u806f\u7d61\u4fe1\u7bb1,\u78ba\u4fdd\u80fd\u9577\u671f\u63a5\u6536FDA\u66f4\u65b0\u901a\u77e5\u3002<\/p>\n<h2>\u5716 2: FDA\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a6\u5927\u5fc5\u5099\u8cc7\u6599\u6e05\u55ae<\/h2>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19932\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-required-documents-checklist-taiwan-sellers-2026.png\" alt=\"FDA\u8a8d\u8b49\u7533\u8acb6\u5927\u5fc5\u5099\u8cc7\u6599\u6e05\u55ae,\u5217\u51fa\u53f0\u7063\u8ce3\u5bb6\u9700\u6e96\u5099\u7684\u8a2d\u65bd\u8cc7\u6599\u3001\u4ee3\u7406\u4eba\u8cc7\u8a0a\u3001\u7522\u54c1\u985e\u5225\u7b49\u6587\u4ef6\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-required-documents-checklist-taiwan-sellers-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-required-documents-checklist-taiwan-sellers-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-required-documents-checklist-taiwan-sellers-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-required-documents-checklist-taiwan-sellers-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-required-documents-checklist-taiwan-sellers-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<p>&nbsp;<\/p>\n<h3>\u8cc7\u65992: \u7f8e\u570b\u4ee3\u7406\u4eba(US Agent)\u8cc7\u8a0a<\/h3>\n<p><strong>\u5fc5\u9808\u63d0\u4f9b\u7684\u8cc7\u8a0a<\/strong>:<\/p>\n<ul>\n<li>\u7f8e\u570b\u4ee3\u7406\u4eba\u516c\u53f8\u540d\u7a31<\/li>\n<li>\u7f8e\u570b\u4ee3\u7406\u4eba\u5b8c\u6574\u5730\u5740(\u5fc5\u9808\u70ba\u7f8e\u570b\u5883\u5167)<\/li>\n<li>\u4ee3\u7406\u4eba\u806f\u7d61\u96fb\u8a71\u8207Email<\/li>\n<li>\u4ee3\u7406\u5354\u8b70\u66f8(\u8b49\u660e\u4ee3\u7406\u95dc\u4fc2)<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u932f\u8aa4<\/strong>:<\/p>\n<ul>\n<li>\u274c \u4f7f\u7528\u865b\u64ec\u8fa6\u516c\u5ba4\u6216\u4fe1\u7bb1\u5730\u5740\u4f5c\u70ba\u4ee3\u7406\u4eba\u5730\u5740<\/li>\n<li>\u274c \u672a\u7c3d\u8a02\u6b63\u5f0f\u4ee3\u7406\u5354\u8b70,\u50c5\u53e3\u982d\u7d04\u5b9a<\/li>\n<li>\u274c \u4ee3\u7406\u4eba\u8cc7\u8a0a\u586b\u5beb\u932f\u8aa4,\u5c0e\u81f4FDA\u7121\u6cd5\u806f\u7e6b<\/li>\n<\/ul>\n<p><strong>\u6e96\u5099\u6280\u5de7<\/strong>:<br \/>\n\u4f9d\u64da <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-1.226\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 1.226<\/a>{:target=&#8221;_blank&#8221;},\u7f8e\u570b\u4ee3\u7406\u4eba\u5fc5\u9808\u5be6\u969b\u4f4d\u65bc\u7f8e\u570b\u5883\u5167,\u4e14\u80fd\u4ee3\u8868\u8a2d\u65bd\u8655\u7406FDA\u901a\u8a0a\u3002\u5efa\u8b70\u9078\u64c7\u5c08\u696dFDA\u4ee3\u7406\u670d\u52d9,\u78ba\u4fdd\u80fd\u5373\u6642\u56de\u61c9FDA\u67e5\u8a62\u3002\u4ee3\u7406\u5354\u8b70\u9700\u660e\u78ba\u8f09\u660e\u4ee3\u7406\u7bc4\u570d\u3001\u6709\u6548\u671f\u9650\u53ca\u96d9\u65b9\u8cac\u4efb\u3002<\/p>\n<h3>\u8cc7\u65993: \u7522\u54c1\u985e\u5225\u6e05\u55ae<\/h3>\n<p><strong>\u5fc5\u9808\u63d0\u4f9b\u7684\u8cc7\u8a0a<\/strong>:<\/p>\n<ul>\n<li>\u7522\u54c1\u901a\u7528\u540d\u7a31(\u5982:\u7f50\u88dd\u6c34\u679c\u3001\u5373\u98df\u9eb5\u3001\u8336\u8449)<\/li>\n<li>FDA\u7522\u54c1\u4ee3\u78bc(Product Code,\u53ef\u65bcFDA\u8cc7\u6599\u5eab\u67e5\u8a62)<\/li>\n<li>\u7522\u54c1\u52a0\u5de5\u65b9\u5f0f(\u51b7\u51cd\/\u7f50\u88dd\/\u4e7e\u71e5\u7b49)<\/li>\n<li>\u662f\u5426\u542b\u4e3b\u8981\u904e\u654f\u539f<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u932f\u8aa4<\/strong>:<\/p>\n<ul>\n<li>\u274c \u7522\u54c1\u5206\u985e\u904e\u65bc\u7c60\u7d71(\u4f8b\u5982\u50c5\u5beb\u300c\u98df\u54c1\u300d)<\/li>\n<li>\u274c \u7522\u54c1\u4ee3\u78bc\u9078\u64c7\u932f\u8aa4,\u5c0e\u81f4\u67e5\u9a57\u6a19\u6e96\u8aa4\u5224<\/li>\n<li>\u274c \u672a\u6a19\u8a3b\u904e\u654f\u539f\u8cc7\u8a0a,\u589e\u52a0\u6263\u95dc\u98a8\u96aa<\/li>\n<\/ul>\n<p><strong>\u6e96\u5099\u6280\u5de7<\/strong>:<br \/>\n\u7522\u54c1\u5206\u985e\u9700\u53c3\u8003 <a href=\"https:\/\/www.fda.gov\/food\/food-labeling-nutrition\" target=\"_blank\" rel=\"noopener\">FDA\u98df\u54c1\u7522\u54c1\u4ee3\u78bc\u8cc7\u6599\u5eab<\/a>{:target=&#8221;_blank&#8221;}\u3002\u82e5\u7522\u54c1\u542b\u82b1\u751f\u3001\u725b\u5976\u3001\u96de\u86cb\u7b49\u4e3b\u8981\u904e\u654f\u539f,\u9700\u660e\u78ba\u6a19\u8a3b\u3002\u5efa\u8b70\u5c07\u7522\u54c1\u6e05\u55ae\u6574\u7406\u6210\u8868\u683c,\u5305\u542b\u4e2d\u82f1\u6587\u540d\u7a31\u3001\u7522\u54c1\u4ee3\u78bc\u53ca\u52a0\u5de5\u65b9\u5f0f,\u65b9\u4fbf\u5f8c\u7e8c\u66f4\u65b0\u3002<\/p>\n<h3>\u8cc7\u65994: DUNS\u865f\u78bc(\u8996\u60c5\u6cc1\u9700\u8981)<\/h3>\n<p><strong>\u4f55\u6642\u9700\u8981<\/strong>:<\/p>\n<ul>\n<li>\u51fa\u53e3\u81f3\u7f8e\u570b\u653f\u5e9c\u6a5f\u69cb(\u5982\u8ecd\u65b9\u3001\u5b78\u6821)<\/li>\n<li>\u53c3\u8207\u7f8e\u570b\u653f\u5e9c\u63a1\u8cfc\u6848<\/li>\n<li>\u7279\u5b9a\u5927\u578b\u96f6\u552e\u5546\u6216\u96fb\u5546\u5e73\u53f0\u8981\u6c42<\/li>\n<\/ul>\n<p><strong>\u5982\u4f55\u53d6\u5f97<\/strong>:<br \/>\nDUNS\u865f\u78bc\u7531Dun &amp; Bradstreet\u6838\u767c,\u53f0\u7063\u4f01\u696d\u53ef\u900f\u904e <a href=\"https:\/\/www.dnb.com\" target=\"_blank\" rel=\"noopener\">Dun &amp; Bradstreet\u53f0\u7063\u5b98\u7db2<\/a>{:target=&#8221;_blank&#8221;} \u7533\u8acb,\u901a\u5e38\u97001-2\u9031\u6838\u767c\u3002<\/p>\n<p><strong>\u5e38\u898b\u932f\u8aa4<\/strong>:<\/p>\n<ul>\n<li>\u274c \u8aa4\u4ee5\u70ba\u6240\u6709FDA\u8a3b\u518a\u90fd\u9700\u8981DUNS\u865f\u78bc<\/li>\n<li>\u274c \u7533\u8acb\u6642\u586b\u5beb\u8cc7\u8a0a\u8207\u8a2d\u65bd\u8a3b\u518a\u4e0d\u4e00\u81f4<\/li>\n<\/ul>\n<p><strong>\u6e96\u5099\u6280\u5de7<\/strong>:<br \/>\n\u4e00\u822c\u53f0\u7063\u8ce3\u5bb6\u51fa\u53e3\u81f3\u79c1\u4eba\u4f01\u696d\u6216\u96fb\u5546\u5e73\u53f0,<strong>\u901a\u5e38\u4e0d\u9700\u8981DUNS\u865f\u78bc<\/strong>\u3002\u50c5\u5728\u7279\u5b9a\u60c5\u5883\u4e0b\u624d\u9700\u63d0\u4f9b\u3002\u82e5\u4e0d\u78ba\u5b9a\u662f\u5426\u9700\u8981,\u5efa\u8b70\u5148\u8a62\u554f\u7f8e\u570b\u8cb7\u5bb6\u6216\u9032\u53e3\u5546\u3002<\/p>\n<h3>\u8cc7\u65995: \u98df\u54c1\u5b89\u5168\u8a08\u756b(\u82e5\u9069\u7528FSMA)<\/h3>\n<p><strong>\u4f55\u6642\u9700\u8981<\/strong>:<br \/>\n\u6839\u64da <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food\" target=\"_blank\" rel=\"noopener\">FSMA\u9810\u9632\u6027\u63a7\u5236\u898f\u5247<\/a>{:target=&#8221;_blank&#8221;},\u5e74\u71df\u6536\u8d85\u904e100\u842c\u7f8e\u5143\u6216\u7522\u54c1\u5c6c\u9ad8\u98a8\u96aa\u985e\u5225\u7684\u8a2d\u65bd,\u9700\u5efa\u7acb\u66f8\u9762\u98df\u54c1\u5b89\u5168\u8a08\u756b,\u5305\u542b:<\/p>\n<ul>\n<li>\u5371\u5bb3\u5206\u6790(Hazard Analysis)<\/li>\n<li>\u9810\u9632\u6027\u63a7\u5236\u63aa\u65bd(Preventive Controls)<\/li>\n<li>\u76e3\u63a7\u7a0b\u5e8f(Monitoring Procedures)<\/li>\n<li>\u77ef\u6b63\u63aa\u65bd(Corrective Actions)<\/li>\n<li>\u9a57\u8b49\u6d3b\u52d5(Verification Activities)<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u932f\u8aa4<\/strong>:<\/p>\n<ul>\n<li>\u274c \u672a\u78ba\u8a8d\u81ea\u8eab\u662f\u5426\u9069\u7528FSMA,\u76f4\u63a5\u7565\u904e<\/li>\n<li>\u274c \u98df\u54c1\u5b89\u5168\u8a08\u756b\u50c5\u8907\u88fd\u7bc4\u672c,\u672a\u4f9d\u5be6\u969b\u88fd\u7a0b\u8abf\u6574<\/li>\n<li>\u274c \u672a\u6307\u5b9a\u5408\u683c\u9810\u9632\u6027\u63a7\u5236\u4eba\u54e1(PCQI)<\/li>\n<\/ul>\n<p><strong>\u6e96\u5099\u6280\u5de7<\/strong>:<br \/>\n\u53f0\u7063\u4e2d\u5c0f\u578b\u98df\u54c1\u5ee0\u82e5\u5e74\u71df\u6536\u672a\u9054\u9580\u6abb,\u53ef\u80fd\u8c41\u514d\u65bcFSMA\u8981\u6c42,\u4f46\u4ecd\u5efa\u8b70\u5efa\u7acb\u57fa\u790e\u98df\u54c1\u5b89\u5168\u7ba1\u7406\u5236\u5ea6\u3002\u82e5\u9069\u7528FSMA,\u9700\u6307\u6d3e\u81f3\u5c11\u4e00\u540d\u5b8c\u6210FDA\u8a8d\u53efPCQI\u8a13\u7df4\u7684\u4eba\u54e1\u8ca0\u8cac\u98df\u54c1\u5b89\u5168\u8a08\u756b\u3002<\/p>\n<h3>\u8cc7\u65996: \u71df\u696d\u8b49\u660e\u6587\u4ef6<\/h3>\n<p><strong>\u5fc5\u9808\u63d0\u4f9b\u7684\u6587\u4ef6<\/strong>:<\/p>\n<ul>\n<li>\u5de5\u5ee0\u767b\u8a18\u8b49(\u4e2d\u82f1\u6587\u7248)<\/li>\n<li>\u71df\u696d\u57f7\u7167\u6216\u5546\u696d\u767b\u8a18\u8b49<\/li>\n<li>\u516c\u53f8\u8a2d\u7acb\u767b\u8a18\u8b49\u660e<\/li>\n<li>\u5176\u4ed6\u653f\u5e9c\u6838\u767c\u7684\u5408\u6cd5\u7d93\u71df\u8b49\u660e<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u932f\u8aa4<\/strong>:<\/p>\n<ul>\n<li>\u274c \u50c5\u63d0\u4f9b\u4e2d\u6587\u7248\u6587\u4ef6,\u672a\u6e96\u5099\u82f1\u6587\u7ffb\u8b6f<\/li>\n<li>\u274c \u8b49\u7167\u5df2\u904e\u671f\u6216\u5730\u5740\u8207\u8a2d\u65bd\u8a3b\u518a\u4e0d\u7b26<\/li>\n<li>\u274c \u4f7f\u7528\u5f71\u672c\u672a\u7d93\u516c\u8b49,FDA\u53ef\u80fd\u4e0d\u63a5\u53d7<\/li>\n<\/ul>\n<p><strong>\u6e96\u5099\u6280\u5de7<\/strong>:<br \/>\n\u5efa\u8b70\u6e96\u5099<strong>\u7d93\u516c\u8b49\u7684\u82f1\u6587\u7ffb\u8b6f\u7248\u672c<\/strong>,\u78ba\u4fddFDA\u6216\u6d77\u95dc\u67e5\u9a57\u6642\u80fd\u5feb\u901f\u78ba\u8a8d\u3002\u6587\u4ef6\u5730\u5740\u3001\u8ca0\u8cac\u4eba\u59d3\u540d\u9700\u8207\u8a2d\u65bd\u8a3b\u518a\u8cc7\u8a0a\u4e00\u81f4\u3002\u82e5\u8fd1\u671f\u6709\u8b8a\u66f4\u767b\u8a18,\u9700\u540c\u6642\u63d0\u4f9b\u8b8a\u66f4\u8b49\u660e\u3002<\/p>\n<hr \/>\n<h3>\u5716 3: FDA\u8a8d\u8b49\u7533\u8acb\u8cc7\u6599\u6e96\u5099\u6642\u7a0b\u898f\u5283<\/h3>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19933\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-application-preparation-timeline-taiwan-sellers-2026.png\" alt=\"FDA\u8a8d\u8b49\u7533\u8acb\u8cc7\u6599\u6e96\u5099\u6642\u7a0b\u898f\u5283\u5716,\u986f\u793a\u5f9e\u78ba\u8a8d\u8a2d\u65bd\u985e\u578b\u5230\u5b8c\u6210\u7dda\u4e0a\u8a3b\u518a\u76845\u968e\u6bb5\u6642\u9593\u5b89\u6392\u8207\u95dc\u9375\u4efb\u52d9\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-application-preparation-timeline-taiwan-sellers-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-application-preparation-timeline-taiwan-sellers-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-application-preparation-timeline-taiwan-sellers-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-application-preparation-timeline-taiwan-sellers-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-application-preparation-timeline-taiwan-sellers-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u76843\u500b\u91cd\u9ede<\/h2>\n<h3>\u91cd\u9ede1: \u8cc7\u6599\u4e00\u81f4\u6027\u6aa2\u67e5<\/h3>\n<p>\u6240\u6709\u6587\u4ef6\u4e2d\u7684\u8a2d\u65bd\u540d\u7a31\u3001\u5730\u5740\u3001\u8ca0\u8cac\u4eba\u8cc7\u8a0a\u5fc5\u9808<strong>\u5b8c\u5168\u4e00\u81f4<\/strong>\u3002FDA\u7cfb\u7d71\u6703\u4ea4\u53c9\u6bd4\u5c0d,\u82e5\u767c\u73fe\u4e0d\u4e00\u81f4\u53ef\u80fd\u8981\u6c42\u88dc\u4ef6\u6216\u66ab\u505c\u5be9\u6838\u3002\u5efa\u8b70\u5728\u63d0\u4ea4\u524d\u88fd\u4f5c\u300c\u8cc7\u6599\u4e00\u81f4\u6027\u6aa2\u6838\u8868\u300d,\u9010\u9805\u78ba\u8a8d\u3002<\/p>\n<h3>\u91cd\u9ede2: \u7f8e\u570b\u4ee3\u7406\u4eba\u9078\u64c7<\/h3>\n<p>\u7f8e\u570b\u4ee3\u7406\u4eba\u662fFDA\u8207\u8a2d\u65bd\u9593\u7684\u4e3b\u8981\u806f\u7e6b\u7a97\u53e3,\u9078\u64c7\u4e0d\u7576\u6703\u5c0e\u81f4\u91cd\u8981\u901a\u77e5\u907a\u6f0f\u3002\u5efa\u8b70\u9078\u64c7:<\/p>\n<ul>\n<li>\u2705 \u6709\u5be6\u9ad4\u8fa6\u516c\u5ba4\u7684\u5c08\u696d\u4ee3\u7406\u516c\u53f8<\/li>\n<li>\u2705 \u719f\u6089FDA\u6cd5\u898f\u8207\u53f0\u7063\u98df\u54c1\u696d\u7279\u6027<\/li>\n<li>\u2705 \u80fd\u63d0\u4f9b\u4e2d\u6587\u6e9d\u901a\u670d\u52d9<\/li>\n<\/ul>\n<p>\u907f\u514d\u9078\u64c7\u50c5\u63d0\u4f9b\u865b\u64ec\u5730\u5740\u6216\u90f5\u4ef6\u8f49\u767c\u670d\u52d9\u7684\u4ee3\u7406\u4eba\u3002<\/p>\n<h3>\u91cd\u9ede3: \u6587\u4ef6\u6709\u6548\u671f\u9650<\/h3>\n<p>\u71df\u696d\u8b49\u660e\u6587\u4ef6\u3001\u5de5\u5ee0\u767b\u8a18\u8b49\u9700\u78ba\u8a8d\u6709\u6548\u671f\u9650\u3002\u82e5\u5728FDA\u8a3b\u518a\u671f\u9593\u904e\u671f,\u9700\u7acb\u5373\u66f4\u65b0\u4e26\u901a\u77e5FDA\u3002\u5efa\u8b70\u5728\u6587\u4ef6\u5230\u671f\u524d3\u500b\u6708\u63d0\u524d\u63db\u767c,\u907f\u514d\u5f71\u97ff\u8a3b\u518a\u72c0\u614b\u3002<\/p>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3FDA\u98df\u54c1\u8a3b\u518a\u7684\u7533\u8acb\u6d41\u7a0b\u8207\u6240\u9700\u6587\u4ef6,\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762,\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\/zh\/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<h2>\u7e3d\u7d50<\/h2>\n<p>\u53f0\u7063\u8ce3\u5bb6\u7533\u8acbFDA\u8a8d\u8b49(\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a)\u9700\u6e96\u50996\u5927\u5fc5\u5099\u8cc7\u6599:<\/p>\n<ul>\n<li>\u2705 \u8a2d\u65bd\u57fa\u672c\u8cc7\u6599(\u5de5\u5ee0\u5730\u5740\u3001\u8ca0\u8cac\u4eba\u3001\u806f\u7d61\u65b9\u5f0f)<\/li>\n<li>\u2705 \u7f8e\u570b\u4ee3\u7406\u4eba\u8cc7\u8a0a(\u4ee3\u7406\u5354\u8b70\u3001\u806f\u7d61\u8cc7\u6599)<\/li>\n<li>\u2705 \u7522\u54c1\u985e\u5225\u6e05\u55ae(\u98df\u54c1\u985e\u578b\u3001\u7522\u54c1\u4ee3\u78bc)<\/li>\n<li>\u2705 DUNS\u865f\u78bc(\u8996\u51fa\u53e3\u5c0d\u8c61\u800c\u5b9a)<\/li>\n<li>\u2705 \u98df\u54c1\u5b89\u5168\u8a08\u756b(\u82e5\u9069\u7528FSMA\u898f\u5247)<\/li>\n<li>\u2705 \u71df\u696d\u8b49\u660e\u6587\u4ef6(\u5de5\u5ee0\u767b\u8a18\u8b49\u3001\u71df\u696d\u57f7\u7167\u82f1\u6587\u7248)<\/li>\n<\/ul>\n<p><strong>\u5efa\u8b70\u63d0\u524d4-6\u9031\u958b\u59cb\u6e96\u5099<\/strong>,\u78ba\u4fdd\u8cc7\u6599\u5b8c\u6574\u6027\u8207\u4e00\u81f4\u6027,\u907f\u514d\u56e0\u6587\u4ef6\u4e0d\u5168\u5c0e\u81f4\u8a3b\u518a\u5931\u6557\u6216\u5f8c\u7e8c\u6263\u95dc\u98a8\u96aa\u3002\u82e5\u5c0dFDA\u98df\u54c1\u5408\u898f\u4ecd\u6709\u7591\u554f,\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/zh\/\" target=\"_blank\" rel=\"noopener\">\u7da0\u5708\u5708\u5b98\u7db2<\/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;Food Facility Registration.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/food-facility-registration<\/a><\/li>\n<li>U.S. Food and Drug Administration. &#8220;FSMA Final Rule on Preventive Controls for Human Food.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food<\/a><\/li>\n<li>Code of Federal Regulations Title 21, \u00a7 1.226. &#8220;Who Must Designate a U.S. Agent?&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-1.226\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/section-1.226<\/a><\/li>\n<\/ol>\n<p><em>\u8a3b:FDA\u6cd5\u898f\u53ef\u80fd\u66f4\u65b0,\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>\u53f0\u7063\u8ce3\u5bb6\u7533\u8acbFDA\u8a8d\u8b49\u9700\u8981\u6e96\u5099\u54ea\u4e9b\u8cc7\u6599? \u6839\u64da FDA\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u898f\u5b9a,\u53f0\u7063\u98df\u54c1\u8ce3\u5bb6\u7533\u8acbFDA\u8a8d\u8b49(\u6b63\u5f0f\u540d\u7a31\u70ba [&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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