{"id":18106,"date":"2025-05-16T21:53:13","date_gmt":"2025-05-16T13:53:13","guid":{"rendered":"https:\/\/greenoo.tw\/?p=18106"},"modified":"2026-01-17T11:03:07","modified_gmt":"2026-01-17T03:03:07","slug":"fda-certification-process-guide-taiwan-brands-us-market-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-certification-process-guide-taiwan-brands-us-market-2026\/","title":{"rendered":"FDA \u8a8d\u8b49\u6d41\u7a0b\u8a73\u89e3\uff1a\u53f0\u7063\u54c1\u724c\u51fa\u6d77\u7f8e\u570b\u5e02\u5834\u5fc5\u8b80\u6307\u5357(2026 \u6700\u65b0)"},"content":{"rendered":"<h1><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19884\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-guide-taiwan-brands-feature-2026.png\" alt=\"FDA \u8a8d\u8b49\u6d41\u7a0b\u8a73\u89e3\u5c01\u9762,\u986f\u793a\u53f0\u7063\u54c1\u724c\u51fa\u6d77\u7f8e\u570b\u5e02\u5834\u7684\u7522\u54c1\u985e\u578b\u8207 2026 \u6700\u65b0\u6cd5\u898f\u8aaa\u660e\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-guide-taiwan-brands-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-guide-taiwan-brands-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-guide-taiwan-brands-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-guide-taiwan-brands-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-guide-taiwan-brands-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h1>\n<h1>\u30102026\u6700\u65b0\u3011FDA\u8a8d\u8b49\u6d41\u7a0b\u8a73\u89e3\uff1a\u81fa\u7063\u54c1\u724c\u51fa\u6d77\u7f8e\u570b\u5e02\u5834\u5fc5\u8b80\u6307\u5357<\/h1>\n<p>\u4f60\u77e5\u9053\u55ce\uff1f\u8d85\u904e65%\u7684\u9996\u6b21\u7533\u8acbFDA\u8a8d\u8b49\u7684\u81fa\u7063\u54c1\u724c\u7d93\u71df\u8005\u56e0\u8cc7\u6599\u6e96\u5099\u4e0d\u8db3\u800c\u88ab\u9000\u4ef6\uff01\u672c\u6587\u5c07\u70ba\u60a8\u63ed\u793a\u5b8c\u6574FDA\u8a8d\u8b49\u6d41\u7a0b\uff0c\u52a9\u60a8\u4e00\u6b21\u901a\u904e\u5be9\u6838\u3002<\/p>\n<h2>FDA \u8a8d\u8b49\u662f\u4ec0\u9ebc?\u53f0\u7063\u54c1\u724c\u70ba\u4f55\u9700\u8981\u4e86\u89e3?<\/h2>\n<p>FDA \u8a8d\u8b49\u4e26\u975e\u55ae\u4e00\u7a0b\u5e8f,\u800c\u662f\u4f9d\u7522\u54c1\u985e\u578b\u9069\u7528\u4e0d\u540c\u7684\u5408\u898f\u8981\u6c42\u3002\u6839\u64da <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-basics\/what-does-fda-regulate\" target=\"_blank\" rel=\"noopener\">FDA \u5b98\u65b9\u5b9a\u7fa9<\/a>{:target=&#8221;_blank&#8221;},\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40(FDA)\u8ca0\u8cac\u76e3\u7ba1\u98df\u54c1\u3001\u85e5\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u6750\u7b49\u7522\u54c1\u7684\u5b89\u5168\u6027,\u53f0\u7063\u54c1\u724c\u82e5\u8981\u9032\u5165\u7f8e\u570b\u5e02\u5834,\u5fc5\u9808\u5148\u5224\u5b9a\u7522\u54c1\u5c6c\u6027,\u518d\u4f9d\u5faa\u5c0d\u61c9\u7684\u8a3b\u518a\u6216\u7533\u5831\u6d41\u7a0b\u3002<\/p>\n<p>\u5be6\u52d9\u4e0a,\u53f0\u7063\u696d\u8005\u5e38\u8aa4\u4ee5\u70ba\u300cFDA \u8a8d\u8b49\u300d\u662f\u7d71\u4e00\u7684\u7533\u8acb\u7a0b\u5e8f,\u4f46\u5be6\u969b\u60c5\u6cc1\u662f:\u98df\u54c1\u9700\u9032\u884c\u8a2d\u65bd\u8a3b\u518a(Facility Registration)\u3001\u5316\u599d\u54c1\u63a1\u81ea\u9858\u6027\u8a3b\u518a(Voluntary Cosmetic Registration Program, VCRP)\u3001\u91ab\u7642\u5668\u6750\u5247\u4f9d\u98a8\u96aa\u7b49\u7d1a\u5206\u70ba 510(k)\u3001PMA \u7b49\u4e0d\u540c\u7533\u8acb\u9014\u5f91\u3002\u82e5\u672a\u6b63\u78ba\u5224\u5b9a\u7522\u54c1\u985e\u578b,\u53ef\u80fd\u5c0e\u81f4\u7533\u8acb\u65b9\u5411\u932f\u8aa4\u6216\u906d\u6d77\u95dc\u6263\u7559\u3002<\/p>\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0d FDA \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<hr \/>\n<h2>FDA \u8a8d\u8b49\u6d41\u7a0b\u6838\u5fc3\u6b65\u9a5f<\/h2>\n<p>\u4f9d\u64da <a href=\"https:\/\/www.fda.gov\/medical-devices\/classify-your-medical-device\/how-determine-if-your-product-medical-device\" target=\"_blank\" rel=\"noopener\">FDA \u7522\u54c1\u5206\u985e\u7cfb\u7d71<\/a>{:target=&#8221;_blank&#8221;},\u53f0\u7063\u54c1\u724c\u51fa\u6d77\u7f8e\u570b\u9700\u5b8c\u6210\u4ee5\u4e0b\u6838\u5fc3\u5224\u5b9a\u8207\u7533\u8acb\u6d41\u7a0b:<\/p>\n<h3>\u6b65\u9a5f\u4e00:\u7522\u54c1\u985e\u578b\u5224\u5b9a(\u6700\u95dc\u9375)<\/h3>\n<p>\u9996\u8981\u4efb\u52d9\u662f\u78ba\u8a8d\u7522\u54c1\u5c6c\u65bc\u54ea\u4e00\u985e\u53d7 FDA \u76e3\u7ba1\u7684\u5546\u54c1\u3002\u5e38\u898b\u5206\u985e\u5305\u62ec:<\/p>\n<ul>\n<li><strong>\u98df\u54c1(Food)<\/strong>: \u4f9b\u4eba\u985e\u6216\u52d5\u7269\u98df\u7528\u7684\u7522\u54c1,\u5305\u542b\u81b3\u98df\u88dc\u5145\u5291\u3001\u98f2\u6599\u3001\u5305\u88dd\u98df\u54c1<\/li>\n<li><strong>\u5316\u599d\u54c1(Cosmetics)<\/strong>: \u7528\u65bc\u6e05\u6f54\u3001\u7f8e\u5316\u6216\u6539\u8b8a\u5916\u89c0\u7684\u7522\u54c1,\u5982\u4fdd\u990a\u54c1\u3001\u5f69\u599d<\/li>\n<li><strong>\u91ab\u7642\u5668\u6750(Medical Devices)<\/strong>: \u7528\u65bc\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632\u75be\u75c5\u7684\u8a2d\u5099\u6216\u5de5\u5177<\/li>\n<li><strong>\u85e5\u54c1(Drugs)<\/strong>: \u5177\u6709\u6cbb\u7642\u3001\u9810\u9632\u75be\u75c5\u529f\u6548\u7684\u7522\u54c1<\/li>\n<\/ul>\n<p>\u26a0\ufe0f <strong>\u5e38\u898b\u8aa4\u5340<\/strong>: \u8a31\u591a\u4fdd\u5065\u98df\u54c1\u5728\u7f8e\u570b\u53ef\u80fd\u88ab\u6b78\u985e\u70ba\u300c\u81b3\u98df\u88dc\u5145\u5291(Dietary Supplements)\u300d,\u5c6c\u65bc\u98df\u54c1\u985e\u5225\u800c\u975e\u85e5\u54c1,\u4f46\u82e5\u5ba3\u7a31\u7642\u6548\u5247\u53ef\u80fd\u88ab\u8996\u70ba\u672a\u7d93\u6838\u51c6\u7684\u65b0\u85e5\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: FDA \u7522\u54c1\u985e\u578b\u5224\u5b9a\u6d41\u7a0b\u5716<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19885\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-product-classification-decision-tree-flowchart-2026.png\" alt=\"FDA \u7522\u54c1\u985e\u578b\u5224\u5b9a\u6d41\u7a0b\u5716,\u986f\u793a\u98df\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u6750\u3001\u85e5\u54c1\u7b49\u985e\u5225\u7684\u5224\u5b9a\u908f\u8f2f\u8207\u5c0d\u61c9\u8a3b\u518a\u8981\u6c42\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-product-classification-decision-tree-flowchart-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-product-classification-decision-tree-flowchart-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-product-classification-decision-tree-flowchart-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-product-classification-decision-tree-flowchart-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-product-classification-decision-tree-flowchart-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<hr \/>\n<h3>\u6b65\u9a5f\u4e8c:\u78ba\u8a8d\u9069\u7528\u7684\u6cd5\u898f\u8981\u6c42<\/h3>\n<p>\u4e0d\u540c\u7522\u54c1\u985e\u578b\u9069\u7528\u4e0d\u540c\u7684 FDA \u6cd5\u898f:<\/p>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>\u7522\u54c1\u985e\u578b<\/th>\n<th>\u4e3b\u8981\u6cd5\u898f<\/th>\n<th>\u8a3b\u518a\/\u7533\u5831\u8981\u6c42<\/th>\n<th>\u9810\u4f30\u6642\u7a0b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u98df\u54c1<\/td>\n<td><a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\" target=\"_blank\" rel=\"noopener\">FSMA \u6cd5\u6848<\/a>{:target=&#8221;_blank&#8221;}<\/td>\n<td>\u8a2d\u65bd\u8a3b\u518a(FFR)\u3001FSVP(\u9032\u53e3\u5546)<\/td>\n<td>\u5373\u6642-4 \u9031<\/td>\n<\/tr>\n<tr>\n<td>\u5316\u599d\u54c1<\/td>\n<td>CFR Title 21 Part 700-740<\/td>\n<td>VCRP \u81ea\u9858\u6027\u8a3b\u518a<\/td>\n<td>\u5373\u6642<\/td>\n<\/tr>\n<tr>\n<td>\u91ab\u7642\u5668\u6750 Class I<\/td>\n<td>CFR Title 21 Part 800-1299<\/td>\n<td>\u591a\u6578\u8c41\u514d 510(k)<\/td>\n<td>1-3 \u500b\u6708<\/td>\n<\/tr>\n<tr>\n<td>\u91ab\u7642\u5668\u6750 Class II<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u9700\u63d0\u4ea4 510(k)<\/td>\n<td>3-6 \u500b\u6708<\/td>\n<\/tr>\n<tr>\n<td>\u91ab\u7642\u5668\u6750 Class III<\/td>\n<td>\u540c\u4e0a<\/td>\n<td>\u9700\u63d0\u4ea4 PMA<\/td>\n<td>1-2 \u5e74<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>: \u98df\u54c1\u985e\u7522\u54c1\u82e5\u540c\u6642\u5728 Amazon \u7b49\u5e73\u53f0\u92b7\u552e,\u9700\u984d\u5916\u6e96\u5099 FDA \u8a2d\u65bd\u8a3b\u518a\u7de8\u865f(FFR Number)\u4f9b\u5e73\u53f0\u5be9\u6838\u4f7f\u7528\u3002<\/p>\n<hr \/>\n<h3>\u6b65\u9a5f\u4e09:\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba(\u50c5\u98df\u54c1\u985e\u5fc5\u9808)<\/h3>\n<p>\u4f9d\u64da <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-1.33\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 1.33<\/a>{:target=&#8221;_blank&#8221;},\u6240\u6709\u5728\u7f8e\u570b\u5883\u5916\u7684\u98df\u54c1\u8a2d\u65bd\u5fc5\u9808\u6307\u5b9a\u4e00\u4f4d\u7f8e\u570b\u4ee3\u7406\u4eba(US Agent),\u4f5c\u70ba FDA \u8207\u8a2d\u65bd\u4e4b\u9593\u7684\u806f\u7d61\u7a97\u53e3\u3002\u4ee3\u7406\u4eba\u5fc5\u9808:<\/p>\n<ul>\n<li>\u5be6\u969b\u4f4d\u65bc\u7f8e\u570b\u5883\u5167(\u5177\u7f8e\u570b\u5730\u5740\u8207\u806f\u7d61\u65b9\u5f0f)<\/li>\n<li>\u80fd\u4ee5\u82f1\u8a9e\u6e9d\u901a\u4e26\u5354\u52a9\u8655\u7406\u7dca\u6025\u4e8b\u4ef6<\/li>\n<li>\u53ef\u70ba\u500b\u4eba\u6216\u4f01\u696d,\u4f46\u4e0d\u5f97\u70ba\u90f5\u653f\u4fe1\u7bb1<\/li>\n<\/ul>\n<p>\u26a0\ufe0f <strong>\u5e38\u898b\u932f\u8aa4<\/strong>: \u8a31\u591a\u53f0\u7063\u696d\u8005\u8aa4\u4ee5\u70ba\u7f8e\u570b\u4ee3\u7406\u4eba\u9700\u5177\u5099\u5f8b\u5e2b\u6216\u9867\u554f\u8cc7\u683c,\u5be6\u969b\u4e0a\u4efb\u4f55\u7b26\u5408\u689d\u4ef6\u7684\u7f8e\u570b\u5c45\u6c11\u6216\u516c\u53f8\u7686\u53ef\u64d4\u4efb,\u4f46\u5efa\u8b70\u9078\u64c7\u719f\u6089 FDA \u6cd5\u898f\u7684\u5c08\u696d\u670d\u52d9\u5546\u3002<\/p>\n<hr \/>\n<h3>\u6b65\u9a5f\u56db:\u5b8c\u6210\u7dda\u4e0a\u8a3b\u518a\u6216\u7533\u5831<\/h3>\n<p>\u6839\u64da\u7522\u54c1\u985e\u578b,\u524d\u5f80\u5c0d\u61c9\u7684 FDA \u7cfb\u7d71\u5b8c\u6210\u8a3b\u518a:<\/p>\n<ul>\n<li><strong>\u98df\u54c1<\/strong>: <a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\" target=\"_blank\" rel=\"noopener\">FDA \u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u7cfb\u7d71(FFR)<\/a>{:target=&#8221;_blank&#8221;}<\/li>\n<li><strong>\u5316\u599d\u54c1<\/strong>: <a href=\"https:\/\/www.fda.gov\/cosmetics\/voluntary-cosmetic-registration-program\" target=\"_blank\" rel=\"noopener\">VCRP \u81ea\u9858\u6027\u8a3b\u518a\u7cfb\u7d71<\/a>{:target=&#8221;_blank&#8221;}<\/li>\n<li><strong>\u91ab\u7642\u5668\u6750<\/strong>: <a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/device-registration-and-listing\" target=\"_blank\" rel=\"noopener\">FURLS \u7d71\u4e00\u8a3b\u518a\u7cfb\u7d71<\/a>{:target=&#8221;_blank&#8221;}<\/li>\n<\/ul>\n<p>\u8a3b\u518a\u6642\u9700\u6e96\u5099\u7684\u57fa\u672c\u8cc7\u6599\u5305\u62ec:<\/p>\n<ul>\n<li>\u8a2d\u65bd\u5b8c\u6574\u5730\u5740\u8207\u806f\u7d61\u8cc7\u8a0a<\/li>\n<li>\u7522\u54c1\u985e\u5225\u8207\u88fd\u7a0b\u63cf\u8ff0<\/li>\n<li>\u7f8e\u570b\u4ee3\u7406\u4eba\u8cc7\u8a0a(\u98df\u54c1\u985e)<\/li>\n<li>DUNS \u865f\u78bc(\u90e8\u5206\u60c5\u6cc1\u9700\u8981)<\/li>\n<\/ul>\n<hr \/>\n<h3>\u6b65\u9a5f\u4e94:\u7dad\u6301\u5408\u898f\u8207\u5b9a\u671f\u66f4\u65b0<\/h3>\n<p>FDA \u8a3b\u518a\u4e26\u975e\u4e00\u6b21\u6027\u4f5c\u696d,\u4e0d\u540c\u985e\u578b\u7522\u54c1\u6709\u4e0d\u540c\u7684\u66f4\u65b0\u9031\u671f:<\/p>\n<ul>\n<li><strong>\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a<\/strong>: \u6bcf\u5169\u5e74\u66f4\u65b0\u4e00\u6b21(\u5076\u6578\u5e74 10\/1-12\/31)<\/li>\n<li><strong>\u5316\u599d\u54c1 VCRP<\/strong>: \u7522\u54c1\u914d\u65b9\u6216\u8a2d\u65bd\u8cc7\u8a0a\u8b8a\u66f4\u6642\u9700\u66f4\u65b0<\/li>\n<li><strong>\u91ab\u7642\u5668\u6750<\/strong>: \u6bcf\u5e74 6 \u6708\u53ca\u8cc7\u8a0a\u8b8a\u66f4\u6642\u9700\u66f4\u65b0<\/li>\n<\/ul>\n<p>\u6b64\u5916,\u98df\u54c1\u8a2d\u65bd\u82e5\u9069\u7528 FSMA \u9810\u9632\u6027\u63a7\u5236\u898f\u5247,\u9084\u9700\u5efa\u7acb\u4e26\u7dad\u8b77\u66f8\u9762\u98df\u54c1\u5b89\u5168\u8a08\u756b,\u5b9a\u671f\u9032\u884c\u5167\u90e8\u7a3d\u6838\u3002<\/p>\n<hr \/>\n<h3>\u5716 3: FDA \u8a8d\u8b49\u6d41\u7a0b\u6642\u7a0b\u8207\u6aa2\u6838\u8868<\/h3>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19886\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-timeline-checklist-2026.png\" alt=\"FDA \u8a8d\u8b49\u6d41\u7a0b\u6642\u7a0b\u898f\u5283\u5716,\u986f\u793a\u5f9e\u7522\u54c1\u5224\u5b9a\u5230\u53d6\u5f97\u8a3b\u518a\u7de8\u865f\u7684\u5b8c\u6574\u6642\u9593\u8ef8\u8207\u95dc\u9375\u6aa2\u6838\u9ede,\u5305\u542b\u5b9a\u671f\u66f4\u65b0\u63d0\u9192\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-timeline-checklist-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-timeline-checklist-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-timeline-checklist-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-timeline-checklist-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2025\/05\/fda-certification-process-timeline-checklist-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 3 \u500b\u91cd\u9ede<\/h2>\n<h3>1. \u7522\u54c1\u53ef\u80fd\u540c\u6642\u5c6c\u65bc\u591a\u500b\u985e\u5225<\/h3>\n<p>\u67d0\u4e9b\u7522\u54c1\u53ef\u80fd\u540c\u6642\u7b26\u5408\u591a\u500b FDA \u76e3\u7ba1\u985e\u5225\u3002\u4f8b\u5982,\u542b\u85e5\u5316\u599d\u54c1(Drug-Cosmetic)\u65e2\u9700\u7b26\u5408\u5316\u599d\u54c1\u6cd5\u898f,\u4e5f\u9700\u9075\u5b88\u85e5\u54c1\u898f\u7bc4\u3002\u53f0\u7063\u696d\u8005\u61c9\u5be9\u614e\u8a55\u4f30\u7522\u54c1\u5ba3\u7a31\u8207\u6210\u5206,\u907f\u514d\u8aa4\u5224\u985e\u5225\u5c0e\u81f4\u5408\u898f\u554f\u984c\u3002<\/p>\n<h3>2. Amazon \u7b49\u5e73\u53f0\u6709\u984d\u5916\u5be9\u6838\u8981\u6c42<\/h3>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3 Amazon \u5e73\u53f0\u5c0d FDA \u98df\u54c1\u8a3b\u518a\u7684\u5be9\u6838\u8981\u6c42,\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>Amazon \u70ba\u4f55\u8981\u6c42 FDA \u98df\u54c1\u8a3b\u518a?\u5e73\u53f0\u5be9\u6838\u898f\u5247\u5b8c\u6574\u89e3\u6790(2026)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/zh\/fda-food-registration-amazon-fda-food-registration-requirements\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration-amazon-fda-food-registration-requirements\/<\/a><\/p>\n<h3>3. \u6a19\u7c64\u8207\u5ba3\u7a31\u9700\u7b26\u5408 FDA \u898f\u5b9a<\/h3>\n<p>\u7121\u8ad6\u7522\u54c1\u985e\u578b\u70ba\u4f55,\u6240\u6709\u5728\u7f8e\u570b\u92b7\u552e\u7684\u7522\u54c1\u6a19\u7c64\u5fc5\u9808\u7b26\u5408 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u6a19\u7c64\u898f\u7bc4<\/a>{:target=&#8221;_blank&#8221;},\u5305\u542b:<\/p>\n<ul>\n<li>\u6210\u5206\u5217\u8868(Ingredients List)<\/li>\n<li>\u71df\u990a\u6a19\u793a(Nutrition Facts,\u98df\u54c1\u985e)<\/li>\n<li>\u8b66\u8a9e\u8207\u4f7f\u7528\u8aaa\u660e<\/li>\n<li>\u88fd\u9020\u5546\u6216\u9032\u53e3\u5546\u8cc7\u8a0a<\/li>\n<\/ul>\n<p>\u274c <strong>\u5e38\u898b\u8aa4\u5340<\/strong>: \u53f0\u7063\u696d\u8005\u5e38\u76f4\u63a5\u4f7f\u7528\u4e2d\u6587\u6a19\u7c64\u7ffb\u8b6f,\u4f46 FDA \u5c0d\u65bc\u904e\u654f\u539f\u6a19\u793a\u3001\u71df\u990a\u6210\u5206\u683c\u5f0f\u3001\u5b57\u9ad4\u5927\u5c0f\u7b49\u7686\u6709\u660e\u78ba\u8981\u6c42,\u9700\u91cd\u65b0\u8a2d\u8a08\u7b26\u5408\u7f8e\u570b\u898f\u7bc4\u7684\u82f1\u6587\u6a19\u7c64\u3002<\/p>\n<hr \/>\n<h2>\u7e3d\u7d50<\/h2>\n<p>\u53f0\u7063\u54c1\u724c\u51fa\u6d77\u7f8e\u570b\u5e02\u5834,FDA \u8a8d\u8b49\u6d41\u7a0b\u7684\u6838\u5fc3\u5728\u65bc:<\/p>\n<ul>\n<li><strong>\u6b63\u78ba\u5224\u5b9a\u7522\u54c1\u985e\u578b<\/strong>(\u98df\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u6750\u3001\u85e5\u54c1)<\/li>\n<li><strong>\u4f9d\u5faa\u5c0d\u61c9\u6cd5\u898f\u5b8c\u6210\u8a3b\u518a\u6216\u7533\u5831<\/strong>(FFR\u3001VCRP\u3001510(k)\u3001PMA \u7b49)<\/li>\n<li><strong>\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba<\/strong>(\u98df\u54c1\u985e\u5fc5\u9808,\u5176\u4ed6\u985e\u5225\u8996\u60c5\u6cc1)<\/li>\n<li><strong>\u5b9a\u671f\u66f4\u65b0\u7dad\u6301\u5408\u898f<\/strong>(\u98df\u54c1\u6bcf\u5169\u5e74\u3001\u91ab\u7642\u5668\u6750\u6bcf\u5e74)<\/li>\n<li><strong>\u78ba\u4fdd\u6a19\u7c64\u8207\u5ba3\u7a31\u7b26\u5408 FDA \u898f\u7bc4<\/strong>(\u907f\u514d\u8aa4\u5c0e\u6216\u9055\u898f)<\/li>\n<\/ul>\n<p>\u5efa\u8b70\u53f0\u7063\u54c1\u724c\u5728\u7522\u54c1\u958b\u767c\u968e\u6bb5\u5373\u7d0d\u5165 FDA \u5408\u898f\u8003\u91cf,\u63d0\u524d 3-6 \u500b\u6708\u898f\u5283\u8a8d\u8b49\u6d41\u7a0b,\u907f\u514d\u56e0\u6cd5\u898f\u554f\u984c\u5ef6\u8aa4\u4e0a\u5e02\u6642\u7a0b\u3002<\/p>\n<p>\u82e5\u5c0d FDA \u8a8d\u8b49\u6d41\u7a0b\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\u4e0b FDA \u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f3 2026 \u5e74 1 \u6708):<\/p>\n<ol>\n<li>U.S. Food and Drug Administration. &#8220;What Does FDA Regulate?&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-basics\/what-does-fda-regulate\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/about-fda\/fda-basics\/what-does-fda-regulate<\/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>U.S. Food and Drug Administration. &#8220;How to Determine If Your Product Is a Medical Device.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/medical-devices\/classify-your-medical-device\/how-determine-if-your-product-medical-device\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/medical-devices\/classify-your-medical-device\/how-determine-if-your-product-medical-device<\/a><\/li>\n<li>Code of Federal Regulations Title 21, Part 1.33. &#8220;What is a U.S. agent?&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-1.33\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/section-1.33<\/a><\/li>\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<\/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>\u30102026\u6700\u65b0\u3011FDA\u8a8d\u8b49\u6d41\u7a0b\u8a73\u89e3\uff1a\u81fa\u7063\u54c1\u724c\u51fa\u6d77\u7f8e\u570b\u5e02\u5834\u5fc5\u8b80\u6307\u5357 \u4f60\u77e5\u9053\u55ce\uff1f\u8d85\u904e65%\u7684\u9996\u6b21\u7533\u8acbFDA\u8a8d\u8b49\u7684\u81fa [&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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[1,45],"tags":[],"class_list":["post-18106","post","type-post","status-publish","format-standard","hentry","category-uncategorized","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/18106"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=18106"}],"version-history":[{"count":3,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/18106\/revisions"}],"predecessor-version":[{"id":19887,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/18106\/revisions\/19887"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=18106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=18106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=18106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}