{"id":19195,"date":"2026-01-02T15:37:18","date_gmt":"2026-01-02T07:37:18","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19195"},"modified":"2026-01-02T15:37:18","modified_gmt":"2026-01-02T07:37:18","slug":"taiwan-seller-fda-medical-device-compliance-guide-classification-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/taiwan-seller-fda-medical-device-compliance-guide-classification-2026\/","title":{"rendered":"\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u51fa\u53e3\u7f8e\u570b FDA \u91ab\u7642\u5668\u68b0\u5408\u898f\u5168\u6307\u5357\uff1a\u4f60\u7684\u7522\u54c1\u5c6c\u65bc\u54ea\u4e00\u985e\uff1f(2026)"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19196\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-medical-device-compliance-classification-guide-2026.png\" alt=\"\u53f0\u7063\u8ce3\u5bb6 FDA \u91ab\u7642\u5668\u68b0\u5408\u898f\u5168\u6307\u5357\u5c01\u9762\uff0c\u986f\u793a\u7522\u54c1\u5206\u985e\u5224\u5b9a\u7591\u554f\u8207 2026 \u6700\u65b0\u6a19\u6e96\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-medical-device-compliance-classification-guide-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-medical-device-compliance-classification-guide-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-medical-device-compliance-classification-guide-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-medical-device-compliance-classification-guide-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/taiwan-seller-fda-medical-device-compliance-classification-guide-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<h2>\u4f60\u7684\u7522\u54c1\u6703\u88ab\u8996\u70ba\u91ab\u7642\u5668\u68b0\u55ce\uff1f\u6838\u5fc3\u5224\u5b9a\u6a19\u6e96<\/h2>\n<p><strong>\u662f\u7684\uff0c\u82e5\u7522\u54c1\u9810\u671f\u7528\u65bc\u8a3a\u65b7\u3001\u6cbb\u7642\u3001\u9810\u9632\u3001\u7de9\u89e3\u75be\u75c5\uff0c\u6216\u5f71\u97ff\u4eba\u9ad4\u7d50\u69cb\/\u529f\u80fd\uff0c\u5373\u4f7f\u672a\u660e\u78ba\u6a19\u793a\u300c\u91ab\u7642\u7528\u9014\u300d\uff0c\u4ecd\u53ef\u80fd\u88ab FDA \u8996\u70ba\u91ab\u7642\u5668\u68b0\uff08Medical Device\uff09\u3002<\/strong> \u95dc\u9375\u5224\u5b9a\u4f9d\u64da\u70ba\u300c\u9810\u671f\u7528\u9014\u300d\uff08Intended Use\uff09\uff0c\u5305\u542b\u7522\u54c1\u6a19\u7c64\u3001\u8aaa\u660e\u66f8\u3001\u884c\u92b7\u5ba3\u7a31\uff0c\u751a\u81f3\u7db2\u7ad9\u63cf\u8ff0\u3002\u8a31\u591a\u53f0\u7063\u5916\u8cbf\u5de5\u5ee0\u8207\u8de8\u5883\u8ce3\u5bb6\u56e0\u4e0d\u719f\u6089\u6b64\u6a19\u6e96\uff0c\u8aa4\u5c07\u91ab\u7642\u5668\u68b0\u7576\u4f5c\u4e00\u822c\u6d88\u8cbb\u54c1\u51fa\u53e3\uff0c\u5c0e\u81f4\u9032\u53e3\u6263\u7559\u6216 FDA \u8b66\u544a\u4fe1\u3002<\/p>\n<p>\u6839\u64da 21 CFR Part 860\uff0cFDA \u5c07\u91ab\u7642\u5668\u68b0\u5206\u70ba Class I\uff08\u4f4e\u98a8\u96aa\uff09\u3001Class II\uff08\u4e2d\u98a8\u96aa\uff09\u3001Class III\uff08\u9ad8\u98a8\u96aa\uff09\u4e09\u985e\uff0c\u4e0d\u540c\u985e\u5225\u5c0d\u61c9\u4e0d\u540c\u5408\u898f\u8981\u6c42\u3002\u4f8b\u5982\uff0c\u9ad4\u6eab\u8a08\u5c6c Class II\uff0c\u9700\u5b8c\u6210 510(k) \u5be9\u67e5\u6216\u7b26\u5408\u8c41\u514d\u689d\u4ef6\uff1b\u800c\u5fc3\u81df\u652f\u67b6\u5c6c Class III\uff0c\u9700\u63d0\u4ea4 PMA\uff08\u4e0a\u5e02\u524d\u6838\u51c6\uff09\u7533\u8acb\u3002\u82e5\u7522\u54c1\u5206\u985e\u932f\u8aa4\u6216\u672a\u5b8c\u6210\u5fc5\u8981\u7533\u5831\uff0c\u5c07\u9762\u81e8\u6cd5\u5f8b\u98a8\u96aa\u8207\u5546\u696d\u640d\u5931\u3002<\/p>\n<p>\u672c\u6587\u5c07\u5b8c\u6574\u89e3\u6790 FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u6a19\u6e96\u3001\u53f0\u7063\u696d\u8005\u5e38\u898b\u8aa4\u5340\u3001\u4ee5\u53ca\u5be6\u52d9\u64cd\u4f5c\u6b65\u9a5f\uff0c\u5e6b\u52a9\u60a8\u5feb\u901f\u5224\u5b9a\u7522\u54c1\u985e\u5225\u4e26\u78ba\u4fdd\u5408\u898f\u51fa\u53e3\u3002<\/p>\n<hr \/>\n<h2>\u70ba\u4f55\u53f0\u7063\u696d\u8005\u5bb9\u6613\u6df7\u6dc6\u91ab\u7642\u5668\u68b0\u8207\u4e00\u822c\u7522\u54c1\uff1f<\/h2>\n<p>\u53f0\u7063\u5916\u8cbf\u5de5\u5ee0\u8207\u8de8\u5883\u8ce3\u5bb6\u5e38\u5c07\u300c\u91ab\u7642\u5668\u68b0\u300d\u8207\u300c\u5065\u5eb7\u7522\u54c1\u300d\u300c\u4fdd\u5065\u5668\u6750\u300d\u6df7\u70ba\u4e00\u8ac7\uff0c\u4e3b\u8981\u539f\u56e0\u6709\u4e09\uff1a<\/p>\n<ol>\n<li><strong>\u9810\u671f\u7528\u9014\uff08Intended Use\uff09\u5b9a\u7fa9\u6a21\u7cca<\/strong>: FDA \u5224\u5b9a\u6a19\u6e96\u4e0d\u50c5\u770b\u7522\u54c1\u672c\u8eab\uff0c\u66f4\u770b\u300c\u5982\u4f55\u5ba3\u7a31\u4f7f\u7528\u300d\u3002\u4f8b\u5982\uff0c\u667a\u80fd\u624b\u74b0\u82e5\u5ba3\u7a31\u300c\u76e3\u6e2c\u5fc3\u7387\u7570\u5e38\u3001\u9810\u9632\u5fc3\u81df\u75c5\u300d\uff0c\u5373\u4f7f\u672a\u6a19\u8a3b\u91ab\u7642\u7528\u9014\uff0c\u4ecd\u53ef\u80fd\u88ab\u8996\u70ba Class II \u91ab\u7642\u5668\u68b0\u3002<\/li>\n<li><strong>\u53f0\u7f8e\u6cd5\u898f\u5dee\u7570<\/strong>: \u53f0\u7063\u885b\u798f\u90e8\u8207 FDA \u7684\u91ab\u7642\u5668\u68b0\u5b9a\u7fa9\u7bc4\u570d\u4e0d\u540c\u3002\u90e8\u5206\u5728\u53f0\u7063\u5c6c\u300c\u4e00\u822c\u5546\u54c1\u300d\u7684\u7522\u54c1\uff08\u5982\u67d0\u4e9b\u6309\u6469\u5668\u3001\u4fdd\u5065\u5100\u5668\uff09\uff0c\u5728\u7f8e\u570b\u53ef\u80fd\u9700\u5b8c\u6210 FDA \u8a3b\u518a\u8207 510(k) \u5be9\u67e5\u3002<\/li>\n<li><strong>\u4ee3\u5de5\u5ee0\u8cac\u4efb\u8a8d\u77e5\u4e0d\u8db3<\/strong>: \u8a31\u591a ODM\/OEM \u4ee3\u5de5\u5ee0\u8a8d\u70ba\u300c\u5408\u898f\u662f\u54c1\u724c\u5546\u8cac\u4efb\u300d\uff0c\u4f46\u6839\u64da FDA \u898f\u5b9a\uff0c\u88fd\u9020\u5546\uff08Manufacturer\uff09\u540c\u6a23\u9700\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\uff08Establishment Registration\uff09\u8207\u5668\u68b0\u5217\u8868\u7533\u5831\uff08Device Listing\uff09\uff0c\u82e5\u54c1\u724c\u5546\u9055\u898f\uff0c\u4ee3\u5de5\u5ee0\u53ef\u80fd\u9762\u81e8\u9023\u5e36\u8cac\u4efb\u3002<\/li>\n<\/ol>\n<p><strong>\u5e38\u898b\u8aa4\u5340\u7bc4\u4f8b<\/strong>:<\/p>\n<ul>\n<li>\u274c \u300c\u6211\u5011\u53ea\u662f\u4ee3\u5de5\uff0c\u4e0d\u9700\u8981 FDA \u8a3b\u518a\u300d\u2192 \u932f\u8aa4\uff01\u88fd\u9020\u5546\u5fc5\u9808\u5b8c\u6210\u8a3b\u518a<\/li>\n<li>\u274c \u300c\u7522\u54c1\u672a\u6a19\u8a3b\u91ab\u7642\u7528\u9014\uff0c\u61c9\u8a72\u4e0d\u7b97\u91ab\u7642\u5668\u68b0\u300d\u2192 \u932f\u8aa4\uff01FDA \u770b\u9810\u671f\u7528\u9014\uff0c\u5305\u542b\u7db2\u7ad9\u5ba3\u7a31<\/li>\n<li>\u274c \u300c\u9ad4\u6eab\u8a08\u5f88\u7c21\u55ae\uff0c\u4e0d\u9700\u8981 510(k)\u300d\u2192 \u932f\u8aa4\uff01\u90e8\u5206\u9ad4\u6eab\u8a08\u9700 510(k)\uff0c\u90e8\u5206\u53ef\u8c41\u514d\u4f46\u4ecd\u9700\u8a3b\u518a<\/li>\n<\/ul>\n<hr \/>\n<h2>FDA \u91ab\u7642\u5668\u68b0\u4e09\u5927\u5206\u985e\u8207\u5224\u5b9a\u6d41\u7a0b<\/h2>\n<h3>Class I\uff08\u4e00\u822c\u7ba1\u5236\uff09\uff1a\u4f4e\u98a8\u96aa\u5668\u68b0<\/h3>\n<p><strong>\u5b9a\u7fa9<\/strong>: \u5c0d\u4eba\u9ad4\u98a8\u96aa\u6700\u4f4e\uff0c\u901a\u5e38\u4e0d\u6d89\u53ca\u4fb5\u5165\u6027\u64cd\u4f5c\u6216\u76f4\u63a5\u63a5\u89f8\u5167\u81df\u3002<\/p>\n<p><strong>\u5e38\u898b\u7522\u54c1<\/strong>: \u624b\u52d5\u8f2a\u6905\u3001\u7e43\u5e36\u3001\u624b\u8853\u624b\u5957\u3001\u7c21\u6613\u9ad4\u6eab\u8a08\uff08\u90e8\u5206\u578b\u865f\uff09\u3001\u7259\u7dda<\/p>\n<p><strong>\u5408\u898f\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\uff08Establishment Registration\uff09<\/li>\n<li>\u5b8c\u6210\u5668\u68b0\u5217\u8868\u7533\u5831\uff08Device Listing\uff09<\/li>\n<li>\u591a\u6578\u7522\u54c1\u8c41\u514d 510(k)\uff0c\u4f46\u4ecd\u9700\u7b26\u5408 QSR\uff0821 CFR Part 820\uff09\u57fa\u672c\u8981\u6c42<\/li>\n<li>\u9700\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba\uff08US Agent\uff09<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u64cd\u4f5c<\/strong>: \u5373\u4f7f\u8c41\u514d 510(k)\uff0c\u4ecd\u9700\u6bcf\u5e74\u66f4\u65b0\u8a3b\u518a\u8cc7\u8a0a\uff0c\u4e26\u78ba\u4fdd\u7522\u54c1\u6a19\u7c64\u7b26\u5408 FDA \u8981\u6c42\uff08\u5305\u542b UDI\u3001\u88fd\u9020\u5546\u8cc7\u8a0a\u3001\u4f7f\u7528\u8aaa\u660e\uff09\u3002<\/p>\n<hr \/>\n<h3>Class II\uff08\u7279\u5225\u7ba1\u5236\uff09\uff1a\u4e2d\u98a8\u96aa\u5668\u68b0<\/h3>\n<p><strong>\u5b9a\u7fa9<\/strong>: \u5c0d\u4eba\u9ad4\u6709\u4e2d\u7b49\u98a8\u96aa\uff0c\u9700\u984d\u5916\u7ba1\u5236\u63aa\u65bd\u78ba\u4fdd\u5b89\u5168\u6709\u6548\u6027\u3002<\/p>\n<p><strong>\u5e38\u898b\u7522\u54c1<\/strong>: \u96fb\u5b50\u9ad4\u6eab\u8a08\u3001\u8840\u58d3\u8a08\u3001X \u5149\u6a5f\u3001\u52a9\u807d\u5668\u3001\u67d0\u4e9b\u8a3a\u65b7\u8a66\u5291\u3001\u5916\u79d1\u624b\u8853\u5668\u68b0<\/p>\n<p><strong>\u5408\u898f\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\u8207\u5668\u68b0\u5217\u8868\u7533\u5831<\/li>\n<li><strong>\u591a\u6578\u9700\u63d0\u4ea4 510(k) Premarket Notification<\/strong>\uff08\u4e0a\u5e02\u524d\u901a\u77e5\uff09\uff0c\u8b49\u660e\u7522\u54c1\u8207\u5df2\u6838\u51c6\u7684\u540c\u985e\u7522\u54c1\uff08Predicate Device\uff09\u5177\u5be6\u8cea\u7b49\u6548\u6027\uff08Substantial Equivalence\uff09<\/li>\n<li>\u90e8\u5206\u7522\u54c1\u53ef\u8c41\u514d 510(k)\uff0c\u4f46\u9700\u7b26\u5408\u7279\u5b9a\u689d\u4ef6\uff08\u53c3\u8003 FDA \u8c41\u514d\u6e05\u55ae\uff09<\/li>\n<li>\u7b26\u5408 QSR \u5168\u9762\u8981\u6c42<\/li>\n<li>\u9700\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u64cd\u4f5c<\/strong>: 510(k) \u5be9\u67e5\u6642\u9593\u901a\u5e38 90-180 \u5929\uff0c\u9700\u6e96\u5099\u6280\u8853\u6587\u4ef6\u3001\u81e8\u5e8a\u6578\u64da\uff08\u82e5\u9700\u8981\uff09\u3001\u8207 Predicate Device \u7684\u6bd4\u8f03\u5206\u6790\u3002\u82e5\u7121\u5408\u9069 Predicate Device\uff0c\u9700\u8003\u616e De Novo \u9014\u5f91\u3002<\/p>\n<hr \/>\n<h3>Class III\uff08\u4e0a\u5e02\u524d\u6838\u51c6\uff09\uff1a\u9ad8\u98a8\u96aa\u5668\u68b0<\/h3>\n<p><strong>\u5b9a\u7fa9<\/strong>: \u5c0d\u4eba\u9ad4\u6709\u9ad8\u98a8\u96aa\uff0c\u901a\u5e38\u6d89\u53ca\u751f\u547d\u7dad\u6301\u3001\u4fb5\u5165\u6027\u64cd\u4f5c\u6216\u690d\u5165\u9ad4\u5167\u3002<\/p>\n<p><strong>\u5e38\u898b\u7522\u54c1<\/strong>: \u5fc3\u81df\u652f\u67b6\u3001\u4eba\u5de5\u5fc3\u81df\u74e3\u819c\u3001\u690d\u5165\u5f0f\u5fc3\u5f8b\u8abf\u7bc0\u5668\u3001\u67d0\u4e9b\u9ad4\u5916\u8a3a\u65b7\u8a2d\u5099\uff08IVD\uff09<\/p>\n<p><strong>\u5408\u898f\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\u8207\u5668\u68b0\u5217\u8868\u7533\u5831<\/li>\n<li><strong>\u5fc5\u9808\u63d0\u4ea4 PMA\uff08Premarket Approval\uff09\u7533\u8acb<\/strong>\uff0c\u5305\u542b\u5b8c\u6574\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u8b49\u660e\u5b89\u5168\u6027\u8207\u6709\u6548\u6027<\/li>\n<li>\u7b26\u5408 QSR \u5168\u9762\u8981\u6c42<\/li>\n<li>\u9700\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba<\/li>\n<li>PMA \u5be9\u67e5\u6642\u9593\u901a\u5e38 180-360 \u5929\u6216\u66f4\u9577<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u64cd\u4f5c<\/strong>: PMA \u7533\u8acb\u6210\u672c\u9ad8\u3001\u5be9\u67e5\u56b4\u683c\uff0c\u9700\u63d0\u4f9b\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u3001\u88fd\u9020\u6d41\u7a0b\u6587\u4ef6\u3001\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u8b49\u660e\u3002\u53f0\u7063\u696d\u8005\u82e5\u6d89\u53ca Class III \u7522\u54c1\uff0c\u5efa\u8b70\u5c0b\u6c42\u5c08\u696d\u6cd5\u898f\u9867\u554f\u5354\u52a9\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u5224\u5b9a\u6c7a\u7b56\u6a39<\/h3>\n<p><strong>\u5716\u7247\u7528\u9014\u8aaa\u660e<\/strong>:<br \/>\n\u6b64\u6c7a\u7b56\u6a39\u5c07\u300c\u7522\u54c1\u662f\u5426\u88ab\u8996\u70ba\u91ab\u7642\u5668\u68b0\u300d\u53ca\u300c\u5c6c\u65bc\u54ea\u4e00\u985e\u300d\u7684\u5224\u5b9a\u908f\u8f2f\u8996\u89ba\u5316\uff0c\u5e6b\u52a9\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u5feb\u901f\u81ea\u6211\u6aa2\u6e2c\u7522\u54c1\u5206\u985e\u8207\u5408\u898f\u8def\u5f91\u3002<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19197\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-classification-decision-tree-taiwan-sellers-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u5206\u985e\u5224\u5b9a\u6c7a\u7b56\u6a39\uff0c\u986f\u793a\u5f9e Intended Use \u5230 Class I\/II\/III \u5224\u5b9a\u7684\u5b8c\u6574\u6d41\u7a0b\u8207\u95dc\u9375\u7bc0\u9ede\uff0c\u5c08\u70ba\u53f0\u7063\u8ce3\u5bb6\u8a2d\u8a08\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-classification-decision-tree-taiwan-sellers-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-classification-decision-tree-taiwan-sellers-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-classification-decision-tree-taiwan-sellers-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-classification-decision-tree-taiwan-sellers-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-classification-decision-tree-taiwan-sellers-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<div class=\"MarkdownCodeBlock_container__nRn2j\">\n<div class=\"MarkdownCodeBlock_codeFooterRightSection__9Hz_z\"><\/div>\n<\/div>\n<hr \/>\n<h2>\u53f0\u7063\u696d\u8005\u6700\u5e38\u8e29\u932f\u7684 6 \u500b\u5408\u898f\u7d05\u7dda<\/h2>\n<h3>\u7d05\u7dda 1: \u7522\u54c1\u5ba3\u7a31\u91ab\u7642\u7528\u9014\u4f46\u672a\u5b8c\u6210 FDA \u8a3b\u518a<\/h3>\n<p><strong>\u60c5\u5883<\/strong>: \u8de8\u5883\u8ce3\u5bb6\u5728 Amazon \u6216\u81ea\u6709\u7db2\u7ad9\u5ba3\u7a31\u7522\u54c1\u300c\u76e3\u6e2c\u8840\u7cd6\u300d\u300c\u9810\u9632\u9ad8\u8840\u58d3\u300d\uff0c\u4f46\u672a\u5b8c\u6210 FDA \u8a2d\u65bd\u8a3b\u518a\u8207\u5668\u68b0\u5217\u8868\u7533\u5831\u3002<\/p>\n<p><strong>\u98a8\u96aa<\/strong>: FDA \u53ef\u767c\u51fa\u8b66\u544a\u4fe1\uff08Warning Letter\uff09\u3001\u9032\u53e3\u6263\u7559\u3001\u751a\u81f3\u6c11\u4e8b\u7f70\u6b3e\u3002\u54c1\u724c\u5546\u8207\u88fd\u9020\u5546\uff08\u4ee3\u5de5\u5ee0\uff09\u5747\u53ef\u80fd\u88ab\u8ffd\u7a76\u8cac\u4efb\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>: \u82e5\u7522\u54c1\u6d89\u53ca\u4efb\u4f55\u91ab\u7642\u5ba3\u7a31\uff0c\u52d9\u5fc5\u5148\u5b8c\u6210 FDA \u8a3b\u518a\u3002\u5373\u4f7f\u662f\u4ee3\u5de5\u5ee0\uff0c\u4e5f\u9700\u4ee5\u88fd\u9020\u5546\u8eab\u5206\u8a3b\u518a\u3002<\/p>\n<hr \/>\n<h3>\u7d05\u7dda 2: \u672a\u63d0\u4ea4 510(k) \u6216\u8aa4\u5224\u8c41\u514d\u689d\u4ef6<\/h3>\n<p><strong>\u60c5\u5883<\/strong>: \u696d\u8005\u8a8d\u70ba\u300c\u7c21\u55ae\u7684\u91ab\u7642\u5668\u68b0\u300d\u4e0d\u9700 510(k)\uff0c\u4f46\u5be6\u969b\u4e0a\u8a72\u7522\u54c1\u4e0d\u7b26\u5408\u8c41\u514d\u6e05\u55ae\u689d\u4ef6\u3002<\/p>\n<p><strong>\u98a8\u96aa<\/strong>: \u672a\u7d93\u6838\u51c6\u5373\u4e0a\u5e02\uff0c\u5c6c\u9055\u6cd5\u884c\u70ba\uff0c\u53ef\u80fd\u9762\u81e8\u7522\u54c1\u53ec\u56de\u3001\u7f70\u6b3e\u3001\u751a\u81f3\u5211\u4e8b\u8cac\u4efb\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>: \u67e5\u95b1 FDA \u5b98\u65b9\u8c41\u514d\u6e05\u55ae\uff0821 CFR Part 862-892\uff09\uff0c\u4e0d\u78ba\u5b9a\u6642\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002\u5373\u4f7f\u8c41\u514d 510(k)\uff0c\u4ecd\u9700\u5b8c\u6210\u8a3b\u518a\u8207 Device Listing\u3002<\/p>\n<hr \/>\n<h3>\u7d05\u7dda 3: \u6a19\u7c64\u672a\u5305\u542b\u5fc5\u8981\u8cc7\u8a0a\uff08UDI\u3001\u88fd\u9020\u5546\u3001\u4f7f\u7528\u8aaa\u660e\uff09<\/h3>\n<p><strong>\u60c5\u5883<\/strong>: \u7522\u54c1\u6a19\u7c64\u50c5\u6a19\u8a3b\u54c1\u724c\u540d\u7a31\u8207\u578b\u865f\uff0c\u672a\u5305\u542b UDI\uff08\u552f\u4e00\u5668\u68b0\u8b58\u5225\u78bc\uff09\u3001\u88fd\u9020\u5546\u8cc7\u8a0a\u3001\u4f7f\u7528\u8aaa\u660e\u3001\u8b66\u544a\u4e8b\u9805\u3002<\/p>\n<p><strong>\u98a8\u96aa<\/strong>: \u9055\u53cd 21 CFR Part 801 \u6a19\u7c64\u8981\u6c42\uff0c\u53ef\u80fd\u5c0e\u81f4\u9032\u53e3\u6263\u7559\u6216 FDA \u8b66\u544a\u4fe1\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>: \u78ba\u4fdd\u6a19\u7c64\u5305\u542b:<\/p>\n<ul>\n<li>UDI\uff08\u7b26\u5408 GUDID \u8cc7\u6599\u5eab\u683c\u5f0f\uff09<\/li>\n<li>\u88fd\u9020\u5546\u540d\u7a31\u8207\u5730\u5740<\/li>\n<li>\u7f8e\u570b\u4ee3\u7406\u4eba\u8cc7\u8a0a<\/li>\n<li>\u4f7f\u7528\u8aaa\u660e\u8207\u8b66\u544a\u4e8b\u9805<\/li>\n<li>\u5fc5\u8981\u6642\u6a19\u8a3b\u300cRx Only\u300d\uff08\u8655\u65b9\u5668\u68b0\uff09\u6216\u300cOTC\u300d\uff08\u975e\u8655\u65b9\u5668\u68b0\uff09<\/li>\n<\/ul>\n<hr \/>\n<h3>\u7d05\u7dda 4: \u672a\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\u6216\u8cc7\u8a0a\u904e\u671f<\/h3>\n<p><strong>\u60c5\u5883<\/strong>: \u4ee3\u5de5\u5ee0\u5b8c\u6210\u521d\u6b21\u8a3b\u518a\u5f8c\uff0c\u672a\u6bcf\u5e74\u66f4\u65b0\u8a3b\u518a\u8cc7\u8a0a\uff08\u6bcf\u5e74 10 \u6708 1 \u65e5\u81f3 12 \u6708 31 \u65e5\u70ba\u66f4\u65b0\u671f\u9650\uff09\u3002<\/p>\n<p><strong>\u98a8\u96aa<\/strong>: \u8a3b\u518a\u5931\u6548\uff0c\u7522\u54c1\u7121\u6cd5\u5408\u6cd5\u9032\u53e3\u7f8e\u570b\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>: \u8a2d\u5b9a\u63d0\u9192\uff0c\u6bcf\u5e74\u66f4\u65b0\u8a3b\u518a\u8cc7\u8a0a\u3002\u82e5\u8a2d\u65bd\u5730\u5740\u3001\u8ca0\u8cac\u4eba\u3001\u7522\u54c1\u7dda\u6709\u8b8a\u66f4\uff0c\u9700\u7acb\u5373\u66f4\u65b0\u3002<\/p>\n<hr \/>\n<h3>\u7d05\u7dda 5: \u672a\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba\u6216\u8cc7\u8a0a\u932f\u8aa4<\/h3>\n<p><strong>\u60c5\u5883<\/strong>: \u696d\u8005\u672a\u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba\uff08US Agent\uff09\uff0c\u6216\u4ee3\u7406\u4eba\u8cc7\u8a0a\u5df2\u904e\u671f\u4f46\u672a\u66f4\u65b0\u3002<\/p>\n<p><strong>\u98a8\u96aa<\/strong>: \u9055\u53cd 21 CFR Part 807.40 \u8981\u6c42\uff0cFDA \u7121\u6cd5\u806f\u7e6b\u696d\u8005\uff0c\u53ef\u80fd\u5c0e\u81f4\u9032\u53e3\u6263\u7559\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>: \u6307\u5b9a\u53ef\u9760\u7684\u7f8e\u570b\u4ee3\u7406\u4eba\uff08\u53ef\u70ba\u500b\u4eba\u6216\u516c\u53f8\uff09\uff0c\u78ba\u4fdd\u4ee3\u7406\u4eba\u8cc7\u8a0a\u6b63\u78ba\u4e14\u96a8\u6642\u53ef\u806f\u7e6b\u3002\u82e5\u4ee3\u7406\u4eba\u8b8a\u66f4\uff0c\u9700\u7acb\u5373\u5411 FDA \u66f4\u65b0\u3002<\/p>\n<hr \/>\n<h3>\u7d05\u7dda 6: \u88fd\u9020\u8a2d\u65bd\u672a\u7b26\u5408 QSR\uff0821 CFR Part 820\uff09\u8981\u6c42<\/h3>\n<p><strong>\u60c5\u5883<\/strong>: \u4ee3\u5de5\u5ee0\u672a\u5efa\u7acb\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff08QMS\uff09\uff0c\u6216 QMS \u6587\u4ef6\u4e0d\u5b8c\u6574\u3001\u672a\u5b9a\u671f\u7a3d\u6838\u3002<\/p>\n<p><strong>\u98a8\u96aa<\/strong>: FDA \u53ef\u9032\u884c\u7a81\u64ca\u6aa2\u67e5\uff08Inspection\uff09\uff0c\u82e5\u767c\u73fe\u4e0d\u7b26\u5408 QSR \u8981\u6c42\uff0c\u53ef\u767c\u51fa Form 483\uff08\u7f3a\u5931\u5831\u544a\uff09\u6216\u8b66\u544a\u4fe1\u3002\u56b4\u91cd\u8005\u53ef\u80fd\u88ab\u5217\u5165\u9032\u53e3\u8b66\u793a\u6e05\u55ae\uff08Import Alert\uff09\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>: \u5efa\u7acb\u5b8c\u6574 QMS\uff0c\u5305\u542b:<\/p>\n<ul>\n<li>\u8a2d\u8a08\u7ba1\u5236\uff08Design Controls\uff09<\/li>\n<li>\u6587\u4ef6\u7ba1\u5236\uff08Document Controls\uff09<\/li>\n<li>\u63a1\u8cfc\u7ba1\u5236\uff08Purchasing Controls\uff09<\/li>\n<li>\u88fd\u7a0b\u9a57\u8b49\uff08Process Validation\uff09<\/li>\n<li>\u4e0d\u826f\u4e8b\u4ef6\u5831\u544a\uff08Adverse Event Reporting\uff09<\/li>\n<li>\u5b9a\u671f\u5167\u90e8\u7a3d\u6838\u8207\u7ba1\u7406\u5be9\u67e5<\/li>\n<\/ul>\n<hr \/>\n<h3>\u5716 3: FDA \u91ab\u7642\u5668\u68b0\u5408\u898f\u7d05\u7dda\u6aa2\u6838\u8868<\/h3>\n<p><strong>\u5716\u7247\u7528\u9014\u8aaa\u660e<\/strong>:<br \/>\n\u6b64\u6aa2\u6838\u8868\u6574\u7406\u53f0\u7063\u8ce3\u5bb6\u8207\u5916\u8cbf\u5de5\u5ee0\u6700\u5e38\u8e29\u932f\u7684 8 \u500b\u91ab\u7642\u5668\u68b0\u5408\u898f\u7d05\u7dda\uff0c\u5e6b\u52a9\u696d\u8005\u5feb\u901f\u81ea\u6211\u6aa2\u67e5\uff0c\u907f\u514d\u9055\u898f\u98a8\u96aa\u8207\u5546\u696d\u640d\u5931\u3002<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19198\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-compliance-red-flags-checklist-taiwan-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u5408\u898f\u7d05\u7dda\u6aa2\u6838\u8868\uff0c\u5217\u51fa\u53f0\u7063\u696d\u8005\u6700\u5e38\u8e29\u932f\u7684 8 \u500b\u9055\u898f\u9677\u9631\uff0c\u5305\u542b\u8a3b\u518a\u3001510(k)\u3001\u6a19\u7c64\u3001QSR \u7b49\u8981\u6c42\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-compliance-red-flags-checklist-taiwan-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-compliance-red-flags-checklist-taiwan-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-compliance-red-flags-checklist-taiwan-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-compliance-red-flags-checklist-taiwan-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-compliance-red-flags-checklist-taiwan-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<div class=\"MarkdownCodeBlock_container__nRn2j\">\n<div class=\"MarkdownCodeBlock_codeBlock__rvLec force-dark\"><\/div>\n<\/div>\n<hr \/>\n<h2>\u5be6\u52d9\u64cd\u4f5c\uff1a\u53f0\u7063\u696d\u8005\u5982\u4f55\u5b8c\u6210 FDA \u5408\u898f\uff1f<\/h2>\n<h3>\u6b65\u9a5f 1: \u5224\u5b9a\u7522\u54c1\u662f\u5426\u70ba\u91ab\u7642\u5668\u68b0<\/h3>\n<p><strong>\u64cd\u4f5c<\/strong>: \u6aa2\u8996\u7522\u54c1\u9810\u671f\u7528\u9014\uff08Intended Use\uff09\uff0c\u5305\u542b:<\/p>\n<ul>\n<li>\u7522\u54c1\u6a19\u7c64\u8207\u8aaa\u660e\u66f8<\/li>\n<li>\u7db2\u7ad9\u5ba3\u7a31\u8207\u884c\u92b7\u6587\u6848<\/li>\n<li>\u7522\u54c1\u529f\u80fd\u8207\u4f7f\u7528\u60c5\u5883<\/li>\n<\/ul>\n<p><strong>\u5224\u5b9a\u6a19\u6e96<\/strong>: \u82e5\u6d89\u53ca\u8a3a\u65b7\u3001\u6cbb\u7642\u3001\u9810\u9632\u3001\u7de9\u89e3\u75be\u75c5\u6216\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\/\u529f\u80fd\uff0c\u5373\u70ba\u91ab\u7642\u5668\u68b0\u3002<\/p>\n<p><strong>\u5e38\u898b\u8aa4\u5340<\/strong>: \u5373\u4f7f\u7522\u54c1\u672a\u660e\u78ba\u6a19\u8a3b\u300c\u91ab\u7642\u7528\u9014\u300d\uff0c\u82e5\u7db2\u7ad9\u5ba3\u7a31\u300c\u6539\u5584\u8840\u6db2\u5faa\u74b0\u300d\u300c\u9810\u9632\u75be\u75c5\u300d\uff0c\u4ecd\u53ef\u80fd\u88ab\u8996\u70ba\u91ab\u7642\u5668\u68b0\u3002<\/p>\n<hr \/>\n<h3>\u6b65\u9a5f 2: \u78ba\u8a8d\u7522\u54c1\u5206\u985e\uff08Class I\/II\/III\uff09<\/h3>\n<p><strong>\u64cd\u4f5c<\/strong>: \u67e5\u95b1 FDA \u7522\u54c1\u5206\u985e\u8cc7\u6599\u5eab\uff08Product Classification Database\uff09\uff0c\u8f38\u5165\u7522\u54c1\u540d\u7a31\u6216\u95dc\u9375\u8a5e\uff0c\u67e5\u8a62\u5c0d\u61c9\u5206\u985e\u4ee3\u78bc\uff08Product Code\uff09\u8207\u7ba1\u5236\u985e\u5225\u3002<\/p>\n<p><strong>\u7bc4\u4f8b<\/strong>:<\/p>\n<ul>\n<li>\u96fb\u5b50\u9ad4\u6eab\u8a08: Product Code FLL, Class II<\/li>\n<li>\u8840\u58d3\u8a08: Product Code DXN, Class II<\/li>\n<li>\u624b\u52d5\u8f2a\u6905: Product Code IOR, Class I<\/li>\n<\/ul>\n<p><strong>\u6ce8\u610f<\/strong>: \u540c\u985e\u7522\u54c1\u53ef\u80fd\u56e0\u8a2d\u8a08\u3001\u7528\u9014\u4e0d\u540c\u800c\u5c6c\u4e0d\u540c\u5206\u985e\u3002\u4f8b\u5982\uff0c\u81e8\u5e8a\u7528\u9ad4\u6eab\u8a08\uff08Class II\uff09\u8207\u5bb6\u7528\u9ad4\u6eab\u8a08\uff08\u90e8\u5206 Class I\uff09\u3002<\/p>\n<hr \/>\n<h3>\u6b65\u9a5f 3: \u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\u8207\u5668\u68b0\u5217\u8868\u7533\u5831<\/h3>\n<p><strong>\u64cd\u4f5c<\/strong>: \u900f\u904e FDA \u96fb\u5b50\u7cfb\u7d71\uff08FURLS\uff09\u5b8c\u6210:<\/p>\n<ol>\n<li><strong>Establishment Registration<\/strong>\uff08\u8a2d\u65bd\u8a3b\u518a\uff09: \u63d0\u4f9b\u88fd\u9020\u5546\u540d\u7a31\u3001\u5730\u5740\u3001\u8ca0\u8cac\u4eba\u8cc7\u8a0a<\/li>\n<li><strong>Device Listing<\/strong>\uff08\u5668\u68b0\u5217\u8868\u7533\u5831\uff09: \u63d0\u4f9b\u7522\u54c1\u540d\u7a31\u3001\u578b\u865f\u3001\u5206\u985e\u4ee3\u78bc\u3001\u9810\u671f\u7528\u9014<\/li>\n<\/ol>\n<p><strong>\u6642\u7a0b<\/strong>: \u521d\u6b21\u8a3b\u518a\u9700 5-10 \u500b\u5de5\u4f5c\u5929\uff0c\u6bcf\u5e74 10-12 \u6708\u9700\u66f4\u65b0\u8a3b\u518a\u8cc7\u8a0a\u3002<\/p>\n<p><strong>\u8cbb\u7528<\/strong>: \u8a2d\u65bd\u8a3b\u518a\u8207 Device Listing \u672c\u8eab\u514d\u8cbb\uff0c\u4f46\u82e5\u9700\u63d0\u4ea4 510(k) \u6216 PMA\uff0c\u9700\u652f\u4ed8\u4f7f\u7528\u8005\u8cbb\u7528\uff08MDUFA\uff09\u3002<\/p>\n<hr \/>\n<h3>\u6b65\u9a5f 4: \u8a55\u4f30\u662f\u5426\u9700\u63d0\u4ea4 510(k) \u6216 PMA<\/h3>\n<p><strong>Class I<\/strong>: \u591a\u6578\u8c41\u514d 510(k)\uff0c\u50c5\u9700\u5b8c\u6210\u8a3b\u518a\u8207 Device Listing\u3002<\/p>\n<p><strong>Class II<\/strong>: \u591a\u6578\u9700\u63d0\u4ea4 510(k)\uff0c\u90e8\u5206\u7522\u54c1\u53ef\u8c41\u514d\uff08\u67e5\u95b1\u8c41\u514d\u6e05\u55ae\uff09\u3002<\/p>\n<p><strong>Class III<\/strong>: \u5fc5\u9808\u63d0\u4ea4 PMA\uff0c\u5305\u542b\u5b8c\u6574\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u3002<\/p>\n<p><strong>510(k) \u6e96\u5099\u6587\u4ef6<\/strong>:<\/p>\n<ul>\n<li>\u7522\u54c1\u6280\u8853\u898f\u683c\u8207\u8a2d\u8a08\u6587\u4ef6<\/li>\n<li>\u8207 Predicate Device \u7684\u6bd4\u8f03\u5206\u6790\uff08Substantial Equivalence\uff09<\/li>\n<li>\u6027\u80fd\u6e2c\u8a66\u6578\u64da\uff08\u5982\u751f\u7269\u76f8\u5bb9\u6027\u6e2c\u8a66\u3001\u96fb\u6c23\u5b89\u5168\u6e2c\u8a66\uff09<\/li>\n<li>\u6a19\u7c64\u8207\u4f7f\u7528\u8aaa\u660e\u66f8<\/li>\n<li>\u88fd\u9020\u6d41\u7a0b\u8207 QMS \u6587\u4ef6<\/li>\n<\/ul>\n<hr \/>\n<h3>\u6b65\u9a5f 5: \u5efa\u7acb\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff08QMS\uff09<\/h3>\n<p><strong>\u64cd\u4f5c<\/strong>: \u4f9d\u64da 21 CFR Part 820\uff08QSR\uff09\u5efa\u7acb QMS\uff0c\u5305\u542b:<\/p>\n<ul>\n<li>\u8a2d\u8a08\u7ba1\u5236\uff08Design Controls\uff09<\/li>\n<li>\u6587\u4ef6\u7ba1\u5236\uff08Document Controls\uff09<\/li>\n<li>\u63a1\u8cfc\u7ba1\u5236\uff08Purchasing Controls\uff09<\/li>\n<li>\u88fd\u7a0b\u9a57\u8b49\uff08Process Validation\uff09<\/li>\n<li>\u4e0d\u826f\u4e8b\u4ef6\u5831\u544a\uff08Adverse Event Reporting\uff0cMDR\uff09<\/li>\n<li>\u5b9a\u671f\u5167\u90e8\u7a3d\u6838\u8207\u7ba1\u7406\u5be9\u67e5<\/li>\n<\/ul>\n<p><strong>\u5efa\u8b70<\/strong>: \u53ef\u53c3\u8003 ISO 13485 \u6a19\u6e96\uff08\u570b\u969b\u91ab\u7642\u5668\u68b0\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff09\uff0c\u6709\u52a9\u65bc\u540c\u6642\u7b26\u5408 FDA \u8207\u5176\u4ed6\u5e02\u5834\uff08\u5982\u6b50\u76df CE Mark\uff09\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h3>\u6b65\u9a5f 6: \u6307\u5b9a\u7f8e\u570b\u4ee3\u7406\u4eba\u4e26\u5b8c\u6210\u7522\u54c1\u6a19\u7c64<\/h3>\n<p><strong>\u7f8e\u570b\u4ee3\u7406\u4eba<\/strong>: \u9700\u70ba\u7f8e\u570b\u5883\u5167\u500b\u4eba\u6216\u516c\u53f8\uff0c\u8ca0\u8cac\u63a5\u6536 FDA \u901a\u77e5\u3001\u5354\u52a9\u6e9d\u901a\u3002<\/p>\n<p><strong>\u7522\u54c1\u6a19\u7c64<\/strong>: \u78ba\u4fdd\u5305\u542b:<\/p>\n<ul>\n<li>UDI\uff08\u552f\u4e00\u5668\u68b0\u8b58\u5225\u78bc\uff0c\u9700\u8a3b\u518a\u81f3 GUDID \u8cc7\u6599\u5eab\uff09<\/li>\n<li>\u88fd\u9020\u5546\u540d\u7a31\u8207\u5730\u5740<\/li>\n<li>\u7f8e\u570b\u4ee3\u7406\u4eba\u8cc7\u8a0a<\/li>\n<li>\u4f7f\u7528\u8aaa\u660e\u8207\u8b66\u544a\u4e8b\u9805<\/li>\n<li>\u5fc5\u8981\u6642\u6a19\u8a3b\u300cRx Only\u300d\u6216\u300cOTC\u300d<\/li>\n<\/ul>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 3 \u500b\u91cd\u9ede<\/h2>\n<h3>\u91cd\u9ede 1: \u4ee3\u5de5\u5ee0\u8207\u54c1\u724c\u5546\u7684\u8cac\u4efb\u6b78\u5c6c<\/h3>\n<p>\u6839\u64da FDA \u898f\u5b9a\uff0c<strong>\u88fd\u9020\u5546\uff08Manufacturer\uff09\u8207\u54c1\u724c\u5546\uff08Labeler\/Distributor\uff09\u5747\u9700\u5b8c\u6210\u8a3b\u518a<\/strong>\u3002\u82e5\u54c1\u724c\u5546\u9055\u898f\uff0c\u4ee3\u5de5\u5ee0\u53ef\u80fd\u9762\u81e8\u9023\u5e36\u8cac\u4efb\u3002\u5efa\u8b70\u5728\u5408\u7d04\u4e2d\u660e\u78ba\u7d04\u5b9a:<\/p>\n<ul>\n<li>\u8ab0\u8ca0\u8cac FDA \u8a3b\u518a\u8207 510(k) \u7533\u8acb<\/li>\n<li>\u8ab0\u8ca0\u8cac\u7522\u54c1\u6a19\u7c64\u8207\u5ba3\u7a31\u5167\u5bb9<\/li>\n<li>\u9055\u898f\u8cac\u4efb\u5982\u4f55\u5206\u6524<\/li>\n<\/ul>\n<h3>\u91cd\u9ede 2: \u91ab\u7642\u5668\u68b0 vs \u9ad4\u5916\u8a3a\u65b7\u8a2d\u5099\uff08IVD\uff09<\/h3>\n<p>\u90e8\u5206\u7522\u54c1\uff08\u5982\u8840\u7cd6\u8a66\u7d19\u3001COVID-19 \u5feb\u7be9\uff09\u5c6c\u9ad4\u5916\u8a3a\u65b7\u8a2d\u5099\uff08In Vitro Diagnostic Devices, IVD\uff09\uff0c\u9069\u7528 21 CFR Part 809-866\uff0c\u7ba1\u5236\u8981\u6c42\u8207\u4e00\u822c\u91ab\u7642\u5668\u68b0\u7565\u6709\u4e0d\u540c\u3002\u82e5\u7522\u54c1\u6d89\u53ca\u5be6\u9a57\u5ba4\u6aa2\u6e2c\u6216\u8a3a\u65b7\uff0c\u9700\u78ba\u8a8d\u662f\u5426\u5c6c IVD\u3002<\/p>\n<h3>\u91cd\u9ede 3: FDA \u8207 CE Mark \u7684\u5dee\u7570<\/h3>\n<p>\u53f0\u7063\u696d\u8005\u82e5\u540c\u6642\u51fa\u53e3\u7f8e\u570b\u8207\u6b50\u76df\uff0c\u9700\u6ce8\u610f:<\/p>\n<ul>\n<li><strong>FDA<\/strong>: \u5f37\u8abf\u4e0a\u5e02\u524d\u5be9\u67e5\uff08510(k)\/PMA\uff09\u8207\u88fd\u9020\u5546\u8a3b\u518a<\/li>\n<li><strong>CE Mark<\/strong>: \u5f37\u8abf\u7b26\u5408\u6027\u8072\u660e\uff08Declaration of Conformity\uff09\u8207\u6280\u8853\u6587\u4ef6\uff08Technical Documentation\uff09<\/li>\n<li><strong>\u5169\u8005\u53ef\u4e92\u88dc<\/strong>: \u7b26\u5408 ISO 13485 \u6709\u52a9\u65bc\u540c\u6642\u6eff\u8db3 FDA QSR \u8207\u6b50\u76df MDR \u8981\u6c42<\/li>\n<\/ul>\n<hr \/>\n<h2>\u7e3d\u7d50<\/h2>\n<ul>\n<li>\u2705 <strong>\u7522\u54c1\u662f\u5426\u70ba\u91ab\u7642\u5668\u68b0\uff0c\u53d6\u6c7a\u65bc\u300c\u9810\u671f\u7528\u9014\u300d\uff08Intended Use\uff09<\/strong>\uff0c\u5305\u542b\u6a19\u7c64\u3001\u8aaa\u660e\u66f8\u3001\u7db2\u7ad9\u5ba3\u7a31<\/li>\n<li>\u2705 <strong>FDA \u5c07\u91ab\u7642\u5668\u68b0\u5206\u70ba Class I\/II\/III<\/strong>\uff0c\u4e0d\u540c\u985e\u5225\u5c0d\u61c9\u4e0d\u540c\u5408\u898f\u8981\u6c42\uff08\u8a3b\u518a\u3001510(k)\u3001PMA\uff09<\/li>\n<li>\u2705 <strong>\u53f0\u7063\u4ee3\u5de5\u5ee0\u8207\u54c1\u724c\u5546\u5747\u9700\u5b8c\u6210 FDA \u8a3b\u518a<\/strong>\uff0c\u4ee3\u5de5\u5ee0\u4e0d\u53ef\u8aa4\u8a8d\u300c\u5408\u898f\u662f\u54c1\u724c\u5546\u8cac\u4efb\u300d<\/li>\n<li>\u2705 <strong>\u6700\u5e38\u898b\u7684\u5408\u898f\u7d05\u7dda\u5305\u542b<\/strong>: \u672a\u5b8c\u6210\u8a3b\u518a\u3001\u672a\u63d0\u4ea4 510(k)\u3001\u6a19\u7c64\u4e0d\u7b26\u3001QSR \u4e0d\u5408\u683c<\/li>\n<li>\u2705 <strong>\u5efa\u8b70\u5efa\u7acb\u5b8c\u6574 QMS\uff08\u7b26\u5408 QSR \u6216 ISO 13485\uff09<\/strong>\uff0c\u6709\u52a9\u65bc\u901a\u904e FDA \u6aa2\u67e5\u4e26\u62d3\u5c55\u5176\u4ed6\u5e02\u5834<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u91ab\u7642\u5668\u68b0\u5408\u898f\u4ecd\u6709\u7591\u554f\uff0c\u6216\u9700\u5354\u52a9\u5224\u5b9a\u7522\u54c1\u5206\u985e\u3001\u6e96\u5099 510(k) \u6587\u4ef6\uff0c\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>","protected":false},"excerpt":{"rendered":"<p>\u4f60\u7684\u7522\u54c1\u6703\u88ab\u8996\u70ba\u91ab\u7642\u5668\u68b0\u55ce\uff1f\u6838\u5fc3\u5224\u5b9a\u6a19\u6e96 \u662f\u7684\uff0c\u82e5\u7522\u54c1\u9810\u671f\u7528\u65bc\u8a3a\u65b7\u3001\u6cbb\u7642\u3001\u9810\u9632\u3001\u7de9\u89e3\u75be\u75c5\uff0c\u6216\u5f71\u97ff\u4eba\u9ad4\u7d50\u69cb\/\u529f\u80fd [&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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