{"id":19205,"date":"2026-01-02T16:11:40","date_gmt":"2026-01-02T08:11:40","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19205"},"modified":"2026-01-02T16:11:40","modified_gmt":"2026-01-02T08:11:40","slug":"fda-medical-device-roles-liability-legal-risk-brand-manufacturer-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/fda-medical-device-roles-liability-legal-risk-brand-manufacturer-2026\/","title":{"rendered":"FDA \u91ab\u7642\u5668\u68b0\u7684\u89d2\u8272\u3001\u8cac\u4efb\u6b78\u5c6c\u8207\u6cd5\u5f8b\u98a8\u96aa\uff1a\u54c1\u724c\u8207\u5de5\u5ee0\u8ab0\u8ca0\u8cac\uff1f\uff082026 \u6700\u65b0\uff09"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-19206\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-brand-manufacturer-responsibility-feature-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u8cac\u4efb\u6b78\u5c6c\u5c01\u9762\uff0c\u986f\u793a\u54c1\u724c\u5546\u8207\u88fd\u9020\u5546\u8cac\u4efb\u722d\u8b70\u7684\u5929\u79e4\u5716\u793a\u8207 2026 \u6cd5\u5f8b\u98a8\u96aa\u8b66\u793a\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-brand-manufacturer-responsibility-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-brand-manufacturer-responsibility-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-brand-manufacturer-responsibility-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-brand-manufacturer-responsibility-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-brand-manufacturer-responsibility-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<h2>\u54c1\u724c\u8207\u5de5\u5ee0\u8ab0\u8ca0\u8cac\uff1fFDA \u660e\u78ba\u898f\u5b9a\u8cac\u4efb\u4e3b\u9ad4<\/h2>\n<p>\u5728 FDA \u91ab\u7642\u5668\u68b0\u6cd5\u898f\u4e0b\uff0c\u8cac\u4efb\u6b78\u5c6c\u53d6\u6c7a\u65bc\u300c\u8ab0\u5411\u7f8e\u570b\u5e02\u5834\u5f15\u5165\u7522\u54c1\u300d\uff08Who introduces the device into U.S. commerce\uff09\u3002\u6839\u64da 21 CFR Part 807 \u8207 21 CFR Part 820\uff0c\u8cac\u4efb\u4e3b\u9ad4\u5305\u542b\u4e09\u5927\u89d2\u8272\uff1a<\/p>\n<ol>\n<li><strong>\u88fd\u9020\u5546\uff08Manufacturer\uff09<\/strong>\uff1a\u5be6\u969b\u751f\u7522\u5668\u68b0\u7684\u5de5\u5ee0\uff0c\u9700\u7b26\u5408 QSR\uff0821 CFR Part 820\uff09\u54c1\u8cea\u7cfb\u7d71\u8981\u6c42<\/li>\n<li><strong>\u898f\u683c\u958b\u767c\u8005\uff08Specification Developer\uff09<\/strong>\uff1a\u5236\u5b9a\u7522\u54c1\u8a2d\u8a08\u898f\u683c\u3001Intended Use \u7684\u54c1\u724c\u5546\u6216\u59d4\u8a17\u65b9<\/li>\n<li><strong>\u7f8e\u570b\u9032\u53e3\u5546\/\u7d93\u92b7\u5546\uff08Initial Distributor\/Importer\uff09<\/strong>\uff1a\u9996\u6b21\u5c07\u7522\u54c1\u5f15\u5165\u7f8e\u570b\u5e02\u5834\u7684\u5be6\u9ad4<\/li>\n<\/ol>\n<p>\u95dc\u9375\u5224\u5b9a\u539f\u5247\uff1a\u82e5\u54c1\u724c\u5546\u50c5\u59d4\u8a17\u4ee3\u5de5\u4f46\u638c\u63e1\u7522\u54c1\u8a2d\u8a08\u3001\u6a19\u7c64\u8207 Intended Use\uff0c\u4ecd\u53ef\u80fd\u88ab\u8996\u70ba Manufacturer \u6216 Specification Developer\uff0c\u9700\u627f\u64d4\u4e3b\u8981\u5408\u898f\u8cac\u4efb\u3002\u82e5\u4ee3\u5de5\u5ee0\u81ea\u884c\u8a2d\u8a08\u7522\u54c1\u4e26\u8cbc\u724c\u92b7\u552e\uff0c\u5247\u4ee3\u5de5\u5ee0\u70ba\u4e3b\u8981\u8cac\u4efb\u65b9\u3002\u5be6\u52d9\u4e0a\uff0cFDA \u53ef\u80fd\u540c\u6642\u8ffd\u7a76\u591a\u65b9\u8cac\u4efb\uff0c\u5f62\u6210\u300c\u9023\u5e36\u8cac\u4efb\u300d\uff08Joint Liability\uff09\u98a8\u96aa\u3002<\/p>\n<hr \/>\n<h2>FDA \u91ab\u7642\u5668\u68b0\u6cd5\u898f\u4e0b\u7684\u4e09\u5927\u6838\u5fc3\u89d2\u8272<\/h2>\n<h3>\u89d2\u8272\u4e00\uff1a\u88fd\u9020\u5546\uff08Manufacturer\uff09\u7684\u8cac\u4efb\u7bc4\u570d<\/h3>\n<p>\u6839\u64da 21 CFR 820.3(o) \u5b9a\u7fa9\uff0c\u88fd\u9020\u5546\u5305\u542b\uff1a<\/p>\n<ul>\n<li><strong>\u5be6\u969b\u751f\u7522\u5668\u68b0\u7684\u5de5\u5ee0<\/strong>\uff08\u542b ODM\/OEM \u4ee3\u5de5\u5ee0\uff09<\/li>\n<li><strong>\u91cd\u65b0\u5305\u88dd\u6216\u91cd\u65b0\u6a19\u7c64\u7684\u7d93\u92b7\u5546<\/strong><\/li>\n<li><strong>\u898f\u683c\u958b\u767c\u8005<\/strong>\uff08Specification Developer\uff0c\u5373\u5236\u5b9a\u8a2d\u8a08\u898f\u683c\u7684\u54c1\u724c\u5546\uff09<\/li>\n<\/ul>\n<p><strong>\u4e3b\u8981\u8cac\u4efb<\/strong>::<\/p>\n<ul>\n<li>\u5b8c\u6210 Establishment Registration\uff08\u8a2d\u65bd\u8a3b\u518a\uff09<\/li>\n<li>\u5b8c\u6210 Device Listing\uff08\u5668\u68b0\u5217\u8868\u7533\u5831\uff09<\/li>\n<li>\u7b26\u5408 QSR\uff0821 CFR Part 820\uff09\u54c1\u8cea\u7cfb\u7d71\u8981\u6c42<\/li>\n<li>\u63d0\u4ea4 510(k)\u3001PMA \u6216 De Novo \u7533\u8acb\uff08\u8996\u7522\u54c1\u5206\u985e\uff09<\/li>\n<li>\u78ba\u4fdd\u7522\u54c1\u6a19\u7c64\u7b26\u5408 21 CFR Part 801 \u8981\u6c42<\/li>\n<li>\u5efa\u7acb UDI\uff08Unique Device Identification\uff09\u7cfb\u7d71<\/li>\n<\/ul>\n<p>\u26a0\ufe0f <strong>important reminder<\/strong>\uff1a\u5373\u4f7f\u662f\u4ee3\u5de5\u5ee0\uff0c\u53ea\u8981\u5be6\u969b\u751f\u7522\u5668\u68b0\uff0c\u5c31\u5fc5\u9808\u5b8c\u6210 FDA \u8a3b\u518a\u8207 Device Listing\uff0c\u4e26\u7b26\u5408 QSR \u8981\u6c42\u3002<\/p>\n<h3>\u89d2\u8272\u4e8c\uff1a\u898f\u683c\u958b\u767c\u8005\uff08Specification Developer\uff09\u7684\u8cac\u4efb\u9677\u9631<\/h3>\n<p><strong>\u9019\u662f\u53f0\u7063\u54c1\u724c\u5546\u6700\u5bb9\u6613\u5ffd\u7565\u7684\u89d2\u8272\uff01<\/strong><\/p>\n<p>\u6839\u64da 21 CFR 820.3(o)\uff0c\u898f\u683c\u958b\u767c\u8005\u6307\u300c\u5236\u5b9a\u6216\u5efa\u7acb\u5668\u68b0\u898f\u683c\u7684\u4eba\u6216\u5be6\u9ad4\u300d\uff0c\u5305\u542b\uff1a<\/p>\n<ul>\n<li>\u5236\u5b9a\u7522\u54c1\u8a2d\u8a08\u898f\u683c\u3001\u529f\u80fd\u8981\u6c42<\/li>\n<li>\u6c7a\u5b9a\u7522\u54c1\u7684 Intended Use\uff08\u9810\u671f\u7528\u9014\uff09<\/li>\n<li>\u63a7\u5236\u7522\u54c1\u6a19\u7c64\u8207\u5ba3\u7a31\u5167\u5bb9<\/li>\n<\/ul>\n<p><strong>\u8cac\u4efb\u9677\u9631<\/strong>::<\/p>\n<ul>\n<li><strong>\u5373\u4f7f\u672a\u5be6\u969b\u751f\u7522\uff0c\u54c1\u724c\u5546\u82e5\u638c\u63e1\u8a2d\u8a08\u898f\u683c\u8207 Intended Use\uff0c\u4ecd\u53ef\u80fd\u88ab\u8996\u70ba Manufacturer<\/strong><\/li>\n<li>\u9700\u8207\u4ee3\u5de5\u5ee0\u5171\u540c\u627f\u64d4 QSR \u5408\u898f\u8cac\u4efb<\/li>\n<li>\u82e5\u7522\u54c1\u51fa\u73fe\u54c1\u8cea\u554f\u984c\u6216\u9055\u898f\uff0cFDA \u53ef\u540c\u6642\u8ffd\u7a76\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0<\/li>\n<\/ul>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>\uff1a\u54c1\u724c\u5546\u61c9\u5728\u5408\u7d04\u4e2d\u660e\u78ba\u7d04\u5b9a\u300c\u8ab0\u662f Manufacturer of Record\u300d\uff08\u8a3b\u518a\u88fd\u9020\u5546\uff09\uff0c\u4e26\u78ba\u4fdd\u8a72\u65b9\u5b8c\u6210\u6240\u6709 FDA \u5408\u898f\u7fa9\u52d9\u3002<\/p>\n<h3>\u89d2\u8272\u4e09\uff1a\u7f8e\u570b\u4ee3\u7406\u4eba\uff08US Agent\uff09\u8207\u9032\u53e3\u5546\u8cac\u4efb<\/h3>\n<p><strong>US Agent<\/strong>::<\/p>\n<ul>\n<li>\u6d77\u5916\u88fd\u9020\u5546\u5fc5\u9808\u6307\u5b9a\u7684\u7f8e\u570b\u5883\u5167\u806f\u7d61\u4eba<\/li>\n<li>\u8ca0\u8cac\u63a5\u6536 FDA \u901a\u8a0a\u8207\u6aa2\u67e5\u901a\u77e5<\/li>\n<li><strong>\u4e0d\u627f\u64d4\u7522\u54c1\u5408\u898f\u8cac\u4efb<\/strong>\uff0c\u50c5\u70ba\u806f\u7d61\u7a97\u53e3<\/li>\n<\/ul>\n<p><strong>\u521d\u59cb\u7d93\u92b7\u5546\/\u9032\u53e3\u5546\uff08Initial Distributor\uff09<\/strong>::<\/p>\n<ul>\n<li>\u9996\u6b21\u5c07\u7522\u54c1\u5f15\u5165\u7f8e\u570b\u5e02\u5834\u7684\u5be6\u9ad4<\/li>\n<li>\u9700\u5b8c\u6210 Establishment Registration\uff08\u82e5\u5f9e\u4e8b\u91cd\u65b0\u5305\u88dd\u6216\u91cd\u65b0\u6a19\u7c64\uff09<\/li>\n<li>\u53ef\u80fd\u56e0\u300c\u5f15\u5165\u4e0d\u5408\u898f\u7522\u54c1\u300d\u88ab FDA \u8ffd\u7a76\u8cac\u4efb<\/li>\n<\/ul>\n<hr \/>\n<h3>\u5716 2: FDA \u91ab\u7642\u5668\u68b0\u8cac\u4efb\u6b78\u5c6c\u5224\u5b9a\u6d41\u7a0b<\/h3>\n<p><strong>Description of the use of the picture<\/strong>:<br \/>\n\u6b64\u6c7a\u7b56\u6a39\u5c07\u300c\u54c1\u724c\u5546 vs \u88fd\u9020\u5546\u300d\u8cac\u4efb\u6b78\u5c6c\u7684\u5224\u5b9a\u908f\u8f2f\u8996\u89ba\u5316\uff0c\u5e6b\u52a9\u53f0\u7063\u696d\u8005\u5feb\u901f\u5224\u65b7\u81ea\u8eab\u89d2\u8272\u8207\u8cac\u4efb\u3002<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-19207\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-determination-decision-tree-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u8cac\u4efb\u6b78\u5c6c\u5224\u5b9a\u6c7a\u7b56\u6a39\uff0c\u986f\u793a\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u8cac\u4efb\u5224\u5b9a\u7684\u5b8c\u6574\u6d41\u7a0b\u8207\u9023\u5e36\u8cac\u4efb\u98a8\u96aa\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-determination-decision-tree-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-determination-decision-tree-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-determination-decision-tree-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-determination-decision-tree-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-liability-determination-decision-tree-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\">\n<div class=\"MarkdownCodeBlock_codeFooterPoePython__8QxYT\">\n<div class=\"MarkdownCodeBlock_codeFooterRightSection__9Hz_z\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<hr \/>\n<h2>5 \u5927\u6cd5\u5f8b\u98a8\u96aa\u60c5\u5883\u8207\u907f\u96aa\u7b56\u7565<\/h2>\n<h3>\u60c5\u5883\u4e00\uff1a\u54c1\u724c\u5546\u88ab\u8996\u70ba Specification Developer<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u54c1\u724c\u5546\u96d6\u672a\u5be6\u969b\u751f\u7522\uff0c\u4f46\u56e0\u5236\u5b9a\u7522\u54c1\u898f\u683c\u8207 Intended Use\uff0c\u88ab FDA \u8996\u70ba Manufacturer\uff0c\u9700\u627f\u64d4 QSR \u5408\u898f\u8cac\u4efb\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u5728\u59d4\u8a17\u5408\u7d04\u4e2d\u660e\u78ba\u7d04\u5b9a\u300c\u4ee3\u5de5\u5ee0\u70ba Manufacturer of Record\u300d<\/li>\n<li>\u78ba\u4fdd\u4ee3\u5de5\u5ee0\u5b8c\u6210 FDA \u8a3b\u518a\u3001Device Listing \u8207 QSR \u8a8d\u8b49<\/li>\n<li>\u54c1\u724c\u5546\u4ecd\u9700\u76e3\u7763\u4ee3\u5de5\u5ee0\u5408\u898f\u72c0\u6cc1\uff08Design Control \u8cac\u4efb\uff09<\/li>\n<\/ul>\n<h3>\u60c5\u5883\u4e8c\uff1a\u4ee3\u5de5\u5ee0\u672a\u5b8c\u6210 FDA \u8a3b\u518a<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u4ee3\u5de5\u5ee0\u672a\u5b8c\u6210 Establishment Registration \u6216 Device Listing\uff0c\u5c0e\u81f4\u7522\u54c1\u88ab\u8996\u70ba\u300c\u672a\u8a3b\u518a\u5668\u68b0\u300d\uff0c\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u53ef\u80fd\u540c\u6642\u88ab FDA \u8b66\u544a\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u51fa\u8ca8\u524d\u78ba\u8a8d\u4ee3\u5de5\u5ee0\u5df2\u5b8c\u6210 FDA \u8a3b\u518a\uff08\u53ef\u65bc FDA \u5b98\u7db2\u67e5\u8a62\uff09<\/li>\n<li>\u8981\u6c42\u4ee3\u5de5\u5ee0\u63d0\u4f9b Registration Number \u8207 Device Listing \u8b49\u660e<\/li>\n<li>\u5408\u7d04\u4e2d\u7d04\u5b9a\u300c\u672a\u5b8c\u6210\u8a3b\u518a\u4e0d\u5f97\u51fa\u8ca8\u300d\u689d\u6b3e<\/li>\n<\/ul>\n<h3>\u60c5\u5883\u4e09\uff1a\u7522\u54c1\u6a19\u7c64\u4e0d\u7b26\u5408 FDA \u8981\u6c42<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u7522\u54c1\u6a19\u7c64\u7f3a\u5c11 UDI\u3001\u88fd\u9020\u5546\u8cc7\u8a0a\u6216\u4f7f\u7528\u8aaa\u660e\uff0c\u5c0e\u81f4\u88ab FDA \u6263\u7559\u6216\u8b66\u544a\uff0c\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u53ef\u80fd\u9023\u5e36\u53d7\u7f70\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u660e\u78ba\u7d04\u5b9a\u300c\u8ab0\u8ca0\u8cac\u6a19\u7c64\u8a2d\u8a08\u8207\u5408\u898f\u5be9\u67e5\u300d<\/li>\n<li>\u78ba\u4fdd\u6a19\u7c64\u5305\u542b 21 CFR Part 801 \u8981\u6c42\u7684\u6240\u6709\u8cc7\u8a0a<\/li>\n<li>\u4f7f\u7528 FDA \u8a8d\u53ef\u7684 UDI Issuing Agency\uff08\u5982 GS1\u3001HIBCC\uff09<\/li>\n<\/ul>\n<h3>\u60c5\u5883\u56db\uff1a\u7522\u54c1\u51fa\u73fe\u54c1\u8cea\u554f\u984c\u6216\u4e0d\u826f\u4e8b\u4ef6<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u7522\u54c1\u767c\u751f\u4e0d\u826f\u4e8b\u4ef6\uff08Adverse Event\uff09\uff0cFDA \u8981\u6c42\u53ec\u56de\uff08Recall\uff09\u6216\u767c\u5e03\u8b66\u544a\u4fe1\uff08Warning Letter\uff09\uff0c\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u53ef\u80fd\u5171\u540c\u627f\u64d4\u8cac\u4efb\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u5efa\u7acb MDR\uff08Medical Device Reporting\uff09\u901a\u5831\u6a5f\u5236<\/li>\n<li>\u5408\u7d04\u4e2d\u7d04\u5b9a\u300c\u54c1\u8cea\u554f\u984c\u8cac\u4efb\u5206\u64d4\u6bd4\u4f8b\u300d<\/li>\n<li>\u8cfc\u8cb7\u7522\u54c1\u8cac\u4efb\u4fdd\u96aa\uff08Product Liability Insurance\uff09<\/li>\n<\/ul>\n<h3>\u60c5\u5883\u4e94\uff1aFDA \u6aa2\u67e5\u767c\u73fe QSR \u7f3a\u5931<\/h3>\n<p><strong>Risks<\/strong>\uff1aFDA \u5c0d\u4ee3\u5de5\u5ee0\u9032\u884c\u6aa2\u67e5\uff0c\u767c\u73fe QSR\uff0821 CFR Part 820\uff09\u7f3a\u5931\uff0c\u54c1\u724c\u5546\u82e5\u70ba Specification Developer\uff0c\u53ef\u80fd\u88ab\u8981\u6c42\u6539\u5584\u6216\u505c\u6b62\u92b7\u552e\u3002<\/p>\n<p><strong>\u907f\u96aa\u7b56\u7565<\/strong>::<\/p>\n<ul>\n<li>\u5b9a\u671f\u7a3d\u6838\u4ee3\u5de5\u5ee0 QSR \u7b26\u5408\u6027\uff08\u81f3\u5c11\u6bcf\u5e74\u4e00\u6b21\uff09<\/li>\n<li>\u8981\u6c42\u4ee3\u5de5\u5ee0\u63d0\u4f9b ISO 13485 \u8a8d\u8b49<\/li>\n<li>\u5efa\u7acb Supplier Quality Agreement\uff08\u4f9b\u61c9\u5546\u54c1\u8cea\u5354\u8b70\uff09<\/li>\n<\/ul>\n<hr \/>\n<h3>\u5716 3: FDA \u91ab\u7642\u5668\u68b0\u6cd5\u5f8b\u98a8\u96aa\u7b49\u7d1a\u77e9\u9663<\/h3>\n<p><strong>Description of the use of the picture<\/strong>:<br \/>\n\u6b64\u98a8\u96aa\u77e9\u9663\u6574\u7406\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u5728\u4e0d\u540c\u60c5\u5883\u4e0b\u7684\u6cd5\u5f8b\u98a8\u96aa\u7b49\u7d1a\uff0c\u5e6b\u52a9\u696d\u8005\u5feb\u901f\u8a55\u4f30\u81ea\u8eab\u98a8\u96aa\u3002<\/p>\n<div class=\"MarkdownCodeBlock_container__nRn2j\">\n<div class=\"MarkdownCodeBlock_codeBlock__rvLec force-dark\">\n<div class=\"MarkdownCodeBlock_codeFooterPoePython__8QxYT\">\n<div class=\"MarkdownCodeBlock_codeFooterRightSection__9Hz_z\"><img decoding=\"async\" class=\"alignnone size-full wp-image-19208\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-legal-risk-matrix-brand-manufacturer-2026.png\" alt=\"FDA \u91ab\u7642\u5668\u68b0\u6cd5\u5f8b\u98a8\u96aa\u7b49\u7d1a\u77e9\u9663\uff0c\u986f\u793a\u54c1\u724c\u5546\u63a7\u5236\u7a0b\u5ea6\u8207\u4ee3\u5de5\u5ee0\u5408\u898f\u7a0b\u5ea6\u7684\u56db\u8c61\u9650\u98a8\u96aa\u8a55\u4f30\u8207\u5efa\u8b70\u884c\u52d5\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-legal-risk-matrix-brand-manufacturer-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-legal-risk-matrix-brand-manufacturer-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-legal-risk-matrix-brand-manufacturer-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-legal-risk-matrix-brand-manufacturer-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/fda-medical-device-legal-risk-matrix-brand-manufacturer-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 3 \u500b\u5408\u898f\u7d05\u7dda<\/h2>\n<h3>\u7d05\u7dda\u4e00\uff1a\u672a\u6307\u5b9a Manufacturer of Record<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u7686\u672a\u65bc FDA \u8a3b\u518a\u70ba Manufacturer\uff0c\u5c0e\u81f4\u7522\u54c1\u88ab\u8996\u70ba\u300c\u7121\u8a3b\u518a\u88fd\u9020\u5546\u300d\uff0c\u53ef\u80fd\u88ab\u6263\u7559\u6216\u7981\u6b62\u9032\u53e3\u3002<\/p>\n<p><strong>Solutions<\/strong>::<\/p>\n<ul>\n<li>\u5728\u59d4\u8a17\u5408\u7d04\u4e2d\u660e\u78ba\u7d04\u5b9a\u300c\u8ab0\u70ba Manufacturer of Record\u300d<\/li>\n<li>\u78ba\u4fdd\u8a72\u65b9\u5b8c\u6210 Establishment Registration \u8207 Device Listing<\/li>\n<li>\u82e5\u54c1\u724c\u5546\u70ba Specification Developer\uff0c\u9700\u8207\u4ee3\u5de5\u5ee0\u5171\u540c\u627f\u64d4\u8cac\u4efb<\/li>\n<\/ul>\n<h3>\u7d05\u7dda\u4e8c\uff1aIntended Use \u8207\u5be6\u969b\u5ba3\u7a31\u4e0d\u4e00\u81f4<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u7522\u54c1\u6a19\u7c64\u6216\u884c\u92b7\u5ba3\u7a31\u8d85\u51fa\u539f\u7533\u5831\u7684 Intended Use\uff0c\u53ef\u80fd\u88ab FDA \u8996\u70ba\u300c\u672a\u6838\u51c6\u65b0\u7528\u9014\u300d\uff08Off-Label Use\uff09\uff0c\u5c0e\u81f4\u8b66\u544a\u4fe1\u6216\u53ec\u56de\u3002<\/p>\n<p><strong>Solutions<\/strong>::<\/p>\n<ul>\n<li>\u6240\u6709\u5ba3\u7a31\u5fc5\u9808\u8207 510(k) \u6216 PMA \u7533\u5831\u7684 Intended Use \u4e00\u81f4<\/li>\n<li>\u907f\u514d\u5728\u6a19\u7c64\u3001\u7db2\u7ad9\u6216\u793e\u7fa4\u5a92\u9ad4\u4e0a\u5ba3\u7a31\u672a\u6838\u51c6\u7684\u529f\u80fd<\/li>\n<li>\u82e5\u9700\u64f4\u5927\u7528\u9014\uff0c\u9700\u63d0\u4ea4\u65b0\u7684 510(k) \u6216 PMA Supplement<\/li>\n<\/ul>\n<h3>\u7d05\u7dda\u4e09\uff1a\u5ffd\u7565 Post-Market \u76e3\u7763\u8cac\u4efb<\/h3>\n<p><strong>Risks<\/strong>\uff1a\u7522\u54c1\u4e0a\u5e02\u5f8c\uff0c\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u672a\u5efa\u7acb MDR\uff08Medical Device Reporting\uff09\u6a5f\u5236\uff0c\u5c0e\u81f4\u4e0d\u826f\u4e8b\u4ef6\u672a\u901a\u5831\uff0c\u53ef\u80fd\u88ab FDA \u91cd\u7f70\u3002<\/p>\n<p><strong>Solutions<\/strong>::<\/p>\n<ul>\n<li>\u5efa\u7acb MDR \u901a\u5831\u6d41\u7a0b\uff0830 \u5929\u5167\u901a\u5831\u56b4\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff09<\/li>\n<li>\u5b9a\u671f\u9032\u884c Post-Market Surveillance\uff08\u4e0a\u5e02\u5f8c\u76e3\u7763\uff09<\/li>\n<li>\u5408\u7d04\u4e2d\u7d04\u5b9a\u300c\u8ab0\u8ca0\u8cac MDR \u901a\u5831\u300d\uff08\u901a\u5e38\u70ba\u54c1\u724c\u5546\uff09<\/li>\n<\/ul>\n<p>\ud83d\udca1 <strong>\u5be6\u52d9\u6280\u5de7<\/strong>\uff1a\u5efa\u8b70\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u7c3d\u7f72\u300cQuality Agreement\u300d\uff08\u54c1\u8cea\u5354\u8b70\uff09\uff0c\u660e\u78ba\u7d04\u5b9a\u5404\u65b9\u8cac\u4efb\u3001\u7a3d\u6838\u983b\u7387\u8207\u4e0d\u826f\u4e8b\u4ef6\u8655\u7406\u6d41\u7a0b\u3002<\/p>\n<hr \/>\n<h2>Conclusion<\/h2>\n<p><strong>\u95dc\u9375\u91cd\u9ede<\/strong>::<\/p>\n<ul>\n<li>FDA \u91ab\u7642\u5668\u68b0\u8cac\u4efb\u6b78\u5c6c\u53d6\u6c7a\u65bc\u300c\u8ab0\u5236\u5b9a\u898f\u683c\u300d\u300c\u8ab0\u5be6\u969b\u751f\u7522\u300d\u300c\u8ab0\u5f15\u5165\u7f8e\u570b\u5e02\u5834\u300d<\/li>\n<li>\u54c1\u724c\u5546\u82e5\u70ba Specification Developer\uff0c\u5373\u4f7f\u672a\u5be6\u969b\u751f\u7522\uff0c\u4ecd\u53ef\u80fd\u88ab\u8996\u70ba Manufacturer<\/li>\n<li>\u4ee3\u5de5\u5ee0\u5fc5\u9808\u5b8c\u6210 FDA \u8a3b\u518a\u3001Device Listing \u8207 QSR \u5408\u898f<\/li>\n<li>\u5be6\u52d9\u4e0a FDA \u53ef\u540c\u6642\u8ffd\u7a76\u54c1\u724c\u5546\u8207\u4ee3\u5de5\u5ee0\u7684\u9023\u5e36\u8cac\u4efb<\/li>\n<li>\u900f\u904e\u5408\u7d04\u660e\u78ba\u7d04\u5b9a\u8cac\u4efb\u5206\u64d4\u3001\u5efa\u7acb\u7a3d\u6838\u6a5f\u5236\u8207\u8cfc\u8cb7\u4fdd\u96aa\uff0c\u53ef\u964d\u4f4e\u6cd5\u5f8b\u98a8\u96aa<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u91ab\u7642\u5668\u68b0\u8cac\u4efb\u6b78\u5c6c\u8207\u6cd5\u5f8b\u98a8\u96aa\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>","protected":false},"excerpt":{"rendered":"<p>\u54c1\u724c\u8207\u5de5\u5ee0\u8ab0\u8ca0\u8cac\uff1fFDA \u660e\u78ba\u898f\u5b9a\u8cac\u4efb\u4e3b\u9ad4 \u5728 FDA \u91ab\u7642\u5668\u68b0\u6cd5\u898f\u4e0b\uff0c\u8cac\u4efb\u6b78\u5c6c\u53d6\u6c7a\u65bc\u300c\u8ab0\u5411\u7f8e\u570b\u5e02\u5834\u5f15\u5165\u7522\u54c1\u300d [&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-19205","post","type-post","status-publish","format-standard","hentry","category-uncategorized","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/19205"}],"collection":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/comments?post=19205"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/19205\/revisions"}],"predecessor-version":[{"id":19209,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/19205\/revisions\/19209"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=19205"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=19205"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=19205"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}