{"id":1206,"date":"2025-01-01T16:02:19","date_gmt":"2025-01-01T07:02:19","guid":{"rendered":"https:\/\/biocongroup.net\/?page_id=1206"},"modified":"2025-07-21T23:22:03","modified_gmt":"2025-07-21T14:22:03","slug":"regpath","status":"publish","type":"page","link":"https:\/\/biocongroup.net\/tw\/home\/regulations\/regpath\/","title":{"rendered":"\u7522\u54c1\u6279\u51c6\u904e\u7a0b"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1206\" class=\"elementor elementor-1206\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2168470 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2168470\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-bfbcdc4\" data-id=\"bfbcdc4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-17b5c4c elementor-widget elementor-widget-heading\" data-id=\"17b5c4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u97d3\u570b\u7684\u91ab\u7642\u5668\u68b0\u6279\u51c6\u904e\u7a0b<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bd45cc1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bd45cc1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6fd14c7\" data-id=\"6fd14c7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-02c1b9e elementor-widget elementor-widget-text-editor\" data-id=\"02c1b9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u91ab\u7642\u5668\u68b0\u7684\u88fd\u9020\u548c\u6d41\u901a\u904e\u7a0b\u7684\u8981\u7d20\u53ef\u4ee5\u7c21\u5316\u70ba\u4ee5\u4e0b\u4e09\u9805\uff1a\u88fd\u9020\u5546\u3001\u92b7\u552e\u5546\u548c\u7522\u54c1\u3002<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84b30f4 elementor-widget elementor-widget-image\" data-id=\"84b30f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"120\" src=\"https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303-300x120.webp\" class=\"attachment-medium size-medium wp-image-1283\" alt=\"\" srcset=\"https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303-300x120.webp 300w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303-1024x410.webp 1024w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303-768x308.webp 768w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303-1536x616.webp 1536w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303-18x7.webp 18w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/\uadf8\ub9ac\uae303.webp 1861w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c782a79 elementor-widget elementor-widget-text-editor\" data-id=\"c782a79\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u5728\u97d3\u570b\u92b7\u552e\u91ab\u7642\u5668\u68b0\uff0c\u5fc5\u9808\u7372\u5f97\u4e0a\u8ff0\u4e09\u9805\u8981\u7d20\u7684\u6279\u51c6\u3002\u00a0<span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">\u6240\u9700\u7684\u6279\u51c6\u985e\u578b\u5982\u4e0b\uff1a<\/span><\/p><ul><li>\u92b7\u552e\u5546\uff1a\u88fd\u9020\u696d\/\u9032\u53e3\u696d\u8a31\u53ef<\/li><li>\u88fd\u9020\u5546\uff08\u5de5\u5ee0\uff09\uff1aKGMP<\/li><li>\u7522\u54c1\uff1a\u7522\u54c1\u8a3b\u518a \u6bcf\u500b\u8981\u7d20\u7684\u8a73\u7d30\u8981\u6c42\u5982\u4e0b\uff1a<\/li><\/ul><p>\u5404\u500b\u8981\u7d20\u7684\u8a73\u7d30\u8981\u6c42\u5982\u4e0b\uff1a<\/p><h5>1. \u88fd\u9020\/\u9032\u53e3\u8a31\u53ef\u8b49<\/h5><ul><li>\u9019\u662f\u6388\u4e88\u91ab\u7642\u5668\u68b0\u88fd\u9020\u5546\u6216\u9032\u53e3\u5546\u7684\u8a31\u53ef\u8b49\u3002\u7533\u8acb\u6642\uff0c\u9808\u660e\u78ba\u6307\u5b9a\u4e00\u540d\u8cea\u91cf\u8cac\u4efb\u8005\uff0c\u8a72\u8cac\u4efb\u8005\u5fc5\u9808\u6eff\u8db3\u300a\u91ab\u7642\u5668\u68b0\u6cd5\u65bd\u884c\u7d30\u5247\u300b\u7b2c11\u689d\u898f\u5b9a\u7684\u8cc7\u8cea\u689d\u4ef6\u3002 <a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/QMR_KOR.pdf\" target=\"_blank\" rel=\"noopener\">\u54c1\u8cea\u4e3b\u4efb\u8cc7\u683c ( \u97d3\u8a9e),<\/a> \u00a0<a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/QMR_EN.pdf\" target=\"_blank\" rel=\"noopener\">\u54c1\u8cea\u4e3b\u4efb\u8cc7\u683c\uff08\u82f1\u8a9e\uff09<\/a><\/li><li>\u6b64\u5916\uff0c\u9084\u9700\u6309\u7167\u91ab\u7642\u5668\u68b0\u88fd\u9020\u548c\u8cea\u91cf\u7ba1\u7406\u898f\u7bc4\u4ee5\u53ca\u9032\u53e3\u5546\u7684\u8981\u6c42\uff0c\u904b\u884c\u6070\u7576\u7684\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u3002<\/li><li>\u8a73\u7d30\u4fe1\u606f\u8acb\u53c3\u95b1\u76f8\u95dc\u6cd5\u5f8b\u6cd5\u898f\uff1a <a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/MD-Importer_KOR.pdf\" target=\"_blank\" rel=\"noopener\">\u9032\u53e3\u5546\u7684\u9075\u5b88\u4e8b\u9805\uff08\u97d3\u8a9e\uff09<\/a> \u00a0<a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/MD-Importer_EN.pdf\" target=\"_blank\" rel=\"noopener\">\u9032\u53e3\u5546\u7684\u9075\u5b88\u4e8b\u9805\uff08\u82f1\u8a9e\uff09<\/a><\/li><li>\u5be9\u6838\u6a5f\u69cb: \u5404\u5730\u98df\u54c1\u85e5\u54c1\u5b89\u5168\u5c40<\/li><\/ul><div>\u00a0<\/div><div><h5>2. KGMP\u8a8d\u8b49<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li>\u5c0d\u91ab\u7642\u5668\u68b0\u88fd\u9020\u5546\u548c\u59d4\u8a17\u88fd\u9020\u5546\u7684\u8cea\u91cf\u7ba1\u7406\u7cfb\u7d71\u9032\u884c\u5be9\u67e5\uff0c\u5206\u70ba\u73fe\u5834\u5be9\u67e5\u548c\u6a94\u5be9\u67e5\u3002<\/li><li>\u5982\u679c\u88fd\u9020\u5546\u64c1\u6709MDSAP\u8a8d\u8b49\uff0c\u521d\u6b21\u5be9\u67e5\u53ef\u7528\u6a94\u5be9\u67e5\u4ee3\u66ff\u3002<\/li><li>\u5be9\u67e5\u6a5f\u69cb: \u97d3\u570b\u98df\u54c1\u85e5\u54c1\u5b89\u5168\u8655(MFDS)\u548c\u98df\u54c1\u85e5\u54c1\u5b89\u5168\u8655\u6307\u5b9a\u7684\u5be9\u67e5\u6a5f\u69cb\uff08KTL\u3001KTR\u3001KCL\u3001KTC\u7b49\uff09<\/li><\/ul><div>\u00a0<\/div><\/div><div><h5>3. \u7522\u54c1\u8a31\u53ef<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li>\u6839\u64da\u91ab\u7642\u5668\u68b0\u7684\u7b49\u7d1a\uff0c\u5206\u70ba\u7522\u54c1\u8a3b\u518a\u3001\u7522\u54c1\u8a8d\u8b49\u548c\u7522\u54c1\u6279\u51c6\uff0c\u4e26\u5c0d\u64ec\u751f\u7522\u6216\u9032\u53e3\u7684\u91ab\u7642\u5668\u68b0\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u9032\u884c\u8a55\u4f30\u3002<\/li><li>\u9700\u8981\u63d0\u4ea4\u8207\u7522\u54c1\u7684\u5b89\u5168\u6027\u548c\u6027\u80fd\u76f8\u95dc\u7684\u8cc7\u6599\uff08\u5982IEC 60601\u3001ISO 10993\u3001\u81e8\u5e8a\u8a66\u9a57\u5831\u544a\u7b49\uff09\u3002<\/li><li>\u5be9\u67e5\u6a5f\u69cb: \u97d3\u570b\u98df\u54c1\u85e5\u54c1\u5b89\u5168\u8655(MFDS)\u548c\u98df\u54c1\u85e5\u54c1\u5b89\u5168\u8655\u6307\u5b9a\u7684\u5be9\u67e5\u6a5f\u69cb\uff08KTL\u3001KTR\u3001KCL\u3001KTC\u7b49\uff09<\/li><li>\u6839\u64da\u7533\u8acb\u7684\u91ab\u7642\u5668\u68b0\u7b49\u7d1a\uff0c\u63d0\u4ea4\u7684\u6750\u6599\u548c\u8655\u7406\u671f\u9650\u6709\u6240\u4e0d\u540c\uff1a<\/li><\/ul><\/div><figure><\/figure>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec8c964 elementor-widget elementor-widget-image\" data-id=\"ec8c964\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"640\" height=\"441\" src=\"https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-1024x706.webp\" class=\"attachment-large size-large wp-image-1308\" alt=\"\" srcset=\"https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-1024x706.webp 1024w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-300x207.webp 300w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-768x529.webp 768w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-1536x1059.webp 1536w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg.webp 1920w, https:\/\/www.biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-18x12.webp 18w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16c81ce elementor-widget elementor-widget-text-editor\" data-id=\"16c81ce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u8a31\u53ef\u8b49\u7684\u6709\u6548\u671f\u70ba5\u5e74\uff0c\u9700\u5728\u5230\u671f\u65e5\u524d\u9032\u884c\u8a31\u53ef\u8b49\u7684\u66f4\u65b0\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f663bb elementor-widget elementor-widget-text-editor\" data-id=\"9f663bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div>\u00a0<\/div><div><h5>\u76f8\u95dc\u6587\u7ae0<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li><a href=\"https:\/\/biocongroup.net\/tw\/home\/regulations\/classification\/\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">\u97d3\u570b\u7684\u91ab\u7642\u5668\u68b0\u7b49\u7d1a<\/span><\/a><\/li><li><a href=\"https:\/\/biocongroup.net\/tw\/home\/regulations\/timeline\/\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">\u97d3\u570b\u91ab\u7642\u5668\u68b0\u5be9\u6279\u6240\u9700\u6642\u9593\u00a0<\/span><\/a><\/li><\/ul><\/div><figure><\/figure>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \uacfc\uc815 \uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \uc720\ud1b5\uacfc\uc815\uc758 \uc694\uc18c\ub294 \uc544\ub798\uc640 \uac19\uc774 \uc81c\uc870\uc790, \ud310\ub9e4\uc5c5\uc790, \uc81c\ud488\uc73c\ub85c \ub2e8\uc21c\ud654 \ud560 \uc218 \uc788\ub2e4. \ud55c\uad6d\uc5d0\uc11c \uc758\ub8cc\uae30\uae30\ub97c \ud310\ub9e4 \ud558\uae30 \uc704\ud574\uc11c\ub294 \uc0c1\uae30 3\uac00\uc9c0 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":796,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-1206","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \uacfc\uc815 - BCG<\/title>\n<meta name=\"description\" content=\"\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \uc81c\uc870\/\uc218\uc785\uc5c5\ud5c8\uac00, KGMP, \ud488\ubaa9\ud5c8\uac00\uc758 \uc694\uad6c\uc870\uac74 \ubc0f \uc2ec\uc0ac \uc18c\uc694\uc77c\ub4f1\uc744 \uc54c\uc544\ubcf4\uc138\uc694\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biocongroup.net\/tw\/home\/regulations\/regpath\/\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \uacfc\uc815 - BCG\" \/>\n<meta property=\"og:description\" content=\"\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \uc81c\uc870\/\uc218\uc785\uc5c5\ud5c8\uac00, KGMP, \ud488\ubaa9\ud5c8\uac00\uc758 \uc694\uad6c\uc870\uac74 \ubc0f \uc2ec\uc0ac \uc18c\uc694\uc77c\ub4f1\uc744 \uc54c\uc544\ubcf4\uc138\uc694\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biocongroup.net\/tw\/home\/regulations\/regpath\/\" \/>\n<meta property=\"og:site_name\" content=\"BCG\" \/>\n<meta property=\"article:modified_time\" 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