{"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\/ko\/home\/regulations\/regpath\/","title":{"rendered":"\uc81c\ud488 \ud5c8\uac00 \uacfc\uc815"},"content":{"rendered":"\t\t<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\">\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \uacfc\uc815<\/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>\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.<\/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>\ud55c\uad6d\uc5d0\uc11c \uc758\ub8cc\uae30\uae30\ub97c \ud310\ub9e4 \ud558\uae30 \uc704\ud574\uc11c\ub294 \uc0c1\uae30 3\uac00\uc9c0 \uc694\uc18c\uc5d0 \ub300\ud55c \ud5c8\uac00\ub97c \ubaa8\ub450 \ub4dd\ud574\uc57c \ud55c\ub2e4.\u00a0<span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">\uc774 \ub54c, \ud544\uc694\ud55c \ud5c8\uac00\uc758 \uc885\ub958\ub294 \ub2e4\uc74c\uacfc \uac19\ub2e4:<\/span><\/p><ul><li>\ud310\ub9e4\uc5c5\uc790: \uc81c\uc870\uc5c5\/\uc218\uc785\uc5c5 \ud5c8\uac00<\/li><li>\uc81c\uc870\uc5c5\uc790(\uacf5\uc7a5): KGMP<\/li><li>\uc81c\ud488: \ud488\ubaa9\ud5c8\uac00<\/li><\/ul><p>\uac01 \uc694\uc18c\uc5d0 \ub300\ud55c \uc138\ubd80 \uc694\uad6c\uc0ac\ud56d\uc740 \uc544\ub798\uc640 \uac19\ub2e4:<\/p><h5>1. \uc81c\uc870\uc5c5\/\uc218\uc785\uc5c5\ud5c8\uac00<\/h5><ul><li>\uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uc790\ub098 \uc218\uc785\uc5c5\uc790\uc5d0 \ub300\ud574 \ubd80\uc5ec\ub418\ub294 \ud5c8\uac00. \uc5c5\ud5c8\uac00\ub97c \uc2e0\uccad\ud558\ub824\uba74 \ud488\uc9c8\ucc45\uc784\uc790\ub97c \ubc18\ub4dc\uc2dc \uc120\uc784\ud574\uc57c \ud558\ub294\ub370, \uc774\ub54c \ud488\uc9c8\ucc45\uc784\uc790\ub294 \uc758\ub8cc\uae30\uae30\ubc95 \uc2dc\ud589\uaddc\uce59 \uc81c11\uc870\uc5d0\uc11c \uc694\uad6c\ud558\ub294 \uc790\uaca9 \uc694\uac74\uc744 \ub9cc\uc871\ud574\uc57c \ud55c\ub2e4: <a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/QMR_KOR.pdf\" target=\"_blank\" rel=\"noopener\">\ud488\uc9c8\ucc45\uc784\uc790\uc758 \uc790\uaca9\uc694\uac74(\ud55c\uad6d\uc5b4),<\/a> \u00a0<a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/QMR_EN.pdf\" target=\"_blank\" rel=\"noopener\">\ud488\uc9c8\ucc45\uc784\uc790\uc758 \uc790\uaca9\uc694\uac74(\uc601\uc5b4)<\/a><\/li><li>\ub610\ud55c, \uc758\ub8cc\uae30\uae30 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900, \uc218\uc785\uc5c5\uc790\uc758 \uc900\uc218\uc0ac\ud56d\uc5d0\uc11c \uc815\uc758\ud558\ub294 \ubc14\uc640 \uac19\uc774 \uc801\uc808\ud55c \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc744 \uc6b4\uc601\ud558\uc5ec\uc57c \ud55c\ub2e4.<\/li><li>\uc138\ubd80\uc0ac\ud56d\uc740 \uad00\ub828 \ubc95\ub839 \ucc38\uc870: <a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/MD-Importer_KOR.pdf\" target=\"_blank\" rel=\"noopener\">\uc218\uc785\uc5c5\uc790\uc758 \uc900\uc218\uc0ac\ud56d(\ud55c\uad6d\uc5b4),<\/a> \u00a0<a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/MD-Importer_EN.pdf\" target=\"_blank\" rel=\"noopener\">\uc218\uc785\uc5c5\uc790\uc758 \uc900\uc218\uc0ac\ud56d(\uc601\uc5b4)<\/a><\/li><li>\uc2ec\uc0ac\uae30\uad00: \uac01 \uc9c0\ubc29 \uc2dd\uc57d\uccad<\/li><\/ul><div>\u00a0<\/div><div><h5>2. KGMP \uc778\uc99d<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li>\uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc790 \ubc0f \uc81c\uc870\uc758\ub8b0\uc790\uc758 \ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc2ec\uc0ac\ub85c, \ud604\uc9c0 \uc2ec\uc0ac \ud639\uc740 \uc11c\ub958 \uc2ec\uc0ac\ub85c \ub098\ub258\uc5b4 \uc9c4\ub2e4.<\/li><li>MDSAP\uc744 \ubcf4\uc720\ud558\uace0 \uc788\ub294 \uc81c\uc870\uc790\ub77c\uba74 \ucd5c\ucd08\uc2ec\uc0ac\ub294 \uc11c\ub958\uc2ec\uc0ac\ub85c \uac08\uc74c\ub420 \uc218 \uc788\ub2e4.<\/li><li>\uc2ec\uc0ac\uae30\uad00: \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98 (MFDS) \ubc0f \uc2dd\uc57d\ucc98 \uc9c0\uc815 \uc2ec\uc0ac\uae30\uad00 (KTL, KTR, KCL, KTC \ub4f1)<\/li><\/ul><div>\u00a0<\/div><\/div><div><h5>3. \ud488\ubaa9 \ud5c8\uac00<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li>\uc758\ub8cc\uae30\uae30\uc758 \ub4f1\uae09\uc5d0 \ub530\ub77c \ud488\ubaa9\uc2e0\uace0, \ud488\ubaa9\uc778\uc99d, \ud488\ubaa9\ud5c8\uac00\ub77c\uace0 \ubd88\ub9ac\uc6b0\uba70, \uc81c\uc870 \ud639\uc740 \uc218\uc785\ud558\ub824\ub294 \uc758\ub8cc\uae30\uae30\uc758 \uc548\uc804\uc131 \ubc0f \uc131\ub2a5\uc5d0 \ub300\ud55c \ud3c9\uac00\uac00 \uc774\ub8e8\uc5b4 \uc9c4\ub2e4.<\/li><li>\uc81c\ud488\uc758 \uc548\uc804\uc131 \ubc0f \uc131\ub2a5\uc5d0 \uad00\ub828\ub41c \uc790\ub8cc (IEC 60601, ISO 10993\ub4f1, \uc784\uc0c1\uc2dc\ud5d8\ubcf4\uace0\uc11c \ub4f1) \uc81c\ucd9c\uc774 \uc694\uad6c\ub41c\ub2e4.<\/li><li>\uc2ec\uc0ac\uae30\uad00: \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98 (MFDS) \ubc0f \uc2dd\uc57d\ucc98 \uc9c0\uc815 \uc2ec\uc0ac\uae30\uad00 (KTL, KTR, KCL, KTC \ub4f1)<\/li><li>\uc2e0\uccad\ud558\ub294 \uc758\ub8cc\uae30\uae30\uc758 \ub4f1\uae09\uc5d0 \ub530\ub77c \uc81c\ucd9c\uc790\ub8cc\uc640 \ucc98\ub9ac\uae30\ud55c\uc774 \uc0c1\uc774\ud558\ub2e4\u00a0:<\/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>\ud5c8\uac00\uc99d\uc758 \uc720\ud6a8\uae30\uac04\uc740 5\ub144\uc774\uba70, \ub9cc\ub8cc\uc77c\uc774 \ub3c4\ub798\ud558\uae30 \uc804\uc5d0 \ud5c8\uac00\uc99d\uc758 \uac31\uc2e0\uc774 \ud544\uc694\ud558\ub2e4.<\/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>\uad00\ub828\ub41c \uae00<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li><a href=\"https:\/\/biocongroup.net\/home\/regulations\/classification\/\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ub4f1\uae09<\/span><\/a><\/li><li><a href=\"https:\/\/biocongroup.net\/home\/regulations\/timeline\/\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \uc2b9\uc778 \ud544\uc694\uae30\uac04\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>\n\t\t","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\/ko\/home\/regulations\/regpath\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\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\/ko\/home\/regulations\/regpath\/\" \/>\n<meta property=\"og:site_name\" content=\"BCG\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-21T14:22:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/mfdsprodreg-1024x706.webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\uc608\uc0c1 \ub418\ub294 \ud310\ub3c5 \uc2dc\uac04\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\ubd84\" \/>\n<script type=\"application\/ld+json\" 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