{"id":1218,"date":"2025-01-01T16:23:21","date_gmt":"2025-01-01T07:23:21","guid":{"rendered":"https:\/\/biocongroup.net\/?page_id=1218"},"modified":"2025-07-21T23:22:08","modified_gmt":"2025-07-21T14:22:08","slug":"timeline","status":"publish","type":"page","link":"https:\/\/biocongroup.net\/en\/home\/regulations\/timeline\/","title":{"rendered":"\uc18c\uc694\uae30\uac04"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1218\" class=\"elementor elementor-1218\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-080ad5a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"080ad5a\" 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-0db60f3\" data-id=\"0db60f3\" 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-55d2d7e elementor-widget elementor-widget-heading\" data-id=\"55d2d7e\" 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\">Korean Medical Device Approval Timeline<\/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-e8aa114 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e8aa114\" 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-6064a76\" data-id=\"6064a76\" 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-69cdb26 elementor-widget elementor-widget-text-editor\" data-id=\"69cdb26\" 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>Medical devices are classified into four categories, and the time required for approval varies depending on the class.<\/p><h5>Class 1<\/h5><ul><li>Class 1 medical devices do not require submission of KGMP certification or product testing data.<\/li><li>Class 1 medical devices typically take 2-3 months for approval (registration).<\/li><li>The following timeline takes into account first and second revisions.<\/li><\/ul><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-c050139 elementor-widget elementor-widget-image\" data-id=\"c050139\" 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\" src=\"https:\/\/biocongroup.net\/wp-content\/uploads\/elementor\/thumbs\/class-1-qzefmgxs138tcyyhap5ld18i8g7ezblb2pytozc3l4.png\" title=\"Class 1\" alt=\"Timeline for class 1 medical device registration\" loading=\"lazy\" \/>\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-1eb61a3 elementor-widget elementor-widget-text-editor\" data-id=\"1eb61a3\" 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>Class 2, 3, 4:<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">The approval time varies depending on whether product testing is conducted in Korea, whether KGMP local audits are required, and whether clinical data review is necessary.<\/span><\/li><li><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">Class 2 devices generally take 6-9 months for approval (certification).<\/span><\/li><li><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">Class 3 and 4 devices typically take 9-12 months for approval, as the review by the Korean MFDS takes more time.<\/span><\/li><li>The following timeline assumes product testing for Class 2 devices, KGMP document review, and no clinical data requirement.<\/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-b79a38c elementor-widget elementor-widget-image\" data-id=\"b79a38c\" 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=\"1920\" height=\"938\" src=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2.webp\" class=\"attachment-full size-full wp-image-1221\" alt=\"Timeline for class 2 medical device registration\" srcset=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2.webp 1920w, https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2-300x147.webp 300w, https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2-1024x500.webp 1024w, https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2-768x375.webp 768w, https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2-1536x750.webp 1536w, https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/class-2-18x9.webp 18w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\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-0a713b9 elementor-widget elementor-widget-text-editor\" data-id=\"0a713b9\" 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>Related Articles<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li><a href=\"https:\/\/biocongroup.net\/en\/home\/regulations\/classification\/\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">Medical Device Classification in Korea<\/span><\/a><\/li><li><a href=\"https:\/\/biocongroup.net\/en\/home\/regulations\/regpath\/\">Korean Medical Device Product Approval Process<\/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 \uc18c\uc694\uae30\uac04 \uc758\ub8cc\uae30\uae30\ub294 \uc544\ub798\uc640 \uac19\uc774 4\uac1c\uc758 \ub4f1\uae09\uc73c\ub85c \ubd84\ub958\ub418\uace0 \uc788\ub2e4. \ub4f1\uae09\uc5d0 \ub530\ub77c \ud5c8\uac00\uc2b9\uc778\uc5d0 \uc18c\uc694\ub418\ub294 \uae30\uac04\uc758 \ucc28\uc774\uac00 \uc788\ub2e4. 1\ub4f1\uae09 1\ub4f1\uae09 \uc758\ub8cc\uae30\uae30\ub294 KGMP \uc778\uc99d \ubc0f \uc81c\ud488\uc2dc\ud5d8\uc5d0 [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":796,"menu_order":2,"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-1218","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\ub8cc\uae30\uae30 \ud488\ubaa9\ud5c8\uac00 \uc18c\uc694\uae30\uac04 - BCG<\/title>\n<meta name=\"description\" content=\"\ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud560 \ub54c, 1, 2, 3, 4\ub4f1\uae09 \uc758\ub8cc\uae30\uae30 \ubc0f \uccb4\uc678\uc9c4\ub2e8 \uc758\ub8cc\uae30\uae30\uc758 \ud488\ubaa9\ud5c8\uac00 \uc808\ucc28\uc640 \uc18c\uc694 \uae30\uac04, \uc138\ubd80 \uc0ac\ud56d\uc744 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