{"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\/en\/home\/regulations\/regpath\/","title":{"rendered":"Product Approval Process"},"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\">Korean Medical Device Approval Process<\/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>The elements of manufacturing and distribution of medical devices can be simplified as follows: manufacturer, seller, and product.<\/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>To sell medical devices in Korea, approval for all three elements mentioned above must be obtained.\u00a0<span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">The required types of approvals are as follows:<\/span><\/p><ul><li>Distributor: Manufacturing\/Import License<\/li><li>Manufacturer (Factory): KGMP<\/li><li>Product: Product Registration The detailed requirements for each element are as follows:<\/li><\/ul><p>The detailed requirements for each element are as follows:<\/p><h5>1. Manufacturing\/Importing License<\/h5><ul><li>This license is granted to medical device manufacturers or importers. To apply for the license, the appointment of a quality manager is mandatory. The quality manager must meet the qualifications specified in Article 11 of the Enforcement Rules of the Medical Device Act. <a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/QMR_KOR.pdf\" target=\"_blank\" rel=\"noopener\">Qualifications for the Quality Manager (Korean),<\/a> \u00a0<a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/QMR_EN.pdf\" target=\"_blank\" rel=\"noopener\">Qualifications of the quality manager (English)<\/a><\/li><li>Additionally, the appropriate quality system must be maintained, as defined by the Medical Device Manufacturing and Quality Management Standards and the requirements for importers.<\/li><li>For detailed information, refer to the relevant regulations: <a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/MD-Importer_KOR.pdf\" target=\"_blank\" rel=\"noopener\">Compliance Requirements for Importers (Korean)<\/a> \u00a0<a href=\"https:\/\/biocongroup.net\/wp-content\/uploads\/2025\/01\/MD-Importer_EN.pdf\" target=\"_blank\" rel=\"noopener\">Compliance Requirements for Importers (English)<\/a><\/li><li>Review Authority: Local Food and Drug Administration (FDA) offices.<\/li><\/ul><div>\u00a0<\/div><div><h5>2. KGMP Certification<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li>This refers to the audit of the quality management system for medical device manufacturers and contract manufacturers, which may be either a local inspection or a document review.<\/li><li>If the manufacturer holds MDSAP certification, the initial audit may be substituted with a document review.<\/li><li>Review Authority: Korea Food and Drug Administration (MFDS) and designated FDA-recognized inspection agencies (e.g., KTL, KTR, KCL, KTC).<\/li><\/ul><div>\u00a0<\/div><\/div><div><h5>3. Product Approval<\/h5><ul style=\"list-style-position: outside; list-style-type: disc;\"><li>Depending on the medical device's classification, this process is called product registration, product certification, or product approval. The safety and performance of the device to be manufactured or imported are evaluated.<\/li><li>Documentation related to the safety and performance of the product (e.g., IEC 60601, ISO 10993, clinical trial reports) must be submitted.<\/li><li>Review Authority: Korea Food and Drug Administration (MFDS) and designated FDA-recognized inspection agencies (e.g., KTL, KTR, KCL, KTC).<\/li><li>The submission materials and processing time vary depending on the classification of the medical device being applied for:<\/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>The validity period of the license is 5 years, and renewal of the license is required before the expiration date.<\/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>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\/timeline\/\"><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\">Timeline for Medical Device Approval in Korea\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 - 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