{"id":309,"date":"2026-07-07T21:40:22","date_gmt":"2026-07-07T12:40:22","guid":{"rendered":"https:\/\/koreahealthshop.com\/?p=309"},"modified":"2026-07-07T21:40:23","modified_gmt":"2026-07-07T12:40:23","slug":"mfds-medical-product-review-innovation-ra-documents","status":"publish","type":"post","link":"https:\/\/www.koreahealthshop.com\/en\/mfds-medical-product-review-innovation-ra-documents\/","title":{"rendered":"\uc2dd\uc57d\ucc98 \uc758\ub8cc\uc81c\ud488 \ud5c8\uac00\u00b7\uc2ec\uc0ac \ud601\uc2e0\ubc29\uc548, \ud5c8\uac00\uc790\ub8cc \uc900\ube44\uc640 RA \uc2e4\ubb34 \uc810\uac80 \ud3ec\uc778\ud2b8"},"content":{"rendered":"<style>\n\/* KHS hide single post author\/category meta *\/<br \/>\nbody.single-post main.wp-block-group > .wp-block-group.alignfull > .wp-block-group.has-small-font-size,<br \/>\nbody.single-post .wp-block-post-featured-image + .wp-block-group.has-small-font-size {<br \/>\n  display: none !important;<br \/>\n}<br \/>\n<\/style>\n<article class=\"khs-article\">\n<p class=\"khs-summary\">\uc2dd\uc57d\ucc98\uc758 \uc758\ub8cc\uc81c\ud488 \ud5c8\uac00\uc2ec\uc0ac \ud601\uc2e0\ubc29\uc548 CEO \uac04\ub2f4\ud68c \ubc1c\ud45c\ub97c \ubc14\ud0d5\uc73c\ub85c, \ud5c8\uac00\uc790\ub8cc \uc900\ube44\uc640 RA\u00b7QA \uc2e4\ubb34 \uc810\uac80 \ud3ec\uc778\ud2b8\ub97c \uc815\ub9ac\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h2>\uc65c \uc2e4\ubb34\uc790\uac00 \ud655\uc778\ud574\uc57c \ud560\uae4c<\/h2>\n<p>\uc758\uc57d\ud488 \uac1c\ubc1c \uae30\uc5c5\uc740 \uc5f0\uad6c\uac1c\ubc1c, \uc784\uc0c1, \ud488\uc9c8, \uc81c\uc870, RA, QA, \uc0ac\uc5c5\uac1c\ubc1c \ubd80\uc11c\uac00 \uc11c\ub85c \ub2e4\ub978 \uc77c\uc815\ud45c\ub97c \uac16\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4. \uc2dd\uc57d\ucc98\uc758 \uc758\ub8cc\uc81c\ud488 \ud5c8\uac00\uc2ec\uc0ac \ud601\uc2e0\ubc29\uc548\uc740 \uc774\ub7ec\ud55c \ub0b4\ubd80 \uc77c\uc815\uacfc \ud5c8\uac00\uc790\ub8cc \uc900\ube44 \ud750\ub984\uc744 \ud568\uaed8 \uc0b4\ud3b4\ubcfc \ud544\uc694\uac00 \uc788\uc74c\uc744 \uc2dc\uc0ac\ud569\ub2c8\ub2e4.<\/p>\n<p>\ub2e4\ub9cc, \uc774\ubc88 \ubc1c\ud45c\ub97c \ud2b9\uc815 \uc81c\ud488\uc758 \ud5c8\uac00 \uc804\ub9dd\uc774\ub098 \uc2ec\uc0ac \uae30\uac04 \ub2e8\ucd95 \ubcf4\uc7a5\uc73c\ub85c \ud574\uc11d\ud574\uc11c\ub294 \uc548 \ub429\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h2>\ud5c8\uac00\uc790\ub8cc \uc900\ube44\uc5d0\uc11c \uba3c\uc800 \ubcfc \ubd80\ubd84<\/h2>\n<p>\ud5c8\uac00\uc790\ub8cc \uc900\ube44\ub294 \ub9c8\uc9c0\ub9c9 \uc81c\ucd9c \uc9c1\uc804\uc5d0\ub9cc \ud655\uc778\ud560 \uc0ac\uc548\uc774 \uc544\ub2d9\ub2c8\ub2e4. \uac1c\ubc1c \ub2e8\uacc4, \uc790\ub8cc \ubc84\uc804, \uadfc\uac70\uc790\ub8cc \ucd9c\ucc98, \uaddc\uc81c\uae30\uad00\uacfc\uc758 \uc18c\ud1b5 \uc774\ub825\uc774 \uc11c\ub85c \ub9de\ub294\uc9c0 \uc815\uae30\uc801\uc73c\ub85c \uac80\ud1a0\ud560 \ud544\uc694\uac00 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h3>\uac1c\ubc1c \ub2e8\uacc4\ubcc4 \uc790\ub8cc \ubc94\uc704<\/h3>\n<p>\uc2e0\uc57d, \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec, \uc758\ub8cc\uae30\uae30\ucc98\ub7fc \uc81c\ud488\uad70\uc774 \ub2e4\ub974\uba74 \ud544\uc694\ud55c \uc790\ub8cc\uc758 \uc131\uaca9\uacfc \uac80\ud1a0 \ud56d\ubaa9\ub3c4 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc2e4\ubb34\uc790\ub294 \ud604\uc7ac \uac1c\ubc1c \ub2e8\uacc4\uc5d0\uc11c \uc5b4\ub5a4 \uc790\ub8cc\uac00 \uc900\ube44\ub418\uc5b4 \uc788\uace0 \uc5b4\ub5a4 \ubd80\ubd84\uc744 \ucd94\uac00 \ud655\uc778\ud574\uc57c \ud558\ub294\uc9c0 \uad6c\ubd84\ud560 \uc218 \uc788\uc5b4\uc57c \ud558\uba70, \uc774\ub97c \ud1b5\ud558\uc5ec \ub0b4\ubd80 \ubb38\uc11c\uc640 \uc77c\uc815 \uad00\ub9ac \ub4f1\uc5d0\uc11c \ube48\ud2c8\uc744 \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h3>\uc81c\ucd9c\uc790\ub8cc\uc758 \uc815\ud569\uc131<\/h3>\n<p>\ud5c8\uac00\uc790\ub8cc\uc5d0\ub294 \uc5f0\uad6c\uc790\ub8cc, \uc2dc\ud5d8\uc790\ub8cc, \uc784\uc0c1 \ub610\ub294 \uc131\ub2a5 \uad00\ub828 \uc790\ub8cc, \uc81c\uc870\u00b7\ud488\uc9c8 \uad00\ub828 \uc790\ub8cc \ub4f1 \uc5ec\ub7ec \ubd80\uc11c\uc758 \ubb38\uc11c\uac00 \uc5f0\uacb0\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ubb38\uc11c\uba85, \ubc84\uc804, \uc791\uc131\uc77c, \uadfc\uac70\uc790\ub8cc \ucd9c\ucc98, \uc81c\ucd9c \uc774\ub825\uc774 \uc11c\ub85c \ub9de\ub294\uc9c0 \ud655\uc778\ud558\ub294 \uc791\uc5c5\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n<p>\ud2b9\ud788 RA\uc640 QA\ub294 \uc790\ub8cc\uc758 \ub0b4\uc6a9 \uc790\uccb4\ubfd0 \uc544\ub2c8\ub77c, \uc791\uc131 \uadfc\uac70\uc640 \ubcc0\uacbd \uc774\ub825\uc744 \ud568\uaed8 \uac80\ud1a0\ud558\uc5ec\uc57c \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<h3>\uc0ac\uc804 \uc18c\ud1b5 \uc77c\uc815<\/h3>\n<p>\uacf5\uc2dd \ubc1c\ud45c\uc5d0\uc11c \uc5b8\uae09\ub418\ub294 \uaddc\uc81c\uc9c0\uc6d0\uacfc \uc18c\ud1b5 \ubc29\ud5a5\uc740 \uac1c\ubc1c \uae30\uc5c5\uc774 \uc77c\uc815 \uad00\ub9ac\uc5d0\uc11c \ucc38\uace0\ud560 \uc218 \uc788\ub294 \uc694\uc18c\uc785\ub2c8\ub2e4. \uc0ac\uc804 \uc0c1\ub2f4\uc774\ub098 \ud68c\uc758\uac00 \uc788\ub294 \uacbd\uc6b0, \ub0b4\ubd80 \uc790\ub8cc \uc900\ube44 \uc77c\uc815\uc744 \uc0ac\uc804\uc5d0 \uc870\uc815\ud558\uc5ec \ucda9\ubd84\ud55c \ub17c\uc758\uac00 \uc774\ub8e8\uc5b4\uc9c8 \uc218 \uc788\ub3c4\ub85d \uc900\ube44\ud574\uc57c \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>\ub2e4\ub9cc \uc0ac\uc804 \uc18c\ud1b5\uc740 \uac1c\ubcc4 \uc81c\ud488\uc758 \ud5c8\uac00 \uacb0\uacfc\ub97c \ubcf4\uc7a5\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \u201c\ud5c8\uac00\ub97c \ubc1b\uc744 \uc218 \uc788\ub2e4\u201d\ub294 \ud45c\ud604\ubcf4\ub2e4 \u201c\uc790\ub8cc \uc900\ube44\uc640 \uc77c\uc815 \uad00\ub9ac \uadf8\ub9ac\uace0 \ud5c8\uac00 \uc900\ube44 \ubc29\ud5a5\uc744 \ud655\uc778\ud560 \uc218 \uc788\ub294 \uae30\ud68c&#8217;\ub85c \uc0dd\uac01\ud574\uc57c \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h2>\ubcf4\uc644 \ub300\uc751 \uccb4\uacc4\uc5d0\uc11c \ud655\uc778\ud560 \uc810<\/h2>\n<p>\ud5c8\uac00\u00b7\uc2ec\uc0ac \uacfc\uc815\uc5d0\uc11c\ub294 \uc790\ub8cc \ubcf4\uc644 \uc694\uccad\uc774 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub54c \uc911\uc694\ud55c \uac83\uc740 \ubcf4\uc644 \uc694\uccad \uc790\uccb4\ub97c \ubd80\uc815\uc801\uc73c\ub85c \ubcf4\ub294 \uac83\uc774 \uc544\ub2c8\ub77c, \uc694\uccad \ud56d\ubaa9\uc744 \uc5b4\ub5bb\uac8c \uae30\ub85d\ud558\uace0 \uc5b4\ub5a4 \uadfc\uac70\uc790\ub8cc\ub85c \ub300\uc751\ud560\uc9c0 \ubbf8\ub9ac \uc815\ub9ac\ud558\ub294 \uc77c\uc785\ub2c8\ub2e4.<\/p>\n<ul>\n<li>\ubcf4\uc644 \uc694\uccad \ubc1c\uc0dd \uc2dc \uac80\ud1a0 \ucc45\uc784 \ubd80\uc11c\uac00 \uc815\ub9ac\ub418\uc5b4 \uc788\ub294\uc9c0<\/li>\n<li>\uc790\ub8cc \ubc84\uc804\uacfc \uc81c\ucd9c \uc774\ub825\uc774 \ucd94\uc801 \uac00\ub2a5\ud55c\uc9c0<\/li>\n<li>\uc2dc\ud5d8\uae30\uad00, \uc81c\uc870, \ud488\uc9c8, \uc784\uc0c1 \ub610\ub294 \uc131\ub2a5 \uad00\ub828 \uc790\ub8cc\uc758 \uc5f0\uacb0\uad00\uacc4\uac00 \ud655\uc778\ub418\ub294\uc9c0<\/li>\n<li>\uaddc\uc81c\uae30\uad00\uacfc\uc758 \uc18c\ud1b5 \uae30\ub85d\uc774 \ub0b4\ubd80 \ubb38\uc11c\uc5d0 \ubc18\uc601\ub418\ub294\uc9c0<\/li>\n<li>\uacf5\uc2dd\uc790\ub8cc\uc640 \uadfc\uac70\uc790\ub8cc\uc758 \ubc94\uc704\ub97c \ub118\uc5b4\uc120 \uc124\uba85\uc774 \ud3ec\ud568\ub418\uc9c0 \uc54a\uc558\ub294\uc9c0<\/li>\n<\/ul>\n<p>\ubcf4\uc644\uc740 \uc900\ube44 \uae30\uac04\uc774 \uc815\ud574\uc838 \uc788\ub294 \ub9cc\ud07c, \ubcf4\uc644 \uc694\uccad \uc0ac\ud56d\uc744 \uc815\ud655\ud788 \uc219\uc9c0\ud558\uace0 \uc0c1\ub2f4\ud55c \ub2e4\uc74c \ubc18\ub4dc\uc2dc \uae30\uac04 \uc548\uc5d0 \uc81c\ucd9c\ud558\uc5ec\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h2>RA\u00b7QA \ud611\uc5c5 \uad00\uc810\uc5d0\uc11c\uc758 \uc758\ubbf8<\/h2>\n<p>\uc758\ub8cc\uc81c\ud488 \ud5c8\uac00\uc790\ub8cc\ub294 RA \ubd80\uc11c\ub9cc\uc758 \ubb38\uc11c\uac00 \uc544\ub2d9\ub2c8\ub2e4. \ud488\uc9c8\uc790\ub8cc, \uc81c\uc870\uc790\ub8cc, \uc5f0\uad6c\uac1c\ubc1c \uc790\ub8cc, \uc784\uc0c1 \ub610\ub294 \uc131\ub2a5 \uad00\ub828 \uc790\ub8cc\uac00 \ud568\uaed8 \uc5f0\uacb0\ub418\ubbc0\ub85c QA\uc640 \uad00\ub828 \ubd80\uc11c\uc758 \ud611\uc5c5\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<p>RA\ub294 \uc81c\ucd9c\uc790\ub8cc\uc758 \uad6c\uc870\uc640 \uaddc\uc81c\uae30\uad00 \uc18c\ud1b5 \uc774\ub825\uc744 \uad00\ub9ac\ud558\uace0, QA\ub294 \ubb38\uc11c \uae30\uc900, \ubcc0\uacbd \uc774\ub825, \ud488\uc9c8 \uad00\ub828 \uadfc\uac70\uac00 \uc77c\uad00\ub418\uac8c \uc720\uc9c0\ub418\ub294\uc9c0 \uad00\ub9ac\ud558\uc5ec, \uc0c1\ud638\ubcf4\uc644\uc801\uc778 \uaddc\uc81c \ub300\uc751 \uccb4\uacc4\ub97c \uac16\ucd94\uc5b4\uc57c \ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>\uc6d0\ubb38 \ucd9c\ucc98<\/h3>\n<p>\uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98 \uacf5\uc2dd\uc790\ub8cc<br \/>\n<a href=\"https:\/\/www.mfds.go.kr\/brd\/m_99\/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=50096&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=\" target=\"_blank\" rel=\"noopener noreferrer\">\uc758\ub8cc\uc81c\ud488 \ud5c8\uac00\u00b7\uc2ec\uc0ac \ud601\uc2e0\ubc29\uc548 CEO \uac04\ub2f4\ud68c<\/a><\/p>\n<hr \/>\n<p><strong>\uac8c\uc2dc\uc2b9\uc778 \uc0c1\ud0dc:<\/strong> \ubbf8\uc2b9\uc778<\/p>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>\uc2dd\uc57d\ucc98 CEO \uac04\ub2f4\ud68c \ubc1c\ud45c\ub97c \ubc14\ud0d5\uc73c\ub85c \uc758\ub8cc\uc81c\ud488 \uac1c\ubc1c \uae30\uc5c5\uc774 \ud5c8\uac00\uc790\ub8cc, \uc0ac\uc804 \uc18c\ud1b5, \ubcf4\uc644 \ub300\uc751 \uccb4\uacc4\ub97c \uc5b4\ub5bb\uac8c \uac80\ud1a0\ud574\uc57c \ud558\ub294\uc9c0 \uc0b4\ud3b4\ubd05\ub2c8\ub2e4. \uac1c\ubcc4 \uc81c\ud488\uc758 \ud5c8\uac00 \uac00\ub2a5\uc131\uc774\ub098 \ud6a8\uacfc \ub2e8\uc815\uc740 \uc81c\uc678\ud588\uc2b5\ub2c8\ub2e4.<\/p>","protected":false},"author":3,"featured_media":546,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[9],"tags":[59,38,37,106,107,104,20,105,24,102,67,103],"class_list":["post-309","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation-claims","tag-k-health","tag-qa","tag-ra","tag-106","tag-107","tag-104","tag-20","tag-105","tag-24","tag-102","tag-67","tag-103"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.9 - aioseo.com -->\n\t<meta name=\"description\" content=\"\uc2dd\uc57d\ucc98\uc758 \uc758\ub8cc\uc81c\ud488 \ud5c8\uac00\u00b7\uc2ec\uc0ac \ud601\uc2e0\ubc29\uc548 CEO \uac04\ub2f4\ud68c \ub0b4\uc6a9\uc744 \ubc14\ud0d5\uc73c\ub85c, \uc2e0\uc57d\u00b7\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\u00b7\uc758\ub8cc\uae30\uae30 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