{"id":336,"date":"2026-07-05T22:29:49","date_gmt":"2026-07-05T13:29:49","guid":{"rendered":"https:\/\/koreahealthshop.com\/?p=336"},"modified":"2026-07-05T22:32:02","modified_gmt":"2026-07-05T13:32:02","slug":"digital-medical-device-guideline-checkpoints","status":"publish","type":"post","link":"https:\/\/koreahealthshop.com\/en\/digital-medical-device-guideline-checkpoints\/","title":{"rendered":"Key Summary of Revisions to Digital Medical Device Guidelines"},"content":{"rendered":"<style>\n\/* KHS hide single post author\/category meta *\/\nbody.single-post main.wp-block-group > .wp-block-group.alignfull > .wp-block-group.has-small-font-size,\nbody.single-post .wp-block-post-featured-image + .wp-block-group.has-small-font-size {\n  display: none !important;\n}\n<\/style>\n<article>\n<section>\n<h2>\ud575\uc2ec \uc694\uc57d<\/h2>\n<p>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \uacf5\uc2dd \uac00\uc774\ub4dc\ub77c\uc778\uc740 \uc81c\ud488 \uac1c\ubc1c, \ud5c8\uac00\u00b7\uc2ec\uc0ac, \uc790\ub8cc \uc900\ube44, \ud45c\uc2dc\u00b7\uad11\uace0 \uac80\ud1a0 \uacfc\uc815\uc5d0\uc11c \uc911\uc694\ud55c \uae30\uc900\uc774 \ub429\ub2c8\ub2e4. \uc774\ubc88 \uae00\uc5d0\uc11c\ub294 \uac00\uc774\ub4dc\ub77c\uc778 \uac1c\uc815 \ub610\ub294 \uc548\ub0b4 \ub0b4\uc6a9\uc744 \ubc14\ud0d5\uc73c\ub85c, \ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\uacfc \uc2e4\ubb34\uc790\uac00 \ud655\uc778\ud574\uc57c \ud560 \uc8fc\uc694 \ubcc0\ud654\uc640 \uc900\ube44\uc0ac\ud56d\uc744 \uc815\ub9ac\ud569\ub2c8\ub2e4.<\/p>\n<p>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uae30\ub2a5, \uc0ac\uc6a9\uc790 \ub300\uc0c1, \uc0ac\uc6a9 \ubaa9\uc801, \uc5c5\ub370\uc774\ud2b8 \ubc29\uc2dd\uc5d0 \ub530\ub77c \uac80\ud1a0 \ubc94\uc704\uac00 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \uac00\uc774\ub4dc\ub77c\uc778\uc744 \ubcfc \ub54c\ub294 \uc81c\ud488\uc758 \uae30\ub2a5 \uc124\uba85\ubfd0 \uc544\ub2c8\ub77c \uc81c\ucd9c\uc790\ub8cc, \uc0ac\uc6a9\uc790 \uc548\ub0b4, \ud45c\uc2dc\u00b7\uad11\uace0 \ubb38\uad6c\uae4c\uc9c0 \ud568\uaed8 \ud655\uc778\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uac00\uc774\ub4dc\ub77c\uc778\uc774 \uc911\uc694\ud55c \uc774\uc720<\/h2>\n<p>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30\ub294 \uc77c\ubc18\uc801\uc778 \ud558\ub4dc\uc6e8\uc5b4 \uc758\ub8cc\uae30\uae30\uc640 \ub2ec\ub9ac \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uae30\ub2a5, \ub370\uc774\ud130 \ucc98\ub9ac, \uc54c\uace0\ub9ac\uc998 \uc5c5\ub370\uc774\ud2b8, \uc0ac\uc6a9\uc790 \uc778\ud130\ud398\uc774\uc2a4\uac00 \uc81c\ud488\uc758 \ud575\uc2ec \uc694\uc18c\uac00 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ud2b9\uc131 \ub54c\ubb38\uc5d0 \uac1c\ubc1c \ucd08\uae30\ubd80\ud130 \uaddc\uc81c \uad00\uc810\uc758 \uc790\ub8cc \uc815\ub9ac\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<p>\uac00\uc774\ub4dc\ub77c\uc778\uc740 \ud5c8\uac00\u00b7\uc2ec\uc0ac \uacfc\uc815\uc5d0\uc11c \uc5b4\ub5a4 \uc790\ub8cc\ub97c \uc900\ube44\ud574\uc57c \ud558\ub294\uc9c0, \uc81c\ud488 \uc124\uba85\uacfc \uc0ac\uc6a9 \ubaa9\uc801\uc744 \uc5b4\ub5bb\uac8c \uc815\ub9ac\ud574\uc57c \ud558\ub294\uc9c0 \ud655\uc778\ud558\ub294 \uae30\uc900\uc774 \ub429\ub2c8\ub2e4. \ub2e4\ub9cc \uac00\uc774\ub4dc\ub77c\uc778 \ud655\uc778\uc774 \uace7\ubc14\ub85c \ud5c8\uac00\ub098 \uc778\uc99d\uc744 \ubcf4\uc7a5\ud558\ub294 \uac83\uc740 \uc544\ub2c8\uba70, \uac1c\ubcc4 \uc81c\ud488\uc758 \uc0ac\uc6a9 \ubaa9\uc801\uacfc \uae30\ub2a5\uc5d0 \ub530\ub77c \ubcc4\ub3c4 \uac80\ud1a0\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\uc774\ubc88 \uac00\uc774\ub4dc\ub77c\uc778 \uac1c\uc815\uc5d0\uc11c \ud655\uc778\ud560 \uc8fc\uc694 \ud750\ub984<\/h2>\n<p>\uc774\ubc88 \uac1c\uc815 \ub610\ub294 \uc548\ub0b4\uc5d0\uc11c \uc2e4\ubb34\uc790\uac00 \uc8fc\ubaa9\ud560 \ubd80\ubd84\uc740 \uc801\uc6a9 \ub300\uc0c1, \uc81c\ucd9c\uc790\ub8cc \ubc94\uc704, \uc131\ub2a5 \ubc0f \uc548\uc804\uc131 \uad00\ub828 \uadfc\uac70\uc790\ub8cc, \ubcc0\uacbd \uad00\ub9ac \uae30\uc900\uc785\ub2c8\ub2e4. \uc81c\ud488\uc774 \uc2e4\uc81c\ub85c \uc5b4\ub5a4 \uae30\ub2a5\uc744 \uc81c\uacf5\ud558\ub294\uc9c0\uc640 \uc0ac\uc6a9\uc790\uac00 \uc5b4\ub5a4 \uc0c1\ud669\uc5d0\uc11c \uc0ac\uc6a9\ud558\ub294\uc9c0\ub97c \uba85\ud655\ud788 \uc815\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uac00\uc774\ub4dc\ub77c\uc778 \ud655\uc778 \uc804 \uc900\ube44\ud560 \uc790\ub8cc<\/h3>\n<ul>\n<li>\uc81c\ud488\uba85, \ubaa8\ub378\uba85, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubc84\uc804 \ub4f1 \uae30\ubcf8 \uc815\ubcf4<\/li>\n<li>\uc0ac\uc6a9 \ubaa9\uc801, \uc0ac\uc6a9\uc790 \ub300\uc0c1, \uc0ac\uc6a9 \ud658\uacbd\uc5d0 \ub300\ud55c \uc124\uba85<\/li>\n<li>\uc8fc\uc694 \uae30\ub2a5, \ub370\uc774\ud130 \ucc98\ub9ac \ubc29\uc2dd, \uc54c\uace0\ub9ac\uc998 \ub610\ub294 \uc5c5\ub370\uc774\ud2b8 \uad00\ub9ac \uc790\ub8cc<\/li>\n<li>\uc131\ub2a5, \uc548\uc804\uc131, \uc720\ud6a8\uc131 \uad00\ub828 \uadfc\uac70\uc790\ub8cc<\/li>\n<li>\uc0ac\uc6a9\uc790 \uc548\ub0b4\ubb38, \ud45c\uc2dc\uc790\ub8cc, \ud64d\ubcf4 \ubb38\uad6c \ucd08\uc548<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uac00\uc774\ub4dc\ub77c\uc778 \uac1c\uc815 \uad00\ub828 \uc8fc\uc694 \uccb4\ud06c\ud3ec\uc778\ud2b8<\/h2>\n<table>\n<thead>\n<tr>\n<th>\uad6c\ubd84<\/th>\n<th>\uc8fc\uc694 \ub0b4\uc6a9<\/th>\n<th>\uc2e4\ubb34 \ud655\uc778 \ud3ec\uc778\ud2b8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\uac00\uc774\ub4dc\ub77c\uc778 \uac1c\uc815<\/td>\n<td>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \uacf5\uc2dd \uae30\uc900\uacfc \uc548\ub0b4\uc0ac\ud56d \ubcc0\uacbd<\/td>\n<td>\uc801\uc6a9 \ub300\uc0c1, \uc2dc\ud589 \uc2dc\uc810, \uad00\ub828 \ubb38\uc11c \ud655\uc778<\/td>\n<\/tr>\n<tr>\n<td>\ud5c8\uac00\u00b7\uc2ec\uc0ac \uc790\ub8cc<\/td>\n<td>\uc81c\ud488 \uc124\uba85, \uc131\ub2a5, \uc548\uc804\uc131, \uc720\ud6a8\uc131 \uad00\ub828 \uc790\ub8cc \uc900\ube44<\/td>\n<td>\uc81c\ucd9c\uc790\ub8cc \ubc94\uc704\uc640 \uadfc\uac70\uc790\ub8cc \uc77c\uce58 \uc5ec\ubd80 \ud655\uc778<\/td>\n<\/tr>\n<tr>\n<td>\uc81c\ud488\uae30\ud68d<\/td>\n<td>\uac1c\ubc1c \ucd08\uae30 \ub2e8\uacc4\uc5d0\uc11c \uaddc\uc81c \uc694\uac74 \ubc18\uc601<\/td>\n<td>\uc81c\ud488 \uae30\ub2a5, \uc0ac\uc6a9\uc790 \ub300\uc0c1, \uc0ac\uc6a9 \ubaa9\uc801 \uba85\ud655\ud654<\/td>\n<\/tr>\n<tr>\n<td>\ud45c\uc2dc\u00b7\uad11\uace0<\/td>\n<td>\uc81c\ud488 \uc124\uba85\uacfc \ud64d\ubcf4 \ubb38\uad6c\uc758 \uc801\uc815\uc131 \uac80\ud1a0<\/td>\n<td>\ud5c8\uac00 \ubc94\uc704\ub97c \ubc97\uc5b4\ub09c \ud45c\ud604\uc774\ub098 \ud6a8\ub2a5 \ubcf4\uc7a5 \ud45c\ud604 \uc8fc\uc758<\/td>\n<\/tr>\n<tr>\n<td>\uc0ac\ud6c4\uad00\ub9ac<\/td>\n<td>\uc81c\ud488 \uc5c5\ub370\uc774\ud2b8, \ubcc0\uacbd\uc0ac\ud56d, \uc0ac\uc6a9\uc790 \uc548\ub0b4 \uad00\ub9ac<\/td>\n<td>\ubcc0\uacbd \ubc1c\uc0dd \uc2dc \ucd94\uac00 \uac80\ud1a0 \ub610\ub294 \uc2e0\uace0 \ud544\uc694 \uc5ec\ubd80 \ud655\uc778<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/section>\n<section>\n<h2>\ud5c8\uac00\u00b7\uc2ec\uc0ac \uc790\ub8cc \uc900\ube44 \uad00\uc810\uc758 \uccb4\ud06c\ud3ec\uc778\ud2b8<\/h2>\n<p>\ud5c8\uac00\u00b7\uc2ec\uc0ac \uc790\ub8cc\ub294 \uc81c\ud488\uc774 \uc5b4\ub5a4 \ubaa9\uc801\uacfc \uae30\ub2a5\uc744 \uac16\ub294\uc9c0 \uc124\uba85\ud558\ub294 \uae30\ubcf8 \uc790\ub8cc\uc785\ub2c8\ub2e4. \uc81c\ud488 \uc124\uba85, \uc131\ub2a5 \uadfc\uac70, \uc548\uc804\uc131 \uc790\ub8cc, \uc0ac\uc6a9\uc790 \uc548\ub0b4\uc790\ub8cc\uac00 \uc11c\ub85c \ub2e4\ub978 \ubc29\ud5a5\uc73c\ub85c \uc791\uc131\ub418\uc9c0 \uc54a\ub3c4\ub85d \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<ul>\n<li>\uc0ac\uc6a9 \ubaa9\uc801\uacfc \uc81c\ud488 \uae30\ub2a5 \uc124\uba85\uc774 \uc77c\uad00\ub418\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc131\ub2a5 \ub610\ub294 \uc548\uc804\uc131 \uad00\ub828 \ud45c\ud604\uc774 \uadfc\uac70\uc790\ub8cc\uc640 \ub9de\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc81c\ucd9c\uc790\ub8cc \ubc94\uc704\uac00 \uc81c\ud488\uc758 \uc2e4\uc81c \uae30\ub2a5\uacfc \uc5c5\ub370\uc774\ud2b8 \ubc29\uc2dd\uc5d0 \ub9de\ub294\uc9c0 \uac80\ud1a0\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc790\ub8cc\uba85, \ubc84\uc804, \uc791\uc131\uc77c, \ubcc0\uacbd \uc774\ub825\uc774 \uad00\ub9ac\ub418\uace0 \uc788\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>\uc81c\ud488\uae30\ud68d\u00b7\uac1c\ubc1c \ub2e8\uacc4\uc5d0\uc11c \ud655\uc778\ud560 \uc0ac\ud56d<\/h2>\n<p>\uc81c\ud488\uae30\ud68d \ub2e8\uacc4\uc5d0\uc11c\ub294 \uae30\ub2a5 \uad6c\ud604\ub9cc\uc774 \uc544\ub2c8\ub77c \uaddc\uc81c\uc0c1 \uc0ac\uc6a9 \ubaa9\uc801\uacfc \uc0ac\uc6a9\uc790 \ub300\uc0c1\ub3c4 \ud568\uaed8 \uc815\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4. \uac1c\ubc1c \ucd08\uae30\uc5d0 \uc815\ub9ac\ud55c \uc81c\ud488 \uc815\uc758\uac00 \uc774\ud6c4 \ud5c8\uac00\u00b7\uc2ec\uc0ac \uc790\ub8cc\uc640 \ud45c\uc2dc\ubb38\uad6c\uc758 \uae30\uc900\uc774 \ub429\ub2c8\ub2e4.<\/p>\n<ul>\n<li>\uc81c\ud488\uc774 \uc81c\uacf5\ud558\ub294 \uae30\ub2a5\uacfc \uc758\ub8cc\uae30\uae30 \ud574\ub2f9 \uc5ec\ubd80\ub97c \uad6c\ubd84\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc0ac\uc6a9\uc790 \ub300\uc0c1, \uc0ac\uc6a9 \ud658\uacbd, \ub370\uc774\ud130 \uc785\ub825\u00b7\ucd9c\ub825 \ud750\ub984\uc744 \uba85\ud655\ud788 \ud569\ub2c8\ub2e4.<\/li>\n<li>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc5c5\ub370\uc774\ud2b8\uac00 \uc81c\ud488 \uc131\ub2a5\uc774\ub098 \uc0ac\uc6a9 \ubaa9\uc801\uc5d0 \uc601\ud5a5\uc744 \uc8fc\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc81c\ud488 \uae30\ub2a5 \uc124\uba85\uc774 \ud5c8\uac00\ub41c \uc0ac\uc6a9 \ubaa9\uc801\ubcf4\ub2e4 \ub113\uac8c \ubcf4\uc774\uc9c0 \uc54a\ub3c4\ub85d \uad00\ub9ac\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>\ud45c\uc2dc\u00b7\uad11\uace0 \ubc0f \uc0ac\uc6a9\uc790 \uc548\ub0b4 \ubb38\uad6c \uc810\uac80\uc0ac\ud56d<\/h2>\n<p>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \ud45c\uc2dc\u00b7\uad11\uace0 \ubb38\uad6c\ub294 \uc81c\ud488\uc758 \ud5c8\uac00 \ubc94\uc704\uc640 \uc0ac\uc6a9 \ubaa9\uc801\uc744 \uae30\uc900\uc73c\ub85c \uac80\ud1a0\ud574\uc57c \ud569\ub2c8\ub2e4. \ud64d\ubcf4 \ubb38\uad6c\uac00 \uc81c\ud488\uc758 \uae30\ub2a5\uc744 \uacfc\ub3c4\ud558\uac8c \ud655\uc7a5\ud558\uac70\ub098, \uc9c8\ubcd1 \uce58\ub8cc\u00b7\uc608\ubc29 \ub610\ub294 \ud6a8\ub2a5 \ubcf4\uc7a5\ucc98\ub7fc \ubcf4\uc774\uc9c0 \uc54a\ub3c4\ub85d \uc8fc\uc758\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<ul>\n<li>\ud5c8\uac00 \ubc94\uc704\ub97c \ubc97\uc5b4\ub09c \ud45c\ud604\uc774\ub098 \ub2e8\uc815\uc801\uc778 \uc131\ub2a5 \ud45c\ud604\uc774 \uc5c6\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc0ac\uc6a9\uc790 \uc548\ub0b4\ubb38\uacfc \uad11\uace0 \ubb38\uad6c\uac00 \uc11c\ub85c \ucda9\ub3cc\ud558\uc9c0 \uc54a\ub294\uc9c0 \uac80\ud1a0\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc571 \ud654\uba74, \uc6f9\ud398\uc774\uc9c0, \ube0c\ub85c\uc288\uc5b4, \uc601\uc5c5\uc790\ub8cc\uc758 \ud45c\ud604 \uc218\uc704\ub97c \ud568\uaed8 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\ud6a8\uacfc\ub97c \ubcf4\uc7a5\ud558\ub294 \ud45c\ud604 \ub300\uc2e0 \uadfc\uac70\uc790\ub8cc\uc640 \uc0ac\uc6a9 \ubaa9\uc801 \ubc94\uc704 \uc548\uc5d0\uc11c \uc124\uba85\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>\uc2e4\ubb34\uc790\uac00 \uc790\uc8fc \ub193\uce58\uae30 \uc26c\uc6b4 \ubd80\ubd84<\/h2>\n<p>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30\ub294 \ucd9c\uc2dc \uc774\ud6c4\uc5d0\ub3c4 \uc5c5\ub370\uc774\ud2b8, \uae30\ub2a5 \ucd94\uac00, \uc0ac\uc6a9\uc790 \uc548\ub0b4 \ubcc0\uacbd\uc774 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc791\uc740 \ubb38\uad6c \ubcc0\uacbd\uc774\ub098 \uae30\ub2a5 \uac1c\uc120\ucc98\ub7fc \ubcf4\uc774\ub294 \uc0ac\ud56d\ub3c4 \uc81c\ud488\uc758 \uc0ac\uc6a9 \ubaa9\uc801\uacfc \uc81c\ucd9c\uc790\ub8cc\uc5d0 \uc601\ud5a5\uc744 \uc904 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h3>\uc81c\ud488 \ubcc0\uacbd \ub610\ub294 \uc5c5\ub370\uc774\ud2b8 \uc2dc \ud655\uc778\uc0ac\ud56d<\/h3>\n<ul>\n<li>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubc84\uc804 \ubcc0\uacbd\uc774 \uc81c\ud488 \uc131\ub2a5 \ub610\ub294 \uc0ac\uc6a9 \ubaa9\uc801\uc5d0 \uc601\ud5a5\uc744 \uc8fc\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc54c\uace0\ub9ac\uc998, \ub370\uc774\ud130 \ucc98\ub9ac \ubc29\uc2dd, \uc0ac\uc6a9\uc790 \ud654\uba74 \ubcc0\uacbd \uc5ec\ubd80\ub97c \uae30\ub85d\ud569\ub2c8\ub2e4.<\/li>\n<li>\uc0ac\uc6a9\uc790 \uc548\ub0b4\ubb38, FAQ, \uad11\uace0 \ubb38\uad6c\uac00 \ubcc0\uacbd \uae30\ub2a5\uacfc \uc77c\uce58\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li>\ubcc0\uacbd \ubc1c\uc0dd \uc2dc \ucd94\uac00 \uac80\ud1a0 \ub610\ub294 \uc2e0\uace0 \ud544\uc694 \uc5ec\ubd80\ub97c \uacf5\uc2dd \uae30\uc900\uc5d0 \ub530\ub77c \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>KHS \ucf54\uba58\ud2b8<\/h2>\n<p>\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uac00\uc774\ub4dc\ub77c\uc778\uc740 \uac1c\ubc1c\ud300\ub9cc \ubcf4\ub294 \ubb38\uc11c\uac00 \uc544\ub2d9\ub2c8\ub2e4. \uc81c\ud488\uae30\ud68d, \uc778\ud5c8\uac00, \ud488\uc9c8, \ub9c8\ucf00\ud305, \ud574\uc678 \ub300\uc751 \ub2f4\ub2f9\uc790\uac00 \uac19\uc740 \uae30\uc900\uc73c\ub85c \uc81c\ud488 \uc124\uba85\uacfc \uc790\ub8cc\ub97c \ub9de\ucd94\ub294 \ub370 \ud544\uc694\ud55c \uc2e4\ubb34 \uae30\uc900\uc785\ub2c8\ub2e4.<\/p>\n<p>\uc81c\ud488 \uae30\ub2a5\uc744 \ub354 \uac15\ud558\uac8c \ubcf4\uc774\uac8c \ub9cc\ub4dc\ub294 \ubb38\uad6c\ubcf4\ub2e4, \ud5c8\uac00\ub41c \uc0ac\uc6a9 \ubaa9\uc801\uacfc \uadfc\uac70\uc790\ub8cc\uc5d0 \ub9de\ub294 \uc124\uba85\uc744 \uc720\uc9c0\ud558\ub294 \uac83\uc774 \ub354 \uc548\uc815\uc801\uc785\ub2c8\ub2e4. \ud2b9\ud788 \ub514\uc9c0\ud138 \uc81c\ud488\uc740 \uc5c5\ub370\uc774\ud2b8\uac00 \uc7a6\uae30 \ub54c\ubb38\uc5d0 \ubcc0\uacbd \uad00\ub9ac\uc640 \ud45c\uc2dc\u00b7\uad11\uace0 \uac80\ud1a0\ub97c \ud568\uaed8 \uc6b4\uc601\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\ucc38\uace0 \ubc0f \uc720\uc758\uc0ac\ud56d<\/h2>\n<p>\uc774 \uae00\uc740 \ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \uacf5\uc2dd \uac00\uc774\ub4dc\ub77c\uc778\uacfc \uc778\ud5c8\uac00 \ub3d9\ud5a5\uc744 \uc774\ud574\ud558\uae30 \uc704\ud55c \uc77c\ubc18 \uc815\ubcf4\uc785\ub2c8\ub2e4. \uac1c\ubcc4 \uc81c\ud488\uc758 \ud5c8\uac00\u00b7\uc2ec\uc0ac \uc790\ub8cc, \ud45c\uc2dc\u00b7\uad11\uace0 \ubb38\uad6c, \uc81c\ud488 \ubcc0\uacbd \uad00\ub9ac \uc5ec\ubd80\ub294 \uc81c\ud488\uc758 \uc0ac\uc6a9 \ubaa9\uc801, \uae30\ub2a5, \uadfc\uac70\uc790\ub8cc, \uad00\ub828 \ubc95\ub839\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\u203b \ubcf8 \uae00\uc740 \ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \uac00\uc774\ub4dc\ub77c\uc778\uacfc \uc778\ud5c8\uac00 \ub3d9\ud5a5\uc5d0 \ub300\ud55c \uc77c\ubc18 \uc815\ubcf4 \uc81c\uacf5\uc744 \ubaa9\uc801\uc73c\ub85c \uc791\uc131\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc2e4\uc81c \ud5c8\uac00\u00b7\uc2ec\uc0ac, \ud45c\uc2dc\u00b7\uad11\uace0 \uac80\ud1a0, \uc81c\ud488 \ubcc0\uacbd \ubc0f \uc778\ud5c8\uac00 \ud310\ub2e8\uc740 \uad00\ub828 \ubc95\ub839\uacfc \uacf5\uc2dd \uc790\ub8cc\ub97c \uae30\uc900\uc73c\ub85c \uac1c\ubcc4 \ud655\uc778\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \ubcf8 \uae00\uc740 \uc9c8\ubcd1\uc758 \uce58\ub8cc\u00b7\uc608\ubc29 \ub610\ub294 \ud2b9\uc815 \uc81c\ud488\uc758 \ud6a8\ub2a5, \ud5c8\uac00 \ub610\ub294 \uc778\uc99d\uc744 \ubcf4\uc7a5\ud558\ub294 \ub0b4\uc6a9\uc774 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>Based on the revised official guidelines for digital medical devices, we have compiled practical checkpoints to consider during the preparation of approval\/review documents, product planning, and review of labeling\/advertising.<\/p>","protected":false},"author":3,"featured_media":490,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[65,9],"tags":[66,21,20,24,67],"class_list":["post-336","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-65","category-regulation-claims","tag-66","tag-21","tag-20","tag-24","tag-67"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.9 - aioseo.com -->\n\t<meta name=\"description\" content=\"\ub514\uc9c0\ud138 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \uacf5\uc2dd \uac00\uc774\ub4dc\ub77c\uc778 \uac1c\uc815 \ub0b4\uc6a9\uc744 \ubc14\ud0d5\uc73c\ub85c \ud5c8\uac00\u00b7\uc2ec\uc0ac \uc790\ub8cc \uc900\ube44, 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