{"id":474605,"date":"2024-02-19T09:51:59","date_gmt":"2024-02-19T01:51:59","guid":{"rendered":"https:\/\/law.asia\/?p=474605"},"modified":"2024-03-19T10:08:02","modified_gmt":"2024-03-19T02:08:02","slug":"healthtech-regulatory-issues-japan","status":"publish","type":"post","link":"https:\/\/law.asia\/ko\/healthtech-regulatory-issues-japan\/","title":{"rendered":"\ubd81\uc544\uc2dc\uc544\uc758 \uc758\ub8cc \uae30\uc220 \uaddc\uc81c \ubb38\uc81c \ube44\uad50: \uc77c\ubcf8"},"content":{"rendered":"<div id=\"_idContainer040\" class=\"Basic-Text-Frame\">\n<table style=\"margin-top: 0px; height: 12px;\" width=\"700\">\n<tbody style=\"border: 1px solid transparent; width: 100%; background-color: #f79433;\">\n<tr style=\"border: 1px solid transparent;\">\n<td style=\"width: 25%; margin: 0px; padding-top: 5px; padding-bottom: 5px; border-right: 2px solid #ffffff;\" valign=\"middle\">\n<p style=\"margin-bottom: 0px; text-align: center;\"><b>\uc77c\ubcf8<\/b><\/p>\n<\/td>\n<td style=\"width: 25%; margin: 0px; padding-top: 5px; padding-bottom: 5px; border-right: 2px solid #ffffff;\" valign=\"middle\">\n<p style=\"margin-bottom: 0px; text-align: center;\"><a href=\"https:\/\/law.asia\/ko\/healthtech-regulatory-issues-korea\/\"><span style=\"color: #ffffff;\"><b>\ud55c\uad6d<\/b><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\uc77c\ubcf8\uc5d0\uc11c \ud5ec\uc2a4\ucf00\uc5b4 \uae30\uc220\uc740 \ud070 \uc8fc\ubaa9\uc744 \ubc1b\uace0 \uc788\uace0, \uc77c\ubcf8 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5\uc758 \uc2dc\uc7a5 \uaddc\ubaa8\ub294 \uc9c0\uc18d\uc801\uc73c\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub41c\ub2e4. \uc77c\ubcf8 \uacbd\uc81c\uc0b0\uc5c5\uc131\uc758 \ubcf4\uace0\uc11c\uc5d0 \ub530\ub974\uba74, 2025\ub144\uc5d0\ub294 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5\uc758 \uac00\uce58\uac00 33\uc870 \uc5d4(2,300\uc5b5 \ub2ec\ub7ec)\uc5d0 \ub2ec\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub41c\ub2e4. \ub610\ud55c \uc77c\ubcf8 \ud2b9\ud5c8\uccad\uc5d0 \ub530\ub974\uba74, \ud5ec\uc2a4\ucf00\uc5b4 \uae30\uc220\uc5d0 \ub300\ud55c \ud2b9\ud5c8 \ucd9c\uc6d0\uc740 \uafb8\uc900\ud788 \uc99d\uac00\ud558\uace0 \uc788\uc73c\uba70, 2013\ub144\ubd80\ud130 2019\ub144\uae4c\uc9c0 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \ub450 \ubc30\ub85c \uc99d\uac00\ud588\ub2e4. \uc77c\ubcf8 \uc815\ubd80\ub294 \ud5ec\uc2a4\ud14c\ud06c\uc640 \uc758\ub8cc \ub514\uc9c0\ud138 \uc804\ud658(DX)\uc744 \uc7a5\ub824\ud558\uace0 \uc788\ub2e4. 2022\ub144 \ub0b4\uac01\ubd80(\u5167\u95a3\u5e9c)\uc5d0 \u2018\uc758\ub8cc DX \ucd94\uc9c4 \ubcf8\ubd80\u2019\ub97c \uc124\ub9bd\ud558\uc5ec DX\uc758 \uc9c4\ucc99 \uc0c1\ud669\uc744 \uacf5\uc720\ud558\uace0 \uac80\uc99d\ud558\uace0 \uc788\ub2e4. \uc774 \ubcf8\ubd80\uc758 \uc5ed\ud560\uc740 \uac1c\uc778\uac74\uac15\uae30\ub85d(PHR)\uc758 \ud65c\uc6a9\uc744 \ucd09\uc9c4\ud558\ub294 \uac83\uc73c\ub85c \ubcf4\uc774\uba70, \uad6d\uac00 \uc2e0\ubd84\uc99d\uc774 PHR\uc758 \ucd9c\ubc1c\uc810\uc774 \ub420 \uac83\uc73c\ub85c \uae30\ub300\ud558\uace0 \uc788\ub2e4. \uc5b4\ub5a4 \ubc29\ud5a5\uc774\ub4e0 \uac1c\uc778 \uc815\ubcf4 \ubcf4\ud638\ub294 \uc758\ub8cc DX\ub97c \ud3ec\ud568\ud55c \ud5ec \ud14c\ud06c \ubd84\uc57c\uc5d0\uc11c \uc911\uc694\ud55c \ubc95\uc801 \ubb38\uc81c\uc774\ub2e4.<\/p>\n<h2 class=\"Normal\" style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong><span class=\"CharOverride-16\">\uc815\ubcf4 \uacf5\uc720 \ubb38\uc81c<\/span><\/strong><\/span><\/h2>\n<figure id=\"attachment_469490\" aria-describedby=\"caption-attachment-469490\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469493 size-full\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/Koji-Sugimura.jpg\" alt=\"Koji Sugimura\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469490\" class=\"wp-caption-text\"><strong>Koji Sugimura<\/strong><br \/>\ub300\ud45c \ud30c\ud2b8\ub108, \ubcc0\ud638\uc0ac<br \/>\ubc95\ub960\/\ud2b9\ud5c8 \uc804\ubb38 \ubcc0\ud638\uc0ac<br \/>SUGIMURA &amp; Partners<br \/>Tokyo<br \/>\uc774\uba54\uc77c: <a href=\"mailto:kjs@sugimura.partners\">kjs@sugimura.partners<\/a><\/figcaption><\/figure>\n<p>\uc758\ub8cc DX\ub294 \ub300\ub7c9\uc758 \uc758\ub8cc \uc815\ubcf4 \uac00\uc6a9\uc131\uc744 \uac1c\uc120\ud558\uace0 \uac1c\uc778\uc815\ubcf4\ub97c \uc801\uc808\ud788 \ubcf4\ud638\ud574\uc57c \ud558\ub294 \uc0c1\ucda9\ub418\ub294 \ubb38\uc81c\ub97c \ub3d9\uc2dc\uc5d0 \ud574\uacb0\ud574\uc57c \ud55c\ub2e4.<\/p>\n<p>\uc758\ub8cc \uc815\ubcf4\ub294 \ub2f9\uc5f0\ud788 &#8216;\uac1c\uc778\uc815\ubcf4&#8217;\ub85c \ubd84\ub958\ub418\uc5b4 \uc77c\ubcf8\uc758 \uac1c\uc778\uc815\ubcf4\ubcf4\ud638\ubc95(APPI)\uc5d0 \ub530\ub77c \ubcf4\ud638\ub41c\ub2e4. \ub610\ud55c \uc758\ub8cc \uc815\ubcf4\ub294 &#8216;\ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4&#8217;\ub85c\uc11c \ub354\uc6b1 \uac15\ub825\ud55c \ubcf4\ud638\ub97c \ubc1b\ub294\ub2e4.<\/p>\n<p>\uc6d0\uce59\uc801\uc73c\ub85c, APPI\ub294 \uc815\ubcf4 \uc8fc\uccb4\uac00 \uc790\uc2e0\uc758 \ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\ub97c \uc81c3\uc790\uc5d0\uac8c \uc81c\uacf5\ud558\ub294 \uac83\uc5d0 \ub3d9\uc758\ud558\ub3c4\ub85d \uc694\uad6c\ud55c\ub2e4. \uadf8\ub7ec\ub098 \uc5f0\uad6c \ub4f1 \ub300\ub7c9\uc758 \uc758\ub8cc \uc815\ubcf4\ub97c \uc218\uc9d1\ud558\uace0 \ubd84\uc11d\ud558\uace0\uc790 \ud558\ub294 \uc758\ub8cc \uae30\uad00\uc758 \uacbd\uc6b0\uc5d0 \uac1c\ubcc4\uc801\uc778 \ub3d9\uc758\ub294 \ud604\uc2e4\uc801\uc778 \uc5b4\ub824\uc6c0\uc774 \uc788\ub2e4.<\/p>\n<p>APPI\ub294 \uc758\ub8cc \uc815\ubcf4\ub97c \ud3ec\ud568\ud55c \ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\ub97c \uac1c\uc778 \uc2dd\ubcc4\uc774 \ubd88\uac00\ub2a5\ud558\ub3c4\ub85d \uc775\uba85 \ucc98\ub9ac\ud55c \uacbd\uc6b0\uc5d0\ub294 \uc815\ubcf4 \uc8fc\uccb4\uc758 \ub3d9\uc758 \uc5c6\uc774 \uc81c3\uc790\uc5d0\uac8c \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \ub300\uc548\uc744 \uc81c\uc2dc\ud55c\ub2e4. \uadf8\ub7ec\ub098, \uc774 \ub300\uc548\uc744 \uc774\uc6a9\ud560 \uacbd\uc6b0 \uac01 \uc758\ub8cc\uae30\uad00\uc740 \ub370\uc774\ud130\ub97c \uc775\uba85\ud654\ud574\uc57c \ud558\ub294 \uc218\uace0\ub97c \ubd80\ub2f4\ud574\uc57c \ud55c\ub2e4. \ub610 \ub2e4\ub978 \ubb38\uc81c\ub294 \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130\uc5d0 \uc0c1\ud638 \ucc38\uc870 \uc815\ubcf4\uac00 \uc5c6\uae30 \ub54c\ubb38\uc5d0 \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc81c\uacf5\ubc1b\ub294 \uc5f0\uad6c \uae30\uad00\uc740 \uae30\uad00 \uac04 \ubd84\uc11d\uc744 \uc218\ud589\ud560 \uc218 \uc5c6\ub2e4\ub294 \uc810\uc774\ub2e4.<\/p>\n<h2 class=\"Normal\" style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong><span class=\"CharOverride-16\">\ucc28\uc138\ub300 \ubc95<\/span><\/strong><\/span><\/h2>\n<p>\uc774\ub7ec\ud55c \ubb38\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud574 2018\ub144 5\uc6d4 11\uc77c \ucc28\uc138\ub300 \uc758\ub8cc \uc778\ud504\ub77c \ubc95(NGMIL, \uc815\uc2dd \uba85\uce6d\uc740 \u2018\uc758\ub8cc \ubd84\uc57c \uc5f0\uad6c \ubc0f \uac1c\ubc1c\uc5d0 \uae30\uc5ec\ud558\uae30 \uc704\ud55c \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130\uc5d0 \uad00\ud55c \ubc95\ub960\u2019)\uc774 \uc81c\uc815\ub418\uc5c8\ub2e4.<\/p>\n<p>\uc774\uac83\uc740 \uac74\uac15\uac80\uc9c4 \uacb0\uacfc, \uc9c4\ub8cc\uae30\ub85d \ub4f1 \uc775\uba85\ud654\ub41c \uac1c\uc778 \uc758\ub8cc\uc815\ubcf4\ub97c \uc758\ub8cc \ubd84\uc57c\uc5d0\uc11c \uc5f0\uad6c\uac1c\ubc1c\uc5d0 \ud65c\uc6a9\ud558\ub294 \uac83\uc744 \ucd09\uc9c4\ud558\uae30 \uc704\ud574 \ub9c8\ub828\ub41c \ubc95\uc774\ub2e4. \ub610\ud55c \uc2e0\uccad \uc0ac\uc5c5\uc790(\uc815\ubcf4 \uc0dd\uc0b0\uc790)\uac00 \ud2b9\uc815\uc758 \uae30\uc220\uc801 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294\uc9c0(\uc608\ub97c \ub4e4\uba74, \ub192\uc740 \uc218\uc900\uc758 \uc815\ubcf4 \ubcf4\uc548\uc744 \ubcf4\uc7a5\ud560 \uc218 \uc788\ub294\uc9c0, \ucda9\ubd84\ud55c \uc775\uba85\ud654 \uae30\uc220\uc744 \ubcf4\uc720\ud558\uace0 \uc788\ub294\uc9c0 \ub4f1), \uc2e0\uccad \uc0ac\uc5c5\uc790\uac00 \uc758\ub8cc\uc815\ubcf4\uc758 \uad00\ub9ac \ubc0f \ud65c\uc6a9\uc744 \uc704\ud574 \uc775\uba85\ud654 \uc791\uc5c5\uc744 \uc801\uc808\ud558\uace0 \uc548\uc815\uc801\uc73c\ub85c \uc218\ud589\ud560 \uc218 \uc788\ub294\uc9c0\uc5d0 \ub300\ud574 \uc815\ubd80\uac00 \uc2ec\uc0ac\ud558\ub294 \uc778\uc99d \uc81c\ub3c4\ub97c \ub9c8\ub828\ud558\uace0 \uc788\ub2e4.<\/p>\n<p>\uc758\ub8cc\uae30\uad00\uc740 \uc815\ubcf4 \uc8fc\uccb4\uac00 \uc815\ubcf4 \uc81c\uacf5\uc744 \uac70\ubd80(\uc635\ud2b8\uc544\uc6c3)\ud560 \ub54c\uae4c\uc9c0 \uc778\uc99d\ub41c \uc815\ubcf4 \uc0dd\uc0b0\uc790\uc5d0\uac8c \uc758\ub8cc \uc815\ubcf4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub2e4. \uc778\uc99d\ub41c \uc815\ubcf4 \uc0dd\uc0b0\uc790\ub294 \uc815\ubcf4\ub97c \uc775\uba85\ud654\ud558\uace0, \uc774\ub807\uac8c \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc758\ub8cc \uc5f0\uad6c \ubc0f \uac1c\ubc1c\uc744 \uc704\ud574 \uc5f0\uad6c \uae30\uad00\uc5d0 \uc81c\uacf5\ud560 \uc218 \uc788\ub2e4.<\/p>\n<p>\ub2ec\ub9ac \ub9d0\ud558\uba74, \uc815\ubcf4 \uc8fc\uccb4\uac00 \uc81c\uacf5\uc744 \uac70\ubd80\ud558\uc9c0 \uc54a\ub294 \ud55c \uc778\uc99d\ub41c \uc815\ubcf4 \uc0dd\uc0b0\uc790\uc5d0\uac8c\ub9cc \uc758\ub8cc \uc815\ubcf4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub3c4\ub85d \ud568\uc73c\ub85c\uc368 \uac1c\uc778\uc758 \uad8c\uc775\uc744 \ubcf4\ud638\ud558\uace0 \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc744 \ucd09\uc9c4\ud558\ub294 \uba54\ucee4\ub2c8\uc998\uc744 \uac1c\ubc1c\ud558\ub294 \uac83\uc774 NGMIL\uc758 \ubaa9\ud45c\uc600\ub2e4.<\/p>\n<h2 class=\"Normal\" style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong><span class=\"CharOverride-16\">NGMIL \uac1c\uc815<\/span><\/strong><\/span><\/h2>\n<figure id=\"attachment_469494\" aria-describedby=\"caption-attachment-469494\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469497 size-full\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/Mitsukuni-Terada.jpg\" alt=\"Mitsukuni Terada\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469494\" class=\"wp-caption-text\"><strong>Mitsukuni Terada<\/strong><br \/>\ubc95\ubb34 \ud300\uc7a5,<br \/>\ubcc0\ud638\uc0ac<br \/>\ubc95\ub960\/\ud2b9\ud5c8 \uc804\ubb38 \ubcc0\ud638\uc0ac<br \/>SUGIMURA &amp; Partners <br \/>Tokyo<br \/>\uc774\uba54\uc77c: <a href=\"mailto:m.terada@sugimura.partners\">m.terada@sugimura.partners<\/a><\/figcaption><\/figure>\n<p>\uadf8\ub7ec\ub098 \uba87 \uac00\uc9c0 \ubb38\uc81c\ub4e4\uc740 \uc5ec\uc804\ud788 \ud574\uacb0\ub418\uc9c0 \uc54a\uc558\ub2e4. \uc778\uc99d\ub41c \uc815\ubcf4 \uc0dd\uc0b0\uc790\ub294 \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130 \ud615\ud0dc\ub85c\ub9cc \uc5f0\uad6c \uae30\uad00\uc5d0 \ub370\uc774\ud130\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub294\ub370, \uadf8 \uc758\ubbf8\ub294 \ub2e4\uc74c\uacfc \uac19\ub2e4.<\/p>\n<ol>\n<li>\uc5f0\uad6c\uae30\uad00\uc774 \uc18c\uc218\uc758 \uc758\ub8cc \uc0ac\ub840\uc640 \uace0\uc720 \ub370\uc774\ud130\uac00 \ud3ec\ud568\ub41c \ub370\uc774\ud130\ub97c \uc6d0\ud558\ub354\ub77c\ub3c4 \ub2e4\ub978 \ub370\uc774\ud130\uc640 \uacb0\ud569\ud560 \uacbd\uc6b0\uc5d0\ub294 \ud2b9\uc815 \uac1c\uc778\uc744 \uc2dd\ubcc4\ud560 \uc218 \uc788\uae30 \ub54c\ubb38\uc5d0 \uc774\ub7ec\ud55c \ub370\uc774\ud130\ub294 \uc0ac\uc2e4\uc0c1 \uc0ac\uc6a9\ud560 \uc218 \uc5c6\ub2e4.<\/li>\n<li>\uac1c\uc815 \uc804 NGMIL \ud558\uc5d0\uc11c\ub294 \ud658\uc790 \uc0c1\ud0dc\uc758 \uc2dc\uac04\uc801 \ubcc0\ud654\ub97c \ucd94\uc801\ud558\uae30 \uc704\ud574 \uac1c\ubcc4 \ud658\uc790\uc758 \uc758\ub8cc \ub370\uc774\ud130\ub97c \uacc4\uc18d \uc81c\uacf5\ud558\ub294 \uac83\uc774 \uac70\uc758 \ubd88\uac00\ub2a5\ud558\ub2e4.<\/li>\n<li>\uc5f0\uad6c\uae30\uad00\uc774 \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \ubd84\uc11d\ud55c \ud6c4 \ucd94\uac00 \uc5f0\uad6c\uac00 \ud544\uc694\ud558\ub2e4\ub294 \uc0ac\uc2e4\uc744 \ubc1c\uacac\ud558\ub354\ub77c\ub3c4, \uc815\ubcf4 \uc8fc\uccb4\uc758 \uc758\ub8cc \uae30\ub85d\uc5d0\uc11c \uc775\uba85\ud654\ub41c \uc758\ub8cc \ub370\uc774\ud130 \ud615\ud0dc\ub85c \ub2e4\ub978 \uc758\ub8cc \uc815\ubcf4\ub97c \uc81c\uacf5\ubc1b\ub294 \uac83\uc740 \uac70\uc758 \ubd88\uac00\ub2a5\ud558\ub2e4.<\/li>\n<li>\uc758\ub8cc \uae30\ub85d\uacfc \uac19\uc740 \ucd5c\ucd08\uc758 \uc758\ub8cc \uc815\ubcf4\ub97c \ub2e4\uc2dc \ucc38\uc870\ud558\uc5ec \uc775\uba85\ud654\ub41c \ud2b9\uc815 \uc758\ub8cc \ub370\uc774\ud130\uc758 \uc2e0\ub8b0\uc131\uc744 \uac80\uc99d\ud558\ub294 \uac83\uc774 \ubc14\ub78c\uc9c1\ud558\uc9c0\ub9cc \uc774\uac83 \ub610\ud55c \uac00\ub2a5\ud558\uc9c0 \uc54a\ub2e4.<\/li>\n<\/ol>\n<p>\uc774\ub7ec\ud55c \ubb38\uc81c\ub4e4\uc744 \ud574\uacb0\ud558\uae30 \uc704\ud574 2023\ub144 5\uc6d4\uc5d0 &#8216;\uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130&#8217;\ub77c\ub294 \uc0c8\ub85c\uc6b4 \ub370\uc774\ud130 \ubc94\uc8fc\ub97c \ud3ec\ud568\ud558\ub3c4\ub85d NGMIL\uc774 \uac1c\uc815\ub418\uc5c8\ub2e4. \uac1c\uc815\ub41c \ubc95\uc740 \uacf5\ud3ec \ud6c4 1\ub144 \uc774\ub0b4, \uc989 2024\ub144 5\uc6d4\ubd80\ud130 \uc2dc\ud589\ub420 \uc608\uc815\uc774\ub2e4.<\/p>\n<p>\ub2e4\ub978 \uc815\ubcf4\uc640 \uc77c\uce58\ud558\uc9c0 \uc54a\ub294 \ud55c, \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub294 \uac1c\uc778\uc744 \uc2dd\ubcc4\ud560 \uc218 \uc5c6\ub3c4\ub85d \ucc98\ub9ac\ub41c \ub370\uc774\ud130\uc774\ub2e4. \uc774\ub7ec\ud55c \uc0c8\ub85c\uc6b4 \ub370\uc774\ud130 \ubc94\uc8fc\ub85c \ubd84\ub958\ub418\uae30 \uc704\ud574 \uac1c\uc778 \uc758\ub8cc \uc815\ubcf4\uc5d0\uc11c \uace0\uc720 \ub370\uc774\ud130\ub97c \uc0ad\uc81c\ud560 \ud544\uc694\ub294 \uc5c6\ub2e4. \uadf8\ub7ec\ub098 \uc774\ub984\uacfc \uae30\ud0c0 \uc2dd\ubcc4 \uc815\ubcf4\ub294 \uc0ad\uc81c\ud574\uc57c \ud55c\ub2e4.<\/p>\n<p><strong>\uac1c\uc815\ub41c \ubc95\uc740 \ub2e4\uc74c\uacfc \uac19\uc740 \uba54\ucee4\ub2c8\uc998\uc744 \uad6c\ucd95\ud55c\ub2e4<\/strong><strong>:<\/strong><\/p>\n<p>\uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc0dd\uc131\ud558\uace0 \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \uc815\ubcf4 \uc0dd\uc0b0\uc790\ub97c \uc778\uc99d\ud558\uace0, \uc778\uc99d\ub41c \uc815\ubcf4 \uc0dd\uc0b0\uc790\uac00 \uc548\uc804 \uad00\ub9ac \ub4f1\uc758 \uae30\uc900\uc5d0 \ub530\ub77c \uc815\ubd80\uac00 \uc778\uc99d\ud55c \uc0ac\uc6a9\uc790\uc5d0\uac8c\ub9cc \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub3c4\ub85d \ud5c8\uc6a9\ud55c\ub2e4.<\/p>\n<p>\uc815\ubd80\uac00 \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc0dd\uc131\ud558\uace0 \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \uc815\ubcf4 \uc0dd\uc0b0\uc790\ub97c \uc778\uc99d\ud558\ub294 \uccab \ubc88\uc9f8 \uba54\ucee4\ub2c8\uc998\uc740 \uc775\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\uc758 \uba54\ucee4\ub2c8\uc998\uacfc \uacf5\ud1b5\ub41c \uad6c\uc870\ub97c \uac00\uc9c0\uace0 \uc788\ub2e4. \ubc18\uba74\uc5d0 \ub450 \ubc88\uc9f8 \uba54\ucee4\ub2c8\uc998\uc740 \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\uc5d0\ub9cc \ud574\ub2f9\ud558\ub294 \uad6c\uc870\uc774\ub2e4.<\/p>\n<p>\uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub294 \uc775\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ubcf4\ub2e4 \uac1c\uc778 \uc2dd\ubcc4\uc774 \uac00\ub2a5\ud560 \uc704\ud5d8\uc131\uc774 \ud6e8\uc52c \ud06c\uae30 \ub54c\ubb38\uc5d0 \uc815\ubd80\uc758 \uc778\uc99d\uc744 \ud1b5\ud574 \uc815\ubcf4 \uc0ac\uc6a9\uc790\ub3c4 \uc81c\ud55c\uc744 \ubc1b\ub294\ub2e4. \ub610\ud55c, \uc758\uc57d\ud488 \uc2dc\ud310 \ud5c8\uac00\ub97c \uc2e0\uccad\ud560 \ubaa9\uc801\uc73c\ub85c \uc778\uc99d\ub41c \uc815\ubcf4 \uc0ac\uc6a9\uc790\ub294 \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130 \uba54\ucee4\ub2c8\uc998\uc5d0 \ub530\ub77c \uc758\uc57d\ud488 \uc758\ub8cc\uae30\uae30 \uc885\ud569\uae30\uad6c(PMDA) \ubc0f \uc678\uad6d\uc758 \uaddc\uc81c \ub2f9\uad6d\uc5d0 \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\uc73c\uba70, \uc778\uc99d\ub41c \uc815\ubcf4 \uc0dd\uc0b0\uc790\ub294 \uc6d0\ubcf8 \ub370\uc774\ud130\ub97c \ub2f9\uad6d\uc5d0 \uc81c\ucd9c\ud560 \uc218 \uc788\ub2e4.<\/p>\n<h2 class=\"Normal\" style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong><span class=\"CharOverride-16\">\uc720\ub7fd\uc758 \uacbd\uc6b0<\/span><\/strong><\/span><\/h2>\n<figure id=\"attachment_469498\" aria-describedby=\"caption-attachment-469498\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469501 size-full\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/Takuya-Izumi.jpg\" alt=\"Takuya Izumi\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469498\" class=\"wp-caption-text\"><strong>Takuya Izumi<\/strong><br \/>\uae00\ub85c\ubc8c \uc0ac\uc5c5 \ubcf8\ubd80\uc7a5,<br \/>\ud2b9\ud5c8 \uc804\ubb38 \ubcc0\ud638\uc0ac<br \/>SUGIMURA &amp; Partners <br \/>Tokyo<br \/>\uc774\uba54\uc77c: <a href=\"mailto:t.izumi@sugimura.partners\">t.izumi@sugimura.partners<\/a><\/figcaption><\/figure>\n<p>\uac1c\uc815\ub41c NGMIL\uc740 \uc758\ub8cc \ub370\uc774\ud130\uc758 1\ucc28 \ubc0f 2\ucc28 \uc0ac\uc6a9\uc744 \uaddc\uc81c\ud558\uae30 \uc704\ud574 \uc720\ub7fd\uc5f0\ud569 \uc9d1\ud589\uc704\uc6d0\ud68c\uc5d0\uc11c \uc81c\uc548\ud55c \uc720\ub7fd \uac74\uac15 \ub370\uc774\ud130 \uacf5\uac04(EHDS)\uacfc \uacf5\ud1b5\uc810\uc774 \uc788\ub294 \uac83\uc73c\ub85c \ubcf4\uc778\ub2e4. \uc544\ub798 \ucc38\uace0:<\/p>\n<p>1\ucc28 \uc0ac\uc6a9\uc774\ub780 \ub370\uc774\ud130 \uc8fc\uccb4\uac00 \uc0ac\uc6a9\ud558\ub294 \uac83\uc744 \ub9d0\ud558\uba70, \uc774\ub97c \ud1b5\ud574 \ud658\uc790\ub294 \uc758\ub8cc \uae30\ub85d\uacfc \ucc98\ubc29\uc804 \ubc0f \uac80\uc0ac \uacb0\uacfc\ub97c EU \ud68c\uc6d0\uad6d \uac04\uc5d0 \ud638\ud658\ub418\ub294 \uc804\uc790 \ub370\uc774\ud130\ub85c \ubcf4\uad00\ud560 \uc218 \uc788\ub2e4. 2\ucc28 \uc0ac\uc6a9\uc774\ub780 \uc5f0\uad6c\uac1c\ubc1c, \uc815\ucc45 \uc218\ub9bd \ub4f1\uc5d0 \ud65c\uc6a9\ud558\ub294 \uac83\uc744 \ub9d0\ud55c\ub2e4.<\/p>\n<p>\uc81c\uc548\ub41c EHDS\uc5d0\uc11c, \ud68c\uc6d0\uad6d\uc740 2\ucc28 \uc0ac\uc6a9\uc744 \uc704\ud574 \uc804\uc790 \uac74\uac15 \ub370\uc774\ud130\uc5d0 \ub300\ud55c \uc811\uadfc \uad8c\ud55c\uc744 \ubd80\uc5ec\ud560 \ucc45\uc784\uc774 \uc788\ub294 \ud558\ub098 \uc774\uc0c1\uc758 \uac74\uac15 \ub370\uc774\ud130 \uc811\uadfc \uae30\uad00(HDAB)\uc744 \uc9c0\uc815\ud574\uc57c \ud55c\ub2e4. \ub370\uc774\ud130 \uc0ac\uc6a9\uc790\ub294 HDAB\uc5d0 \ub370\uc774\ud130 \uc811\uadfc \uad8c\ud55c\uc744 \uc2e0\uccad\ud560 \uc218 \uc788\uace0, \uad8c\ud55c\uc774 \ubd80\uc5ec\ub418\uba74 \uac74\uac15 \ub370\uc774\ud130\ub97c \uc0ac\uc6a9\ud560 \uc218 \uc788\ub2e4.<\/p>\n<p>\uc81c\uc548\ub41c \ud2c0 \ub0b4\uc5d0\uc11c, \ub370\uc774\ud130 \uc0ac\uc6a9\uc790\ub294 HDAB\uac00 \ucc98\ub9ac\ud55c \uc775\uba85\ud654 \ub610\ub294 \uac00\uba85 \ucc98\ub9ac\ub41c \uac74\uac15 \ub370\uc774\ud130\ub9cc \uc0ac\uc6a9\ud560 \uc218 \uc788\ub2e4. \uc815\ubd80\uac00 \uc9c0\uc815\ud55c \ud2b9\uc815 \uae30\uad00\uc774 \ub370\uc774\ud130 \uc81c\uacf5\uc790 \ubc0f \ub370\uc774\ud130 \ucc98\ub9ac\uc790 \uc5ed\ud560\uc744 \ud558\uba74\uc11c \uc775\uba85\ud654 \ub610\ub294 \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \uc815\ubcf4\ub97c \uc774\uc6a9\ud560 \uc218 \uc788\ub3c4\ub85d \ud568\uc73c\ub85c\uc368 \uc758\ub8cc \uc815\ubcf4\uc758 \uad11\ubc94\uc704\ud55c \ud65c\uc6a9\uc744 \ubaa9\ud45c\ub85c \ud55c\ub2e4\ub294 \uc810\uc5d0\uc11c \uac1c\uc815\ub41c NGMIL\uc740 EHDS \uc81c\uc548\uc758 2\ucc28 \ud65c\uc6a9 \uba54\ucee4\ub2c8\uc998\uacfc \uacf5\ud1b5\uc810\uc774 \uc788\ub2e4\uace0 \ud560 \uc218 \uc788\ub2e4.<\/p>\n<p>\uc77c\ubcf8\uc758 \uac1c\uc778\uc815\ubcf4 \ubcf4\ud638 \uc2dc\uc2a4\ud15c\uc740 \uc815\ubcf4 \uc8fc\uccb4\uc758 \ub3d9\uc758\uc5d0 \ud06c\uac8c \uc758\uc874\ud558\uace0 \uc788\ub2e4. \uadf8\ub7ec\ub098 \uac1c\uc815\ub41c NGMIL\uacfc \uc81c\uc548\ub41c EHDS \ub4f1 \uc815\ubcf4 \uc8fc\uccb4\uc758 \ub3d9\uc758 \uc5c6\uc774 \uac1c\uc778\uc815\ubcf4\ub97c \ud65c\uc6a9\ud560 \uc218 \uc788\ub294 \uc81c\ub3c4 \uc124\uacc4\uac00 \uc787\ub530\ub77c \uac80\ud1a0\ub418\uace0 \uc788\ub2e4\ub294 \uc0ac\uc2e4\uc740 \uc77c\ubcf8\uc5d0\uc11c\ub3c4 \ub3d9\uc758 \uc911\uc2ec\uc758 \uac1c\uc778\uc815\ubcf4 \ubcf4\ud638 \uc811\uadfc \ubc29\uc2dd \uc790\uccb4\ub97c \uc7ac\uac80\ud1a0\ud574\uc57c \ud55c\ub2e4\ub294 \uac83\uc744 \uc2dc\uc0ac\ud558\ub294 \uac83\uc73c\ub85c \ubcf4\uc778\ub2e4.<\/p>\n<h2 class=\"Normal\" style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong><span class=\"CharOverride-16\">\uc804\ub9dd<\/span><\/strong><\/span><\/h2>\n<p>NGMIL\uacfc \uadf8 \uac1c\uc815\uc548\uc740 \uc758\ub8cc \uc815\ubcf4\uc758 \ud65c\uc6a9\uc744 \ucd09\uc9c4\ud558\uae30 \uc704\ud55c \uac83\uc73c\ub85c, \uc758\uc2ec\ud560 \uc5ec\uc9c0\uc5c6\uc774 \uba87 \uac00\uc9c0 \uc2e4\uc9c8\uc801\uc778 \ubb38\uc81c\ub97c \ud574\uacb0\ud588\ub2e4. \uadf8\ub7fc\uc5d0\ub3c4 \ubd88\uad6c\ud558\uace0, \uc2dc\uc2a4\ud15c \uc790\uccb4\uc5d0 \ub300\ud55c \uc778\uc2dd \ubd80\uc871\uc73c\ub85c \ud06c\uac8c \ud65c\uc6a9\ub418\uc9c0 \ubabb\ud558\ub294 \ubd80\ubd84\ub3c4 \uc788\ub2e4.<\/p>\n<p>\ubb3c\ub860 \uc774\uac83\uc774 \uc55e\uc73c\ub85c\ub3c4 \ub9ce\uc774 \ud65c\uc6a9\ub418\uc9c0 \uc54a\uc744 \uac83\uc774\ub77c\ub294 \uc758\ubbf8\ub294 \uc544\ub2c8\ub2e4. \uc800\uc790\ub4e4\uc740 \uc758\ub8cc DX\uc758 \ucd94\uc9c4\ub825\uc740 \uc57d\ud654\ub418\uc9c0 \uc54a\uc744 \uac83\uc774\ub77c\uace0 \uc0dd\uac01\ud55c\ub2e4. \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc640 \uae30\ud0c0 \ud50c\ub7ab\ud3fc\uc774 \uac1c\ubc1c\ub418\uace0 \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc774 \ub354\uc6b1 \ud65c\ubc1c\ud574\uc9c0\uba74 \uc758\ub8cc \ubd84\uc57c\uc5d0 \uc815\ud1b5\ud55c \uac1c\uc778\uc815\ubcf4 \ubcf4\ud638\ubc95 \uc804\ubb38\uac00\uc5d0 \ub300\ud55c \uc218\uc694 \ub610\ud55c \ud55c\uce35 \ucee4\uc9c8 \uac83\uc774\ub2e4.<\/p>\n<\/div>\n<div id=\"_idContainer041\" class=\"Basic-Text-Frame\" style=\"text-align: justify;\">\n<section class=\"format-info\">\n<p class=\"Normal ParaOverride-8\" style=\"text-align: justify;\"><strong><img class=\"aligncenter wp-image-469476\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1024x336.jpg\" alt=\"\" width=\"500\" height=\"164\" srcset=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1024x336.jpg 1024w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-300x99.jpg 300w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-768x252.jpg 768w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1536x504.jpg 1536w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-2048x673.jpg 2048w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-696x229.jpg 696w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1068x351.jpg 1068w, https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/SUGIMURA_logo-1279x420.jpg 1279w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>SUGIMURA &amp; PARTNERS<\/strong><br \/>\n36F, Common Gate West Tower<br \/>\n3-2-1 Kasumigaseki, Chiyoda-ku<br \/>\nTokyo 100-0013 JAPAN<br \/>\n\uc804\ud654: +81 3 3581 2241<br \/>\n\uc774\uba54\uc77c: <a href=\"mailto:legal@sugimura.partners\">legal@sugimura.partners<\/a><br \/>\n\uc774\uba54\uc77c: <a href=\"mailto:jpatent@sugimura.partners\">jpatent@sugimura.partners<\/a><\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\uc77c\ubcf8 \ud55c\uad6d \uc77c\ubcf8\uc5d0\uc11c \ud5ec\uc2a4\ucf00\uc5b4 \uae30\uc220\uc740 \ud070 \uc8fc\ubaa9\uc744 \ubc1b\uace0 \uc788\uace0, \uc77c\ubcf8 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5\uc758 \uc2dc\uc7a5 \uaddc\ubaa8\ub294 \uc9c0\uc18d\uc801\uc73c\ub85c \uc131\uc7a5\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub41c\ub2e4. \uc77c\ubcf8 \uacbd\uc81c\uc0b0\uc5c5\uc131\uc758 \ubcf4\uace0\uc11c\uc5d0 \ub530\ub974\uba74, 2025\ub144\uc5d0\ub294 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5\uc758 \uac00\uce58\uac00 33\uc870 \uc5d4(2,300\uc5b5 \ub2ec\ub7ec)\uc5d0 \ub2ec\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ub41c\ub2e4. \ub610\ud55c \uc77c\ubcf8 \ud2b9\ud5c8\uccad\uc5d0 \ub530\ub974\uba74, \ud5ec\uc2a4\ucf00\uc5b4 \uae30\uc220\uc5d0 \ub300\ud55c \ud2b9\ud5c8 \ucd9c\uc6d0\uc740 \uafb8\uc900\ud788 \uc99d\uac00\ud558\uace0 \uc788\uc73c\uba70, 2013\ub144\ubd80\ud130 2019\ub144\uae4c\uc9c0 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \ub450 \ubc30\ub85c \uc99d\uac00\ud588\ub2e4. \uc77c\ubcf8 \uc815\ubd80\ub294 \ud5ec\uc2a4\ud14c\ud06c\uc640 \uc758\ub8cc<\/p>\n","protected":false},"author":18,"featured_media":469541,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"sfsi_plus_gutenberg_text_before_share":"","sfsi_plus_gutenberg_show_text_before_share":"","sfsi_plus_gutenberg_icon_type":"","sfsi_plus_gutenberg_icon_alignemt":"","sfsi_plus_gutenburg_max_per_row":"","meta-author":"Koji Sugimura, Mitsukuni Terada\uadf8\ub9ac\uace0Takuya Izumi, SUGIMURA & Partners"},"categories":[8398,77915],"tags":[142641,142642,142643,142636,8400],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v17.7 (Yoast SEO v17.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<meta name=\"description\" content=\"\uc77c\ubcf8\uc5d0\uc11c \ud5ec\uc2a4\ucf00\uc5b4 \uae30\uc220\uc740 \ud070 \uc8fc\ubaa9\uc744 \ubc1b\uace0 \uc788\uace0, \uc77c\ubcf8 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5\uc758 \uc2dc\uc7a5 \uaddc\ubaa8\ub294 \uc9c0\uc18d\uc801\uc73c\ub85c 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