{"id":588843,"date":"2025-05-09T11:25:44","date_gmt":"2025-05-09T03:25:44","guid":{"rendered":"https:\/\/beta3.law.asia\/?p=588843"},"modified":"2025-05-27T08:03:09","modified_gmt":"2025-05-27T00:03:09","slug":"healthcare-life-science-regulation-japan","status":"publish","type":"post","link":"https:\/\/beta3.law.asia\/ko\/healthcare-life-science-regulation-japan\/","title":{"rendered":"\uc77c\ubcf8\uc758 \uc758\ub8cc \ubc0f \uc0dd\uba85\uacfc\ud559 \uaddc\uc81c"},"content":{"rendered":"<p><span class=\"vantage-grey\"><em><strong>\uc77c\ubcf8\uc740 \uc758\ub8cc \ub370\uc774\ud130 \ud65c\uc6a9 \ucd09\uc9c4\uc5d0 \uc911\uc810\uc744 \ub450\uba74\uc11c \ub450 \uac00\uc9c0 \uc8fc\uc694 \ubc95\ub960\uc5d0 \ub530\ub77c \uc758\ub8cc \ub370\uc774\ud130\uc5d0 \ub300\ud55c \uaddc\uc81c \ub610\ud55c \uc644\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4<\/strong><\/em><\/span><\/p>\n<p>\uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc740 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5 \ud601\uc2e0\uc758 \ud575\uc2ec\uc774\uc9c0\ub9cc, \uc77c\ubcf8\uc5d0\uc11c\ub294 \uc774\ub7ec\ud55c \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc774 \uad11\ubc94\uc704\ud558\uac8c \uc81c\ud55c\ub418\uc5b4 \uc654\ub2e4. \uc774\ub7ec\ud55c \uc758\ub8cc \ub370\uc774\ud130\uc5d0\ub294 \ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\uac00 \ud3ec\ud568\ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uae30 \ub54c\ubb38\uc774\ub2e4. \uadf8\ub7ec\ub098 \uc77c\ubcf8 \uc815\ubd80\ub294 \uac1c\uc778\uc815\ubcf4\ubcf4\ud638\ubc95(APPI) \ubc0f \uae30\ud0c0 \uc0c8\ub85c\uc6b4 \ubc95\ub960\uc5d0 \ub530\ub77c \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc744 \uc7a5\ub824\ud558\ub294 \ubc29\ud5a5\uc73c\ub85c \uc804\ud658\ud558\ub294 \ub3d9\uc2dc\uc5d0 \ud658\uc790\uc758 \uc0ac\uc0dd\ud65c \ubc0f \uac1c\uc778\uc815\ubcf4\ub97c \ubcf4\ud638\ud558\ub294 \ub370 \ud544\uc218\uc801\uc778 \uc870\uce58\ub97c \ubcd1\ud589\ud558\uace0 \uc788\ub2e4.<\/p>\n<p>\ubcf8 \uae30\uace0\ubb38\uc740 \uc758\ub8cc \uc815\ubcf4\uc640 \uad00\ub828\ub41c \uac1c\uc778\uc815\ubcf4 \ubcf4\ud638 \uaddc\uc81c\uc758 \ucd5c\uadfc \ub3d9\ud5a5\uc744 \uc804\ubc18\uc801\uc73c\ub85c \uc0b4\ud3b4\ubcf4\uace0, AI \uad00\ub828 \uae30\uc220\uc744 \ud3ec\ud568\ud55c \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5 \ub0b4 \uc2e0\uae30\uc220\uc5d0 \uc801\uc6a9\ub418\ub294 \ubc95\ub960 \ubc0f \uaddc\uc815\uc5d0 \ub300\ud55c \uac1c\uc694\ub3c4 \uc81c\uacf5\ud560 \uc608\uc815\uc774\ub2e4.<\/p>\n<h2><strong><span class=\"vantage-red\">\uc758\ub8cc \uc815\ubcf4\uc758 \ud65c\uc6a9<\/span><\/strong><\/h2>\n<figure id=\"attachment_585420\" aria-describedby=\"caption-attachment-585420\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-585420 size-full\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2025\/05\/Mika-Okada-City-Yuwa-Partners.jpg\" alt=\"Mika Okada, City-Yuwa Partners\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-585420\" class=\"wp-caption-text\"><strong>Mika Okada<\/strong><br \/>\ud30c\ud2b8\ub108 \ubcc0\ud638\uc0ac<br \/>City-Yuwa Partners<br \/>\ub3c4\ucfc4<br \/>\uc804\ud654: +81 3 6212 5527<br \/>\uc774\uba54\uc77c: <a href=\"mailto:mika.okada@city-yuwa.com\">mika.okada@city-yuwa.com<\/a><\/figcaption><\/figure>\n<p class=\"Normal ParaOverride-3\"><span class=\"CharOverride-12\">APPI \ud558\uc758 \ud65c\uc6a9 \uac1c\uc694. \uc758\ub8cc \uc815\ubcf4\uc5d0\ub294 \uc885\uc885 \ubcd1\ub825\uc774 \ud3ec\ud568\ub418\uba70, \uc774\ub294 APPI\uac00 \uc815\uc758\ud558\ub294 \u201c\ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\u201d\uc5d0 \ud574\ub2f9\ud55c\ub2e4. \uc774\ub7ec\ud55c \ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\uc758 \ud65c\uc6a9\uc740 \ubc95\uc73c\ub85c \uc5c4\uaca9\ud788 \uc81c\ud55c\ub41c\ub2e4. \uc608\ub97c \ub4e4\uc5b4, \uc774\ub7ec\ud55c \ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\ub294 \uc635\ud2b8\uc544\uc6c3 \uc808\ucc28\ub85c \uc81c3\uc790\uc5d0\uac8c \uc81c\uacf5\ub420 \uc218 \uc5c6\uc73c\uba70 \uac1c\uc778\uc758 \uba85\uc2dc\uc801 \uc0ac\uc804 \ub3d9\uc758\ub97c \ubc1b\uc544\uc57c \ud55c\ub2e4.<\/span><\/p>\n<p>APPI\ub294 \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc5d0 \ub300\ud574 \uba87 \uac00\uc9c0 \uc81c\ud55c\uc801\uc778 \uc608\uc678\ub97c \ud5c8\uc6a9\ud558\uace0 \uc788\uc9c0\ub9cc, \uc5ec\uae30\uc5d0\ub294<\/p>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li>\uacf5\uc911\uc704\uc0dd\uc744 \uac1c\uc120\ud558\uac70\ub098 \uac74\uac15\ud55c \uc544\ub3d9 \ubc1c\ub2ec\uc744 \ucd09\uc9c4\ud574\uc57c \ud558\ub294 \ud2b9\ubcc4\ud55c \ud544\uc694\uc131<\/li>\n<li>\ud559\uc220 \uc5f0\uad6c \ubaa9\uc801 \ub4f1\uc774 \ud3ec\ud568\ub418\uba70, \uc774\ub7ec\ud55c \uc608\uc678\ub294 \uad11\ubc94\uc704\ud558\uac8c \uc801\uc6a9\ub418\uc9c0 \uc54a\ub294\ub2e4.<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p>\uad6c\uccb4\uc801\uc73c\ub85c, \uc608\uc678\ub97c \uc801\uc6a9\ud558\ub824\uba74 \uac1c\uc778\uc758 \ub3d9\uc758\ub97c \uc5bb\uc5b4\uc57c \ud558\ub294\ub370, \uc774\ub294 \uc27d\uc9c0 \uc54a\uc73c\uba70 \uc758\ub8cc \uc815\ubcf4\uac00 \uc81c\ud488 \uac1c\ubc1c\uc5d0 \uc774\uc6a9\ub418\ub294 \uacbd\uc6b0\uc5d0\ub294 \uc801\uc6a9\ub418\uc9c0 \uc54a\ub294\ub2e4.<\/p>\n<p>\uc775\uba85\ud654 \ubc0f \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \uc815\ubcf4. APPI\uc5d0 \ub530\ub978 \ubcf5\uc7a1\ud558\uace0 \uc5c4\uaca9\ud55c \uaddc\uc81c\ub294 \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc5d0 \uac78\ub9bc\ub3cc\uc774 \ub418\uc5b4 \uc654\ub2e4. \uc758\ub8cc \uc815\ubcf4\ub294 \uc758\ub8cc \uc11c\ube44\uc2a4 \uc9c8 \ud5a5\uc0c1\uacfc \uc758\ud559 \uc5f0\uad6c \ucd09\uc9c4\uc5d0 \ud544\uc694\ud55c \uadc0\uc911\ud55c \uc790\uc6d0\uc774\ub2e4. \uc774\ub7ec\ud55c \ubb38\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud574 \uc77c\ubcf8\uc5d0\uc11c\ub294 APPI\uc758 \ud2b9\ub840\ubc95\uc73c\ub85c \u2018\uc758\ud559 \ubd84\uc57c \uc5f0\uad6c\uac1c\ubc1c \uae30\uc5ec\uc6a9 \uc775\uba85\ud654 \uc758\ub8cc \ub370\uc774\ud130\uc5d0 \uad00\ud55c \ubc95\ub960\u2019\uc744 \uc81c\uc815\ud588\uc73c\uba70, \uacf5\uc2dd \uba85\uce6d\uc740 \ucc28\uc138\ub300 \uc758\ub8cc \uc778\ud504\ub77c \ubc95(Next Generation Medical Infrastructure Law, NGMIL)\uc774\ub2e4.<\/p>\n<p>NGMIL\uc740 \u2018\uc775\uba85\ud654\ub41c \uc758\ub8cc \uc815\ubcf4\u2019\ub77c\ub294 \uac1c\ub150\uc744 \ub3c4\uc785\ud588\ub2e4. \uc774\ub294 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc775\uba85\ud654 \uae30\uc220\uc744 \ubcf4\uc720\ud558\uace0 \uc788\ub2e4\uace0 \ub2f9\uad6d\uc758 \uc778\uc99d\uc744 \ubc1b\uc740 \ud2b9\uc815 \uae30\uad00(\uc778\uc99d\ub41c \uc775\uba85\ud654 \uc758\ub8cc \uc815\ubcf4 \uc791\uc131\uc790)\uc774 \uc758\ub8cc \uc815\ubcf4\ub97c \uc775\uba85\ud654\ud574\uc57c \ud568\uc744 \uc758\ubbf8\ud55c\ub2e4. \uc758\ub8cc \uae30\uad00\uc740 \ud658\uc790\uc758 \uba85\uc2dc\uc801 \ub3d9\uc758 \uc5c6\uc774 \uc635\ud2b8\uc544\uc6c3 \uc808\ucc28\ub97c \ud1b5\ud574 \uc774\ub4e4 \uc791\uc131\uc790\uc5d0\uac8c \uc758\ub8cc \uc815\ubcf4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub2e4. \uc791\uc131\uc790\ub294 \ud574\ub2f9 \uc758\ub8cc \uc815\ubcf4\ub97c \uc775\uba85\ud654\ud55c \ud6c4 \uc5f0\uad6c\uae30\uad00\uc774\ub098 \uc81c\uc57d\ud68c\uc0ac\uc5d0 \uc81c\uacf5\ud55c\ub2e4. \uadf8\ub7ec\ub098 \uc775\uba85\ud654 \uacfc\uc815\uc5d0\uc11c \uc77c\ubd80 \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc0ad\uc81c\ud574\uc57c \ud558\ubbc0\ub85c \uc775\uba85\ud654 \uc758\ub8cc \uc815\ubcf4\uac00 \ud56d\uc0c1 \uc720\uc6a9\ud55c \uac83\uc740 \uc544\ub2c8\ub2e4.<\/p>\n<figure id=\"attachment_585437\" aria-describedby=\"caption-attachment-585437\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-585437 size-full\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2025\/05\/Kosuke-Hasegawa-City-Yuwa-Partners.jpg\" alt=\"Kosuke Hasegawa, City-Yuwa Partners\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-585437\" class=\"wp-caption-text\"><strong>Kosuke Hasegawa<\/strong><br \/>\ud30c\ud2b8\ub108 \ubcc0\ud638\uc0ac<br \/>City-Yuwa Partners<br \/>\ub3c4\ucfc4<br \/>\uc804\ud654: +81 3 6212 5641<br \/>\uc774\uba54\uc77c: <a href=\"mailto:kosuke.hasegawa@city-yuwa.com\">kosuke.hasegawa@city-yuwa.com<\/a><\/figcaption><\/figure>\n<p>\uc774\ub7ec\ud55c \ubb38\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud574 NGMIL\uc740 2023\ub144 5\uc6d4 \ucd94\uac00 \uac1c\uc815\uc744 \ud1b5\ud574 \uc758\ub8cc \ub370\uc774\ud130\ub97c \uc0ad\uc81c\ud558\uc9c0 \uc54a\uace0\ub3c4 \ud65c\uc6a9\ud560 \uc218 \uc788\ub294 \u2018\uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \uc815\ubcf4\u2019\ub97c \ub3c4\uc785\ud588\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc5f0\uad6c \ubd84\uc57c\uc758 \ub2e4\uc74c\uacfc \uac19\uc740 \ud544\uc694\ub97c \ucda9\uc871\ud560 \uc218 \uc788\uac8c \ub410\ub2e4.<\/p>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol>\n<li>\ud76c\uadc0\uc9c8\ud658 \ub370\uc774\ud130 \uc81c\uacf5<\/li>\n<li>\ub3d9\uc77c \ub300\uc0c1\uad70\uc5d0 \ub300\ud55c \uc9c0\uc18d\uc801\u00b7\ubc1c\uc804\uc801 \ub370\uc774\ud130 \uc81c\uacf5<\/li>\n<li>\uc758\uc57d\ud488 \ud5c8\uac00 \uc2e0\uccad \uc2dc \ud544\uc218 \uc694\uac74\uc778 \uc9c4\uc704 \ud655\uc778\uc744 \uc704\ud574 \uc6d0\uc2dc \ub370\uc774\ud130\ub85c \ub418\ub3cc\ub824 \uc2e0\ub8b0\uc131\uc744 \uc785\uc99d\ud560 \uc218 \uc788\ub2e4\ub294 \uc810<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p>\uac1c\uc815\ub41c NGMIL\uc740 \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \uc815\ubcf4\uc640 \uc77c\ubcf8 \uac74\uac15\ubcf4\ud5d8\uccad\uad6c \ubc0f \ud2b9\uc815\uac74\uac15\uac80\uc9c4 \uad6d\uac00 \ub370\uc774\ud130\ubca0\uc774\uc2a4 \uac04 \uc5f0\uacc4 \ubd84\uc11d\uc744 \ud5c8\uc6a9\ud55c\ub2e4. \uac00\uba85 \ucc98\ub9ac\ub41c \uc758\ub8cc \uc815\ubcf4\ub294 \ub2f9\uad6d\uc758 \uc778\uc99d\uc744 \ubc1b\uc740 \ud2b9\uc815 \uae30\uad00\uc774 \ucc98\ub9ac\ud574\uc57c \ud558\uba70, \uc774\ub97c \ud65c\uc6a9\ud558\ub294 \uc0ac\uc5c5\uc790\ub3c4 \ub2f9\uad6d\uc758 \uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud55c\ub2e4.<\/p>\n<p>APPI\uc5d0 \ub300\ud55c \ucd94\uac00\uc801\uc778 \ub17c\uc758. APPI\uc5d0 \ub300\ud55c \uc815\uae30\uc801 \uac80\ud1a0\uc758 \uc77c\ud658\uc73c\ub85c \uac1c\uc778\uc815\ubcf4\ubcf4\ud638\uc704\uc6d0\ud68c\ub294 \ud2b9\uc815 \uc0c1\ud669(\uc608: \ud1b5\uacc4 \uc791\uc131\uc5d0\ub9cc \uc0ac\uc6a9\ub418\ub294 \uac1c\uc778\uc815\ubcf4 \uc81c\uacf5)\uc5d0 \ud55c\ud574 \uac1c\uc778\uc815\ubcf4 \ud65c\uc6a9 \uc694\uac74\uc744 \uc644\ud654\ud558\ub294 \ucd94\uac00 \uac1c\uc815\uc548\uc744 \ub17c\uc758\ud558\uace0 \uc788\ub2e4.<\/p>\n<h2><span class=\"vantage-red\"><strong>\uc2e0\uae30\uc220 \uaddc\uc81c<\/strong><\/span><\/h2>\n<figure id=\"attachment_585441\" aria-describedby=\"caption-attachment-585441\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-585441 size-full\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2025\/05\/Yudai-Oka-City-Yuwa-Partners.jpg\" alt=\"Yudai Oka, City-Yuwa Partners\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-585441\" class=\"wp-caption-text\"><strong>Yudai Oka<\/strong><br \/>\uc18c\uc18d \ubcc0\ud638\uc0ac <br \/>City-Yuwa Partners<br \/>\ub3c4\ucfc4<br \/>\uc804\ud654: +81 3 6212 5655<br \/>\uc774\uba54\uc77c: <a href=\"mailto:yudai.oka@city-yuwa.com\">yudai.oka@city-yuwa.com<\/a><\/figcaption><\/figure>\n<p>\uc758\ub8cc\uae30\uae30\ub85c\uc11c\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4(SaMD). \ud604\uc7ac \ub9ce\uc740 \ud5ec\uc2a4\ucf00\uc5b4 \uc571\uc774 \uc2a4\ub9c8\ud2b8\ud3f0\u00b7\uc2a4\ub9c8\ud2b8\uc6cc\uce58 \ub4f1 \ub2e4\uc591\ud55c \ub514\uc9c0\ud138 \uae30\uae30\ub97c \ud1b5\ud574 \ub110\ub9ac \uc774\uc6a9\ub418\uace0 \uc788\ub2e4. \uc774\ub4e4 \uc911 \uc77c\ubd80 \uc571\uc740 \u2018\uc758\uc57d\ud488\u00b7\uc758\ub8cc\uae30\uae30 \ub4f1\uc758 \ud488\uc9c8\u00b7\ud6a8\ub2a5 \ubc0f \uc548\uc804\uc131 \ud655\ubcf4\uc5d0 \uad00\ud55c \ubc95\ub960\u2019(PMD\ubc95)\uc5d0 \ub530\ub77c \uc758\ub8cc\uae30\uae30\ub85c \uac04\uc8fc\ub420 \uc218 \uc788\ub2e4.<\/p>\n<p>\uc18c\ud504\ud2b8\uc6e8\uc5b4\uac00 \uc758\ub8cc\uc801 \ubaa9\uc801(\uc608: \uc9c8\ubcd1\uc758 \uc9c4\ub2e8, \uce58\ub8cc \ub610\ub294 \uc608\ubc29)\uc5d0 \uc0ac\uc6a9\ub418\uba70, \uadf8 \uacb0\ud568\uc774 \ud658\uc790 \ub610\ub294 \uc0ac\uc6a9\uc790\uc758 \uc0dd\uba85\uc774\ub098 \uac74\uac15\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\ub294 \uacbd\uc6b0 \ud574\ub2f9 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 PMD\ubc95\uc0c1 \uc758\ub8cc\uae30\uae30\ub85c \ubd84\ub958\ub41c\ub2e4.<\/p>\n<p>\uc774\ub7ec\ud55c \uacbd\uc6b0, \ud574\ub2f9 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 \uc2dc\ud310 \uc2b9\uc778 \ub610\ub294 \uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud558\uba70, \uc774\ub97c \uc2dc\ud310\ud558\ub294 \uae30\uc5c5\uc740 PMD\ubc95\uc5d0 \ub530\ub77c \uad00\ub828 \uc2dc\ud310\uc5c5 \ud5c8\uac00\ub97c \ucde8\ub4dd\ud574\uc57c \ud55c\ub2e4. \uc758\ub8cc\uc801 \ubaa9\uc801 \uc5ec\ubd80\ub294 \uc81c\ud488 \uc131\ub2a5, \ub300\uc0c1 \uc0ac\uc6a9\uc790 \ubc0f \uc0ac\uc6a9 \uaddc\uce59\uc758 \ud45c\uc2dc, \uad11\uace0\ub0b4\uc6a9 \ub4f1\uc744 \uc885\ud569\uc801\uc73c\ub85c \uace0\ub824\ud558\uc5ec \ud310\ub2e8\ub41c\ub2e4.<\/p>\n<p>\ud6c4\uc0dd\ub178\ub3d9\uc131(MHLW)\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc758\ub8cc\uae30\uae30 \uc801\uc6a9 \uc5ec\ubd80\ub97c \ud310\ub2e8\ud558\ub294 \ubc29\ubc95\uc5d0 \ub300\ud574 \uc124\uba85\ud558\ub294 \u2018\ud504\ub85c\uadf8\ub7a8\uc758 \uc758\ub8cc\uae30\uae30 \ud574\ub2f9\uc131\uc5d0 \uad00\ud55c \uac00\uc774\ub4dc\ub77c\uc778\u2019\uc744 \ubc1c\uac04\ud588\ub2e4.<\/p>\n<p>\ud6c4\uc0dd\ub178\ub3d9\uc131\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc758\ub8cc\uae30\uae30 \uc801\uc6a9 \uc5ec\ubd80\uc5d0 \uad00\ud55c \uc0ac\ub840 \uc608\uc2dc\uc640 SaMD \uad00\ub828 \ub370\uc774\ud130\ubca0\uc774\uc2a4\ub97c \ucd94\uac00\ub85c \ubc1c\ud45c\ud588\ub2e4. \uc758\ub8cc\uae30\uae30 \uc801\uc6a9 \uc5ec\ubd80\uc5d0 \ub300\ud574\uc11c\ub294 \ud6c4\uc0dd\ub178\ub3d9\uc131 \ub0b4 \uad00\ub828 \ubd80\uc11c\uc5d0 \uc0c1\ub2f4\ud560 \uc218 \uc788\uc73c\uba70, \uc758\uc57d\ud488\uc758\ub8cc\uae30\uae30\uc885\ud569\uae30\uad6c(PMDA)\ub3c4 SaMD \uad00\ub828 \uc6d0\uc2a4\ud1b1 \uc0c1\ub2f4 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud55c\ub2e4.<\/p>\n<p>AI \uae30\ubc18 \uae30\uc220\uc758 \ud65c\uc6a9. \uc778\uacf5\uc9c0\ub2a5\uc740 \uc774\ubbf8 \uc9c4\ub2e8 \ubc0f \uce58\ub8cc \ubcf4\uc870\uc5d0 \ub110\ub9ac \ud65c\uc6a9\ub418\uace0 \uc788\ub2e4. \uc758\uc0ac\ubc95 \uc81c17\uc870\ub294 \uc758\ub8cc\uc778\uc774 \uc544\ub2cc \uc790\uc758 \uc758\ub8cc\ud589\uc704\ub97c \uae08\uc9c0\ud558\uace0 \uc788\uc73c\ubbc0\ub85c, \uc778\uacf5\uc9c0\ub2a5 \uae30\ubc18 \uc9c4\ub2e8 \uc2dc\uc2a4\ud15c\uc774 \uc2a4\uc2a4\ub85c \ucd5c\uc885 \uc9c4\ub2e8\uc744 \ub0b4\ub9ac\ub294 \uac83\uc740 \uc774 \ubc95 \uc704\ubc18\uc774 \ub41c\ub2e4.<\/p>\n<p>\uc774\uc640 \uad00\ub828\ud558\uc5ec \ud6c4\uc0dd\ub178\ub3d9\uc131\uc740 2018\ub144 12\uc6d4 19\uc77c AI \ubcf4\uc870 \uc9c4\ub2e8\u00b7\uce58\ub8cc \ub4f1\uc744 \uc9c0\uc6d0\ud558\ub294 \ud504\ub85c\uadf8\ub7a8\uacfc \uc758\uc0ac\ubc95 \uc81c17\uc870\uc758 \uad00\uacc4\uc5d0 \uad00\ud55c \uac00\uc774\ub4dc\ub77c\uc778\uc744 \ubc1c\ud45c\ud588\ub2e4. \uc774 \uac00\uc774\ub4dc\ub77c\uc778\uc740 \uc758\ub8cc\uc778\uc774 \uc801\uadf9\uc801\uc73c\ub85c \uc9c4\ub2e8\uc744 \uc81c\uacf5\ud558\uace0 AI \uae30\ubc18 \ud504\ub85c\uadf8\ub7a8\uc774 \ub2e8\uc21c\ud788 \ud574\ub2f9 \uc9c4\ub2e8\uc744 \ubcf4\uc870\ud558\ub294 \uacbd\uc6b0\uc5d0\ub294 \uc758\uc0ac\ubc95 \uc81c17\uc870 \uc704\ubc18\uc774 \uc544\ub2c8\ub77c\uace0 \uba85\uc2dc\ud558\uace0 \uc788\ub2e4. \uc774\ub294 \uc77c\ubcf8\uc5d0\uc11c AI \uae30\ubc18 \uc758\ub8cc \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud560 \ub54c \uace0\ub824\ud574\uc57c \ud560 \ud604\uc9c0 \uaddc\uc81c \uc911 \ud558\ub098\ub2e4.<\/p>\n<p>\uc77c\ubcf8 \uacbd\uc81c\uc0b0\uc5c5\uc131(METI)\uc640 \ucd1d\ubb34\uc131\uc740 AI \uad00\ub828 \ube44\uc988\ub2c8\uc2a4\uc5d0 \uc801\uc6a9\ub418\ub294 \uac00\uc774\ub4dc\ub77c\uc778\uc73c\ub85c, 2024\ub144 12\uc6d4 25\uc77c \u2018AI \ube44\uc988\ub2c8\uc2a4 \uac00\uc774\ub4dc\ub77c\uc778 \ubc84\uc804 1.01\u2019\uc744 \uacf5\ub3d9\uc73c\ub85c \ubc1c\ud45c\ud588\ub2e4. \uc774 \uac00\uc774\ub4dc\ub77c\uc778\uc740 AI \uc6d0\uce59 \uad6c\ud604\uc744 \uc704\ud55c \uae30\uc874\uc758 \uc5f0\uad6c\u00b7\uac1c\ubc1c, \ud65c\uc6a9 \ubc0f \uac70\ubc84\ub10c\uc2a4 \uc9c0\uce68\uc744 \ud1b5\ud569\ud55c \uac83\uc774\ub2e4. \ub610\ud55c AI \uac1c\ubc1c\uc790, \uc81c\uacf5\uc790 \ubc0f \ube44\uc988\ub2c8\uc2a4 \uc0ac\uc6a9\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \ud22c\uba85\uc131, \uc815\uc758\uc640 \uacf5\uc815\uc131, \uc545\uc601\ud5a5 \ubc29\uc9c0 \ub4f1 AI \uc724\ub9ac\uc758 \uae30\ubcf8 \uc6d0\uce59\uc744 \uac01\uac01 \uc124\uba85\ud55c\ub2e4.<\/p>\n<p>METI\ub294 \ucd5c\uadfc \uc0ac\uc5c5\uc790\uac00 AI \uad00\ub828 \uacc4\uc57d\uc744 \uccb4\uacb0\ud560 \ub54c \ud65c\uc6a9\ud560 \uc218 \uc788\ub294 \u2018AI \ud65c\uc6a9\u00b7\uac1c\ubc1c \uad00\ub828 \uacc4\uc57d \uccb4\ud06c\ub9ac\uc2a4\ud2b8\u2019 \ub610\ud55c \ubc1c\ud45c\ud588\ub2e4.<\/p>\n<p>\uc758\ub8cc \uad00\ub828 \uae30\uc5c5\uc758 AI \uac70\ubc84\ub10c\uc2a4\uc5d0 \uad00\ud574, \ub514\uc9c0\ud138 \ud5ec\uc2a4 \uc0b0\uc5c5\uc5d0 \uc885\uc0ac\ud558\ub294 \uc815\ubcf4\ud1b5\uc2e0\uae30\uc220 \uae30\uc5c5, \ubca4\ucc98 \uae30\uc5c5, \uc81c\uc57d\u00b7\uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub85c \uad6c\uc131\ub41c \uc77c\ubcf8 \ub514\uc9c0\ud138 \ud5ec\uc2a4 \uc5bc\ub77c\uc774\uc5b8\uc2a4\ub294 \u2018\uc758\ub8cc \uc0ac\uc5c5\uc790\ub97c \uc704\ud55c \uc0dd\uc131 AI \ud65c\uc6a9 \uac00\uc774\ub4dc\ub77c\uc778 \ubc84\uc804 2.0\u2019\uc744 \ubc1c\ud589\ud588\ub2e4. \uc774 \uac00\uc774\ub4dc\ub77c\uc778\uc740 \uc0dd\uc131 AI \uc81c\ud488 \ubc0f \uc11c\ube44\uc2a4\uc758 \uac1c\ubc1c\uacfc \uc758\ub8cc\uae30\uad00 \ub0b4 \ud65c\uc6a9\uc5d0 \ub300\ud55c \uc2e4\uc9c8\uc801\uc778 \uc9c0\uce68\uc744 \uc81c\uacf5\ud55c\ub2e4.<\/p>\n<p>\uc815\ubd80\ub294 2025\ub144 2\uc6d4 \u2018\uc778\uacf5\uc9c0\ub2a5 \uad00\ub828 \uae30\uc220\uc758 \uc5f0\uad6c\uac1c\ubc1c \ubc0f \ud65c\uc6a9 \ucd09\uc9c4\uc5d0 \uad00\ud55c \ubc95\uc548\u2019(AI \ubc95\uc548)\uc744 \uc81c\ucd9c\ud588\ub2e4. \uc774 \ubc95\uc548\uc740 \uad6d\uac00 \ucc28\uc6d0\uc758 AI \uac1c\ubc1c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uc2dc\ud558\uace0 AI \uad00\ub828 \uae30\uc220\uc744 \uc815\uc758\ud558\uba70, AI \uad00\ub828 \uae30\uc220\uc744 \ud65c\uc6a9\ud558\ub294 \uc0ac\uc5c5\uc790\uc5d0\uac8c \uc815\ubd80\uc758 \uc870\uce58\uc5d0 \ud611\ub825\ud560 \uc758\ubb34\ub97c \ubd80\uacfc\ud55c\ub2e4. \ud574\ub2f9 \ubc95\uc548\uc740 2025\ub144 4\ubd84\uae30\uc5d0 \uad6d\ud68c\uc5d0\uc11c \ud1b5\uacfc\ub420 \uac83\uc73c\ub85c \uc608\uc0c1\ub41c\ub2e4.<\/p>\n<section class=\"format-info\">\n<p style=\"text-align: justify;\"><strong><img class=\"aligncenter wp-image-572979 \" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/07\/Logo-3-scaled.jpg\" alt=\"City-Yuwa Partners\" width=\"395\" height=\"94\" \/>CITY-YUWA PARTNERS<\/strong><br \/>\nMarunouchi Mitsui Building<br \/>\n2-2-2 Marunouchi, Chiyoda-ku,<br \/>\nTokyo 100-0005, Japan<br \/>\n\uc804\ud654: +81 3 6212 5500<br \/>\n\ud329\uc2a4: +81 3 6212 5700<br \/>\n<a href=\"https:\/\/www.city-yuwa.com\/global\/en\/\">www.city-yuwa.com\/global\/en\/<\/a><\/p>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>\uc77c\ubcf8\uc740 \uc758\ub8cc \ub370\uc774\ud130 \ud65c\uc6a9 \ucd09\uc9c4\uc5d0 \uc911\uc810\uc744 \ub450\uba74\uc11c \ub450 \uac00\uc9c0 \uc8fc\uc694 \ubc95\ub960\uc5d0 \ub530\ub77c \uc758\ub8cc \ub370\uc774\ud130\uc5d0 \ub300\ud55c \uaddc\uc81c \ub610\ud55c \uc644\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4 \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc740 \ud5ec\uc2a4\ucf00\uc5b4 \uc0b0\uc5c5 \ud601\uc2e0\uc758 \ud575\uc2ec\uc774\uc9c0\ub9cc, \uc77c\ubcf8\uc5d0\uc11c\ub294 \uc774\ub7ec\ud55c \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc774 \uad11\ubc94\uc704\ud558\uac8c \uc81c\ud55c\ub418\uc5b4 \uc654\ub2e4. \uc774\ub7ec\ud55c \uc758\ub8cc \ub370\uc774\ud130\uc5d0\ub294 \ubbfc\uac10\ud55c \uac1c\uc778\uc815\ubcf4\uac00 \ud3ec\ud568\ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uae30 \ub54c\ubb38\uc774\ub2e4. \uadf8\ub7ec\ub098 \uc77c\ubcf8 \uc815\ubd80\ub294 \uac1c\uc778\uc815\ubcf4\ubcf4\ud638\ubc95(APPI) \ubc0f \uae30\ud0c0 \uc0c8\ub85c\uc6b4 \ubc95\ub960\uc5d0 \ub530\ub77c \uc758\ub8cc \uc815\ubcf4 \ud65c\uc6a9\uc744<\/p>\n","protected":false},"author":13501,"featured_media":585445,"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":"Mika Okada, Kosuke Hasegawa, and Yudai Oka, City-Yuwa Partners"},"categories":[8398,77915],"tags":[167194,116113,8400,167200,167199,167195,167201,167197,167196,167192,167198,167193],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium 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