{"id":19,"date":"2025-09-12T15:00:02","date_gmt":"2025-09-12T06:00:02","guid":{"rendered":"https:\/\/www.mdrex.co.jp\/service\/sample-service2\/"},"modified":"2025-11-17T10:26:55","modified_gmt":"2025-11-17T01:26:55","slug":"license","status":"publish","type":"service","link":"https:\/\/www.mdrex.co.jp\/ko\/service\/license\/","title":{"rendered":"\uc778\ud5c8\uac00"},"content":{"rendered":"<div class=\"tcdce-body\"><p>\uc77c\ubcf8\uc758 \u300c\uc57d\uae30\ubc95(Pharmaceutical and Medical Device Act, PMD Act)\u300d\uc5d0\uc11c\ub294 \uc77c\ubcf8 \uad6d\ub0b4\uc5d0\uc11c \uc720\ud1b5\u00b7\ud310\ub9e4\ub418\ub294 \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud574, PMDA \ub610\ub294 RCB \uae30\uad00\uc73c\ub85c\ubd80\ud130 \ud074\ub798\uc2a4\ubcc4\ub85c \uc2b9\uc778 \ub610\ub294 \uc778\uc99d\uc744 \ubc1b\ub294 \uac83\uc774 \uc694\uad6c\ub429\ub2c8\ub2e4.<br \/>\n\ub2e4\ub9cc, \ubc95 \uc81c68\uc870\uc5d0 \ub530\ub77c \ud658\uc790 \uce58\ub8cc \ubaa9\uc801\uc0c1 \uae34\uae09\ud788 \uc0ac\uc6a9\ud574\uc57c \ud558\ub294 \uacbd\uc6b0\uc5d0\ub294 \uc758\uc0ac\uc758 \ucc45\uc784\ud558\uc5d0 \uc81c\ud488\uc744 \uc218\uc785\/\uc0ac\uc6a9\ud560 \uc218 \uc788\uc73c\ub098, \uc774\ub7ec\ud55c \uc81c\ud488\uc740 \uc0c1\uc5c5\uc801\uc73c\ub85c \ud310\ub9e4\ud560 \uc218 \uc5c6\uc73c\uba70 \uc81c\ud55c\ub41c \ud658\uc790 \uce58\ub8cc\ub098 \uc5f0\uad6c \ubaa9\uc801\uc5d0\uc11c\ub9cc \uc0ac\uc6a9\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p>\ub610\ud55c, \uc77c\ubcf8 \ub0b4\uc5d0\uc11c \uc0c1\uc5c5\uc801\uc73c\ub85c \uc720\ud1b5\u00b7\ud310\ub9e4\ud558\uae30 \uc704\ud574\uc11c\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \ud5c8\uac00 \uc808\ucc28\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<div class=\"service_design_contents_type3\"><div class=\"item\"><div class=\"title_area\"><span class=\"label\">STEP1<\/span><div class=\"title\">\uc2e0\uccad\uc11c \uc81c\ucd9c<\/div><\/div><div class=\"desc_area\"><p class=\"item_desc\">\ud6c4\uc0dd\ub178\ub3d9\uc131\uc5d0 \uc2b9\uc778\uc744 \uc694\uccad\ud558\ub294 \uc2e0\uccad\uc11c\ub97c \uc791\uc131\ud558\uc5ec \uc81c\ucd9c\ud569\ub2c8\ub2e4.<\/p><\/div><\/div><div class=\"item\"><div class=\"title_area\"><span class=\"label\">STEP2<\/span><div class=\"title\">\uc2e0\ub8b0\uc131 \uc870\uc0ac<\/div><\/div><div class=\"desc_area\"><p class=\"item_desc\">\uc2e0\uccad\uc11c\uc758 \uadfc\uac70\uac00 \ub418\ub294 \uc784\uc0c1\uc2dc\ud5d8 \uc790\ub8cc \ub4f1\uc740 \uc81c\ud488\uc774 \uacfc\ud559\uc801, \uc724\ub9ac\uc801\uc73c\ub85c \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294\uc9c0 \ud655\uc778\ud558\uae30 \uc704\ud574 [\uc2e0\uccad \uc790\ub8cc\uc758 \uc2e0\ub8b0\uc131 \uae30\uc900]\uc5d0 \ub530\ub77c \ud6c4\uc0dd\ub178\ub3d9\uc131\ub839\uc5d0\uc11c \uc815\ud55c GCP\ub97c \uc900\uc218\ud558\uba70 \uc218\uc9d1\ub418\uc5c8\ub294\uc9c0, \uc2dc\ud5d8 \uc2e4\uc2dc \uacc4\ud68d\uc11c\uc5d0 \ub530\ub77c \uc218\ud589\ub418\uc5c8\ub294\uc9c0\ub97c \uba74\ubc00\ud788 \uac80\ud1a0\ud569\ub2c8\ub2e4.<\/p><\/div><\/div><div class=\"item\"><div class=\"title_area\"><span class=\"label\">STEP3<\/span><div class=\"title\">\uc81c\ud488 \uc81c\uc870\uc18c \uc870\uc0ac<\/div><\/div><div class=\"desc_area\"><p class=\"item_desc\">\uc81c\uc870\uc18c \uc870\uc0ac\ub294 \u300c\uc81c\uc870 \uacf5\uae09 \ub2a5\ub825\uc774 \uc788\ub294\uc9c0\u300d\u300c\ud488\uc9c8 \uad00\ub9ac\uac00 \uc801\uc808\ud55c\uc9c0\u300d\ub97c \ud310\ub2e8\ud558\ub294 \uac83\uc744 \ubaa9\uc801\uc73c\ub85c \ud569\ub2c8\ub2e4.<br \/>\r\n\ud5a5\ud6c4 \u300c\uc548\uc815\uc801\uc73c\ub85c \uc81c\ud488\uc744 \uc81c\uc870\u00b7\uacf5\uae09\ud560 \uc218 \uc788\ub294\uc9c0\u300d\ub97c \ud655\uc778\ud558\uae30 \uc704\ud55c \uc870\uc0ac\uc785\ub2c8\ub2e4.<\/p><\/div><\/div><div class=\"item\"><div class=\"title_area\"><span class=\"label\">STEP4<\/span><div class=\"title\">\ud6c4\uc0dd\ub178\ub3d9\uc131 \uc7a5\uad00\uc758 \uc2b9\uc778<\/div><\/div><div class=\"desc_area\"><p class=\"item_desc\">\uc774\ub7ec\ud55c \uc5c4\uaca9\ud55c \uc2ec\uc0ac\ub97c \uac70\uccd0, \ud6c4\uc0dd\ub178\ub3d9\uc131 \uc7a5\uad00\uacfc \uc2ec\uc758\ud68c\ub97c \ud1b5\ud574 \uc2b9\uc778\uc744 \ubc1b\uac8c \ub429\ub2c8\ub2e4.<\/p><\/div><\/div><\/div>\n<h2 class=\"custom_h2\">\ud074\ub798\uc2a4\ubcc4 \uc2b9\uc778 \/ \uc778\uc99d\uc758 \uc885\ub958\uc640 \uc2ec\uc0ac \uae30\uad00<\/h2>\n<div class=\"s_table\"><table>\n<tr>\n<th><b>\uc758\ub8cc\uae30\uae30 \ubd84\ub958<\/b><\/th>\n<th><b>\uc885\ub958<\/b><\/th>\n<th><b>\uc2ec\uc0ac<\/b><\/th>\n<\/tr>\n<tr>\n<td><strong>\ud074\ub798\uc2a4 IV (\uace0\uc704\ud5d8): \uace0\ub3c4 \uad00\ub9ac \uc758\ub8cc\uae30\uae30<\/strong><br \/>\uc624\uc791\ub3d9\uc774 \ubc1c\uc0dd\ud560 \uacbd\uc6b0 \uc0dd\uba85\uc5d0 \uc9c1\uc811\uc801\uc778 \uc704\ud5d8\uc774 \uc788\ub294 \uae30\uae30<br \/>(\uc608) \ud398\uc774\uc2a4\uba54\uc774\ucee4, \uc778\uacf5 \uc2ec\uc7a5\ud310<\/td>\n<td rowspan=\"2\">\uc2b9\uc778<br \/>(\uc77c\ubd80 \uc778\uc99d \uc788\uc74c)<\/td>\n<td rowspan=\"2\">\ub3c5\ub9bd\ud589\uc815\ubc95\uc778<br \/>\uc758\uc57d\ud488\uc758\ub8cc\uae30\uae30\uc885\ud569\uae30\uad6c<br \/>PMDA<\/td>\n<\/tr>\n<tr>\n<td><strong>\ud074\ub798\uc2a4 III (\uc911\uc704\ud5d8): \uace0\ub3c4 \uad00\ub9ac \uc758\ub8cc\uae30\uae30<\/strong><br \/>\uc624\uc791\ub3d9\uc774 \ubc1c\uc0dd\ud560 \uacbd\uc6b0 \uc778\uccb4\uc5d0 \ube44\uad50\uc801 \ub192\uc740 \uc704\ud5d8\uc774 \uc788\ub294 \uae30\uae30<br \/>(\uc608) \ud22c\uc11d\uae30, \uc778\uacf5\ubf08, \uc778\uacf5\ud638\ud761\uae30<\/td>\n<\/tr>\n<tr>\n<td><strong>\ud074\ub798\uc2a4 II (\uc800\uc704\ud5d8): \uad00\ub9ac \uc758\ub8cc\uae30\uae30<\/strong><br \/>\uc624\uc791\ub3d9\uc774 \ubc1c\uc0dd\ud558\ub354\ub77c\ub3c4 \uc778\uccb4\uc5d0 \ube44\uad50\uc801 \ub0ae\uc740 \uc704\ud5d8\uc774 \uc788\ub294 \uae30\uae30<br \/>(\uc608) MRI, \uc804\uc790 \ub0b4\uc2dc\uacbd, \uc18c\ud654\uae30\uc6a9 \uce74\ud14c\ud130<\/td>\n<td>\uc778\uc99d<br \/>(\uc77c\ubd80 \uc2b9\uc778 \uc788\uc74c)<\/td>\n<td>\uc81c3\uc790 \uc778\uc99d \uae30\uad00<br \/>\uff08ARCB\uff09<\/td>\n<\/tr>\n<tr>\n<td><strong>\ud074\ub798\uc2a4 I (\uadf9\uc800\uc704\ud5d8): \uc77c\ubc18 \uc758\ub8cc\uae30\uae30<\/strong><br \/>\uc624\uc791\ub3d9\uc774 \ubc1c\uc0dd\ud558\ub354\ub77c\ub3c4 \uc778\uccb4\uc5d0 \ub9e4\uc6b0 \ub0ae\uc740 \uc704\ud5d8\uc774 \uc788\ub294 \uae30\uae30<br \/>(\uc608) X\uc120 \ud544\ub984<\/td>\n<td>\uc2e0\uace0<\/td>\n<td>&nbsp;<\/td>\n<\/tr>\n<\/table><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"\u65e5\u672c\u306e\u300c\u85ac\u6a5f\u6cd5(Pharmaceutical and Medical Device Act, PMDA Act)\u300d\u3067\u306f\u3001\u65e5\u672c\u56fd\u5185\u3067\u6d41\u901a\/\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001PMDA\u307e\u305f\u306fRCB\u6a5f\u95a2\u304b\u3089\u30af\u30e9\u30b9\u5225\u306b\u627f\u8a8d\u307e\u305f\u306f\u8a8d\u8a3c\u304c\u8981\u6c42\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u305f\u3060\u3057\u540c\u6cd5\u7b2c68\u6761\u306b\u3088\u308a\u3001\u60a3\u8005\u306e\u6cbb\u7642\u76ee\u7684\u3067\u7dca\u6025\u306b\u4f7f\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u5834\u5408\u306f\u533b\u5e2b\u306e\u8cac\u4efb\u3067\u88fd\u54c1\u3092\u8f38\u5165\/\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u3053\u306e\u3088\u3046\u306a\u88fd\u54c1\u306f\u5546\u696d\u7684\u306b\u8ca9\u58f2\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u305a\u3001\u9650\u3089\u308c\u305f\u60a3\u8005\u306e\u6cbb\u7642\u3084\u7814\u7a76\u76ee\u7684\u3067\u306e\u307f\u4f7f\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 \u3055\u3089\u306b\u3001\u5546\u696d\u7684\u306b\u65e5\u672c\u56fd\u5185\u3067\u6d41\u901a\u30fb\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8a31\u8a8d\u53ef\u624b\u7d9a\u304d\u304c\u5fc5\u8981\u3067\u3059\u3002 \u30af\u30e9\u30b9\u5225\u627f\u8a8d\/\u8a8d\u8a3c\u306e\u7a2e\u985e\u3068\u5be9\u67fb\u6a5f\u95a2 \u533b\u7642\u6a5f&hellip;","protected":false},"author":1,"featured_media":86,"template":"","class_list":["post-19","service","type-service","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.mdrex.co.jp\/ko\/wp-json\/wp\/v2\/service\/19","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mdrex.co.jp\/ko\/wp-json\/wp\/v2\/service"}],"about":[{"href":"https:\/\/www.mdrex.co.jp\/ko\/wp-json\/wp\/v2\/types\/service"}],"author":[{"embeddable":true,"href":"https:\/\/www.mdrex.co.jp\/ko\/wp-json\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.mdrex.co.jp\/ko\/wp-json\/wp\/v2\/media\/86"}],"wp:attachment":[{"href":"https:\/\/www.mdrex.co.jp\/ko\/wp-json\/wp\/v2\/media?parent=19"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}