{"id":9492,"date":"2026-02-16T17:31:59","date_gmt":"2026-02-16T09:31:59","guid":{"rendered":"https:\/\/regask.com\/?p=9492"},"modified":"2026-02-16T17:31:59","modified_gmt":"2026-02-16T09:31:59","slug":"%e3%82%aa%e3%83%bc%e3%82%b9%e3%83%88%e3%83%a9%e3%83%aa%e3%82%a2tga%e3%80%81ai%e5%af%be%e5%bf%9c%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%82%bd%e3%83%95%e3%83%88%e3%82%a6%e3%82%a7%e3%82%a2%e3%81%a8artg","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/","title":{"rendered":"\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2TGA\u3001AI\u3092\u6d3b\u7528\u3057\u305f\u533b\u7642\u958b\u767a\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u66f4\u65b0"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e742\u67085\u65e5<\/strong>\u3001 <strong>\u533b\u85ac\u54c1\u7ba1\u7406\u5c40 (TGA)<\/strong> \u65b9\u6cd5\u3092\u660e\u78ba\u306b\u3057\u305f\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b <strong>\u4eba\u5de5\u77e5\u80fd\u5bfe\u5fdc\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2<\/strong> \u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306f\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u898f\u5236\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001AI\u99c6\u52d5\u578b\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u958b\u767a\u3001\u4f9b\u7d66\u3001\u307e\u305f\u306f\u4fdd\u5b88\u3092\u884c\u3046\u7d44\u7e54\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u3001\u898f\u5236\u4e0a\u306e\u5206\u985e\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u751f\u6210\u3001\u304a\u3088\u3073\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u306b\u95a2\u3059\u308b\u3088\u308a\u660e\u78ba\u306a\u671f\u5f85\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-1125643019\">\n\n\t<div id=\"col-203795766\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1475263184\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1475263184 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u8a73\u7d30<\/h2>\n\t<div id=\"gap-1198978603\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1198978603 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001 <strong>AI\u5bfe\u5fdc\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001\u305d\u306e\u672c\u6765\u306e\u76ee\u7684\u306b\u57fa\u3065\u3044\u3066\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u898f\u5236\u3055\u308c\u3066\u304a\u308a\u3001,<\/strong> \u57fa\u76e4\u3068\u306a\u308b\u6280\u8853\u3084\u914d\u4fe1\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u95a2\u4fc2\u306a\u304f\u3001 <strong>\u8a3a\u65ad\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u307e\u305f\u306f\u6cbb\u7642<\/strong> \u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044 <strong>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u533b\u85ac\u54c1\u767b\u9332\u7c3f\uff08ARTG\uff09<\/strong> \u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u4f9b\u7d66\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\u524d\u306b\u3002.<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u306e\u7ba1\u7406\u7fa9\u52d9\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u308b\u3002 <strong>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u66f4\u65b0\u3068\u30b9\u30b3\u30fc\u30d7\u30af\u30ea\u30fc\u30d7\u3001,<\/strong> \u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3084\u6027\u80fd\u3092\u5909\u3048\u308b\u3088\u3046\u306a\u5909\u66f4\u306f\u3001 <strong>\u30ea\u30ea\u30fc\u30b9\u524d\u306b\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u3092\u5f97\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/strong> \u307e\u305f\u3001 <strong>\u9069\u5fdc\u5916\u4f7f\u7528\u3001,<\/strong> \u305d\u306e\u3088\u3046\u306a\u4f7f\u7528\u304c\u691c\u51fa\u3055\u308c\u305f\u5834\u5408\u3001\u88fd\u9020\u696d\u8005\u306f\u305d\u308c\u3092\u5236\u9650\u3059\u308b\u304b\u3001\u65b0\u3057\u3044\u9069\u5fdc\u75c7\u306b\u3064\u3044\u3066 ARTG \u3078\u306e\u8ffd\u52a0\u3092\u6c42\u3081\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002.<\/p>\n<p>\u8a3c\u62e0\u4f5c\u6210\u306b\u95a2\u3057\u3066\u3001TGA\u306f\u6b21\u306e\u3088\u3046\u306a\u671f\u5f85\u3092\u660e\u78ba\u306b\u3057\u3066\u3044\u308b\u3002 <strong>\u5408\u6210\u30c7\u30fc\u30bf\u3001,<\/strong> \u81e8\u5e8a\u7684\u8a3c\u62e0\u3092\u88dc\u8db3\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3067\u304d\u308b\u3082\u306e\u306e\u3001 <strong>\u5b9f\u969b\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u7f6e\u304d\u63db\u3048\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/strong> \u691c\u8a3c\u306b\u5408\u6210\u30c7\u30fc\u30bf\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u3001\u88fd\u9020\u696d\u8005\u306f\u3001 <strong>\u4f7f\u7528\u306e\u6839\u62e0<\/strong> \u305d\u3057\u3066<strong> \u305d\u308c\u3092\u751f\u6210\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u65b9\u6cd5\u3002.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-203795766 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-44812833\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u767a\u52b9\u65e5<\/h2>\n\t<div id=\"gap-1868949607\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1868949607 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>AI\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306b\u95a2\u3059\u308bTGA\u306e\u6700\u65b0\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>2026\u5e742\u67085\u65e5\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-44812833 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1539709223\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-10190474\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-10190474 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u6539\u8a02\u306b\u3088\u308a\u3001AI\u99c6\u52d5\u578b\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308b\u8a55\u4fa1\u3001\u4fdd\u5b88\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u53d6\u5f97\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u898f\u5236\u4e0a\u306e\u660e\u78ba\u5316\u304c\u5f37\u5316\u3055\u308c\u307e\u3059\u3002\u30c7\u30b8\u30bf\u30eb\u30d8\u30eb\u30b9\u6280\u8853\u3001\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u7ba1\u7406\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u57fa\u6e96\u306b\u95a2\u3059\u308b\u671f\u5f85\u5024\u3092\u660e\u78ba\u306b\u8a2d\u5b9a\u3059\u308b\u3053\u3068\u3067\u3001\u672c\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u898f\u5236\u5bfe\u8c61\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u306b\u3068\u3063\u3066\u306e\u4e0d\u78ba\u5b9f\u6027\u3068\u4e0d\u5fc5\u8981\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8ca0\u62c5\u3092\u8efd\u6e1b\u3057\u306a\u304c\u3089\u3001\u3088\u308a\u4e00\u8cab\u3057\u305f\u898f\u5236\u4e0a\u306e\u6574\u5408\u6027\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1539709223 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1332402149\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8ab0\u306b\u95a2\u4fc2\u304c\u3042\u308b\u304b<\/h2>\n\t<div id=\"gap-888920734\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-888920734 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306b\u304a\u3051\u308b AI \u30d9\u30fc\u30b9\u306e\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u958b\u767a\u3068\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u306b\u643a\u308f\u308b\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u60a3\u8005\u306e\u5b89\u5168\u3001\u6cd5\u52d9\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u5546\u696d\u304a\u3088\u3073\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u3001\u7814\u7a76\u958b\u767a\u30c1\u30fc\u30e0\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1332402149 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1570549475\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-1446277750\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1446277750 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7d44\u7e54\u306f\u3001\u73fe\u5728\u304a\u3088\u3073\u5c06\u6765\u958b\u767a\u4e2d\u306eAI\u5bfe\u5fdc\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u88fd\u54c1\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u660e\u78ba\u5316\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u306e\u6574\u5408\u6027\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <strong>ARTG\u306e\u5305\u542b\u57fa\u6e96<\/strong> \u304a\u3088\u3073\u6587\u66f8\u5316\u306e\u671f\u5f85\u3002\u7ba1\u7406\u306e\u305f\u3081\u306e\u5185\u90e8\u30d7\u30ed\u30bb\u30b9 <strong>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8<\/strong> \u305d\u3057\u3066 <strong>\u9069\u5fdc\u5916\u4f7f\u7528\u306e\u691c\u51fa<\/strong> \u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u8a55\u4fa1\u3057\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u6226\u7565\u3092\u898b\u76f4\u3059\u5fc5\u8981\u304c\u3042\u308b\u3002 <strong>\u5408\u6210\u30c7\u30fc\u30bf<\/strong> \u691c\u8a3c\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n<p>AI \u99c6\u52d5\u578b\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u898f\u5236\u4e0a\u306e\u671f\u5f85\u306f\u9032\u5316\u3057\u7d9a\u3051\u3066\u3044\u308b\u305f\u3081\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u3092\u5148\u53d6\u308a\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002. <strong><a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u3001\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u3092\u7a4d\u6975\u7684\u306b\u4e57\u308a\u8d8a\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3059\u308b\u3001\u696d\u754c\u3092\u30ea\u30fc\u30c9\u3059\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u3068\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> 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class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h3>\n\t<div id=\"gap-427595693\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-427595693 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306f AI \u5bfe\u5fdc\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u898f\u5236\u3055\u308c\u308b\u306e\u306f\u3044\u3064\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-1788286757\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1788286757 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>AI\u5bfe\u5fdc\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001 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10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u306f\u3044\u3002\u8a3a\u65ad\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u307e\u305f\u306f\u6cbb\u7642\u3092\u76ee\u7684\u3068\u3057\u305fAI\u5bfe\u5fdc\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u3001 <strong>\u4f9b\u7d66\u524d\u306eARTG<\/strong> \u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1038565323 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2083567947\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u5408\u6210\u30c7\u30fc\u30bf\u306f\u81e8\u5e8a\u7684\u8a3c\u62e0\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u304b?<\/h4>\n\t<div id=\"gap-1569193494\" class=\"gap-element clearfix\" style=\"display:block; 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\u4e3b\u5c0e\u306e\u6d1e\u5bdf\u3092\u4f7f\u7528\u3057\u3066\u6e96\u62e0\u3057\u305f\u5bfe\u5fdc\u3092\u8abf\u6574\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1264128889 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>2026\u5e742\u67085\u65e5\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u533b\u85ac\u54c1\u898f\u5236\u5f53\u5c40\uff08TGA\uff09\u306f\u3001\u4eba\u5de5\u77e5\u80fd\uff08AI\uff09\u642d\u8f09\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u3069\u306e\u3088\u3046\u306b\u898f\u5236\u3055\u308c\u308b\u304b\u3092\u660e\u78ba\u306b\u3059\u308b\u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u66f4\u65b0\u306f\u3001AI\u3092\u6d3b\u7528\u3057\u305f\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u958b\u767a\u3001\u4f9b\u7d66\u3001\u307e\u305f\u306f\u4fdd\u5b88\u3059\u308b\u7d44\u7e54\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u3001\u898f\u5236\u4e0a\u306e\u5206\u985e\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u751f\u6210\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u306b\u95a2\u3059\u308b\u3088\u308a\u660e\u78ba\u306a\u8981\u4ef6\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>","protected":false},"author":43,"featured_media":9493,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,511,39],"tags":[],"class_list":["post-9492","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-australia-regulations","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- 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content=\"Australia TGA updates guidance on AI-enabled medical device software, clarifying ARTG evidence requirements for manufacturers.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2tga\u3001ai\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068artg\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-16T09:31:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/02\/australia-tga-updates-guidance-ai-enabled-medical-device-software-artg-evidence-requirements.png\" \/>\n\t<meta property=\"og:image:width\" content=\"904\" \/>\n\t<meta property=\"og:image:height\" content=\"622\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" 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