{"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":"%e6%be%b3%e5%a4%a7%e5%88%a9%e4%ba%9a%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80-tga-%e6%9b%b4%e6%96%b0%e4%ba%86%e5%85%b3%e4%ba%8e%e4%ba%ba%e5%b7%a5%e6%99%ba%e8%83%bd%e5%8c%bb%e7%96%97%e5%99%a8","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/australia-tga-updates-guidance-on-ai-enabled-medical-device-software-and-artg-evidence-requirements\/","title":{"rendered":"\u6fb3\u5927\u5229\u4e9a\u836f\u54c1\u7ba1\u7406\u5c40\u66f4\u65b0\u4eba\u5de5\u667a\u80fd\u8f85\u52a9\u533b\u7597\u8bbe\u5907\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e742\u67085\u65e5<\/strong>\uff0c \u8fd9 <strong>\u6cbb\u7597\u7528\u54c1\u7ba1\u7406\u5c40\uff08TGA\uff09<\/strong> \u53d1\u5e03\u66f4\u65b0\u540e\u7684\u6307\u5357\uff0c\u9610\u660e\u5982\u4f55 <strong>\u4eba\u5de5\u667a\u80fd\u8f6f\u4ef6<\/strong> \u5728\u6fb3\u5927\u5229\u4e9a\uff0c\u8be5\u4ea7\u54c1\u88ab\u5f52\u7c7b\u4e3a\u533b\u7597\u5668\u68b0\u3002\u6b64\u6b21\u66f4\u65b0\u5f71\u54cd\u5230\u5f00\u53d1\u3001\u4f9b\u5e94\u6216\u7ef4\u62a4\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u578b\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u673a\u6784\uff0c\u5e76\u660e\u786e\u89c4\u5b9a\u4e86\u76d1\u7ba1\u5206\u7c7b\u3001\u8bc1\u636e\u751f\u6210\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u65b9\u9762\u7684\u8981\u6c42\u3002.<\/p>\n<div class=\"row\"  id=\"row-636562556\">\n\n\t<div id=\"col-933135962\" 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-405295380\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-405295380 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1016783414\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1016783414 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u540e\u7684\u6307\u5357\u660e\u786e\u6307\u51fa\uff1a <strong>\u6839\u636e\u5176\u9884\u671f\u7528\u9014\uff0c\u4eba\u5de5\u667a\u80fd\u8f6f\u4ef6\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u8fdb\u884c\u76d1\u7ba1\u3002,<\/strong> \u65e0\u8bba\u5e95\u5c42\u6280\u672f\u6216\u4ea4\u4ed8\u5e73\u53f0\u5982\u4f55\u3002\u8f6f\u4ef6\u65e8\u5728 <strong>\u8bca\u65ad\u3001\u76d1\u6d4b\u6216\u6cbb\u7597<\/strong> \u5fc5\u987b\u5305\u542b\u5728 <strong>\u6fb3\u5927\u5229\u4e9a\u6cbb\u7597\u7528\u54c1\u6ce8\u518c\u5c40 (ARTG)<\/strong> \u4e4b\u540e\u624d\u80fd\u5728\u6fb3\u5927\u5229\u4e9a\u4f9b\u5e94\u3002.<\/p>\n<p>\u8be5\u6307\u5357\u89e3\u91ca\u4e86\u5236\u9020\u5546\u5728\u7ba1\u7406\u65b9\u9762\u7684\u4e49\u52a1\u3002 <strong>\u8f6f\u4ef6\u66f4\u65b0\u548c\u8303\u56f4\u8513\u5ef6\uff0c,<\/strong> \u5f3a\u8c03\u6539\u53d8\u9884\u671f\u7528\u9014\u6216\u6027\u80fd\u7684\u53d8\u5316\u53ef\u80fd\u4f1a\u5f15\u53d1\u4ee5\u4e0b\u9700\u6c42\uff1a <strong>\u4e0a\u5e02\u524d\u9700\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u3002.<\/strong> \u5b83\u8fd8\u6d89\u53ca <strong>\u975e\u9002\u5e94\u75c7\u7528\u836f,<\/strong> \u58f0\u660e\u6307\u51fa\uff0c\u4e00\u65e6\u53d1\u73b0\u6b64\u7c7b\u7528\u9014\uff0c\u5236\u9020\u5546\u5fc5\u987b\u9650\u5236\u6b64\u7c7b\u7528\u9014\uff0c\u6216\u5bfb\u6c42\u5c06\u65b0\u9002\u5e94\u75c7\u7eb3\u5165\u6fb3\u5927\u5229\u4e9a\u836f\u54c1\u6ce8\u518c\u540d\u5f55 (ARTG)\u3002.<\/p>\n<p>\u5173\u4e8e\u8bc1\u636e\u751f\u6210\uff0cTGA\u660e\u786e\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u9884\u671f\uff1a <strong>\u5408\u6210\u6570\u636e,<\/strong> \u9700\u8981\u6307\u51fa\u7684\u662f\uff0c\u867d\u7136\u5b83\u53ef\u4ee5\u7528\u6765\u8865\u5145\u4e34\u5e8a\u8bc1\u636e\uff0c\u4f46\u5b83 <strong>\u4e0d\u80fd\u53d6\u4ee3\u771f\u5b9e\u4e16\u754c\u7684\u4e34\u5e8a\u6570\u636e\u3002.<\/strong> \u5982\u679c\u4f7f\u7528\u5408\u6210\u6570\u636e\u8fdb\u884c\u9a8c\u8bc1\uff0c\u5236\u9020\u5546\u5fc5\u987b\u8bb0\u5f55\u8fd9\u4e24\u65b9\u9762\u7684\u60c5\u51b5\u3002 <strong>\u4f7f\u7528\u7406\u7531<\/strong> \u548c<strong> \u7528\u4e8e\u751f\u6210\u5b83\u7684\u65b9\u6cd5\u3002.\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-933135962 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1709131429\" 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>\u751f\u6548\u65e5\u671f<\/h2>\n\t<div id=\"gap-1715662196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1715662196 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>TGA\u5173\u4e8e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u6700\u65b0\u6307\u5357\u9002\u7528\u4e8e <strong>2026\u5e742\u67085\u65e5\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1709131429 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-874725407\" 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>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-191995548\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-191995548 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u6b21\u66f4\u65b0\u8fdb\u4e00\u6b65\u660e\u786e\u4e86\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5728\u5176\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u7684\u8bc4\u4f30\u3001\u7ef4\u62a4\u548c\u8bc1\u636e\u6536\u96c6\u65b9\u5f0f\u3002\u901a\u8fc7\u5bf9\u6570\u5b57\u5065\u5eb7\u6280\u672f\u3001\u66f4\u65b0\u7ba1\u7406\u548c\u8bc1\u636e\u6807\u51c6\u8bbe\u5b9a\u66f4\u6e05\u6670\u7684\u9884\u671f\uff0c\u8be5\u6307\u5357\u65e8\u5728\u4fc3\u8fdb\u66f4\u4e00\u81f4\u7684\u76d1\u7ba1\u534f\u8c03\uff0c\u540c\u65f6\u51cf\u5c11\u53d7\u76d1\u7ba1\u5229\u76ca\u76f8\u5173\u8005\u7684\u4e0d\u786e\u5b9a\u6027\u548c\u4e0d\u5fc5\u8981\u7684\u5408\u89c4\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-874725407 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-165798519\" 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>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-1724256538\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1724256538 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u9002\u7528\u4e8e\u6fb3\u5927\u5229\u4e9a\u53c2\u4e0e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5f00\u53d1\u548c\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u76d1\u7ba1\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u60a3\u8005\u5b89\u5168\u3001\u6cd5\u5f8b\u548c\u5408\u89c4\u3001\u5546\u4e1a\u548c\u8425\u9500\u4ee5\u53ca\u7814\u53d1\u56e2\u961f\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-165798519 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1230304022\" 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>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-2001194251\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2001194251 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5404\u7ec4\u7ec7\u5e94\u5ba1\u67e5\u5f53\u524d\u548c\u6b63\u5728\u7814\u53d1\u7684AI\u8d4b\u80fd\u8f6f\u4ef6\u4ea7\u54c1\uff0c\u4ee5\u786e\u8ba4\u5176\u4e0e\u5df2\u6f84\u6e05\u7684\u8981\u6c42\u662f\u5426\u4e00\u81f4\u3002 <strong>ARTG\u7eb3\u5165\u6807\u51c6<\/strong> \u4ee5\u53ca\u6587\u6863\u8981\u6c42\u3002\u5185\u90e8\u7ba1\u7406\u6d41\u7a0b <strong>\u8f6f\u4ef6\u66f4\u65b0<\/strong> \u548c <strong>\u975e\u6807\u7b7e\u7528\u9014\u68c0\u6d4b<\/strong> \u5e94\u8fdb\u884c\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u5176\u7b26\u5408\u66f4\u65b0\u540e\u7684\u6307\u5357\uff0c\u5e76\u5e94\u5ba1\u67e5\u8bc1\u636e\u7b56\u7565\uff08\u5982\u9002\u7528\uff09\u3002 <strong>\u5408\u6210\u6570\u636e<\/strong> \u7528\u4e8e\u9a8c\u8bc1\u3002.<\/p>\n<p>\u968f\u7740\u76d1\u7ba1\u673a\u6784\u5bf9\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u578b\u533b\u7597\u5668\u68b0\u7684\u671f\u671b\u4e0d\u65ad\u53d8\u5316\uff0c\u53ca\u65f6\u4e86\u89e3\u6700\u65b0\u6307\u5357\u81f3\u5173\u91cd\u8981\u3002. <strong><a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0\uff0c\u65e8\u5728\u5e2e\u52a9\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u5728\u5185\u7684\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u5168\u7403\u4f01\u4e1a\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c, <a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a><\/strong> <strong>\u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u964d\u4f4e\u98ce\u9669\uff0c\u5e76\u52a0\u901f\u8fdb\u5165 160 \u591a\u4e2a\u56fd\u5bb6\u7684\u5e02\u573a\u3002.<\/strong> <a href=\"http:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong><\/a> \u6216\u8005 <a href=\"https:\/\/regask.com\/zh\/\"><strong>\u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1230304022 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1762274058\">\n\n\t<div id=\"col-1826416144\" 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>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-1939258166\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1939258166 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u5728\u6fb3\u5927\u5229\u4e9a\uff0c\u4eba\u5de5\u667a\u80fd\u8f6f\u4ef6\u4f55\u65f6\u4f1a\u88ab\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u8fdb\u884c\u76d1\u7ba1\uff1f<\/h4>\n\t<div id=\"gap-163031012\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-163031012 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5f53\u4eba\u5de5\u667a\u80fd\u8f6f\u4ef6\u88ab\u8ba4\u5b9a\u4e3a\u533b\u7597\u5668\u68b0\u65f6\uff0c\u5b83\u5c31\u4f1a\u53d7\u5230\u76f8\u5e94\u7684\u76d1\u7ba1\u3002 <strong>\u9884\u671f\u7528\u9014<\/strong> \u53ef\u7528\u4e8e\u8bca\u65ad\u3001\u76d1\u6d4b\u6216\u6cbb\u7597\uff0c\u65e0\u8bba\u4f7f\u7528\u4f55\u79cd\u6280\u672f\u6216\u5e73\u53f0\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1826416144 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1089868488\" 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>\u57fa\u4e8e\u4eba\u5de5\u667a\u80fd\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u662f\u5426\u5fc5\u987b\u83b7\u5f97ARTG\u8ba4\u8bc1\uff1f<\/h4>\n\t<div id=\"gap-1567633250\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1567633250 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u662f\u7684\u3002\u7528\u4e8e\u8bca\u65ad\u3001\u76d1\u6d4b\u6216\u6cbb\u7597\u7684\u4eba\u5de5\u667a\u80fd\u8f6f\u4ef6\u5fc5\u987b\u5305\u542b\u5728\u5185\u3002 <strong>ARTG \u4f9b\u5e94\u524d<\/strong> \u5728\u6fb3\u5927\u5229\u4e9a\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1089868488 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2037706784\" 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>\u6839\u636e\u66f4\u65b0\u540e\u7684\u6307\u5357\uff0c\u5408\u6210\u6570\u636e\u80fd\u5426\u53d6\u4ee3\u4e34\u5e8a\u8bc1\u636e\uff1f<\/h4>\n\t<div id=\"gap-712421267\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-712421267 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4e0d\u3002\u5408\u6210\u6570\u636e\u53ef\u80fd <strong>\u8865\u5145\u800c\u975e\u53d6\u4ee3\u4e34\u5e8a\u8bc1\u636e,<\/strong> \u5176\u4f7f\u7528\u5fc5\u987b\u6709\u6b63\u5f53\u7406\u7531\u5e76\u6709\u636e\u53ef\u67e5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2037706784 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1360654088\" 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>RegASK \u5982\u4f55\u4e3a\u7ba1\u7406 AI \u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\u7684\u56e2\u961f\u63d0\u4f9b\u652f\u6301\uff1f<\/h4>\n\t<div id=\"gap-800374569\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-800374569 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u5e2e\u52a9\u7ec4\u7ec7\u8ddf\u8e2a\u76d1\u7ba1\u66f4\u65b0\uff08\u4f8b\u5982 TGA \u6307\u5357\uff09\uff0c\u8bc4\u4f30\u5bf9\u4ea7\u54c1\u7ec4\u5408\u7684\u5f71\u54cd\uff0c\u5e76\u5229\u7528\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u6d1e\u5bdf\u529b\u4e0e\u4e13\u5bb6\u76d1\u7ba1\u76f8\u7ed3\u5408\u6765\u534f\u8c03\u5408\u89c4\u5e94\u5bf9\u63aa\u65bd\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1360654088 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On February 5, 2026, the Therapeutic Goods Administration (TGA) published updated guidance clarifying how artificial intelligence enabled software is regulated as a medical device in Australia. The update affects organizations developing, supplying, or maintaining AI-driven medical device software and outlines clearer expectations for regulatory classification, evidence generation, and lifecycle management.<\/p>","protected":false},"author":41,"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":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Australia TGA Updates Guidance on AI-Enabled Devices<\/title>\n<meta name=\"description\" content=\"Australia TGA updates guidance on AI-enabled medical device software, clarifying ARTG evidence requirements for manufacturers.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/\u6fb3\u5927\u5229\u4e9a\u836f\u54c1\u7ba1\u7406\u5c40-tga-\u66f4\u65b0\u4e86\u5173\u4e8e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Australia TGA Updates Guidance on AI-Enabled Medical Device Software and ARTG Evidence Requirements\" \/>\n<meta property=\"og:description\" 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\/zh\/\u6fb3\u5927\u5229\u4e9a\u836f\u54c1\u7ba1\u7406\u5c40-tga-\u66f4\u65b0\u4e86\u5173\u4e8e\u4eba\u5de5\u667a\u80fd\u533b\u7597\u5668\/\" \/>\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\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta 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