Under the Therapeutic Goods Administration (TGA) regulations in Australia, some Clinical Decision Support Systems (CDSS) may be considered exempt medical devices \u2014 but only if they meet specific criteria.<\/p>\n\n\n\n
A CDSS is only considered exempt if it meets all three of these: <\/p>\n\n\n\n
\u2714\ufe0f It supports or provides recommendations to a health professional (e.g. for prevention, diagnosis, or treatment) <\/p>\n\n\n\n
\u2714\ufe0f It does not directly analyse medical images or signals from another medical device <\/p>\n\n\n\n
\u2714\ufe0f It does not replace the clinical judgement of a health professional <\/p>\n\n\n\n
\ud83d\udea8 With the rapid uptake of AI in healthcare, it\u2019s critical to note that AI-enabled CDSS will NOT meet the exemption criteria. <\/p>\n\n\n\n
\ud83d\udc49 If your software meets all three (and is not AI-enabled), it\u2019s likely an exempt medical device \u2014 but regulatory obligations still apply. <\/p>\n\n\n\n
\u26a0\ufe0f Even for exempt CDSS, you must: <\/p>\n\n\n\n
\u2022 Notify the TGA within 30 working days of supply using the CDSS Exemption Notification Form <\/p>\n\n\n\n
\u2022 Ensure compliance with the Essential Principles (safety, performance, design, manufacture, and intended use) <\/p>\n\n\n\n
\u2022 Be aware that the TGA can take regulatory action (e.g. recalls or hazard alerts)<\/p>\n\n\n\n
\u2022 Report adverse events to the TGA <\/p>\n\n\n\n
\u2022Comply with advertising requirements for therapeutic goods <\/p>\n\n\n\n
\ud83d\udce9 Not sure where your software stands? Contact us to help assess your medical device and guide you through the regulatory pathway.<\/p>\n","protected":false},"excerpt":{"rendered":"
Under the Therapeutic Goods Administration (TGA) regulations in Australia, some Clinical Decision Support Systems (CDSS) may be considered exempt medical devices \u2014 but only if they meet specific criteria. A CDSS is only considered exempt if it meets all three of these: \u2714\ufe0f It supports or provides recommendations to a health professional (e.g. for prevention, diagnosis, or treatment) \u2714\ufe0f It does not directly analyse medical images or signals from another medical device \u2714\ufe0f It does not replace the clinical judgement of a health professional \ud83d\udea8 With the rapid uptake of AI in healthcare, it\u2019s critical to note that AI-enabled CDSS will NOT meet the exemption criteria. \ud83d\udc49 If your software[…]<\/p>\n","protected":false},"author":1,"featured_media":4032,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4031","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/4031","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4031"}],"version-history":[{"count":1,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/4031\/revisions"}],"predecessor-version":[{"id":4033,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/4031\/revisions\/4033"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/media\/4032"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4031"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4031"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4031"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}