{"id":3666,"date":"2024-07-09T12:22:52","date_gmt":"2024-07-09T02:22:52","guid":{"rendered":"https:\/\/compliancems.com.au\/?p=3666"},"modified":"2024-07-09T12:22:52","modified_gmt":"2024-07-09T02:22:52","slug":"tga-regulatory-changes-to-software-based-medical-devices","status":"publish","type":"post","link":"https:\/\/compliancems.com.au\/?p=3666","title":{"rendered":"TGA Regulatory changes to software-based medical devices"},"content":{"rendered":"\n<p>Just a reminder to all Medical device software manufacturers and in light of the TGA\u2019s recently published regulatory changes to software-based medical devices, up-classification to most medical device software is almost a definite. Terminology such as screening, risk factor, etc., cannot be considered as class I SaMD. Contact us for a preliminary assessment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Just a reminder to all Medical device software manufacturers and in light of the TGA\u2019s recently published regulatory changes to software-based medical devices, up-classification to most medical device software is almost a definite. Terminology such as screening, risk factor, etc., cannot be considered as class I SaMD. Contact us for a preliminary assessment.<\/p>\n","protected":false},"author":2,"featured_media":3667,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[30,1],"tags":[29,24,59,55,35,51,21,49,52,23],"class_list":["post-3666","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tga-sponsor","category-uncategorized","tag-artg","tag-australia","tag-europe","tag-ivdr-2017-746","tag-mdr","tag-mdsap","tag-sponsor","tag-tfda","tag-tg-md-regs-2002","tag-tga"],"_links":{"self":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/3666","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3666"}],"version-history":[{"count":1,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/3666\/revisions"}],"predecessor-version":[{"id":3668,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/posts\/3666\/revisions\/3668"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=\/wp\/v2\/media\/3667"}],"wp:attachment":[{"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3666"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3666"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/compliancems.com.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3666"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}