{"id":18489,"date":"2021-06-24T10:57:34","date_gmt":"2021-06-24T08:57:34","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18489"},"modified":"2023-01-25T17:21:51","modified_gmt":"2023-01-25T16:21:51","slug":"australia-tga-reclassification-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/06\/24\/australia-tga-reclassification-medical-devices\/","title":{"rendered":"AUSTRALIA: TGA reclassifies Medical Devices"},"content":{"rendered":"\r\n<p>The <strong>Australian Therapeutic Goods Administration (TGA)<\/strong> has issued <strong>guidelines for the reclassification of Medical Devices and relative temporary arrangements<\/strong>.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-18434\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/06\/australia-tga-riclassificazione-dispositivi-medici-1024x536.jpg\" alt=\"Australia TGA reclassification  Medical Devices Sydney\" \/>\r\n<figcaption>TGA reclassifies Medical Devices<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>The guidelines clarify the arrangements made by the <strong>Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019<\/strong>, which were scheduled to come into effect on 25 August 2020 but, due to the COVID-19 pandemic, have been postponed to<strong> 25 November 2021<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>We should also keep in mind that the TGA is substantially changing the classification of Medical Devices and aims at making its standards more similar to those used in the European Union.<\/p>\r\n\r\n\r\n\r\n<p>In view of the expiry date on 25 November 2021, date in which the classification rules should come into effect, it is advisable to plan now the actions needed to carry out a proper assessment and thus continue to market your Medical Devices in Australia.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Reclassification by category<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>The <strong>new classification rules <\/strong>apply to the following categories of <strong>Medical Devices<\/strong>:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>implantable spinal devices<\/strong>;<\/li>\r\n<li><strong>active implantable devices<\/strong>;<\/li>\r\n<li>devices intended for the administration of medicinal products or biological products through <strong>inhalation<\/strong>;<\/li>\r\n<li>devices containing <strong>substances<\/strong> (or combinations of substances) to be directly input into the body;<\/li>\r\n<li>therapeutic active ingredients which include a <strong>diagnostic function<\/strong>;<\/li>\r\n<li>devices intended to be used in direct contact with the <strong>heart<\/strong>, the <strong>circulatory system<\/strong> or the <strong>nervous system<\/strong>.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>For the time being, only the <strong>classification rules for the following three types of devices <\/strong>have been clarified:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Active Medical Devices for Diagnostic Therapy<\/strong>: they must meet the regulatory requirements of <strong>Class III<\/strong> Medical Devices; prior to the effectiveness of the new regulation, these devices were classified as DM Class IIa\/IIb.<\/li>\r\n<li><strong>Medical devices for the administration of medicinal products or biological products through inhalation<\/strong>: they must meet the regulatory requirements of <strong>Class IIa<\/strong> or <strong>IIb<\/strong> DMs.<\/li>\r\n<li><strong>Active implantable medical devices (AIMD)<\/strong>: these must be reclassified as <strong>Class III<\/strong> devices.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Deadlines and temporary arrangements for reclassified Medical Devices<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>For devices listed in the Australian Register of Therapeutic Goods (ARTG) <strong>before 25 November 2021<\/strong>, the Manufacturer or Sponsors must notify the TGA <strong>by 25 May 2022<\/strong>, in order to inform the Regulatory Authority that their product must be reclassified.<\/p>\r\n\r\n\r\n\r\n<p>Following this, <strong>by 1 November 2024 <\/strong>the same organisations must submit the application to request <strong>the registration of their device in the ARTG register<\/strong>, according to the new classification rules.<\/p>\r\n\r\n\r\n\r\n<p>In the event that the manufacturer does not submit the application by the second deadline (1 November 2024) the<strong> marketing of the device will be suspended<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p><strong>Do you want to <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/\">market<\/a><\/strong> your devices in Australia?<\/p>\r\n\r\n\r\n\r\n<p><a href=\"mailto:sales@thema-group.it\"><strong>Contact us!<\/strong><\/a> We can offer you the right support to sell your products in Australia in full compliance with the Regulations.<\/p>\r\n\r\n\r\n\r\n<p><em>Sources:<\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.tga.gov.au\/resource\/reclassification-active-medical-devices-therapy-diagnostic-function\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"\u201dReclassification of active medical devices for therapy with a diagnostic function\u201d, TGA, 12 may 2021 (si apre in una nuova scheda)\">\u201dReclassification of active medical devices for therapy with a diagnostic function\u201d, TGA, 12 may 2021<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.tga.gov.au\/resource\/reclassification-medical-devices-administer-medicines-or-biologicals-inhalation\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"\u201dReclassification of medical devices that administer medicines or biologicals by inhalation\u201d, TGA, 12 may 2021 (si apre in una nuova scheda)\">\u201dReclassification of medical devices that administer medicines or biologicals by inhalation\u201d, TGA, 12 may 2021<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.tga.gov.au\/resource\/reclassification-active-implantable-medical-devices-aimd\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"\u201dReclassification of active implantable medical devices (AIMD)\u201d, TGA, 12 may 2021 (si apre in una nuova scheda)\">\u201dReclassification of active implantable medical devices (AIMD)\u201d, TGA, 12 may 2021<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.tga.gov.au\/therapeutic-goods-medical-devices-application-form-inclusion-approval-2021\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">\u201dTherapeutic Goods (Medical Devices \u2013 Application Form for Inclusion) Approval 2021\u201d, TGA, 20 may 2021<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>The Australian Therapeutic Goods Administration (TGA) has issued guidelines for the reclassification of Medical Devices and relative temporary arrangements. The guidelines  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23059,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-18489","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>AUSTRALIA: TGA reclassification Medical Devices<\/title>\n<meta name=\"description\" content=\"The Australian Therapeutic Goods Administration (TGA) has issued guidelines for the reclassification of Medical Devices and relative temporary arrangements.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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