{"id":32221,"date":"2024-03-20T10:30:38","date_gmt":"2024-03-20T09:30:38","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=32221"},"modified":"2024-03-20T10:33:21","modified_gmt":"2024-03-20T09:33:21","slug":"australia-updated-medical-device-labelling-requirements","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/03\/20\/australia-updated-medical-device-labelling-requirements\/","title":{"rendered":"AUSTRALIA: Updated Medical Device Labelling Requirements"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>On <strong>February<\/strong> <strong>19,<\/strong> <strong>2024<\/strong>, the Australian regulatory authority, Therapeutic Good Administration <strong>(TGA)<\/strong>, updated the requirements regarding the <strong>labelling <\/strong>of medical devices detailing the obligations of the Manufacturer and Sponsor.<\/h2>\n<p>The manufacturer of a medical device, who is also responsible for <strong>labelling<\/strong>, must include information such as the <strong>name<\/strong> and <strong>address<\/strong> of the manufacturer.<\/p>\n<p>Furthermore, the relabelling of devices by a party other than the Manufacturer, e.g. the Sponsor, does not make it a Manufacturer.<\/p>\n<p>The <strong>Sponsor<\/strong>, i.e. the person who adds a Medical Device to the Australian Register of Therapeutic Products, must ensure that their <strong>name<\/strong> and <strong>address<\/strong> appear on the labelling. However, if this is not possible, the information must be included on the <strong>packaging<\/strong> or the <strong>leaflet<\/strong>. Moreover, in the latest update, it is specified that the label must not in any way modify the device or obscure the information provided with the device by the manufacturer.<\/p>\n<p><strong>Information<\/strong> to be included on the label by the Manufacturer<\/p>\n<ul>\n<li>Manufacturer&#8217;s name or trade name and address;<\/li>\n<li>Intended use, user, patient of the device;<\/li>\n<li>Sufficient information for the user to identify the device or package contents;<\/li>\n<li>Any special handling or storage requirements applicable to the device;<\/li>\n<li>Any warnings, restrictions or precautions concerning the device;<\/li>\n<li>Any special operating instructions for using the device;<\/li>\n<li>Indication &#8216;for single use only&#8217;, if applicable;<\/li>\n<li>Indication that the device has been custom-made, if applicable;<\/li>\n<li>Indication that the device is intended for pre-marketing clinical investigations, if applicable;<\/li>\n<li>Insertion of the word &#8216;sterile&#8217; and the method of sterilisation, if sterile device;<\/li>\n<li>Entry of batch code, batch number or serial number of the device;<\/li>\n<li>Indication of the date (month and year) until which the device can be safely used, if applicable.<\/li>\n<\/ul>\n<p>The TGA&#8217;s updating of the <strong>labelling requirements for Medical Devices<\/strong> aims to update the Australian regulatory framework to keep pace with other countries around the world such as the USA, Europe and China, ensuring safe and effective devices and thus safeguarding patients&#8217; lives.<\/p>\n<p>&gt;&gt; Through the services of <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>strategic-regulatory consulting<\/strong><\/a> Thema supports the<strong>\u00a0<\/strong><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/\"><strong>registration with Therapeutic Good Administration<\/strong><\/a> for the marketing of medical devices and IVDs in Australia.<\/p>\n<p><strong>Source<\/strong><\/p>\n<p><a href=\"https:\/\/www.tga.gov.au\/resources\/resource\/guidance\/medical-device-labelling-obligations#manufacturer-obligations\">Medical device labelling obligations<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32218,"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-32221","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 - 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