{"id":17087,"date":"2021-01-25T17:49:38","date_gmt":"2021-01-25T16:49:38","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17087"},"modified":"2021-01-25T17:49:38","modified_gmt":"2021-01-25T16:49:38","slug":"tga-priority-applicant-guidelines-medical-devices-ivds","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/01\/25\/tga-priority-applicant-guidelines-medical-devices-ivds\/","title":{"rendered":"AUSTRALIA: TGA priority applicant guidelines for Medical Devices and IVDs"},"content":{"rendered":"\n<p>On 2 December 2020, the <strong>TGA <em>priority applicant <\/em>guidelines<\/strong> for <strong>Medical Devices <\/strong>and <strong>IVDs\u00a0<\/strong>were published: \u201cPriority applicant guidelines for medical devices (including IVDs)\u201d. <br>The purpose of these guidelines is to provide MD Manufacturers and Sponsors with information on the criteria and on the process of definition of the <em>priority applicant status<\/em> for all MD types, including IVDs, in order to comply with the current regulations. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/01\/linee-guida-tga-priority-applicant-dispositivi-medici-ivd-1024x536.jpg\" alt=\"TGA priority applicant guidelines for Medical Devices and IVDs\" class=\"wp-image-17063\"\/><figcaption>TGA priority applicant guidelines for Medical Devices and IVDs<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Process for defining\nthe <\/strong><strong><em>priority applicant<\/em><\/strong><strong><\/strong><\/h2>\n\n\n\n<p>The regulatory framework provides for <strong>two types of <em>priority applicant status<\/em>:<\/strong> one for the <strong>conformity assessment <\/strong>certificate issued by TGA; the other for <strong>inclusion<\/strong> in the Australian Register of Therapeutic Goods (<strong>ARTG<\/strong>).<\/p>\n\n\n\n<p>When a <em>priority applicant status <\/em>is carried out, the corresponding\napplication for a conformity assessment certificate or for inclusion in the ARTG\nis checked as a matter of priority. This means that it is given the priority <em>\u201c<strong>front-of-queue<\/strong>\u201d<\/em>,\nduring the relevant assessment processes carried out by TGA.<\/p>\n\n\n\n<p><strong>Attention!<\/strong> Even if you get a <em>priority\napplicant status<\/em>, it is still required to comply with all relevant\nlegislative requirements (Therapeutic Goods Act 1989 particularly Chapter 4 of\nthe Act and Therapeutic Goods (Medical Devices) Regulations 2002).<\/p>\n\n\n\n<p>Another important aspect is the <strong>timing <\/strong>of applications. In fact, it is necessary to present them within <strong>6 months<\/strong> from the date on which the <em>priority applicant status <\/em>was granted, otherwise this condition is no longer valid.<\/p>\n\n\n\n<p>For more information on submitting applications, please consult the\nguide \u201cPre-submission meetings with TGA\u201d.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Three TGA criteria for the definition of the <em>priority applicant<\/em><\/strong><\/h2>\n\n\n\n<p>In the guideline TGA stresses that in order to benefit from the definition of the <em>priority applicant status<\/em>, the Medical Device must meet three criteria, which we report below: <br><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><em>\u201cLife-threatening or seriously debilitating condition\u201d<\/em>. This criterion requires that the intended purpose of the MD is monitoring, treatment, prevention or diagnosis of a life-threatening and\/or severely debilitating condition;<\/li><li><em>\u201cUnmet need \/ significant improvement\u201d<\/em>. This criterion can be met in two ways. In the first case in the ARTG there is no MD which is intended for the same purpose, while in the second case the new MD shows a significant improvement compared to the existing MDs already included in the ARTG.<br><\/li><li><em>\u201cMajor clinical advantage (or in the case of IVDs, major public health benefit)\u201d<\/em>. For all MDs, including IVDs, this criterion may be met if at least one of the following case applies to the device: the new MD has an innovative technology and there is evidence that demonstrates a greater clinical advantage over existing technology or the MD offers an important clinical advantage over devices already included in the ARTG. In addition, if the device is an IVD and it is available in advance in Australia, the criterion can be met, as it can be an important benefit to public health.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you need more information?<\/strong><strong><\/strong><\/h2>\n\n\n\n<p><a href=\"mailto:sales@thema-group.it\"><strong>Contact us<\/strong><\/a><strong> <\/strong>if you need more details or if you wish to request strategic-regulatory consultancy in this matter.<\/p>\n\n\n\n<p><em>Sources:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.tga.gov.au\/resource\/priority-applicant-guidelines-medical-devices-including-ivds\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Priority applicant guidelines for medical devices (including IVDs)<\/a> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.tga.gov.au\/resource\/pre-submission-meetings-tga\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Pre-submission meetings with TGA<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 2 December 2020, the TGA priority applicant guidelines for Medical Devices and IVDs\u00a0were published: \u201cPriority applicant guidelines for medical devices  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[1],"tags":[],"class_list":["post-17087","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>TGA priority applicant guidelines for Medical Devices and IVDS<\/title>\n<meta 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