{"id":1005,"date":"2011-11-24T12:35:50","date_gmt":"2011-11-24T01:35:50","guid":{"rendered":"https:\/\/www.bitemagazine.com.au\/news_blog\/?p=1005"},"modified":"2011-12-07T21:12:07","modified_gmt":"2011-12-07T10:12:07","slug":"adia-backs-senate-committee%e2%80%a8recommendations-on-medical-device-regulation-%e2%80%a8%e2%80%a8%e2%80%a8","status":"publish","type":"post","link":"https:\/\/www.bitemagazine.com.au\/adia-backs-senate-committee%e2%80%a8recommendations-on-medical-device-regulation-%e2%80%a8%e2%80%a8%e2%80%a8\/","title":{"rendered":"ADIA backs Senate Committee \u2028recommendations on medical device regulation \u2028\u2028\u2028"},"content":{"rendered":"<figure id=\"attachment_1006\" aria-describedby=\"caption-attachment-1006\" style=\"width: 300px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300.jpg\"><img decoding=\"async\" class=\"size-full wp-image-1006 lazyload\" title=\"Import300\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300.jpg\" alt=\"\" width=\"300\" height=\"199\" data-srcset=\"https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300.jpg 300w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-226x150.jpg 226w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-113x75.jpg 113w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-286x190.jpg 286w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-150x100.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><noscript><img decoding=\"async\" class=\"size-full wp-image-1006 lazyload\" title=\"Import300\" src=\"https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300.jpg\" alt=\"\" width=\"300\" height=\"199\" srcset=\"https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300.jpg 300w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-226x150.jpg 226w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-113x75.jpg 113w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-286x190.jpg 286w, https:\/\/www.bitemagazine.com.au\/wp-content\/uploads\/2011\/11\/Import300-150x100.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/noscript><\/a><figcaption id=\"caption-attachment-1006\" class=\"wp-caption-text\">A Senate committee has recommended overhauling the rules governing the importation of dental devices.<\/figcaption><\/figure>\n<p>A Senate Committee report that recommends an overhaul of regulations governing the importation of dental product has been endorsed by the Australian Dental Industry Association (ADIA), the national body representing the manufacturers, importers and suppliers of quality dental product.<\/p>\n<p>According to ADIA, the recommendations from the Senate Community Affairs References Committee\u2019s inquiry into the regulatory standards for the approval of medical devices in Australia will allow patients to have continued confidence in dental product.<\/p>\n<p>The committee\u2019s report was tabled on Wednesday.<\/p><div class=\"bitem-article-desktop-720x300-in-text\" id=\"bitem-2440326842\"><!-- Bite 720x300 [async] -->\r\n<script type=\"text\/javascript\">if (!window.AdButler){(function(){var s = document.createElement(\"script\"); s.async = true; s.type = \"text\/javascript\";s.src = 'https:\/\/servedby.engagemedia.com.au\/app.js';var n = document.getElementsByTagName(\"script\")[0]; n.parentNode.insertBefore(s, n);}());}<\/script>\r\n<script type=\"text\/javascript\">\r\nvar AdButler = AdButler || {}; AdButler.ads = AdButler.ads || [];\r\nvar abkw = window.abkw || '';\r\nvar plc705185 = window.plc705185 || 0;\r\ndocument.write('<'+'div id=\"placement_705185_'+plc705185+'\"><\\\/'+'div>');\r\nAdButler.ads.push({handler: function(opt){ AdButler.register(165450, 705185, [720,300], 'placement_705185_'+opt.place, opt); }, opt: { place: plc705185++, keywords: abkw, domain: 'servedby.engagemedia.com.au', click:'CLICK_MACRO_PLACEHOLDER' }});\r\n<\/script><\/div>\n<p>\u201cOver recent years, ADIA has been lobbying to secure reforms to the medical device regulatory framework to ensure the continued availability of quality dental product in Australia.<\/p>\n<p>The Senate committee\u2019s recommendations recognised that the importation of dental product is an area requiring reform, placing it firmly on the policy agenda,\u201d said Troy Williams, ADIA Executive Officer.<\/p>\n<p>In a submission to the Senate committee, ADIA raised a number of issues relating to the regulations governing the supply of medical devices, primarily dealing with the importation of dental product via the internet.<\/p>\n<p>The committee\u2019s report states that the unregulated importation of dental devices via the internet may indicate a much broader problem of inadequate regulation of other medical devices purchased through the internet.<\/p>\n<p>The Senate committee is of the view that this requires further investigation and assessment by the Therapeutic Goods Administration (TGA).<\/p>\n<p>\u201cWe endorse the Senate committee\u2019s comment without reserve and look forward to working with the TGA to improve safeguards in this area,\u201d Mr Williams said.<\/p>\n<p>The committee also noted that custom made dental devices appear to escape TGA scrutiny.<\/p>\n<p>The Senate committee received advice that up to fifty per cent of custom made dental prostheses are manufactured overseas, with no validation at the source of manufacture.<\/p>\n<p>\u201cSenators should be congratulated for recognising this as an area where reform is needed and again, ADIA looks forward to working with the TGA to improve patient safety,\u201d Mr Williams said.<\/p>\n<p>According to Mr Williams, ADIA will set about working with the TGA to review the regulatory solution model suggested by the Senate committee, whereby patients are offered a statement of manufacture for the custom made dental devices, and practitioners are obliged to retain this statement for the lifetime of the prosthesis, and must record whether the statement was provided to the patient or not.<\/p>\n<p>\u201cThe Senate committee has noted the lack of effective regulation associated with the importation of medical devices by individuals is very concerning and should be addressed as a matter of urgency. ADIA supports this inclusion entirely,\u201d Mr Williams stated.<\/p>\n<p>&nbsp;<\/p>\n<p><em>Bite Magazine and website is published by <a href=\"http:\/\/www.engagemedia.com.au\">Engage Media<\/a>. All material is protected by copyright and may not be reproduced in any form without prior written permission.<\/em><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Senate Committee report that recommends an overhaul of regulations governing the importation of dental product has been endorsed by the Australian Dental Industry Association (ADIA), the national body representing the manufacturers, importers and suppliers of quality dental product. According to ADIA, the recommendations from the Senate Community Affairs References Committee\u2019s inquiry into the regulatory [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":1006,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[8],"tags":[57,154,226],"class_list":{"0":"post-1005","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-dental_news","8":"tag-adia","9":"tag-imported-dental-products","10":"tag-senate"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.9 (Yoast SEO v25.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ADIA backs Senate Committee \u2028recommendations on medical device regulation \u2028\u2028\u2028 - Bite Magazine<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bitemagazine.com.au\/adia-backs-senate-committee\u2028recommendations-on-medical-device-regulation-\u2028\u2028\u2028\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ADIA backs Senate Committee \u2028recommendations on medical device regulation \u2028\u2028\u2028\" \/>\n<meta property=\"og:description\" content=\"A Senate Committee report that recommends an overhaul of regulations governing the importation of dental product has been endorsed by the Australian Dental Industry Association (ADIA), the national body representing the manufacturers, importers and suppliers of quality dental product. 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