The TGA proposed regulatory reforms during October 2010 in response to the Australian Government Health Technology Assessment Review (HTA) and after considerable consultation further information has been released. The announced reforms will have an effect on almost all medical device manufacturers and sponsors placing medical devices on the market in Australia. Read on to see how the reforms affect you....
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Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The joint scheme will reduce regulatory burden for industry in both Australia and New Zealand....
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The Therapeutic Goods Administration (TGA) local representative (termed sponsor by the TGA) requirements can be a significant road block for non-Australian based manufacturers. KD&A can provide an effective and reliable solution....
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The internet is a vast resource and hunting through available information can be time consuming – making it difficult for you to find what you need, when you need it. As an Australian medical device or IVD manufacturer or sponsor there are some key websites which allow you to have valuable and reliable information at your fingertips. The sites below are worth adding to your favourites list. The Therapeutic Goods Administration website acts as an excellent resource, providing information such as the Australian Regulatory Guidelines for Medical Devices and IVD guidance......
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The 4 Corners program on ABC television which aired on the 16th of May explored the failure and subsequent recall of the DePuy Orthopaedics ASR hip replacement device, raising questions regarding the regulation of joint implants in Australia....
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On 4 May 2011 the TGA is going to launch its new website. A site map and navigation guide have been released by the TGA to assist users, these documents can be found at http://www.tga.gov.au/newsroom/media-2011-website-110406.htm. The TGA information email service is also undergoing change, including more frequent emails and a new format....
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Recently there has been significant discussion on the future direction of the GHTF. In a statement released on March 28 2011, Larry Kelly, the chair of the GHTF, confirmed that the current GHTF structure will morph into a Regulator’s Group. This was considered the best way to continue to work towards the objective of harmonised regulatory requirements by GHTF senior officials....
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New IVD requirements (Regulations implemented on July 1, 2010) have brought a number of challenges for IVD manufacturers and sponsors in Australia. To assist, the TGA have released a number of guidance documents, the most recent being ‘What a sponsor needs to know about conformity assessment and manufacturer’s evidence’. The guidance document is intended to describe the conformity assessment process in detail, along with providing specific instructions relating to manufacturer’s evidence. Despite the release of guidance documents, IVD manufacturer and sponsors still have their work cut out to ramp up regulatory actions......
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Greater scrutiny for in-vitro diagnostic (IVD) devices In-vitro diagnostic (IVD) device companies will soon be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs into line with medical devices by requiring standard technical documentation (STED) and in some cases, a full quality system....
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