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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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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In an effort to improve the process for listing, evaluating and funding new medical technology, the Australian Government Department of Health and Ageing recently completed a review of health technology assessment (HTA) agencies in Australia. To be listed on the Australian Medicare Benefits Schedule (MBS), a new medical procedure must be submitted to Medical Services Advisory Committe (MSAC) for an HTA....
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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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