The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical device. This guidance replaces the 1997 guidance document and is important to those considering making changes to a previously approved device....
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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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Health Canada has changed its rules and requirements concerning Medical Device Establishment Licensing (MDEL), which provides a regulatory framework for selling or importing medical devices into Canada. Specifically, it serves as the method by which medical device companies selling on the Canadian market demonstrate to Health Canada that their product meets all of the applicable regulatory requirements. This includes procedural documentation, handling of complaints, storage and delivery of devices, and installation and servicing of devices (if applicable). KD&A can develop documentation in conjunction with your organisation to ensure the Health Canada regulatory......
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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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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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