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One submission for multiple markets a future reality?
Posted by:admin
September 16, 2016
in:EU, FDA, News, TGA
The International Medical Device Regulators Forum (IMDRF) was created in February 2011 as a forum of medical device regulators from different regions around the world with the aim to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization. The IMDRF members are Australia, Brazil, Canada, China, Europe, Japan, Russia, and USA.The latest development of the IMDRF is the creation of a Table of Contents (ToC) intended to provide a harmonised international electronic submission structure for the evaluation......
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The EU new Medical Device Regulation (MDR) could be ready for adoption as early as by the end of 2015. Although it is more realistic to think the new regulations will be ready to be implemented in early 2016, it is important that all Australian manufacturers and exporters to the EU are aware of the changes currently taking place with the medical device regulations in the EU. The new MDR proposes to replace the current Medical Device and IVD Directives. The main points that are currently being evaluated by the European Commission......
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If you are a medical device sponsor, you would have received or you are about to receive the TGA annual charge invoice. It is important to ensure all your details are up to date with the TGA and that the payment of the invoice is done no later than September 15th to avoid cancellations of your ARTG Certificate. If you qualified in the past for the Low Value Turnover (LVT) scheme, from July 1st 2015 the scheme was replaced by the Annual Charge Exemption (ACE) scheme. The TGA pre-qualified certain entries that......
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Time is up for the manufacturers and sponsors of IVD devices in Australia. July 1st 2015 is the deadline for the transitional period to ensure compliance with the new regulatory framework which was introduced in 2010....
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After the reclassification of hip, knee and shoulder joint replacement from Class IIb to Class III medical devices on 1 July 2012, there was a 3 year transition to complete the reclassification process. The reclassification in Australia was modelled on the reclassification of these implants in the EU as Class III implants. During the Australian transition, it became apparent that there were differences in interpretation of the classification rules within the EU itself. And since many manufacturers rely on European certification to support market entry in Australia, it was agreed that clarification......
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In an effort to improve the current customer experience with the TGA ebs site, the TGA has developed a new customer friendly portal that promises to improve the on-line experience for manufacturers, sponsors and TGA agents. The new site is being launched on Tuesday 28 April 2015 and will be called TGA Business Services. There will be a series of upgrades that will be slowly implemented. The first upgrade will allow eBS clients to access a user-friendly site that will allow them to: Access and manage their contact details and other information,......
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The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue. Recently the Australian and New Zealand governments announced their agreement to cease the Australia New Zealand Therapeutic Products Agency (ANZTPA). After conducting a comprehensive review of progress and assessment of the costs, it was determined that the mutual Agency was not going to benefit either country....
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The following announcement was made in October by the Therapeutic Goods Administration: ‘New regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies.’ Fiona Nash, The Assistant Minister for Health, announced that, under the Government’s Industry Innovation and Competitiveness Agenda, new regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies. This change will benefit Australian manufacturers by providing them with process flexibility and......
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Do you have a medical device and don’t know what to do? Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical device also includes in vitro diagnostic (IVD) devices. If you are lost in the regulatory maze, don’t panic, KD&A can help you out. The Medical device regulatory framework is complex and varies significantly from device to device and region to region. KD&A has more than 21 years of experience working hand in hand with manufacturers, sponsors and distributors through the......
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The world of medical device regulation is a complicated one. There is a lot of guidance documents available, but it’s very difficult to tell which will be useful and practical in the early stages of understanding the Australian regulatory framework. KD&A have put together a list of what we consider to be our vital five Therapeutic Goods Administration (TGA) guidance documents. Here they are: The Australian Regulatory Guidelines for Medical Devices (ARGMD). This is the go to document for all TGA medical device related information. Broken up into 3 sections, this......
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