TGA


TGA Joint Replacements Refunds on Related Ancillary Devices

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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New TGA Business Site

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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Red light on ANZTPA

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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Conformity Assessment limitations to be removed for Australian manufacturers of medical devices

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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KD&A's Guide of Guides - Australia

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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Revised Medical Device Definitions Implemented in New Zealand – Effective 1 July 2014

In preparation for the merge of the Australian Therapeutic Goods Administration (TGA) and New Zealand (NZ) Medsafe, Medsafe have published a change the existing process for defining medical devices and pharmaceuticals in NZ. Medsafe has released the Medicines Amendment Act of 2013 which alters the existing Medsafe system to align more closely with Australia’s framework for determination and classification from 1 July 2014. As part of this change, Medsafe have developed product categorisation guidelines to reflect the updated definitions and guidance manufacturers. Medsafe now distinguishes devices from drugs based on mode of......

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TGA Release New Fee Schedule

Are you planning on lodging a new medical device application with the TGA and wondering what fees apply to you?  The TGA have published the new fee schedule for 2014/2015. See below. The TGA fees for medical devices can be found here. The TGA fees for IVDs can be found here. The TGA fees for other bits and pieces which might relate to you can be found here. For a full understanding of the regulatory requirements associated to your medical device or IVD, including TGA fees and other costs you can expect,......

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TGA Fees & Timeframes - MTAA White Paper Bares All

The Medical Technology Association of Australia (the MTAA) has released a white paper on the regulatory burdens medical device companies face in Australia. They key focus of the paper regulatory costs and timeframes. The MTAA white paper published in May 2014 is designed to outline some of the “regulatory challenges experienced by Australian businesses involved in the supply of medical technology and propose an improved system that reduces the regulatory burden on industry, without compromising safety and performance of medical devices”. The paper describes what many device manufacturers and sponsors see as......

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Advertising - What's Required? All the Info You'll Need for Australia and New Zealand

In the world of marketing, it is very easy to forget that there are legal requirements associated with the advertising of therapeutic goods. Medical device suppliers and manufacturers must comply with both regulation and advertising requirements when placing product on the market. Australia In Australia, the Therapeutic Goods Advertising Code (TGAC) 2007 outlines the requirements for therapeutic goods advertising. It’s vital to consider these when creating all device materials as the term advertising really does cover a lot! The Therapeutic Goods Act 1989 and the TGAC define advertising as the following: Advertisement......

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TGA Product Registration - KD&A's Tips and Tricks

If you wish to sell medical devices in Australia, the Therapeutic Goods Administration (TGA) require you to include the device on the Australian Register for Therapeutic Goods (ARTG) under your company name as a sponsor. This process is called product registration or inclusion. Here are some of our tips and tricks for product registration… Importantly, the first step of product registration is to confirm that your product is in fact a medical device. The medical device definition given below is taken from the Therapeutic Goods Act 1989… 41BD What is a medical......

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