TGA


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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TGA Extend Reclassification Transition Deadline

The TGA have announced an extension to the deadline for the reclassification of hip, knee and shoulder joints. The due date for final transition has been extended by one year to 30 June 2015. There will be no annual charges applied for transitioned Class III joint implants until after 30 June 2015, and reclassification applications submitted by 30 June 2015 are not subject to mandatory audit requirements or related audit fees (reclassification applications may be selected for discretionary audit, for which no fees apply). Why the extension? The TGA indicate that the......

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TGA Time Frames - How Long Should You Wait?

Are you waiting to hear from the TGA about your new medical device or IVD application? Maybe it’s an application audit response…. read on for more information about TGA time frames… There are two categories of time frames used within the Australian medical devices regulatory framework. These are as follows: 1.        Legislated time frames: these are times that are specified within the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002. 2.        Target time frames: these are anticipated time frames that......

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TGA Reclassification Deadline Drawing Closer

The TGA announced the reclassification of hip, knee and shoulder joint implants (total and partial) in 2012. The announcement required medical device manufacturers and sponsors to update their product certification and Australian Register for Therapeutic Goods (ARTG) inclusion – transitioning from a Class IIa/IIb to a Class III.  A transition period was granted however this is due to conclude on the 30th June 2014. As described in our news story dated September 2012, reclassification applies to a number of products. The GMDN codes associated with affected devices on the Australian Register for Therapeutic......

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KD&A - How Can We Help you in 2014?

KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance. Regulatory Strategy Development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market. Quality Management......

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