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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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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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Updated Standards to Keep Manufacturer's Busy

This year will see the introduction of many new or revised harmonised standards relating to medical devices. Harmonised standards are used by medical device and IVD manufacturers to demonstrate compliance with Regulations and Directives. They provide a guide for manufacturers to demonstrate compliance and take the guess work out of the selecting suitable testing, materials, design features, etc....

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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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Medical Device Software - Potential for Consistent Regulation in Asia

The Asian Harmonization Working Party (AHWP) has published a white paper on medical software for comment. The AHWP has developed the paper in conjunction with the EU and the US with the aim of developing a consistent approach for a regulatory framework for medical software to be shared among the AHWP. Singapore has been a primary contributor to the paper which provides an overview of requirements in place for medical device software in larger jurisdictions such as Australia, the US, EU, Japan, and Canada. In a story published by Clinica, Peter Linders,......

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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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Medical Devices in Malaysia - Tips to Master Market Access!

Malaysia has a well established regulatory system for medical devices governed by the Health Sciences Authority (HSA). The market has a reputation for being difficult to enter from a regulatory perspective – often deemed time consuming and complicated. Clinica recently published a story on ‘cracking the market’ in Malaysia, using the words of experience from Dr Henningsen, who has first-hand experience of accessing the market in Singapore. Dr Henningsen described the regulations as: complex – but well documented; meticulous – but not unreasonable; and offering a slow e-system – but it works.......

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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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