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KD&A Involved in Workshop in August 2013

REALISE. COMMERCIALISE. OPTIMISE. PATHWAYS TO ACHIEVING MEDICAL DEVICE COMMERCIAL SUCCESS This workshop will benefit those involved in medical devices & IVDs in Australia across the full lifecycle – from concept development, commercial market release to penetration of the target prevalence pool.  Together,  Australian Healthcare Solutions and KD&A will share their extensive experience in the device arena to help you deliver effective, resource efficient, regulatory and strategic commercialisation solutions to optimise your business outcomes. Full day workshop, catering provided. Cost: $395 (inclusive of GST). Dates and locations are listed below. BRISBANE: Thursday 1st......

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Do your device materials comply with the Therapeutic Goods Advertising Code 2007? Don’t get caught out!

Medical devices and IVDs are almost always supplied with labelling, instructions for use and packaging – which often includes a web address and other marketing materials. The Therapeutic Goods Administration (the TGA) define all of these to be advertisements in relation to therapeutic goods. Whilst we all busily ensure our materials comply with the Therapeutic Goods (Medical Device) Regulations, we often forget they must also meet the requirements of the Therapeutic Goods Advertising Code 2007 also. For device and IVD manufacturers, not complying with the code can result in review from the......

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IVD Point of Care Tests Go Under the Spotlight

The Therapeutic Goods Administration (TGA) ACMD (Advisory Committee on Medical Devices) recently held a meeting to review the requirements for IVD Point of Care Tests (class 3 IVDs) when it comes to performance and testing.  The IVD regulation is reasonably new (having come into force in 2010) and new IVD manufacturers are still in the process of better understanding requirements. The ACMD is a statutory advisory committee established by the Therapeutic Goods Regulations 1990. The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific......

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Electronic Age: UK MHRA Issue Guidance On eIFU Requirements

The EU regulation on electronic Instructions for Use (IFU) (Regulation 207/2012) came into force on March 1st 2013. In response to the implementation of electronic IFUs, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a guidance document to provide device manufacturers with an overview of requirements described in Regulation 207/2012. The Regulation defines IFU as information provided by the manufacturer to inform the user of the device of its safe and proper use, of its intended performances and of any precautions to be taken as outlined in the Directives......

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European Union Commission Release New Vigilance Guidance

The EU Commission have released revision 8 of MEDDEV 2.12-1: Guidelines on a Medical Device Vigilance System. The updated version includes guidelines for In Vitro Fertilisation (IVF)/Assistive Reproductive Therapies (ART) devices, in addition to medical devices.  The guidance remains for the most part unchanged, however the inclusion of IVF/ART devices results in changes to the incident reporting criteria for manufacturers. The guidance also explores the difficult task of defining indirect harm and serious deterioration of patient health for IVF/ART device manufacturers. MEDDEV 2.12-1, revision 8 is applicable from July 2013. Ensure your......

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Regulatory Requirements: A Simple Guide for Australian Medical Device Distributors

So you’ve found a new medical device that is just what Australia needs? Follow these steps to better understand the regulatory requirements for selling medical devices in Australia. Before we start, remember KD&A can assist you with all of the actions listed below, visit our Product Registration page for more information.  FIRST THINGS FIRST Ensure the device manufacturer will work with you to obtain Therapeutic Goods Administration (TGA) Australian Register for Therapeutic Goods (ARTG) inclusions (which allows you to put the device on the market. We recommend you get this in writing.......

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TGA Release Proposal Paper: Are Tighter Controls and Alternative Options for Conformity Assessment Ahead?

The TGA have released a proposal paper introducing changes which could shake things up for Australian and overseas medical and IVD device manufacturers. The paper explores changes which could affect all companies entering the Australian market, particularly new medical devices which are higher risk (IIb, III and AIMD). In an attempt to improve control of devices and improve transparency, the following has been proposed. Mandatory Application Audits (MAA) changes. The potential overhaul includes two key actions; Expanding the list of devices requiring MAA which falls in line with recent changes to the......

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The Mutual Recognition Agreement between Australia and the European Union (EU), the EC MRA, facilitates medical device sponsors (entities or individuals who place medical devices on the market in Australia) to use CE Marking certificates as evidence of conformity to Australian regulatory requirements for some medical devices. Since being signed in 1998, the Agreement has provided a much shorter path to market in Australia for most CE Marked medical devices. However, the EC MRA has recently undergone changes which restrict previously covered devices. Changes came into affect on January 1 2013 and......

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Early Warning Mechanisms for Australia and New Zealand

The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing an early warning system for adverse event and recall situations. The system is one of many projects being worked on as part of the creation of one regulatory agency, the Australian New Zealand Therapeutic Products Agency (ANZTPA)....

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GHTF Release New Standard

In light of the recent PIP breast implant adverse events and other significant device recalls,  the GHTF has finalised a new standard called N87 (based on a previous guidance document GHTF/SG2/N54:2006). The new standard outlines a system for medical device manufacturers and competent and regulatory authorities to exchange information regarding medical device adverse events electronically....

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