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Information Feature: TGA Application Audit

As part of medical device framework reforms, the TGA seem to be dramatically increasing the number audits completed on medical device applications for inclusion on the Australian Register for Therapeutic Goods (ARTG). A bit of background As a result of the Mutual Recognition Agreement held between Australia and the EU, Australian Sponsors can make device applications using an overseas manufacturer’s European certification (CE Marking to the Medical Device Directive 93/42/EEC) as evidence of compliance with the Australian regulations. This abridged application process means significantly reduced costs and time frames for Sponsors. However......

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TGA Move to Improve Access to Device Information

The TGA have implemented two new website functions to provide better access to device information. Details are below. Adverse Event Database (DAEN) In a response to the need for more information about device adverse events to be publicly available, the TGA have launched an adverse event database called DAEN – database of adverse event notifications. The database provides public information regarding adverse events and near adverse events occurring in Australia. It includes only events captured using the online reporting system starting in June 2012 and includes reports from a wide range of......

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To manufacture and sell a medical device in Australia, you must hold certification from the Therapeutic Goods Administration (TGA). Depending on the risk level of the device you manufacture, requirements can vary significantly. Read on to learn key information for device manufacturers.  Is it a medical device? There’s no better way to start than reviewing the medical device definition to justify and confirm whether your product is in fact a medical device. The definition below is taken from the Therapeutic Goods Act 1989 (41BD). A medical device is: a. any instrument, apparatus,......

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Workshop - Key Topic Information

REALISE. COMMERCIALISE. OPTIMISE. PATHWAYS TO ACHIEVING MEDICAL DEVICE COMMERCIAL SUCCESS. COMMERCIALISE “By failing to prepare, you are preparing to fail” Benjamin Franklin This workshop will help you: Avoid commercial failure by understanding critical drivers for success Plan an effective pre and post commercialisation strategy Plan and prioritise your regulatory submission Hit the ground running to commercialise your device. Full day workshop, catering provided. Cost: $395 (GST inclusive). Dates and locations are listed below. BRISBANE: Thursday 1st August 2013, Ashurst, Level 38, Riverside Centre, 123 Eagle Street MELBOURNE: Tuesday 6th August 2013, Ashurst,......

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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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