News


Technical Documentation: What is it all about?

Technical Documentation is a vital component of gaining regulatory certification for all medical devices, including in vitro diagnostic devices (IVDDs).  Technical Documentation often called a Technical File, Design Dossier, or STED (Summary Technical Documentation) describes a device,  including the intended purpose, history, design, manufacture and validation.  Manufacturer’s use Technical Documentation to confirm that their device is safe and effective in carrying out its intended purpose, and conforms to regulatory requirements. Technical Documentation is generally developed in line with the internationally acknowledged Standard Technical Documentation (STED) guidelines created by the Global Harmonisation Task......

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NZ Medical Device Recalls Remind Medical Device Suppliers to be Prepared

New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should an adverse event occur with a supplied device. Medsafe advise, recall actions are serious matters.  They are also not isolated matters.  Between 1-Jul-2012 and 30-Jun-2013 Medsafe was advised of 705 medical device market actions, resulting in 101 recalls, 173 corrective actions, and 25 alerts.  The balance of actions related to devices where the affected lots/batches/versions were not supplied in New Zealand, or where the device......

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TGA Medical Device Reforms - Product Names Requirement Cancelled

The TGA have announced that a component of the medical device reforms outlined in the TGA blueprint will not go ahead. The initiative to record all devices included under a device kind/type Australian Register for Therapeutic Goods (ARTG) inclusion was designed to improve medical device traceability and identification. The proposal required Sponsors to nominate the names of all individual devices included under one ARTG. Feedback received by the TGA showed strong support from consumers however industry were less positive about the change. In an update published in early August, the TGA indicate......

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Regulatory Strategy - Key to Success

The term strategy is defined as ‘a high level plan to achieve one or more goals under conditions of uncertainty‘. A Regulatory Strategy created by KD&A specifically for your organisation is the best way to ensure success in bringing your medical device from concept to market.  Meeting regulatory requirements can often be an uncertain and complex task for new medical device manufacturers, but with a comprehensive Regulatory Strategy prepared by KD&A, the path to market can be much less daunting. Designed to provide your organisation with an understanding of specific regulatory requirements......

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Hip, Knee and Shoulder Joint Reclassification: Only 12 Months Remain

The TGA are working towards the deadline of 30 July 2014 to finalise the reclassification of total or partial hip, knee and should joints. In another step towards this deadline, the reclassification application fee waiver in place has ceased. Sponsors applying for reclassification will now pay the application fee for a Class III device (currently AUD$1180) to the TGA. As described in our news story dated September 2012, reclassification applies to a number of products. The GMDN codes used to describe devices on the Australian Register for Therapeutic Goods (ARTG) listed below......

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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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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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