2013 is quickly drawing to a close – ensure you carry out a regulatory and quality management system (QMS) tidy up within your organisation before the Christmas break is here. KD&A recommend the following tasks: Complete product registration for medical devices (including IVDDs) that your organisation wish to place on the market in 2014. Ensure all outstanding QMS activities are seen to. Review registers and forms to ensure they’re suitably complete. Consider scheduling internal auditing, standards review, post market surveillance and management review activities for 2014 – adding reminders to your diary......
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Formal decisions which will shape the future regulatory landscape of the EU are yet to be made by officials. Significant change is on the horizon however it is difficult to say when and how this will play out. Information being released shows the EU remains indecisive however the concepts of a centralised regulatory body and two regulations to replace the Medical Device Directive, IVD Directive and Active Implantable Device Directive are well and truly looking likely. Stay tuned for further updates as the EU grind slowly towards to a safe and efficient......
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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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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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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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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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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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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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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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