The TGA have introduced a new online MDIR System for sponsors and manufacturers which is accessible via their eBusiness system (also used to submit applications). The eBusiness system can only be accessed by companies who have completed a TGA Client Details Form to establish themselves with the TGA (and have the necessary eBusiness username and password). The System is designed to improve ongoing reporting and monitoring for adverse events which have been reported to the TGA using the online adverse event incident reporting form (acessible here or from an eBusiness account). The......
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The International Medical Device Regulators Forum (IMDRF) began work on developing documentation to facilitate the Medical Device Single Audit Program (MDSAP) in Singapore in 2012. The Pilot Program is now due to begin in 2014 and will bring a new era for medical device manufacturers. The global approach to consistent audit requirements is hoped to facilitate improved monitoring of devices and reduce burden for manufacturers. The MDSAP is designed to ensure a single audit of a medical device manufacturer will provide efficient and thorough coverage of the diverse international regulatory requirements of......
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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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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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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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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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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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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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