TGA


TGA Extend Reclassification Transition Deadline

The TGA have announced an extension to the deadline for the reclassification of hip, knee and shoulder joints. The due date for final transition has been extended by one year to 30 June 2015. There will be no annual charges applied for transitioned Class III joint implants until after 30 June 2015, and reclassification applications submitted by 30 June 2015 are not subject to mandatory audit requirements or related audit fees (reclassification applications may be selected for discretionary audit, for which no fees apply). Why the extension? The TGA indicate that the......

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TGA Time Frames - How Long Should You Wait?

Are you waiting to hear from the TGA about your new medical device or IVD application? Maybe it’s an application audit response…. read on for more information about TGA time frames… There are two categories of time frames used within the Australian medical devices regulatory framework. These are as follows: 1.        Legislated time frames: these are times that are specified within the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002. 2.        Target time frames: these are anticipated time frames that......

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TGA Reclassification Deadline Drawing Closer

The TGA announced the reclassification of hip, knee and shoulder joint implants (total and partial) in 2012. The announcement required medical device manufacturers and sponsors to update their product certification and Australian Register for Therapeutic Goods (ARTG) inclusion – transitioning from a Class IIa/IIb to a Class III.  A transition period was granted however this is due to conclude on the 30th June 2014. As described in our news story dated September 2012, reclassification applies to a number of products. The GMDN codes associated with affected devices on the Australian Register for Therapeutic......

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KD&A - How Can We Help you in 2014?

KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance. Regulatory Strategy Development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market. Quality Management......

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Therapeutic Goods Administration (TGA) Introduce Online Medical Device Incident Reporting (MDIR) System

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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Medical Device Single Audit Program (MDSAP)

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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Time for a Regulatory and QMS Tidy Up

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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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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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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