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 that since 2010 a number of developments have occurred meaning the original initiative is both ineffective and inefficient. These developments include:

• Announcements in the EU and the US to implement the use of Unique Device Identifiers (UDIs) for medical devices.
  • UDIs are unique codes for particular medical devices which will be stored in a central database that identify a particular device at product level. The TGA propose that UDIs will have a significant effect on identification and traceability in Australia as both the EU and the US are the originators of the majority of medical devices used in Australia.
• The development of the National Product Catalogue in Australia, a database developed as an eHealth initiative containing product and pricing data for healthcare purchases. The database includes medical devices which can be identified by name and ARTG inclusion.
• The reclassification of hip, knee and shoulder joint implants meaning a significant number of devices will now be class III, which require individual ARTG inclusion.
• The announcement of post market medical device registers for breast implants and cardiac devices in the 2013-2014 Budget, which will assist in traceability of high risk devices.

Whilst this planned initiative has been cancelled, many other reforms are in progress. Stay tuned for further updates.

Does your organisation require guidance to better understand the medical device reforms ahead and how they affect you? KD&A can provide you with a personalised Regulatory Strategy to ensure you are prepared and ready to comply with regulatory requirements.  Contact us for a quotation, or visit our Regulatory Strategy page.