May 2, 2012

Faulty joint replacement implants have been the subject of much concern in Australia recently. In response, the Government will implement a number of modifications in the regulation of medical devices.

In a recent publication on TGA reform, the Australian Government proposed that the TGA make changes in the ARTG to facilitate future recalls. The TGA will require that Sponsors include product names under each ARTG entry for each kind of medical device. Currently, general device family names are used (Class IIb and lower risk), but the change will mean that all ARTG entries will need to include name details such as trade names and/or model numbers related to the product. Emergo Group will continue to monitor the changes in ARTG and the consequences of this ambitious endeavor. As soon as more information is made available, this will be shared.

ANZTPA to increase safety and quality

More progress has been made to launch the trans-Tasman agency ANZTPA which will streamline and enhance safety and quality processes. To this end, ministers from both countries met in Melbourne earlier this year. This new regulatory Agency will replace both the TGA in Australia and MedSafe in New Zealand and will eventually implement a single device approval process for both countries. ANZTPA will share resources to ensure stringent pre-market evaluation and post-market surveillance of therapeutic products.

TGA offers online incident reports

In an effort to enhance its services, the TGA simplifies its adverse event reporting system. The TGA encourages online reporting on its web site IRIS (Incident Reporting and Investigation Scheme). IRIS now offers Incident Report forms both for medical device users and sponsors/manufacturers. We will work with the manufacturer to report incidents in Australia.

TGA makes logistical updates

The TGA has advised that if an ARTG entry is to be canceled from The Register, this must be performed before COB (Australia time) June 1, 2012 in order to avoid the annual fees for FY July 1, 2012 through June 30, 2013.


  • Stewart Eisenhart