Nov 11, 2011

In September, the TGA released a response to the to the Australian Government Health Technology Assessment HTA recommendations of December 2009.

A proposal of particular interest is the requirement for manufacturers to provide product name details for all listed devices. As a departure from the current system in which the ARTG listing for lower risk devices is by a device family, the proposed change will require that the trade name and model number for each model be listed. For manufacturers who maintain large product families, compliance to this requirement could be onerous. There will be a 2 year transition period beginning in July 2012, and fees to amend the listing will be waived for this amendment.

License Cancellation for Non-Payment of Fees

The TGA published clarification regarding actions triggered by non-payment of fees. After 28 days of delinquency, the TGA will cancel device listing, at which point sale of the device on the Australian market will become illegal. Outstanding fees are not forgiven, and the manufacturer and Sponsor will remain liable to the Commonwealth of Australia until fees are settled. After cancelation, a new application must be lodged in order to regain listing.

Australia Continues as Leading Member in GHTF Successor Organization

As reported previously by Emergo Group, the GHTF will be succeeded by the International Medical Device Regulators' Forum (IMDRF). As a founding member of the GHTF, Australia will continue as a member of the IMDRF, which will have its inaugural meeting in early 2012.

ARTG Database

As a reminder, the TGA maintains a database of all listed devices in the Australian Register of Therapeutic Goods (ARTG). This database can be queried by various fields, including product and sponsor name. Each device record includes a GMDN code for the product, making the database a useful resource for competitor analysis and GMDN determination. The TGA reports that, as of January 2011, the database contained approximately 62,600 products, including medicines. Emergo Group’s analysis of the database indicates the number of medical devices to be around 39,000 (as of November 2011).

Australian Senate Inquiry into Joint Replacements

In June of this year, the Australian Senate launched an inquiry into the standards for approval of medical devices in the country, with particular focus on joint replacements. According to the Parliament of Australia website, the inquiry will consider the role of the TGA in regulating the quality of devices available in Australia, as well as post-market issues related to notification and corrective actions for devices with high revision rates (i.e., the need for additional corrective surgery).

The committee involved in the inquiry—the Senate Community Affairs Committee—is seeking public input. Comments on the matters under consideration can be submitted to the committee until November 22, 2011.

Although the impetus behind the inquiry is unclear, it is noteworthy that the TGA response to the HTA report discussed later in this article devoted a special section to improvements on regulation of joint replacements because of the high revision rate.


  • Stewart Eisenhart