IVD Australia


Industry News

Medicare and MBS Reviews

The press release and subsequent press conference(s) by Hon. Sussan Ley MP, Health Minister, announced three priority areas for further consideration. Two of these will potentially have a significant impact on the IVD Industry and the way it does business.

IVD Australia is cautiously supportive of these reviews and in its submission to Treasury earlier this year, IVD Australia called on the Australian Government to consider the ongoing sustainability of the reimbursement system for pathology tests.

IVD Australia acknowledges that there is a lack of global and Australian data that provides legitimate detail on the impact that Pathology has on healthcare expenditure; but is concerned that the benefits of IVD-driven diagnosis in keeping patients out of hospital are not recognised by the MBS system. The inability of the system to provide a mechanism to move funds from areas where savings could be made to those areas, such as pathology, where the savings can be generated is a “key failing of the Australian Healthcare System”. The IVD Australia Pre-Budget Submission to Treasury can be found here.

  • The IVD Industry wants to bring new developments to patients that will lower the cost of healthcare whilst improving treatment outcomes. However, the increasing market restraint of unclear and inconsistent reimbursement practices and decisions, is having a detrimental effect on the industry and its sustainability.

    Concerns, as with all government-led reviews, is that appropriate consultation with industry is conducted and that the outcomes will not be used simply to save the government money. 
  • For more information, members can click here.



Changes to Sponsorship of Therapeutic Goods

20 April 2015

Changes to the sponsorship of therapeutic goods in an entry in the ARTG must be notified to the TGA within 3 months.

Circumstances in which the TGA is to be notified are:



Global Diagnostic Market Statistics - Quantifying Australia's Place in International Trade 

The IVD global market revenue was estimated at approximately $USD 53 billion in 2013 and with a compound annual growth rate of 5.34%, by 2020 this will be in the vicinity of $USD 75 billion. Australia is estimated to be comprise about 2% of the world market, putting Australian market revenue at close to $AUD2 billion. The Global Diagnostic Market Statistics (GDMS) project being supported by IVD Australia is focused on determining a substantiated figure on the size of the Australian market. The IVD Industry in Australia needs this figure to underpin its approaches to government for improved reimbursement and to facilitate innovation in our sector of industry.

One of the goals of IVD Australia is to 'drive industry development'. One of the ways in which we can focus better government attention and initiatives for our industry is to be able to quantify our contribution to the Australian economy. however, we can't achieve this without knowing the size of our industry. Therefore, IVD Australia has committed to funding member participation in the EDMA Global Market Statistics program. The outcomes are useful, not only for the industry as a whole, but also your company.

Only IVD Australia members are able to enter data, and thus have access to these very valuable market statistics. Click here for more information.

GDMS is important …

  • One consistent set of reports for Australia
  • Understand company performance versus competition based on reliable country information – Is your country growth in-line with market growth?
  • Reliable basis for strategy development activities, planning and budgeting 

If you haven't yet signed up, please give your participation serious consideration. Email IVD Australia for more information.