News Feature | October 30, 2014

Australian Government To Initiate Review Of Medical Device Regulations

By Nick Otto

Australia Proposes Domestic Device Registration Using European CE Marking

A group of experts will review the Australian Therapeutic Goods Administration’s (TGA) framework for the regulation of medical devices and pharmaceuticals, according to a recent government announcement.

The announcement from Peter Dunn, Australia’s minister of health, and Fiona Nash, assistant minister of health, says the review “will identify ways to assist medicine and medical device producers and suppliers struggling with complex and costly regulatory pathways, while upholding the safety and efficacy of therapeutic goods available in Australia.”

According to the notice, the specifics of the review will evaluate the country’s regulatory framework for therapeutic goods, specifically identifying:

  • Areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia
  • Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing, and regulation of therapeutic goods

The Department of Health (DoH) has named the three members of the review panel: Lloyd Sansom, an educator, researcher, and policy adviser; John Horvath, the former chief medical officer and contributor to current health policy; and Will Delaat, an experienced pharma professional with a noted 40 years of experience.

According to the Australian Government, the panel is slated to release a discussion paper to encourage industry to contribute ideas. The panel will also be consulting with consumer groups and health professionals.

A deadline of March 31, 2015 has been set for the panel to issue recommendations to enhance Australia’s regulatory framework.

In a recent effort to ease regulatory burdens on industry, Australia’s prime minister announced new proposals that would allow domestic device makers to bypass registration of “routine” devices using conformity assessment certificates from European notified bodies.

The initiative was the result of a recent World Economic Forum Global Competitiveness Report ranking Australia 124 of 144 countries in terms of burdens caused by government regulation.

Image Credit: “Australian Flag Tri,” Mike Cassano, 2012 CC BY 2.0: