Australia Proposes Domestic Device Registration Using European CE Marking

By Nick Otto

Australia’s prime minister recently issued a new proposal that would allow Australian device makers to register “routine” medical devices using conformity assessment certifications acquired from European notified bodies.

The initiative is a new effort to reduce Australia’s regulatory burdens, according to the Industry Innovation And Competitiveness Agenda released by the Australian government.

According to the document, a 2014 to 2015 World Economic Forum Global Competitiveness Report ranked Australia 124 of 144 countries in terms of burdens caused by government regulation.

Current regulations allow device imports from foreign manufacturers with CE Marking, according to Emergo Group. However, domestic device makers must still register with the country’s Therapeutic Goods Administration (TGA) to receive Australian marketing authorization. 

“What this could mean is that in Australia, importers and local manufacturers would be on the same footing,” said Mike Skalsky, managing director at Emergo Australia, in the Emergo article. “But remember that the TGA recently adopted a more scrutinizing approach to CE Marking from some Notified Bodies due to safety and performance issues,” he added.

The Medical Technology Association of Australia (MTAA) lauded and encouraged the government’s initiative.

“The MTAA has been pressing government for this regulatory change for several years, culminating recently in the release of the MTAA White Paper for Improvements to the Australian Regulatory System for Medical Devices,” the industry group noted in a press release.

“Once in effect, this change will allow Australian manufacturers to compete on a level playing field with their international competitors for the first time,” MTAA chief executive Susi Tegen added in the press release.

And while the group is excited at the prospects of a less burdensome entry into the Australian medical device market, it said it will continue to “pursue other possible improvements” that will lighten the regulatory load of Australian manufacturers “while maintaining patient safety,” according to the press release.

Still, there could be other hurdles for device makers seeking approval down under. As Emergo’s Skalsky noted last month, the TGA said it plans to obtain its own evidence on the quality of certificates and reports issued by a select number of EU notified bodies, after a report in the British Medical Journal (BMJ) cast doubt on the thoroughness of the reviews notified bodies were performing following quality issues with artificial hip implants.

According to the TGA, the BMJ article pointed to eight European notified bodies, suggesting they were “likely to be more interested in repeat business than patient safety.”

Image Credit: “Australian Flag Tri,” Mike Cassano, 2012 CC BY 2.0: https://creativecommons.org/licenses/by/2.0/