The Assistant Minister for Health, Fiona Nash, today confirmed that, under the Government’s Industry Innovation and Competitiveness Agenda, new regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies.

“With these changes, Australian manufacturers can choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body," Minister Nash said.  

“This will cut red tape, provide more flexibility for local medical device manufacturers and, in many cases, enable devices to get to market more quickly, which will benefit the public.” 

Minister Nash said the new arrangements would bring Australian manufacturers in line with the regulations for overseas manufacturers. 

"The new rules will not, however, apply to the very highest risk devices. These devices will still need TGA conformity assessment. These include devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 in vitro diagnostics (IVDs), for example, drug-eluting stents or tests for HIV respectively," she said.

For more details, go to: http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2014-nash056.htm