Australian Government proposed to bypass TGA for medical devices with CE Marking...

Under the Leadership of Prime Minister Tony Abbott Australian Government has proposed to allow domestic medical device manufacturers to register their routine products in the country using CE Marking certificates from European Notified Bodies.

This proposal which is part of new government  position paper pushing innovation with competitiveness issue in essence to remove TGA Certification requirements for Australian medical devices that have received CE Marking from European Authorities.

TGA allow import of medical devices with CE Marking from foreign manufacturers, even domestic manufacturers that have received CE Marking for their products still have to register with TGA for marketing authorization to market in Australia.

For more information view/download the Position Paper on Industry Innovation and Competitiveness of Australian Government.

to register their “routine” products in the country using CE Marking certificates from European Notified Bodies - See more at: http://www.raps.org/Regulatory-Focus/News/2014/10/22/20608/Australian-Government-Proposes-Bypassing-TGA-for-Medical-Devices-with-CE-Marking/#sthash.tjxSuOxM.dpuf

to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. - See more at: http://www.emergogroup.com/blog/2014/10/australian-government-proposes-bypassing-tga-medical-devices-ce-marking#sthash.ESZxrSZx.dpuf