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
