www.fdanews.com/articles/168556-australia-opens-door-to-ce-mark-for-routine-medical-devices
Australia Opens Door to CE Mark for ‘Routine’ Medical Devices
November 14, 2014
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on conformity certificates issued by European notified bodies, under a government action plan unveiled Oct. 14.
International Medical Device Regulatory Monitor