Fiona Nash (NSW, National Party, Assistant Minister for Health) Share this | Hansard source

This government is committed to building a modern regulatory framework that provides timely access to innovative treatments, supports Australian businesses and maintains the high standards of safety and quality that consumers expect. The coalition recently introduced new regulations 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 have conformity assessment conducted by either the TGA or a trusted European body. This will cut red tape and provide more flexibility for local manufacturers.

The new arrangements will also bring Australian manufacturers in line with the regulatory requirements for overseas manufacturers. Mr Chris Roberts, the CEO of Cochlear Australia, recently said, 'This change alone means thousands of Australians will have their hearing restored with the latest technology, sometimes up to a year earlier than otherwise may have been the case. The social and economic benefits of this change are immense.' (Time expired)