Oct 20, 2014

The Australian Department of Health has published additional details on the government’s plan to allow domestic medical device manufacturers to leverage CE Marking for faster registration in their home market.

According to an announcement by Assistant Minister for Health Fiona Nash, the government plans to amend the Therapeutic Goods (Medical Devices) Regulations 2002 and implement changes by the end of 2014.

The changes will allow Australian device manufacturers the option of either undergoing conformity assessments by the Therapeutic Goods Administration (TGA) or use CE Mark certification obtained from a European Notified Body in order to register to sell on the Australian market.

These changes will not apply, however, to high-risk devices such as combination products or Class IV in vitro diagnostic (IVD) devices. Full TGA reviews of these devices will still be required. Lower-risk Class II and III devices including hearing aids and joint implants manufactured in Australia will qualify for the new option, states Nash.

Emergo will provide more detailed analysis of the upcoming TGA regulatory changes once they’re published.


  • Stewart Eisenhart