Regulatory decisions & notices (medical devices & IVDs)

6 June 2018

Regulatory decisions for medical devices & IVDs

Notices and advice for industry about medical devices & IVDs

2018 2017

2018

2017

  • Automatic conditions for medical devices - legislative amendments
    14 July 2017: Legislative amendments have come into effect that automatically impose a number of standard conditions on all medical device entries in the ARTG. These conditions relate to storage and transport requirements, record keeping, annual reporting, and notification of information relating to certain IVD medical devices.
  • Annual Charges for IVDs effective from 1 July 2017
    8 June 2017: Annual charges for IVDs included on the Australian Register of Therapeutic Goods (ARTG) will commence from 1 July 2017. The annual charge per ARTG entry for the 2017/2018 financial year will be $660 for all classes of IVDs.