Regulatory decisions & notices (medical devices & IVDs)

Regulatory decisions for medical devices & IVDs

Notices and advice for industry about medical devices & IVDs

2016 2015 2014 2013 2012

2016

  • New Tyvek® materials: regulatory obligations
    22 January 2016: In order to meet the conditions of inclusion on the ARTG, manufacturers need to check that the performance and safety of their medical devices continue to meet the Australian Essential Principles (EPs)

2015

2014

2013

2012