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


  • Planning ARTG inclusion for your Class III or AIMD medical device?
    26 May 2016: Note that mandatory audits for these medical devices are currently delayed due to a wait time of approximately 8-9 months for commencement of the clinical assessment component
  • 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)