Regulatory decisions & notices (medical devices & IVDs)

9 August 2016

Regulatory decisions for medical devices & IVDs

Notices and advice for industry about medical devices & IVDs

2016 2015 2014 2013 2012


  • Medical device quality management systems: transition to new standard
    In March of this year the International Organization for Standardization (ISO) published a new revision to ISO 13485, the medical device quality management systems (QMS) standard for regulatory purposes, which replaces the previous version from 2003.
  • Annual charges for IVDs effective from 1 July 2017
    21 July 2016: The transition period for the in vitro diagnostic medical devices (IVDs) regulatory framework will cease on 30 June 2017. During the transition period there are no annual charges for entries in the Australian Register of Therapeutic Goods (ARTG) for IVDs. Annual Charges will commence from 1 July 2017. Further information on the proposed annual charges for IVD medical devices will be provided when available. For information on current fees for applications for conformity assessment or inclusion in the ARTG, please refer to Summary of fees and charges from 1 January 2016.
  • Planning ARTG inclusion for your Class III or AIMD medical device?
    9 June 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. TGA recognises this backlog impacts industry and is hiring more medical officers. Once the new staff members are trained to undertake clinical assessments, the backlog will lessen and timeframes will improve significantly.
  • 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)