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Medical devices & IVDs (archived)

The information in this section relates to regulatory decisions and notices about the regulation of medical devices. This information is over 2 years old, revoked or superseded.

2016 2015 2014 2014 2013 2012 2011 2010 2008 2005 2003

2016

  • Medical device quality management systems: transition to new standard
    8 December 2016: 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.
  • 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

2011

  • IMDRF establishment, 6-7 October 2011
    5 November 2011: On 6-7 October 2011, representatives from the medical device regulatory authorities met in Ottawa to address the establishment and operation of a new organisation, the International Medical Device Regulators' Forum (IMDRF)

2010

2008

2005

2003