Regulatory decisions for medical devices & IVDs

• Medical devices and IVDs compliance actions
  List of medical devices and IVDs subject to regulatory compliance actions
• Regulation impact statements for medical devices
  Links to regulation impact statements for medical devices

Notices and advice for industry about medical devices & IVDs

2017 2016 2015 2014 2013 2012

2017

• 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.

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

• TGA pilot of IMDRF Table of Contents for medical device submissions
  4 December 2015: The TGA is participating in the pilot program to trial the ToCs for conformity assessment pre-market applications
• Amendments to the regulatory framework for in vitro diagnostic medical devices (IVDs)
  16 November 2015: Amendments have now taken effect and a summary is provided
• Joint replacement definition - regulatory amendment
  20 April 2015: A regulatory amendment has been enacted to include definitions of hip, knee and shoulder joint replacement medical devices and related ancillary devices, as part of the reclassification of joint replacement medical devices
• Reclassification of hip, knee and shoulder joint implants
  8 July 2015: Total and partial hip, knee or shoulder joint implants were reclassified as Class III medical devices on 1 July 2012

2014

• IVD term development handover to GMDN Agency
  19 December 2014: The TGA assisted industry by ensuring that relevant preferred terms (PTs) and collective terms (CTs) were available in the GMDN database for their IVDs
• Declaration that certain IVDs are medical devices
  18 December 2014: The TGA has finalised a legislative instrument to ensure that certain pathology tests and related instrumentation are regulated as medical devices
• Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)
  17 October 2014: The TGA has finalised the regulation impact statement that outlines amendments to the regulatory framework for in vitro diagnostic medical devices
• Increased application audit requirements for some medical devices applications
  16 September 2014: The TGA is conducting application audits to obtain its own evidence of the quality of certificates and reports issued by selected European notified bodies
• HIV self-tests in Australia: Supply restrictions lifted
  9 July 2014: The Secretary of the Department of Health has signed the legislative instrument to amend the Therapeutic Goods (Excluded Purposes) Specification 2010 to allow the future supply of HIV self-tests
• Joint reclassification advice: Extension of the timeframe for TGA to select a reclassification application for audit
  4 July 2014: A regulatory amendment has been enacted to extend the timeframe for an application for reclassification of a joint implant to be selected for audit from 20 working days to 60 working days.
• Conformity assessment and summary technical reports for Class III medical devices
  17 June 2014: This guidance is intended for applicants (the sponsors) seeking ARTG inclusion for Class III medical devices that are of a lower classification in Europe
• Joint reclassification advice: Transition timeframe extended to June 2015
  29 April 2014: On 24 April 2014, a regulatory amendment was enacted to extend the transition period by one year to 30 June 2015 for the reclassification of partial and total hip, knee and shoulder joint replacements

2013

• Impacts on medical devices due to changes to the European Restriction of Hazardous Substances (RoHS) Directive
  13 November 2013: Guidance provided to Industry regarding the changes to the European Restriction of Hazardous Substances (RoHS) Directive

2012

• Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013
  30 November 2012: Amendments to the EU-Australia MRA (Mutual Recognition Agreements) on conformity assessment to come into force on 1 January 2013