2015 2014 2013 2010 2009 2008 2004 and older

2015

• Consultation: Software as a Medical Device (IMDRF Working Group)
  Consultation on proposed document - Software as a Medical Device (SaMD): Application of Quality Management System released by the International Medical Device Regulators Forum. Closing date: 27 May 2015
• Consultation: Proposed performance requirements and risk mitigation strategies for HIV tests
  Consultation on the proposed performance requirements and risk mitigation strategies for HIV tests. Closing date: 30 January 2015

2014

• Consultation: Software as a medical device (IMDRF working group)
  The TGA (together with all other working group members) invited interested parties to comment. Closing date: 31 May 2014
• Consultation: Supply of in vitro diagnostic devices for self-testing (home testing) for the presence of human immunodeficiency virus in Australia
  Consultation on supply of in vitro diagnostic devices for self-testing (home testing) for the presence of human immunodeficiency virus in Australia. Closing date: 6 May 2014

2013

• Consultation: Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (IVDs)
  Consultation on four outstanding issues identified during the first two years (July 2010 - July 2012) of the transition period of the new regulatory framework for IVDs. Closing date: 7 June 2013
• Consultation: Regulation Impact Statement: Changes to premarket assessment requirements for medical devices
  Consultation on the exposure draft of the Regulation Impact Statement (RIS): Changes to premarket assessment for medical devices. Closing date: 3 June 2013

2010

• Reforms in the medical devices regulatory framework
  Consultation on proposals to reform the regulatory framework for medical devices. Closing date: 17 December 2010

2009

• Use of third party conformity assessment bodies for medical devices supplied in Australia
  Consultation on the use of third party conformity assessment bodies for medical devices supplied in Australia. Closing date: 27 March 2009
• Draft guidance on the regulation of custom made medical devices
  Consultation on a draft guidance document on the regulation of custom made medical devices. Closing date: 31 March 2009

2008

• Regulation of hypoxic therapy and altitude training devices (hypoxicators) in Australia
  Consultation on the regulation of hypoxic therapy and altitude training devices (hypoxicators) in Australia. Closing date: 5 September 2008
• Medical device & conformity assessment standards orders
  Consultation on a proposal to adopt 4 standards orders. Closing date: 15 August 2008
• Updated medical device & conformity assessment standards orders
  Comments are sought on the proposal to register these revised Orders in the Federal Register of Legislative Instruments (FRLI). Closing date: 15 February 2008

2004 and older

• Reducing the public health risks associated with reusable medical devices
  Examines the public health issues associated with reusable medical devices that are difficult to clean, disinfect and sterilise
• Draft guidelines: In vitro diagnostic goods for home-use
  Draft guidelines that outline the approach of the TGA to the regulation of home-use IVDs and identify key issues to be considered by manufacturers and sponsors of home-use IVDs. Closing date: 1 August 2003