Regulation of medical devices in Australia

Closed/historical consultations and reviews

These documents remain on this website for historical reference.

• Australian Regulatory Guidelines for Medical Devices: Classification of medical devices
  closed 22 August 2008
• Stakeholder consultation on updated Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs) <http://www.tga.gov.au/devices/drmdsocaso2.htm>
  closed 15 August 2008
• Australian Regulatory Guidelines for Medical Devices: Fees and charges
  <http://www.tga.gov.au/devices/argmd.htm>
  closed 30 July 2008
• Australian Regulatory Guidelines for Medical Devices: Conformity assessment evidence
  <http://www.tga.gov.au/devices/argmd.htm>
  closed 27 June 2008
• Proposed changes to the regulatory requirements for hospital, household and commercial grade disinfectants
  <http://www.tga.gov.au/devices/disregfw.htm>
  closed 28 April 2008
• Australian Regulatory Guidelines for Medical Devices: Essential principles of safety and performance
  <http://www.tga.gov.au/devices/argmd.htm>
  closed 24 April 2008
• Updated Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs)
  <http://www.tga.gov.au/devices/drmdsocaso.htm>
  closed 15 February 2008
• Revision of the Australian code of good wholesaling practice for therapeutic goods for human use
  <http://www.tga.gov.au/consult/2006/cgwp-dr.htm>
  closed 11 August 2006
• Public access to information contained in ARTG entries for therapeutic goods
  <http://www.tga.gov.au/consult/2005/artgaccess.htm>
  closed 3 February 2006
• Disinfectants (hospital, household and commercial grade)
  <http://www.tga.gov.au/consult/2005/disinfectants.htm>
  closed 30 September 2005
• Reducing the public health risks associated with reusable medical devices
  <http://www.tga.gov.au/devices/reusdev_phr.htm>
  May 2004
• In vitro diagnostic goods for home-use - draft guidelines for sponsors
  <http://www.tga.gov.au/docs/html/ivdhomedr.htm>
  June 2003