In vitro diagnostic devices

• Current IVD regulatory requirements
• Forthcoming (new) regulatory framework for IVDs
• Laboratory-specific information

Sterilants & disinfectants

• How are disinfectants regulated?
  <http://www.tga.gov.au/othertg/disinfectants/disinfreg.htm>
• Regulation of alcohol wipes
  <http://www.tga.gov.au/devices/alcoholwipes.htm>
• Hard surface disinfectants and instrument grade disinfectants (including sterilants)
  <http://www.tga.gov.au/devices/fs-disinf.htm>
• Guidelines for the evaluation of sterilants and disinfectants
  <http://www.tga.gov.au/docs/html/disinfectants.htm>
• Therapeutic goods orders
  • TGO 54B (Amendment TGO 54)
    <http://www.tga.gov.au/docs/html/tgo/tgo54b.htm>
  • TGO 54A (Amendment TGO 54)
    <http://www.tga.gov.au/docs/html/tgo/tgo54a.htm>
  • TGO 54 Standard for disinfectants and sterilants
    <http://www.tga.gov.au/docs/html/tgo/tgo54.htm>

Tampons & menstrual cups

• How are tampons regulated?
  <http://www.tga.gov.au/othertg/tampons/tamponsreg.htm>
• How are menstrual cups regulated?
  <http://www.tga.gov.au/othertg/tampons/menstcupsreg.htm>

"DR4"

• "DR4" - Australian medical device requirements under the Therapeutic Goods Act 1989
  <http://www.tga.gov.au/docs/html/dr4.htm>
  • The information contained in DR4 is now relevant only for:
    • Diagnostic goods for in vitro use
    • Devices incorporating human materials
    • Hospital, household and commercial grade disinfectants
    • Menstrual tampons

Related information

• Forms for product sponsors
  <http://www.tga.gov.au/othertg/forms.htm>
• Regulatory affairs consultants
  <http://www.tga.gov.au/docs/html/regafair.htm>
• Transmissible spongiform encephalopathies (TSEs)
  <http://www.tga.gov.au/docs/html/tse.htm>

General regulatory information

• How do I determine whether my product is a therapeutic product?
  <http://www.tga.gov.au/docs/html/determine.htm>
• Regulation of therapeutic products in Australia
  <http://www.tga.gov.au/docs/html/tga/tgaginfo.htm>
• Australian Register of Therapeutic Goods
  <http://www.tga.gov.au/docs/html/artg.htm>