Current regulatory requirements for in vitro diagnostic devices (IVDs)

• Current regulation of in vitro diagnostic devices (IVDs) in Australia
  <http://www.tga.gov.au/ivd/fscurrent.htm>
  Fact sheet
• Acceptable evidence of good manufacturing practice (GMP) for IVDs
  <http://www.tga.gov.au/devices/ivd-evidence.htm>
  Guidance document
• In vitro diagnostic goods for home-use - draft guidelines for sponsors
  <http://www.tga.gov.au/docs/html/ivdhomedr.htm>
  Guidelines
• IVDs - lodging effective submissions
  <http://www.tga.gov.au/devices/pres-ivdsubmis.htm>
  Presentation
• Australian medical device requirements under the Therapeutic Goods Act 1989 - "DR4"
  <http://www.tga.gov.au/docs/html/dr4.htm>
  Guidance document
• The regulation of nutrigenetic tests in Australia
  <http://www.tga.gov.au/devices/ivd-nutrigenetic.htm>
  Guidance document