Regulation of IVDs & other therapeutic goods
If you have an enquiry about IVDs & other therapeutic goods that is not answered by this website, please see the contact details below.
In vitro diagnostic devices
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>
- TGO 54B (Amendment TGO 54)
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
- The information contained in DR4 is now relevant only for:
Contact details for enquiries about IVDs and other therapeutic goods
If your enquiry is not specifically about IVDs and other therapeutic goods, see: Contact the TGA <http://www.tga.gov.au/contact.htm>
If you are a sponsor and your query is about how to lodge an application electronically, see: Device Electronic Application Lodgement (DEAL)
- Email: cab.medical.device.information@tga.gov.au
- Phone:
- 1800 141 144 (freecall within Australia) and select from the following 4 options:
- press 1: For sponsors with queries regarding Overseas Manufacturers Evidence (ie certifications for overseas manufacturers of medical devices)
- press 2: For sponsors with queries about Application Audits or Manufacturers who are applying for Conformity Assessment Certificates
- press 3: For queries regarding In Vitro Diagnostics
- press 4: For queries of a general nature concerning medical devices
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- 1800 141 144 (freecall within Australia) and select from the following 4 options:
- Fax: 02 6232 8785
- Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia