Medical devices & IVDs

Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.

Contact details for premarket enquiries about medical devices or IVDs

If your enquiry is not about medical devices or IVDs, see: Contact the TGA

Email: devices@tga.gov.au
Phone:
  • 1800 141 144 (freecall within Australia) and select from the following 4 options:
    • press 1: For enquires about Applications to include Medical devices or Notifications to lodge Manufacturer's evidence
    • press 2: For Manufacturers who are applying for Conformity Assessment Certificates
    • press 3: For queries regarding In Vitro Diagnostics
    • press 4: For queries regarding Clinical trials and Special Access Scheme use of unapproved 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
Fax: +61 2 6232 8785
Post: Office of Devices Authorisation, TGA, PO Box 100, Woden ACT 2606, Australia
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia

Contact details for postmarket enquiries about medical devices or IVDs

If your enquiry is not about medical devices or IVDs, see: Contact the TGA

If you are a sponsor and wish to recall a product, contact TGA recalls.

Email:

For general postmarket medical device enquiries and adverse event reporting: iris@tga.gov.au

For medical device annual reports and product reviews: postmarketdevices@tga.gov.au
Phone (adverse event reports only):
  • For adverse event reports related to medical devices, you may phone: 1800 809 361 (freecall within Australia)
  • 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
Fax (adverse event reports only): For adverse event reports related to medical devices, you may fax: +61 2 6203 1713
Post: Devices Vigilance and Monitoring, Office of Product Review, TGA, PO Box 100, Woden ACT 2606, Australia
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia