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Medical devices & IVDs

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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 enquiries about medical devices or IVDs

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

In this section: Premarket enquiries | Postmarket enquiries

Premarket enquiries

Contact details for premarket enquiries
Email: devices@health.gov.au for general medical device enquiries COVDtests@tga.com.au for enquiries about COVID test kits
Phone:
  • 1800 141 144 (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 141 144
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 141 144
Post: Medical Devices Authorisation Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)		 Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia

Postmarket enquiries

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

Contact details for postmarket enquiries
Email:

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

For medical device annual reports and product reviews: postmarketdevices@health.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 809 361
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 809 361
Fax (adverse event reports only): For adverse event reports related to medical devices, you may fax: +61 2 6203 1713
Post: Devices Post Market Monitoring
Medical Devices Surveillance Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)		 Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia