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Medical devices and IVDs contacts

Last updated

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

Premarket enquiries

Contact details for premarket enquiries
Email:

Email us for general medical device enquiries

IVDs@tga.gov.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
27 Scherger Drive
Fairbairn 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):

  • 1800 809 361 (freecall within Australia)
  • Call the National Relay Service if you're deaf or have a hearing or speech impairment:
    • 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):

+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
27 Scherger Drive
Fairbairn ACT 2609
Australia

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