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.
If your enquiry is not about medical devices or IVDs, see: Contact the TGA
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 |
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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
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Post: |
Medical Devices Authorisation Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia |
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Street address
(for deliveries) |
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia |
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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
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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
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Fax (adverse event reports only): |
For adverse event reports related to medical devices, you may fax: +61 2 6203 1713 |
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Post: |
Devices Post Market Monitoring
Medical Devices Surveillance Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia |
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Street address
(for deliveries) |
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia |
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