Medical devices and IVDs

Last updated

20 May 2024

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.

Face masks and COVID-19
Compilation of resources related to face masks and COVID-19
COVID-19 tests
General information about rapid antigen testing in Australia
COVID-19 rapid antigen point-of-care tests
General information about rapid antigen point-of-care testing in Australia
Medical devices regulation basics
General information about how medical devices are regulated in Australia
IVD medical devices regulation basics
IDVs in Australia: how they're regulated
Demonstrating compliance with the Essential Principles
Medical device manufacturers have to demonstrate their devices comply with the Essential Principles
Standards, guidelines and publications (medical devices and IVDs)
Medical devices and in vitro diagnostic medical devices standards, guidelines, and publications
Medical devices reforms
The Medical Devices Reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety.
Regulatory decisions and notices (medical devices and IVDs)
Medical device and in vitro diagnostic regulatory decisions, like advertising exemptions
Australian Conformity Assessment bodies
Australian corporations can apply to become an Australian Conformity Assessment Body.

Contact

Premarket enquiries

Contact details for premarket enquiries
Email:	Email us for general medical device enquiries IVD s@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

Topics

In Vitro Diagnostic medical devices (IVDs)

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Medical devices and IVDs

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Premarket enquiries

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Medical devices and IVDs

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