Regulation of medical devices
Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.
If you have an enquiry about medical devices that is not answered by this website, please see the contact details below.
Regulatory guidelines & standards
- Overview of the medical devices regulatory system
<http://www.tga.gov.au/devices/overview.htm> - Core components of the medical devices regulatory system
<http://www.tga.gov.au/devices/core.htm> - Guidance for medical device manufacturers
<http://www.tga.gov.au/devices/manuf.htm> - Guidance for medical device sponsors
<http://www.tga.gov.au/devices/sponsors.htm> - Post market activities
<http://www.tga.gov.au/devices/postmarket.htm> - Therapeutic devices guidelines & standards
<http://www.tga.gov.au/devices/tdevices.htm> - Vigilance & reporting adverse events
<http://www.tga.gov.au/safety/monitoring.htm#devices> - How do I determine whether my product is a therapeutic product?
<http://www.tga.gov.au/docs/html/determine.htm> - Development of Australian Regulatory Guidelines for Medical Devices (ARGMD)
<http://www.tga.gov.au/devices/argmd.htm>
Regulation of
- In vitro diagnostic devices (IVDs)
<http://www.tga.gov.au/devices/ivd.htm> - Class 1 medical devices
<http://www.tga.gov.au/devices/fs_class1.htm> - Single use devices
<http://www.tga.gov.au/devices/sud.htm> - Dental products
<http://www.tga.gov.au/docs/html/dentalreg.htm> - Variants for Class III and AIMD medical devices
<http://www.tga.gov.au/docs/html/devguid13.htm> - Medical devices containing animal material
<http://www.tga.gov.au/docs/html/devguid14.htm> - Device/medicine boundary products
<http://www.tga.gov.au/devices/boundary.htm> - Medical devices packaged together
<http://www.tga.gov.au/devices/fs_packtog.htm> - Remote control drug infusion devices via data communication interface
<http://www.tga.gov.au/devices/fs_druginfus.htm> - Medical devices in alternative therapies
<http://www.tga.gov.au/docs/html/devguid7.htm>
Contact details for enquiries about medical devices
If your enquiry is not specifically about medical devices, see: Contact the TGA <http://www.tga.gov.au/contact.htm>
General enquiries about medical devices (including device labelling)
- Email: cab.medical.device.information@tga.gov.au
- 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 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8785
- Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia
Enquiries about device testing
- Email: cab.medical.device.information@tga.gov.au
- Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia