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Medical devices
The information in this section is about medical devices and has been written for health professionals.
A
- Advertising health services with medical devices
Information to consider when advertising health services that involve medical devices (including in vitro diagnostic devices) - Advice about medical devices for health professionals
How health professionals can find TGA advice about medical devices
C
- Custom made medical devices
Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA.
H
- How to tell if a medical device is legally supplied for use in Australia
Unless exempt, medical devices must be 'included' onto the ARTG before they may be supplied in or exported from Australia
I
- Importing & supplying medical devices
The TGA regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989
M
- Medical devices: providing feedback to the TGA
There are various feedback mechanisms available - Medical devices reforms
The TGA has begun work on a series of reforms to the regulation of medical devices, including the hip, knee and shoulder joint implant reclassification - Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration
Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration - Metal-on-metal hip replacement implants
Updated information for general practitioners, orthopaedic surgeons and other health professionals
R
- Reducing the public health risks associated with reusable medical devices
Examines the public health issues associated with reusable medical devices that are difficult to clean, disinfect and sterilise
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- What are 'therapeutic goods'?
Many of us use medicines or medical devices in our daily lives - What is a medical device?
Medical devices are used on humans, have therapeutic benefits, have a physical effect on the body