Medical devices
The information in this section is about medical devices and has been written for health professionals.
- Alere Determine HIV 1/2 Ag/Ab Combo test: questions and answers
Questions and answers about the Alere Determine HIV1/2 Ag/Ab Combo test for health professionals - Metal-on-metal hip replacement implants
Updated information for general practitioners, orthopaedic surgeons and other health professionals - Increasing scrutiny of hip, knee and shoulder joint implants
From 1 July 2012, the Therapeutic Goods Administration (TGA) will be changing the regulation requirements for hip, knee and shoulder joint implants in Australia - The use of point of care tests for HIV in Australia
Background to the status of rapid tests for HIV in Australia - 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 - Custom made medical devices
Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA. - 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 - 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 - 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 - Advice about medical devices for health professionals
How health professionals can find TGA advice about medical devices - Medical devices: providing feedback to the TGA
There are various feedback mechanisms available
Web page last updated: Friday, 18 March 2011
URL: http://www.tga.gov.au/hp/information-devices.htm