Medical devices

Medical devices can be used to diagnose, prevent, treat and monitor medical conditions. They include things like surgical equipment, syringes, gloves, pacemakers, baby incubators and implants. Find out what we’re doing to make sure these products are safe to use.

Regulating medical devices

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices in Australia. 

Action plan for medical devices

The action plan is a 3-part strategy to strengthen Australia’s regulatory system whilst continuing to be patient focused and have greater transparency.

Reporting problems with medical devices

You should report all problems with medical advices to the Therapeutic Goods Administration (TGA).

The Prostheses List

Find out what the Prostheses List includes, when we update it, and how to apply to list products on the Prostheses List or change current listings.

What medical devices are

Medical devices are defined in the Therapeutic Goods Act 1989 as any of the following items for human use:

  • instrument
  • apparatus
  • appliance
  • software
  • implant
  • reagent
  • material or other article. 

Medical devices are used to: 

  • diagnose, prevent, monitor, predict outcomes of, treat, or ease symptoms of medical conditions 
  • replace or enhance parts of the body 
  • control or support conception 
  • examine specimens from the human body. 

These products play an important role in health care, so it’s important they’re safe to use and work properly. 

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices in Australia. 

In vitro diagnostic devices

In vitro diagnostic (IVDs) are typically tests that are used to examine human samples to assist with diagnosing and managing a patient’s health. IVDs are regulated as medical devices. They include reagents, kits, calibrators, controls, laboratory analysers and software, as well as tests used at the point of care, or in the home, such as COVID-19 rapid antigen self-tests and glucose monitoring tests by diabetics. 

Classifying medical devices

The TGA classifies medical devices into classes. Classes are associated with the level of risk they pose, and affect how the TGA assesses and regulates them.

Learn more about the classification of medical devices.

Cost of medical devices

Medicare covers the cost of some medical devices, see what Medicare covers on the Services Australia website.

The Prostheses List and private health insurance

By law, private health insurers must pay a benefit for a product on the Prostheses List such as: 

  • hip, knee or shoulder joint replacement devices 
  • vascular and cardiac stents 
  • human tissue items, like bone or bone fragments and heart valves 
  • cardiac remote monitoring systems. 

The Prostheses List Advisory Committee (PLAC) is responsible for assessing and recommending medical devices and their costs for inclusion on the Prostheses List.  

We are working with insurers, hospitals, medical device companies and clinicians to make the list more efficient, more transparent and better able to keep up with technological advances

Learn more about the Prostheses List and see the current items. 

The Stoma Appliance Scheme

The Stoma Appliance Scheme provides free stoma appliances and products to people who have a stoma (ostomates). This helps them live their lives normally without added financial stress. 

The Stoma Appliance Scheme Schedule lists all the items subsidised under the scheme. 

The Stoma Product Assessment Panel is responsible for assessing and recommending medical devices and their costs for inclusion in the Stoma Appliance Scheme Schedule.  

Learn more about the Stoma Appliance Scheme and see the current subsidised items. 

Safety monitoring and reporting

Manufacturers, suppliers, and the TGA continue to monitor medical devices after they are approved for supply. The majority of medical devices are included in the Australian Register of Therapeutic Goods (ARTG).



Prescribed List of Medical Devices and Human Tissue Products

This page lists the medical devices and human tissue products private health insurers must pay benefits for to the patients who have appropriate insurance policies. The latest version of the Prescribed List is effective from 1 July 2024.

Metal-backed patellae

This report summarises the process, findings, and outcome of our post-listing review of metal-backed patellae.

Spinal cord stimulators

This report was prepared by Health Research Consulting and summarises their review into clinical and cost effectiveness of spinal cord stimulators. The information in this report was considered during our post-listing review of spinal cord stimulators.