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).
Prescribed List
Find out what the Prescribed List includes, when we update it, and how to apply to list devices and products on the Prescribed 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 Prescribed List and private health insurance
By law, private health insurers must pay a benefit for a device or product on the Prescribed 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 Medical Devices and Human Tissue Advisory Committee (MDHTAC) is responsible for assessing and recommending devices or products and their costs for inclusion on the Prescribed 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 Prescribed 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).
Resources
Resources
Cost Recovery Implementation Statement – Administration of the Prescribed List of Medical Devices and Human Tissue Products
National Clinical Quality Registry Program – Participating sites
Advice on the benefit reductions to Cardiac Implantable Electronic Devices
