Medical devices

Medical devices in Australia

Doctors and health professionals use medical devices to:

• provide medical and health services
• diagnose, prevent, monitor or treat medical conditions
• replace or enhance parts of the body.

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

Patients may also directly purchase or borrow many medical devices.

What we’re doing about medical devices

We regulate medical devices through the Therapeutic Goods Administration.

• assess medical devices for their safety and quality
• make sure they do what they say they will do
• publish information about approved products in the Australian Register of Therapeutic Goods
• monitor medical devices after they have been approved to make sure they continue to meet quality and safety standards, and are doing what they said they would do
• take action if there is an issue with a medical device – such as recall a medical device, or suspend it or remove it from the Australian Register of Therapeutic Goods.

We also subsidise the cost of some devices (and related services) through:

• the Pharmaceutical Benefits Scheme (PBS)
• the Medicare Benefits Schedule (MBS)
• private health insurance reimbursement of prostheses.