Medical devices
Medical devices help doctors and health professionals 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.
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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.
Key action plan

Action plan for medical devices
Our action plan for medical devices will:
- improve the process to get new devices on the market
- strengthen monitoring and follow-up of devices already in use
- provide more information to patients about the devices they use.
Laws

About the Australian therapeutic goods legislation
This legislation and its regulations and orders set out what can be included in the Australian Register of Therapeutic Goods. Find out more about the laws that apply to medical devices.
Resources

Expert review of medicines and medical devices regulation
This review looked at Australia’s regulatory processes for medicines and medical devices to identify:
- where improvements could be made without lowering safety standards
- changes that help us respond to new trends in this field.