Medical devices
Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it.
Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. While the objective of these products is to help improve your health and wellbeing, it's important to know that their use also has potential risks.
Please report any adverse events associated with medical devices.
Key information
- For information on obtaining market authorisation go to Supply a medical device.
- For information on medical device manufacture go to Manufacture a medical device.
More information
- Importing & supplying medical devices
- Advice for health procurement teams about therapeutic goods and medical devices
- Off-label use of medical devices: Frequently asked questions
Cyber security of medical devices
- Medical device cyber security information for users
- Medical device cyber security - Consumer information
Action plan for medical devices
- Medical devices reforms: An Action Plan for Medical Devices
- An Action Plan for Medical Devices
- Action Plan for Medical Devices - Progress Report Card: April 2020
- Action Plan for Medical Devices - Progress Report Card: June 2021
Medical device reforms
- Regulatory changes for software based medical devices
- Reclassification of active medical devices for therapy with a diagnostic function
- Reclassification of active implantable medical devices (AIMD)
- Reclassification of medical devices that administer medicines or biologicals by inhalation
- Refinements to the Personalised Medical Device Framework