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. For example, medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment.
While medical devices aim to improve your health and wellbeing, it's important to know that their use also has potential risks.
You should report a problem or side effect associated with medical devices.
Key information
- To obtain market authorisation see Supply a medical device.
- For information on medical device manufacture go to Manufacture a medical device.
More information
- Importing and supplying medical devices
- Advice for health procurement teams about therapeutic goods and medical devices
- Off-label use of medical devices
Cyber security of medical devices
- Medical device cyber security information for users
- Medical device cyber security - Consumer information
Action plan for medical devices
Medical device reforms
Latest alerts
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The affected bi-level positive airway pressure (BiPAP) devices may stop providing therapy on an intermittent or permanent basis and the ‘Ventilator Inoperative’ alarm will sound.
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Be alert to the issue of unexpected shut down of the A30 and A40 series bi-level positive airway pressure (BiPAP) devices. This can cause interruptions and loss of therapy for patients.
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Be alert about a higher risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system. Read this if you're a patient, carer or health care provider.
Latest articles
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Medical devices affected by 3G network closure in October 2024
From 28 October 2024, Telstra and Optus are switching off their 3G networks. Medical devices and products like personal medical alarms could be affected by these closures. -
Therapeutic Goods (Poisons Standard) (Therapeutic Vaping Goods) Labelling Exemption 2024
This instrument is made under section 39 of the current Poisons Standard. -
Medtronic Australasia Pty Ltd ordered to pay $22 million - the largest ever penalty for unlawful supply of therapeutic goods
The Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020.
Events and webinars
Latest publications
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Read key points of discussion from the meeting 14 of the Medical Devices Consumer Working Group (MDCWG).
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Find out how we are managing shortages of medicines and taking action to limit their effects. Read our 2024 report.
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This Cost Recovery Implementation Statement (CRIS) 2024-2025 provides information on how we implement, and cost recover our regulatory activities.
Latest consultations
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Have your say on the proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles). Closing date has been extended from 16 October to 13 November 2024.
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This consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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We are seeking feedback on draft guidance documentation 'Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial, or recombinant origin - guidance on the new regulatory requirements and transition arrangements'.