Medical devices include a wide range of products, such as medical gloves, bandages, syringes, software and AI, blood pressure monitors, and X-ray equipment.
They differ from medicines as they generally have a physical or mechanical effect on the body or are used to measure (or monitor) the body and its functions.
While the objective of medical devices is to help improve your health and wellbeing, it's important to know that their use also has potential risks.
Software as a medical device
Personalised medical devices
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PageInformation about how we regulate personalised medical devices. These include patient-matched medical devices, custom-made medical devices and adaptable medical devices.
Laboratory and diagnostic tests
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PageInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.
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DatasetView the TGA’s list of approved companion diagnostics (CDx) in Australia, including details on in vitro diagnostic devices linked to specific medicines.
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PageAll collection swabs are medical devices and must be included in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing.
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PageWe have developed several questions and answers to provide consumers, manufacturers and sponsors information about the supply and use of these tests.
Personal Protective Equipment (PPE)
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PageInformation to help healthcare organisations update their operating procedures.
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PageLearn how the TGA regulates face masks and respirators used during COVID‑19, including safety requirements, classifications, and guidance for consumers and suppliers.
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PageHow to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG).
Implantable medical devices
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PageAll implantable and active implantable medical devices must come with patient information materials.
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PageIt's important that you discuss the risks and benefits of all options available to you with your health professional before making a decision.
Product types