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
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GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.
Personalised medical devices
Laboratory and diagnostic tests
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PageLaboratory-specific information for the regulation of IVDs.
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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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DatasetSearch companion diagnostics (CDx) we have approved for supply in Australia.
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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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PageInformation on the different types of face masks and respirators.
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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.