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Specific types of medical devices

Links to information on laboratory tests, software and AI based medical devices, personal protective equipment (PPE) and implantable medical devices.

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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

  • Digital scribes

    Page
    When digital scribes are regulated as medical devices

Personalised medical devices

  • Personalised medical devices

    Page
    Information 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

  • HIV testing in Australia

    Page
    Information 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.

  • Companion Diagnostics (CDx) list

    Dataset
    View the TGA’s list of approved companion diagnostics (CDx) in Australia, including details on in vitro diagnostic devices linked to specific medicines.

  • Specimen collection swabs

    Page
    All collection swabs are medical devices and must be included in the Australian Register of Therapeutic Goods (ARTG).

Personal Protective Equipment (PPE)

Implantable medical devices

Product types