Specific types of medical devices

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.

Please report any adverse events associated with medical devices.

Software as a medical device 

Software based medical devices are medical devices that incorporate software or are software

• Understanding regulation of software-based medical devices

Personalised medical devices

This includes patient-matched, adaptable medical devices; and custom-made medical devices.

• Personalised or custom-made medical devices

Laboratory and diagnostic tests

• Regulation of IVDs: laboratory-specific information
• The regulation of nutrigenetic tests in Australia
• HIV testing in Australia
• IVD companion diagnostics
  • TGA Companion Diagnostics (CDx) List
• Specimen collection swabs
• COVID-19 rapid antigen self-tests (for home use)
• Q&As on combination rapid antigen self-tests

Personal Protective Equipment (PPE)

• Guidance on Personal Protective Equipment for Health Professionals
• Face masks and respirators that are regulated by the TGA
• Evidence requirements for face masks that are medical devices

Implantable medical devices

• Implanting medical devices
• Patient information material for implantable medical devices
• Medical device patient information materials: health professionals
• Patient information materials for medical implants: consumers
• Five questions to ask your health professional before you get a medical implant