Wearable medical devices are products worn on the body that collect health-related data or deliver therapeutic functions. These may include smartwatches, fitness trackers, biosensors, or patches that monitor vital signs or deliver medication.
Wearable devices are considered medical devices if they are intended for:
- diagnosis, prevention, monitoring, prediction, prognosis, or treatment of a disease, injury, or disability
- alleviation of, or compensation for, an injury or disability
- investigation of the anatomy or of a physiological process
- control or support of conception.
To be legally supplied in Australia, medical devices must undergo pre-market assessment and be included in the Australian Register of Therapeutic Goods (ARTG) unless excluded or exempt.
Software as a medical device (SaMD) and smart devices
Many wearable devices rely on SaMD to perform their intended function. SaMD may use data collected from sensors integrated into consumer smart devices such as smartphones, tablets, or laptops.
Our regulatory position on data collection components
- When sensors or data collection components are integrated into a finished consumer product (like a smartphone or tablet), the device itself is not required to be included in the ARTG.
- However, the SaMD must be included in the ARTG before it can be supplied in Australia.
- The SaMD must be validated against the data collection components and/or smart device to ensure it is safe, effective, and fit for its intended purpose.
- The level of scrutiny applied to the validation process depends on the risk classification of the SaMD. For example, a Class III SaMD used to diagnose a life-threatening condition must undergo rigorous validation of any sensors it relies on, such as a camera.
For consumers
What you should know
Wearable medical devices and health apps can offer useful insights, but they also come with risks –especially if used without proper medical advice.
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Check the claims
If a wearable device or app claims to diagnose or monitor a health condition, it may be a regulated medical device.
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Look for ARTG inclusion
Regulated medical devices and SaMD must be listed in the ARTG. You can search the ARTG to confirm if a product is approved for supply in Australia.
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Be cautious of false reassurance
Some products may give the impression that everything is fine, even when there could be a problem. This can delay seeking timely medical advice. Don’t ignore warning signs because your device hasn’t indicated there is a problem.
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Talk to a health professional
Never rely solely on a wearable device or app to assess your health. Always consult a qualified health professional if you have concerns.