The recent proliferation of wearable medical and health technology products ("wearables") raises a range of regulatory issues in Australia, including implications of their possible classification as medical devices, to general issues of privacy and data protection.
The Therapeutic Goods Administration (TGA) already regulates medical devices, including software, used for therapeutic purposes. Section 41BD of the Therapeutic Goods Act 1989 (Cth) defines a "medical device" as any instrument, apparatus, application, material or object that is intended to diagnose, prevent, monitor or treat a disease or injury in humans. In practical terms, wearables can be caught under this definition either as a stand-alone product, for the software embedded within, or both.
At present, the TGA places a clear emphasis on the intention and marketing practices of the manufacturer or supplier of the device or software in that, if the device is intended to be used for one of the Section 41BD purposes, it is likely to be regulated as a medical device. However, the TGA has not reached a formal position on this, and has commenced a formal review into medical device regulation in Australia (Discussion Paper issued in December 2014), which raises the possibility of introducing regulatory exemptions for quasi-medical health and fitness devices and software along the lines of those issued by the US Food and Drug Administration (US FDA) in January 2015.
The US FDA guidance document contains non-binding recommendations, which consider that low-risk 'general wellness products' should not be subject to FDA examination. Low risk products which make claims to improve your general health, such as weight management, physical fitness or stress management. In contrast, if a product claims to treat or diagnose obesity, anorexia, anxiety or some other disease or condition, it is more likely to have a therapeutic use and therefore be regulated as a medical device under the FDA.
Submissions to the Expert Panel conducting the review have now closed. A copy of the Discussion Paper is available here.
For more information, please contact Anne-Marie Allgrove, Toby Patten or Jarrod Bayliss-McCulloch.