In response to COVID-19, the Therapeutic Goods Administration (TGA) has received a significant number of applications from sponsors (the person or company legally responsible for the product) and manufacturers for the inclusion of thermometers and other temperature measuring medical devices in the Australian Register of Therapeutic Goods (ARTG).
The TGA is also aware of thermal imaging systems and devices being used to screen people in public places that include an infrared radiation measurement technique.The following guidance is designed to support:
- manufacturers and suppliers in deciding whether their product is a medical device
- manufacturers with ensuring that their thermometers or any other temperature measuring medical devices meet all relevant regulatory obligations
- sponsors with submitting their applications for thermometers or any other temperature measuring medical devices to be included in the ARTG.
Is my thermal imaging product a medical device?
All manufacturers and suppliers of temperature measuring products need to ascertain whether or not their product is a medical device regulated by the TGA.
In Australia, by law, a product is a medical device when it is intended by its manufacturer to be used for the:
- diagnosis, prevention, monitoring, treatment or alleviation of a disease, injury or disability;
- compensation for an injury or disability;
- investigation of the anatomy or of a physiologic process; or
- control of conception.
Therefore, any temperature measuring product for use on humans for the intended purpose of screening potentially febrile individuals during a pandemic meets the legal definition of a medical device and is required to comply with the Australian regulatory requirements set out in the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) and the Therapeutic Goods Regulations 1990.
Body temperature measuring devices, such as those used for screening people in public places that include an infrared radiation measurement technique are regulated as Class IIa medical devices, and are required to be included in the ARTG prior to their importation and supply.
To determine if these products are intended for a medical purpose, the TGA will consider whether:
- they are labelled, promoted or otherwise intended for use by a health care professional;
- they are labelled, promoted or otherwise for use in a health care facility or environment; or
- they are labeled or promoted for an intended use that meets the definition of a medical device, for example, body temperature measurement for diagnostic and diagnostic purposes, including in non-medical environments.
Advice to manufacturers and suppliers of thermal imaging products
Products intended by the manufacturer for a medical purpose are regulated by the TGA as medical devices.
Should the product not be intended by the manufacturer for a medical purpose, suppliers and retailers cannot represent the product as a medical device and cannot promote the product for the purpose of screening potentially febrile individuals. The Act includes offences for such actions. For example, in situations where thermal imaging technology intended by the manufacturer for security systems or night vision is advertised for a therapeutic purpose, such as for the monitoring of body temperatures of people entering Australia, any such promotion must cease and may lead to compliance action by the TGA.
Additionally, under the Act, it is an offence to advertise to any person a medical device for purposes other than the manufacturer’s intended purpose.
The TGA has the power to use compliance and enforcement tools to address non-compliant advertising of therapeutic goods; these include direction notices and infringement notices. The TGA may also pursue court action against non-compliant advertisers, which can result in significant financial penalties. See compliance actions and outcomes