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10 July 2020: Updated to include: Advice on thermal imaging systems and products.
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.
Note
On 4 March 2021, the US Food and Drug Administration (FDA) released an alert regarding the improper use of thermal imagers.
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 for more information.
Classification of thermometers and any other temperature measuring medical devices, including thermal imaging systems
Before you submit an application for inclusion of a thermometer or any other temperature measuring medical device in the ARTG, you should establish the classification of your product. An online classification tool is available to help you determine the classification of your device in accordance with the classification rules as set out in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
While the classification of your thermometer or any other temperature measuring medical device will be dependent on the design, duration and intended purpose of the device, generally:
- clinical thermometers that are not battery-powered, such as those containing mercury, will be regulated as Class I (measuring) devices
- battery-powered digital thermometers, such as infrared or electronic thermometers, that work by converting energy from electric/infrared light/radiation to thermal/heat energy will be regulated as Class IIa devices.
- body temperature measuring devices, such as those used for screening people in public places that include an infrared radiation measurement technique will be regulated as Class IIa devices.
Note
It is your responsibility to ensure you submit your medical device application under the correct classification.
Applications made using an incorrect classification will fail preliminary assessment and your application fee will not be refunded.
Manufacturing thermometers and any other temperature measuring medical devices
If you are manufacturing a temperature measuring device for use on humans your product will meet the definition of a medical device and will need to meet the regulatory requirements under:
- the Therapeutic Goods Act 1989 (the Act)
- the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
- the Therapeutic Goods Regulations 1990.
All classes of medical devices need conformity assessment evidence before they can be manufactured and supplied. Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including in vitro diagnostic medical devices) complies with the Essential Principles. The Essential Principles relate to aspects of the device including its design and construction. Demonstrating compliance with the Essential Principles establishes that the product is safe and fit for its intended purpose.
Manufacturers of all medical devices (including in vitro diagnostic medical devices) manufactured and/or supplied in Australia should ensure that they have:
- appropriate conformity assessment procedures in place for the device
- appropriate documentation demonstrating compliance of the device with the Essential Principles.
Compliance with the Essential Principles can be demonstrated by showing that your product meets an applicable standard.
Compliance with the Essential Principles will also require thermometers or any other temperature measuring devices to have their battery compartments secured to avoid the ingestion of button batteries by children.
Note
Although the use of standards to demonstrate compliance with the Essential Principles is not mandated under the Regulations, the TGA recognises certain standards to assist manufacturers in complying with the conformity assessment procedures and the Essential Principles.
Manufacturers and sponsors should note that the Minamata Convention on Mercury has not yet been ratified by Australia, but is intended to phase-down use of mercury, including in medical devices such as thermometers.
Supplying thermometers and any other temperature measuring medical devices in Australia
If your product meets the definition of a medical device and you intend to supply it in Australia, you will need to ensure that your product is included in the ARTG before you import or supply your product. The following guidance aims to assist you with including your device in the ARTG, thereby allowing you to supply it within Australia.
Note
The sponsor of a medical device is the legal entity responsible for the importation and/or supply of the device within Australia. Sponsors must be an Australian based legal entity.
The guidance below for including a medical device in the ARTG is a summary only. For the full guidance, see Medical device inclusion process.
| Steps to include a medical device in the ARTG |
|---|
STEP 1 Complete an organisation details form and submit it to eBS@health.gov.au. This will allow you to become a client of the TGA. You will be given a username and password in order to access our online eBusiness portal. The portal allows you to submit applications for medical devices to be included in the ARTG. |
STEP 2 Ensure that your manufacturer has:
For information about the kind of evidence/documentation that you can use, see Table 2 in Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs). |
STEP 3 Once you have received your client logon details, log into the TGA Business Services online portal and submit a Manufacturer's Evidence application. There are no charges or fees associated with submitting this application. Note: If your manufacturer is new to the TGA you will need to lodge their details. This can be done using the New Manufacturer function in the Manufacturer Evidence form. |
STEP 4 Once you have received notification that the Manufacturer's Evidence has been accepted by the TGA, log into the TGA Business Services online portal and submit an application for your device to be included in the ARTG. For guidance to assist you with this process, see Medical device inclusion process. |
STEP 5 You will receive an invoice which you can view and pay for through the TGA Business Services portal. For Class I measuring and Class IIa devices, the application fee is currently $1060. Once you have paid the application fee, the TGA will commence processing your application. |
Note
The TGA is prioritising and expediting all COVID-19-related assessments, reviews, and responses to queries. For more information, see TGA response to COVID-19.
You do not need to contact the TGA to ask that your application is expedited - our assessors will automatically process your application as an urgent priority.
We will be in contact with you if we require more information to support your application.