The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid antigen self-tests in the context of the outbreak of Coronavirus Disease 2019 (COVID-19) for identifying the virus SARS-CoV-2 (the “novel coronavirus”). The document constitutes the initial version of the guidance issued by the authority in September 2021.

Regulatory Background 

First, the authority mentions that the use of self-tests for COVID-19 is currently prohibited. However, the TGA is considering uplifting the restrictions, provided there are efficient regulatory mechanisms in place. In this regard, the authority already encourages parties interested in placing such devices on the Australian market to provide information about their products in order to facilitate review and reduce the time necessary to obtain marketing approval once the regulatory framework for self-tests is amended, allowing the use of such devices in Australia. Thus, interested parties may notify the regulating authority about their intent to supply such devices via email. 

The present TGA guidance is intended to provide medical device manufacturers and other parties involved with additional clarifications regarding the suggested regulatory framework for software that will be used to analyze and interpret testing results. The authority also mentions that software intended to process patient-related information or transmit such information falls outside the scope of the present guidance. 

According to the guidance, COVID-19 rapid antigen self-tests are tests that allow individuals to collect a specimen, conduct tests and interpret the results by themselves. The main distinguishing feature of tests of this type is that they could be performed by laypersons outside the clinical environment. Hence, neither specific knowledge and qualifications nor special conditions are needed to use these tests. It is stated that such tests provide the most accurate results when being used by the person experiencing symptoms. 

Provisions of the present guidance are aligned with the general TGA guidance on COVID-19 rapid antigen self-tests and also with the Therapeutic Goods (Medical Devices) Regulations 2002. The document also contains references to other guidance documents dedicated to various regulatory matters related to in vitro diagnostic (IVD) medical devices and covering such aspects as clinical evidence, application audit, and classification. 

Once the regulatory requirements are amended, and the existing prohibition is repealed, interested parties will be able to apply for marketing approval for COVID-19 rapid antigen self-tests. Under the general rule, in order to be allowed for marketing and use in Australia, any and all healthcare products should be included in the Australian Register of Therapeutic Goods (ARTG), the national register of healthcare products, including medical devices. The same approach should be applied with regard to the COVID-19 rapid antigen self-test as well. The regulating authority will assess the applications submitted in order to determine whether the appropriate safety and performance requirements are met, and all the measures necessary to mitigate risks are duly implemented by the manufacturer. Some such products could be accompanied by mobile apps. The regulatory status of such apps would depend on their functionality. For instance, apps solely intended to process digital health records could be excluded from regulation, while those intended to assist users in interpreting the results would fall within the scope of the medical devices framework and be regulated accordingly. 

Software: Regulatory Approach 

As stated by the TGA, the appropriate provisions of the Medical Device Regulations could be applied irrespectively of the type of software or platform it is based on, provided such software falls within the scope of the definition of a medical device. Hence, the existing regulatory framework covers standalone apps, cloud solutions, as well as server-based systems. As mentioned, some of the COVID-19 rapid antigen self-tests would be supplied accompanied by special software, including but not limited to mobile apps and web versions. According to the applicable legislation, the regulatory status of such software solutions should be determined depending on their intended purpose. 

In accordance with the guidance, software should be subject to regulation by the TGA if it analyses or enables interpretation of the test sample or results in any way (whether by the user or another person). Such products should be considered medical devices and thus subject to mandatory inclusion in the ARTG. Due to the high risks associated with the intended use, such products would be assigned to Class 3. It is important to mention that in this case, the software would be subject to inclusion in the ARTG as a separate product and not as a component of a self-test IVD medical device. The TGA additionally emphasizes that software that allows a user to combine their test results with other symptoms to provide an indication or likelihood of having COVID would also be regulated as an IVD medical device. 

At the same time, the software that is used simply for registration, recording of results and tracking, or for generation or update of a digital health record, would not be a medical device and so would not be regulated by the TGA. The same approach should be applied in the case of the software intended to submit test results to a database. 

The authority further mentions that in case the software subject to review contains both functions subject to regulation by the TGA and explicitly exempted ones, it would still be considered a medical device and require inclusion in the appropriate national register in order to be allowed for marketing and use in Australia. In such a case, the authority will focus its attention on medical functions. However, the authority would also ensure the non-medical functions of the software do not negatively impact the medical ones. 

Software Examples 

The document further provides several examples of software that could be used in connection with COVID-19 rapid antigen self-tests. For instance, a mobile app could be used to scan the QR code placed on the IVD medical device. The regulatory status of such an app would depend on its functionality, namely:

  1. If the app would route the user to the manufacturer’s website and facilitate uploading test data to the database, it would not be considered a medical device. 
  2. At the same time, if the app would also make a photo of the test and send it to the manufacturer for interpretation, such an app would be subject to regulation as a medical device enabling interpretation of the results by another person. 

In summary, the present TGA guidance provides an overview of the regulatory requirements to which COVID-19 rapid antigen self-tests could be subject. The document also describes the approach to be applied when determining the regulatory status of software products, including mobile apps that accompany such tests. 


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