The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia.

The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published an updated guidance dedicated to the regulation of software-based medical devices. The document described in detail the regulatory approach to be applied with respect to the products that are medical devices incorporating software or are software themselves. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.

Regulatory Background

First of all, the authority acknowledges the increasing importance of software-based products used in healthcare nowadays. At the same time, regulation of such products poses additional challenges due to their specific nature. According to the guidance, “software-based medical devices” are medical devices that incorporate software or are software, including software as a medical device, or software that relies on particular hardware to function as intended, and are regulated in Australia by the Therapeutic Goods Administration (TGA). The authority also mentions that the software will be subject to regulation as a medical device in the case it meets the definition of a medical device set forth by the Therapeutic Goods Act 1989. 

The TGA further acknowledges that some of the applications are merely sources of information, or tools intended to manage a healthy lifestyle. Such products are falling outside the scope of a medical device definition and, consequently, are not subject to regulation as medical devices. 

The authority also mentions that recommendations provided in this guidance are not exhaustive, so case-specific advice should be requested when applying for marketing approval. 

The guidance further provides references to separate guidance documents issued by the TGA to address specific aspects related to software-based medical devices, their regulatory status, as well as the requirements they are subject to. Apart from that, the document highlights certain specific aspects to be taken into consideration by medical device manufacturers (software developers).

Use of Data Collection Components

One of the aspects described in the guidance relates to the use of data collection components in software-based medical devices. In this respect, the document states the following:

  • Where the data collection components are integrated into a smart device, the smart device is a finished consumer product. In this circumstance, the smart device is not required to be included in the Australian Register of Therapeutic Goods (ARTG).
  • In order to demonstrate compliance with the essential principles, it is a requirement that the SaMD is validated against the data collection component(s) and/or smart device. The data collection components or smart device must also be validated for the intended use of the SaMD to ensure it is safe and fit for purpose.
  • It should be expected that the level of scrutiny applied to such data collection component(s) would be commensurate with the level of risk associated with the intended use. 

As a summary, the authority states that products subject to regulation as SaMD should be included in the country’s register of therapeutic products together with the evidence of validation against the data collection components such products may contain. The testing to be conducted should correspond to the state of technology development. At the same time, the data collection components such devices contain are not subject to separate inclusion in the register provided they are integrated into finished products.

International Regulatory Activities

The document also outlines international regulatory activities the TGA participates in to ensure the regulatory approach it applies is in line with the recent regulatory developments. In this respect, it is important to mention that the Australian regulating authority is among the founding members of the International Medical Device Regulators Forum (IMDRF), an association of national regulating authorities cooperating for further improvement of the medical devices regulatory framework. Within the said organization, a special working group has been established to develop the approach to be applied to software-based medical devices. The documents developed by this working group include the following: 

  • Software as a Medical Device (SaMD): Key Definitions;
  • Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations;
  • Software as a Medical Device (SaMD): Application of Quality Management System; 
  • Software as a Medical Device (SaMD): Clinical Evaluation. 

The above documents are developed in cooperation with other national regulating authorities and are now used as a basis for further regulatory developments.

Artificial Intelligence Chat, Text, and Language

The guidance dedicated to software-based medical devices also pays attention to such innovative technologies as artificial intelligence text-based products like ChatGPT, GPT-4, and other large language models (LLMs). According to the guidance, should such products be intended to be used for medical purposes in Australia, they will be subject to regulation under the medical device framework, and the requirements for software-based medical devices will apply irrespective of the specific technology used, while their developer will be considered a medical device manufacturer, resulting in all the obligations and responsibilities of the latter being applicable. Furthermore, it will be necessary to provide sufficient clinical and technical evidence demonstrating compliance with the applicable essential principles, as well as safety and proper performance. 

In summary, the present TGA guidance provides an overview of the regulatory approach the Australian regulating authority applies with respect to software-based medical devices. The document also highlights the key points to be taken into consideration with respect to the products utilising innovative technologies.

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