The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on regulatory changes for software-based medical devices. The present document constitutes an updated version of guidance issued by the TGA in order to provide medical device manufacturers (software developers) and other parties involved with additional clarifications and recommendations to be considered.

The authority emphasizes the non-binding nature of the guidance and mentions that in the case of any discrepancies with the provisions of the current legislation, the latter should prevail.

The document provides an overview of recent changes in the regulatory framework for software-based medical devices entered into force earlier in February 2021. The scope of the guidance also covers software as a medical device (SaMD). By virtue of the guidance, the authority provides additional clarifications regarding the applicable transitional regime intended to ensure the uninterrupted availability of vitally important medical devices on the market. The recommendations and clarifications provided by the TGA are based on the provisions of the Therapeutic Goods (Medical Devices) Regulations 2002.

With regard to determining whether the particular software product should be subject to regulation as a medical device, the TGA refers to the appropriate guidance.

Key Changes 

Under the general rule, any and all products subject to regulation under the medical devices’ framework should be entered into the Australian Register of Therapeutic Goods (ARTG), the country’s national register of regulated products, except in certain cases when such products meet eligibility criteria for specific exemptions. The TGA acknowledges the accelerated development of novel technologies expanding the scope of software products used for medical purposes. Some of these software products are based on the utilization of general-purpose platforms, such as smartphones or tablets. All this requires the corresponding improvement of the existing regulatory framework, which should be amended accordingly to cover new technologies and new use scenarios. For this purpose, the authority has duly performed public consultations with industry representatives and other stakeholders in order to develop a new regulatory approach to be implemented. 

According to the present guidance, the most important changes which have entered into force since February 25, 2021 include:

  • Clarifying the boundary of regulated software products (including “carve outs”);
  • Introducing new classification rules;
  • Providing updates to the essential principles to more clearly express the requirements for software-based medical devices. 

Exclusions and Exemptions 

As mentioned, in certain cases, software products could be subject to exemptions where medical devices’ regulations would not be applicable. The authority emphasizes the importance of distinguishing software products subject to regulation as medical devices from those falling outside the scope of the regulatory framework in order to reduce the unneeded regulatory burden. 

The principles applied for determining whether the software products should be subject to regulation or not include the following:

  • Harmonization of the national regulatory framework with the relevant rules adopted in other countries;
  • Excluding products that are not associated with significant risks;
  • Avoiding cross-regulation when one product falls within the scope of several regulatory frameworks simultaneously. 

Consequently, there were specific exclusions and exemptions implemented. In order to assist medical device manufacturers (software developers) in the correct interpretation of the terms used in this context, the TGA provides the following clarification:

  • Exclusion means that the devices are completely unregulated by the TGA;
  • Exemption means that TGA retains some oversight for advertising, adverse events and notification. Registration of the devices is not required. 

For instance, the scope of exempted products covers certain clinical decision support systems. In this regard, the authority refers to the appropriate guidance describing the matter in detail. 

Additional exemptions are introduced under the Therapeutic Goods (Excluded Goods) Determination 2018, which provides exemptions for:

  • Consumer health products that are not intended to be used to provide specific treatment. This category includes self-management software, general wellness products, as well as coaching software, provided such products are not providing recommendations requiring interpretation by a healthcare professional. Additionally, this category includes Digital mental health tools (including a cognitive behavior therapy tool). 
  • Enabling technology used in the context of telehealth or similar purposes, including communication software, general administration software used in healthcare facilities to coordinate internal processes and operations, tools used to store patient-related information and data, as well as clinical workflow management software. This category also includes software products that provide alerts or supplementary information, as long as the final decision regarding the following actions is taken by a healthcare professional. 
  • Digitization tools used to reduce paperwork and expand the use of paperless technologies in day-to-day operations, as well as other software products used for routine tasks. This category includes calculators based on generally accepted standards, as well as Electronic Patient Records (EMRs) and Electronic Health Records (EHRs) based on the use of the same standards. 
  • Population-based analytics tools used to process and analyze depersonalized information that is not related to particular patients and is not used for making clinical decisions in particular cases. 
  • Laboratory Information Management Systems – software products used in laboratories to automate and facilitate internal processes and procedures in the course of their ordinary day-to-day activity. 

New Classification Rules 

The guidance published by the TGA also outlines the new classification rules becoming applicable from February 2021 for all software-based medical devices except those intended to be used for in vitro diagnostic purposes. The new rules should be applied for medical devices that:

  • Provide a diagnosis of screens for a disease or condition;
  • Monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
  • Specify or recommend a treatment or intervention;
  • Provide therapy through the provision of information. 

Should the software product in question fall within the scope of the new rules, a transitional regime should be applied. According to the guidance, the interim period for such products would be until November 1, 2024. An interim framework has been introduced in order to ensure the uninterrupted availability of medical devices subject to reclassification during the transitional period. Under this framework, the manufacturer (developer) will be allowed to supply its products while applying for inclusion in the national register (ARTG) in accordance with the new classification. 

In summary, the present TGA guidance highlights the most important aspects related to the new regulatory approach for software-based medical devices introduced in Australia earlier in February 2021. The document pays special attention to the scope of products covered by new regulatory requirements and also describes a special transitional period to be applied by medical device manufacturers (software developers) for marketing their products before getting them registered under the new framework. 


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