By Dr Teresa Nicoletti, Partner, Darcy O’Brien, Lawyer. 

The rapid development of technology has resulted in widespread changes to the way healthcare is delivered, with the emergence of a range of apps and software being used to diagnose and treat diseases. This advancement has resulted in confusion regarding the distinction between software that is to be regulated as a medical device (SaMD) and software which falls outside the ambit of the Therapeutic Goods Administration (TGA).

In 2019, the TGA held a consultation focusing on proposed regulatory reforms for SAMD (the Consultation)  and recently passed the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 (the Amendment). This article explores the impact of the Consultation and the current state of SaMD in Australia.

What is SaMD?

The concept of SaMD involves assessing whether the use of particular software falls within the definition of a ‘medical device’ pursuant to section 41BD of the Therapeutic Goods Act 1989 (Cth). Software which is used in conjunction with physical accessories requires an assessment of the device as a whole, rather than the software on its own or its individual components.

Examples of SaMD include:

1. smart phone apps that are able to measure the user’s blood glucose levels and calculate insulin doses (in this case, the app, phone and monitoring system are assessed as a whole);
2. X-ray image-processing software; and
3. software with the ability to diagnose a patient.

Lifestyle and fitness-based software such as that used in fitness trackers and pedometers generally falls outside this framework as it os not used for therapeutic purposes.

The Consultation

The Consultation focused on three key issues:

1. The classification rules under the current regulations did not adequately consider the potential for SaMD products to cause harm to patients;
2. There was no entity responsible for regulating the safety and performance of directly-imported or downloaded SaMD; and
3. Confusion regarding the regulatory requirements for demonstrating the safety and performance of SaMD.

Three key changes to the regulatory framework were proposed as part of the Consultation:

1. Changes to ensure that the classification rules would appropriately classify SaMD products according to the potential harm they could cause to patients;
2. Changes to exclude SaMD products from the personal importation exceptions and require them to be included in the Australian Register of Therapeutic Goods and have an Australian sponsor; and
3. Changes to ensure that the essential principles for medical devices include requirements for demonstrating the safety and performance of SaMD.

The submissions received

There was general support in the submissions for the three proposed reforms:

1. It was proposed to align the classification rules with the EU Medical Device Regulation or the classification principles of the International Medical Device Regulators Forum (both these frameworks are consistent with one another);
2. It was proposed to require all downloaded software to have an Australian sponsor; and
3. It was proposed to clarify the essential principles for software to make pre-market requirements more transparent.

The Amendment

The Amendment is the first set of regulatory changes introduced by the TGA following the Consultation. It introduces one key change that the TGA foreshadowed: SaMD will now be classified according to its potential to cause harm through the provision of incorrect information.
Under the Amendment, a device’s potential to cause harm will be measured by its use and the risk it poses to public health. SaMD with a high risk to public health, or that is likely to lead to a person’s death or severe deterioration in their health, is likely to be classified as a Class III device and be subject to stringent regulation. On the other hand, SaMD with a moderate risk to public health and that may be otherwise harmful to a person is likely to be classified as a class IIa device and be subject to less stringent regulation.

What next?

The Amendment only deals with one area that the Consultation focused on, making this a space to watch in the future for further amendments and development of the framework. The changes introduced by the amendment commence on 25 August 2020 and will potentially make existing SaMD subject to more stringent regulation. Those operating in this space who have an existing SaMD included in the ARTG should assess whether the recent regulatory developments will change its  classification. Sponsors of SaMD will need to ensure that their medical devices are included in the ARTG under their correctly classification or risk having them cancelled.

Sponsor 1 November 2024 to apply for approval under the new regulatory regime. Please contact Dr Teresa Nicoletti if you have any concerns regarding the classification of your device or require assistance lodging an application for re-approval of a device.