TGA launches new regulation for software-based medical devices

Software is changing how clinicians practice medicine, how individuals manage their own health and how patients interact with their healthcare providers.

From 25 February 2021, the way that software-based medical devices (SaMD) are regulated in Australia will change.

According to the TGA, rapid innovation in technology has driven significant changes to software function and adoption, giving rise to a larger number of devices able to inform, drive or replace clinical decisions, or directly provide therapy to an individual. Access to software has become much easier, with personal devices including smartphones, wearables and tablets becoming ubiquitous, and improvements to network technology providing increased connectivity via technologies such as Bluetooth and WiFi.

The regulatory changes follow an extensive consultation and revision process, which was delayed by the COVID-19 pandemic. Many of the 48 companies who made submissions during the consultation process indicated that where products impact patient safety and public health safety, these should not have reduced regulatory oversight unless risks are well understood by the users. Patients and clinicians who use the software based medical devices, including apps, must be able to trust the efficacy and accuracy and this needs to be assessed by a trusted entity, independent of the software developers.

The changes will 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.

The new rules provide that all SaMD products will be classified according to intended purpose (diagnosis, screening, monitoring, providing therapy) and the level of risk to the individual or public health.

The new classification rules will apply to all new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) made on or after 25 February 2021.

Transitional arrangements will apply to devices which are currently included in the ARTG, or which are the subject of an application lodged before 25 February 2021, and would receive a higher classification under the new rules. Such products may continue to be supplied during the transition period under their existing classification as long as the TGA is notified by 25 August 2021. The transition period will end on 1 November 2024.

More information can be found at Regulatory changes for software based medical devices.