Research: Software as a Medical Device and Cyber Security for Medical Devices

7 August 2018

Globally, regulators of therapeutic goods are faced with numerous challenges concerning emerging medical device technology. The Therapeutic Goods Administration (TGA) recognises that, to continue providing a clear regulatory environment for medical devices in Australia, it is essential that we engage with the medical devices ecosystem during the development of new regulatory recommendations and guidelines.

The TGA has commenced consultation, through CSIRO Futures, in the areas of Software as a Medical Device (SaMD), and Cyber Security for Medical Devices (CSfMD). Regulation of SaMD is challenged by the emergence of new players that may not have had the opportunity to engage with the TGA, or are lacking an awareness of the regulatory requirements in Australia. CSfMD challenges arise due to the increasing impact and complexity of the cyber threat landscape, and the lack of current regulatory guidelines to effectively address this.

The TGA has engaged CSIRO to develop reports for both SaMD and CSfMD that help shape recommendations moving forward.

Opportunity to have your say

CSIRO Futures has set out how it intends to conduct the research across two key streams:

Software as a Medical Device

To assist the TGA to identify stakeholders in this environment, CSIRO will engage with industry to understand their activities and their needs for further engagement in order to appropriately support their knowledge of regulatory requirements relating to medical software innovations.

If you or your company identify with this emerging industry, go to the CSIRO projects page Mapping the emerging innovation landscape for more information on how you can be involved.

Cyber Security for Medical Devices

The TGA, through CSIRO Futures, is seeking participants for an upcoming dual format consultation consisting of an auditorium presentation held in Canberra (14 September 2018) with a simultaneous live stream webinar. The consultation will seek to explore and capture the complexities of the Australian medical device cyber security landscape before commencing the development of new industry guidance.

Further details can be found at on the CSIRO projects page: Cyber security for medical devices guidelines.