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TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance

Posted 09 August 2018 | By Ana Mulero 

TGA Seeks to Support Software as a Medical Device, Develop Cybersecurity Guidance

Australia’s Therapeutic Goods Administration (TGA) is calling on industry to help tackle existing regulatory challenges in the medical device areas of software and cybersecurity.
 
“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,” TGA said in a notice posted Tuesday.
 
The regulatory authority is working in collaboration with Australia’s Commonwealth Scientific and Industrial Research Organisation (CISRO) to develop research reports on Software as a Medical Device (SaMD) and on Cyber Security for Medical Devices (CSfMD).
 
The reports will be used to determine how TGA can advance innovation among SaMD product developers through further engagement and to develop new industry guidance on CSfMD.
 
Challenges facing SaMD regulation relate to “the emergence of new players,” whereas those with CSfMD “arise due to the increasing impact and complexity of the cyber threat landscape, and the lack of current regulatory guidelines to effectively address this,” according to TGA.
 
CISRO, the Australian government agency responsible for conducting scientific research, is charged with engaging device firms on the two research topics as part of these TGA efforts. The plans involve encouraging firms to share their SaMD needs by 20 August 2018 via a new CSIRO portal on the research project and a CSfMD workshop set for 14 September 2018.
 
TGA

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