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Understanding the emerging medical devices landscape and the associated regulatory environment

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Update: Draft regulatory guidance on cyber security for medical devices now open for comment

The TGA have now released Draft regulatory guidance and information materials concerning cyber security for medical devices. The TGA is seeking comments from interested parties on the applicability and usefulness of the content, and will accept submissions up to the close of business on the 14th of February. Please visit this TGA website for links to the Draft and information on how to submit feedback.

Project Background

Digital technologies are providing the foundation for many emerging global healthcare innovations, and the Australian healthcare sector has been quick to both develop and adopt these for cost-effective outcomes benefiting the clinician and the patient. To provide a sustainable and competitive environment for this to continue, consideration must be given on how to cultivate a health technology ecosystem which allows developers to harness both clinical and technical expertise while maintaining a clear focus on safety and quality.

Of pivotal importance is the medical devices ecosystem. Traditionally involving factory-based manufacturing of devices with physical action, it has rapidly evolved to include software, communicative, and responsive technology. These devices have the potential to provide significant positive impact, but for peace of mind for consumers this needs to be balanced against patient safety, with two key areas of interest: the cyber security of all medical devices, and the emerging profile of medical device developers focused on software.

The Therapeutic Goods Administration (TGA) has engaged CSIRO to conduct research in order to build an understanding of Australia’s Software as a Medical Device innovators, and to learn how and when agencies such as the TGA can support them in demonstrating safety of their products on the global market. In addition, CSIRO will conduct research into medical device cyber security to support the development of a TGA guidance document. This will assist the medical devices ecosystem to implement best-practice approaches to cyber security.

CSIRO is currently engaging with the medical device industry to better understand their work and how we can work together to continue developing and implementing safe medical device technology.

To find out more about this project and the consultation process please contact CSIRO project team member Dr Shane Seabrook.

Project updates