Artificial intelligence

Australia has recognised strengths in MedTech, yet pivotal trials and first approvals (including for Australian-origin devices) often occur offshore. The Therapeutic Goods Administration (TGA) is well-positioned to further support local innovation while maintaining confidence in the medical devices approved for use by shifting effort earlier in development. We outline the current landscape of risk-based regulation across the medical device lifecycle and frame the issues for clinicians during an upcoming period of active discussion and consultation. The existing priority review pathway could be refined for devices under development. Targeted early access approaches must recognise unmet needs and carefully weigh uncertainties around safety and performance. Internationally, regulators increasingly act as collaborators as well as adjudicators of innovation, helped by targeted programs. The TGA aims for an optimised regulatory system that responsibly facilitates access by Australians to MedTech innovation, while aligning timelines with clinical need and sustaining public trust.

Jeffrey J. Brownscombe, Christine E. Gee, David T. Hau, Kyle A. Sheldrick, Mario E. Vittorino, Tracey L. Duffy