TGA draft guidance calls for heightened cybersecurity for medical devices in Australia

The Therapeutic Goods Administration (TGA) in Australia has released a draft regulation guidance on cybersecurity for medical devices. The draft guidance calls for a clear regulatory environment for connected medical devices and emphasizes the need for risk assessment, cross-functional collaboration, and staff training to ensure the safety and security of medical devices. The TGA has invited industry and other stakeholders to provide feedback on the draft guidance.