Australia Diagnostic and Monitoring Devices Market Size and Forecast by Offering, Technology, Clinical Application, Distribution Channel, and End User: 2019-2033

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Industry Assessment Overview

Industry Findings: Regulatory modernization and a renewed focus on supply-chain resilience are altering supplier selection and product lifecycles. Australia’s TGA Action Plan and progress reporting have signalled an active reform program to strengthen pre- and post-market controls and support local innovation (May-2024). That policy posture encourages hospital buyers to prioritise vendors with transparent regulatory compliance, robust post-market surveillance and demonstrable service networks.

Industry Progression: A concrete regulatory milestone was the TGA’s implementation of revised medical-device application/audit rules and other application reforms that took effect around Jul-2024, reducing certain mandatory audits but raising expectations for device evidence and controls. That Jul-2024 change sped up some approvals while increasing scrutiny on higher-risk device authorisations, a combination that pushes vendors to refine evidence packages and lifecycle data collection strategies.

Industry Player Insights: Australia’s structural shifts are influenced by ResMed, Nanosonics, Cochlear, and Fisher & Paykel Healthcare etc. Local and regional vendors are translating policy clarity into expansion: Nanosonics’ FY-2024 investor disclosure and product roadmap (Aug-2024) showed revenue growth and R&D investment in infection-prevention devices, while ResMed’s regional tech-centre and product rollouts (2023–2024) expanded local support for home monitoring. These vendor initiatives reduce execution risk for Australian purchasers and boost adoption of device-plus-service models.