Australia: Comparison of Australian TGA Fees and Annual Charges for Medical Devices and IVDs (2025 vs. 2026) – June/July 2026

• 2026-07-28 02:39:21

Starting July 2026, the Australian Therapeutic Goods Administration (TGA) will implement an overall increase in regulatory fees and annual charges for medical devices and in vitro diagnostic (IVD) devices. This article provides a detailed 2025 versus 2026 fee comparison, highlighting an upward adjustment of approximately 4.7% to 6.3% across various submission and maintenance categories. It also includes strategic insights from Qualtech on leveraging overseas approvals and managing hidden compliance costs to optimize long-term operational budgets and market access strategies

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