Australia's TGA understaffed as medical device safety net strains

The Therapeutic Goods Administration (TGA), which oversees the safety of about 1.4 million medical devices in Australia, is operating with roughly half of its budgeted staff. Documents obtained under freedom of information show the regulator expected a ten‑fold rise in adverse‑event reports after a mandatory hospital reporting regime began in March 2024, but the federal government declined to approve additional funding.

The TGA estimates that handling the most time‑consuming steps of these reports would require up to 150 extra staff members, costing an estimated AU$15.8 million annually. A 2025 internal presentation highlighted significant IT and data‑handling shortcomings that further hamper the agency’s ability to screen reports efficiently. The staffing shortfall and system issues raise concerns about the regulator’s capacity to catch faulty devices such as the Dexcom G7 glucose monitor, SynchroMed II pain pump, Euky Bear humidifier and CellAED defibrillator before they cause patient harm.