PERTH, Australia – A review by Australia’s Therapeutic Goods Administration (TGA) revealed that medical device recall databases may significantly under-represent software errors, causing harm to patients. These under-reported events are due to patients being unaware how to report problems, inadequate information being reported, effects of software errors being too subtle or difficult to detect, or root cause analyses that may not identify software as the source of error when it causes other components to fail.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.

PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.