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.