Tracey Duffy | First Assistant Secretary
Australian Government Department of Health, Disability and Ageing

Tracey Duffy leads the Medical Devices and Product Quality Division at the Therapeutic Goods Administration (TGA). The TGA is part of the Commonwealth Department of Health, Disability and Ageing. Her Division is responsible for medical device regulation, good manufacturing practices and laboratory testing. The TGA is the national regulator of software and AI when it is intended for medical or therapeutic use. Tracey has held several leadership roles within the Department of Health and private sector consultant advisory roles. She is also a member of international committees and working groups driving global harmonisation of medical device regulations.