Speakers Introduction

Tracey Duffy is the First Assistant Secretary of the Medical Devices and Product Quality Division at the Therapeutic Goods Administration (TGA) in Australia. The TGA is Australia’s national safety regulator for medicines, biologicals and medical devices.

Her team is responsible for assessing, approving and monitoring medical devices. Tracey is a Management Committee (MC) member on the International Medical Devices Regulators Forum (IMDRF), she was the Chair of the IMDRF MC in 2022, Chair of the IMDRF Personalised Medical Devices Working Group and is the current Chair of the Medical Devices Single Audit Program (MDSAP). She has also held a number of senior positions in the Department of Health in Australia including for health technology assessment.