A27. Impact of the European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape
Tracks
Medical Devices Regulation
| Wednesday, June 12, 2024 |
| 4:30 PM - 5:30 PM |
| Parkside 1 |
Chair & Speakers
Dr Orin Chisholm
Program Director
The University Of Sydney
Chair: Impact of the European European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape
Abstract
This session will cover the European Medical Device Directive to Medical Device Regulations transition and its impact on the Australian regulatory landscape. A TGA representative is requested to cover the basics of the transition and its impact on TGA regulatory processes. The second speaker, Michael Sullivan, will present his Advanced Masters research project results of an industry survey of the impact of this transition on Australian regulatory professionals and their companies. The project began with a literature review of what was known about the transition, highlighting the lack of data on the impact of this transition on jurisdictions outside the EU. This data gap was addressed by a small industry survey to gain some initial insights into the impact of the transition on companies operating within Australia and relying on European certification for listing on the ARTG. The results will be discussed in the presentation.
Biography
Orin is the program director for the postgraduate programs in Pharmaceutical and Medical Device Development at the University of Sydney. She has academic appointments with UNSW and Arizona State University, USA. Orin is on the Board of the Association of Graduate Regulatory Educators (USA) and is a founding member of the Regulatory Affairs Education Alliance. Orin received the TOPRA, UK award for excellence in regulatory education in 2017; became a Senior Fellow of the Higher Education Academy (UK) in 2018 and was elected a Fellow of the Regulatory Affairs Professionals Society in the USA in 2021. Her research focuses on regulatory science, workforce development and pharmaceutical policy.
Mr Michael Sullivan
Head of Marketing for ANZ
University of Sydney/Avanos Medical
Impact of the European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape
Biography
Xin-Lin Goh
Director, Devices Reforms Taskforce, Medicine Device Surveillance Branch,
Department of Health and Aged Care (TGA)
Impact of the European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape
Abstract
This session will cover the European Medical Device Directive to Medical Device Regulations transition and its impact on the Australian regulatory landscape. A TGA representative is requested to cover the basics of the transition and its impact on TGA regulatory processes. The second speaker, Michael Sullivan, will present his Advanced Masters research project results of an industry survey of the impact of this transition on Australian regulatory professionals and their companies. The project began with a literature review of what was known about the transition, highlighting the lack of data on the impact of this transition on jurisdictions outside the EU. This data gap was addressed by a small industry survey to gain some initial insights into the impact of the transition on companies operating within Australia and relying on European certification for listing on the ARTG. The results will be discussed in the presentation.
Biography
Dr Xin-Lin Goh is the Director of the Devices Reforms Taskforce, within the Medical Devices and Product Quality Division of the TGA, which was established to finalise and deliver the policy objectives, and progress implementation, of the medical device projects in accordance with An Action Plan for Medical Devices. The Action Plan is a three-part patient-focused strategy designed to increase transparency and public confidence in Australia’s regulatory system for medical devices. Prior to this, Dr Goh was the Director of the Devices Applications Section within the Medical Devices Authorisation Branch, responsible for the regulatory and technical assessment of applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG), including managing the impact of the EU MDR transition on medical devices supplied in Australia. Dr Goh also has prior experience in administering intellectual property rights (patents) for medical devices at IP Australia, as well as managing reforms and program/project delivery at the Australian National University. She has a special interest in medical innovation and enabling health outcomes. She holds a Master of Biomedical Engineering from the University of New South Wales and a PhD from the Australian National University.
