A17. TGA Reforms and implications for Medical Device Sponsors
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Medical Devices Regulation Summit
| Tuesday, June 3, 2025 |
| 2:45 PM - 3:45 PM |
| Parkside 1 |
Chair & Speakers
Jean Boudaud
Director, Medtech Services APAC
PharmaLex Pty Ltd
TGA Reforms and implications for Medical Device Sponsors
Abstract
The TGA has been undertaking a significant program of reforms aimed at strengthening the regulation of medical devices and IVDs in Australia. These reforms span all phases of the medical device lifecycle, from the application of classification rules, to conformity assessments, application audits, through to post-market surveillance and vigilance, and patient access to information. Join us as we explore the latest medical device reform updates from the TGA, and what the recent and upcoming changes may mean for industry, manufacturers and sponsors. Sponsors and manufacturers can expect to gain a better understanding of their responsibilities as the Australian medical device regulatory landscape evolves, and identify the implications of the changes on their systems, documentation and processes. In this session, the TGA will provide an update on the most recent and upcoming changes in the TGA Regulations pertaining to Medical Devices and IVDs. Industry experts will then share some insights on key challenges and trends observed and provide recommendations to ensure robust systems are implemented at all levels, to help drive and maintain regulatory compliance in this changing environment. A Q&A session will then follow.
Biography
Jean brings 18+ years of industry experience in Project Management, Quality Assurance and Regulatory Affairs primarily gathered in the Medical Device/IVD industry.
He has significant experience in Management Consulting and leads PharmaLex's APAC Medtech Services.
He puts into practice his strong technical background and hands-on expertise to provide practical solutions to the challenges faced by his clients in any phase of their product lifecycle.
He focuses on implementing strategies that meet business requirements and bring efficiencies, whilst meeting the strict regulatory obligations of our industry.
Jean is a Certified Engineer from France and holds a Master’s Degree of Engineering (Mechanical). He received ASQ Certification for Auditing in 2013 and is bilingual in French and English.
Mrs Nehzat HAZRATIAN
Ra Manager
Arthrex Australia & New Zealand
TGA Reforms and implications for Medical Device Sponsors
Abstract
The TGA has been undertaking a significant program of reforms aimed at strengthening the regulation of medical devices and IVDs in Australia. These reforms span all phases of the medical device lifecycle, from the application of classification rules, to conformity assessments, application audits, through to post-market surveillance and vigilance, and patient access to information. Join us as we explore the latest medical device reform updates from the TGA, and what the recent and upcoming changes may mean for industry, manufacturers and sponsors. Sponsors and manufacturers can expect to gain a better understanding of their responsibilities as the Australian medical device regulatory landscape evolves, and identify the implications of the changes on their systems, documentation and processes. In this session, the TGA will provide an update on the most recent and upcoming changes in the TGA Regulations pertaining to Medical Devices and IVDs. Industry experts will then share some insights on key challenges and trends observed and provide recommendations to ensure robust systems are implemented at all levels, to help drive and maintain regulatory compliance in this changing environment. A Q&A session will then follow.
Biography
With 10+ years of industry experience, Nehzat has a strong technical background spanning Quality Assurance, Quality Engineering, Regulatory Affairs and Market access across all stages of the product lifecycle within the Medical Device /(IVD) industry.
Her expertise includes regulatory strategy development, market access planning, and submissions to regulatory authorities such as the TGA, with knowledge of global frameworks including EU MDR and FDA requirements. She is skilled in process optimisation, strategic planning, and cross-functional collaboration to ensure compliance while aligning regulatory activities with broader business objectives.
Nehzat holds a Bachelor’s degree in Industrial Engineering and a Postgraduate Diploma in Biomedical Engineering from the University of New South Wales (UNSW), Sydney. Her combined regulatory knowledge and operational experience enable her to navigate complex regulatory environments and deliver results that support timely and effective market access.
Jenny Lin
Senior Manager, Medical Devices/IVD
PharmaLex Pty Ltd
A17. TGA Reforms and implications for Medical Device Sponsors
Abstract
The TGA has been undertaking a significant program of reforms aimed at strengthening the regulation of medical devices and IVDs in Australia. These reforms span all phases of the medical device lifecycle, from the application of classification rules, to conformity assessments, application audits, through to post-market surveillance and vigilance, and patient access to information. Join us as we explore the latest medical device reform updates from the TGA, and what the recent and upcoming changes may mean for industry, manufacturers and sponsors. Sponsors and manufacturers can expect to gain a better understanding of their responsibilities as the Australian medical device regulatory landscape evolves, and identify the implications of the changes on their systems, documentation and processes. In this session, the TGA will provide an update on the most recent and upcoming changes in the TGA Regulations pertaining to Medical Devices and IVDs. Industry experts will then share some insights on key challenges and trends observed and provide recommendations to ensure robust systems are implemented at all levels, to help drive and maintain regulatory compliance in this changing environment. A Q&A session will then follow.
Biography
Jenny provides practical solutions in the Medtech regulatory space across multiple markets. With over five years of research experience in molecular biology, microbiology, immunology, and biomedical engineering in both academic and clinical settings, she joined PharmaLex in 2016, bringing extensive medical science knowledge. Her previous role as a patent engineer at an intellectual property law firm provided her with valuable insight into the healthcare industry.
In addition to her technical expertise, Jenny is adept at navigating complex regulatory environments, fostering collaboration, mentoring team members, and driving projects to approvals. She has comprehensive project management experience throughout product development phases and the registration cycle, including regulatory strategy provision, technical file development, lab testing coordination, regulatory support for clinical trials, quality management, and post-market compliance.
Jenny holds a Master of Professional Engineering (Biomedical), a Master of Science (Microbiology), and a Bachelor of Science (Life Science).
Xin-Lin Goh
Director
Therapeutic Goods Administration, Australian Government, Department of Health, Disabiity and Ageing
TGA Reforms and implications for Medical Device Sponsors
Abstract
The TGA has been undertaking a significant program of reforms aimed at strengthening the regulation of medical devices and IVDs in Australia. These reforms span all phases of the medical device lifecycle, from the application of classification rules to conformity assessments, application audits, through to post-market surveillance and vigilance, and patient access to information.
Join us as we explore the latest medical device reform updates from the TGA, and what the recent and upcoming changes may mean for industry, manufacturers and sponsors. Sponsors and manufacturers can expect to gain a better understanding of their responsibilities as the Australian medical device regulatory landscape evolves and identify the implications of the changes on their systems, documentation and processes.
In this session, the TGA will provide an update on the most recent and upcoming changes in the TGA regulations pertaining to medical devices and IVDs. Industry experts will then share some insights on key challenges and trends observed and provide recommendations to ensure robust systems are implemented at all levels, to help drive and maintain regulatory compliance in this changing environment. An interactive Q&A session will then follow.
Join us as we explore the latest medical device reform updates from the TGA, and what the recent and upcoming changes may mean for industry, manufacturers and sponsors. Sponsors and manufacturers can expect to gain a better understanding of their responsibilities as the Australian medical device regulatory landscape evolves and identify the implications of the changes on their systems, documentation and processes.
In this session, the TGA will provide an update on the most recent and upcoming changes in the TGA regulations pertaining to medical devices and IVDs. Industry experts will then share some insights on key challenges and trends observed and provide recommendations to ensure robust systems are implemented at all levels, to help drive and maintain regulatory compliance in this changing environment. An interactive Q&A session will then follow.
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 medical device reforms in accordance with An Action Plan for Medical Devices. The Action Plan is a three-part strategy to strengthen Australia’s regulatory system whilst continuing to be patient focused and have greater transparency. It outlines actions that continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices.
