On Tuesday 19 May there is a workshop taking place that will provide the perfect way to start your week at AusMedtech 2026. Please review the workshop below and note that spaces are limited – if you wish to attend it is advised to register as soon as possible.
Utilising international recognition for MDIVD market access in EU and UK
- Date: Tuesday 19 May
- Time: 08.30am – 11.30am
- Venue: Crown Towers, Perth
Regulatory Affairs is a critical but finite resource within Medical Device and IVD companies, Socio-economic factors are driving down the costs of diagnostics, at a time when regulatory burden and complexity is going up. The result is a squeeze on the return of investment in lower revenues in highly regulated market. Organisations need be more efficient in the utilisation of global registrations and supporting technical documentation to ensure there is a commercial benefit to putting devices on market.
Regulatory barriers are there for a reason: ensuring patient and user safety, but there is also a need to build proportionate regulatory barriers based on a true risk-based approach, and utilising international recognition and reliance opportunities where practical.
The workshop will explore the current thinking from IMDRF, MDSAP and international regulators on International Recognition and will begin with the specific pathways recently proposed by the UK and discuss how on how international recognition pathways could work. We aim to explore the opportunities and challenges for the industry regarding these new initiatives
Speakers
John Jamieson, Assistant Secretary, Medical Devices Authorisation, Therapeutic Goods Administration (TGA)
John Jamieson is the Assistant Secretary, Medical Devices Authorisation Branch at the Therapeutic Goods Administration (TGA). John also represents the TGA on the International Medical Device Regulators Forum (IMDRF) Management Committee and on the Regulatory Authority Council of the Medical Devices Single Audit Program (MDSAP). John’s branch manages the TGA’s conformity assessment certification and comparable overseas regulator reliance arrangements for medical devices, including in-vitro diagnostics and software as a medical device.
Stuart Angell, Head of Regulatory Affairs, 2San. Chair of Reg Affairs Working Party, BIVDA
Stuart is a regulatory leader, mentor, and trusted advisor in Regulatory Affairs for in-vitro diagnostics medical devices (IVD). He is a internationally recognised expert in IVD UKCA, EU IVDR, and ISO 13485 and MDSAP. He is the co-founder and Managing Director of IVDeology., providing specialist compliance services to the IVD and medical device industry, and currently holds the position of Head of Regulatory Affairs at 2San, a worldwide distributor and sponsor of IVD self-test medical devices.
Is also the current Chair of BIVDA (British IVD Association) Regulatory Affairs Working Party, chair of TOPRA (The Organisation of Professional Regulatory Affairs) Medtech SPIN, and Chair of the RAPS (Regulatory Affairs Professional Society) RCC certification programme for EU IVDR a current member of the British Standards Committee TV/212 (IVDs) With 20+ years in the IVD industry, and visiting lecturer at the University of Birmingham Biomedical School,
His mission is to ensure that regulatory compliance is not just a hurdle, but a strategic advantage, where ISO 13485 and MDSAP is rooted in technical integrity and patient safety standards I uphold regardless of the organizational environment.
Chelsea Tooze, Director of Quality & Regulatory, 2San
Previously a key member of the UKHSA’s COVID Devices team, Chelsea Tooze’s experience in RAQA within the Medical Device industry provides a unique perspective on how distributors can collaboratively enhance the innovation pathway, moving beyond their traditional roles to become integral partners in the acceleration of healthcare advancements.
Chelsea Ashton Tooze is a seasoned leader in global quality and regulatory affairs, specializing in the medical device sector. As the Director of Global Quality & Regulatory at 2San, she plays a pivotal role in ensuring compliance with international standards and driving innovation in diagnostic technologies. Her expertise encompasses ISO 13485 compliance, quality systems management, and regulatory strategy, making her a trusted advisor for startups navigating the complexities of medical device development.
In addition to her corporate role, Chelsea is the Managing Director of Tooze Consulting Limited, where she provides strategic consulting services to emerging companies in the healthcare and medical device industries. Her consultancy focuses on guiding startups through the regulatory landscape, helping them transform early challenges into opportunities for growth and resilience.
With a background in biomedical sciences, Chelsea combines scientific acumen with practical regulatory experience. She is passionate about fostering a culture of resilience within startups, emphasizing the importance of learning from early failures to build robust, market-ready products.
Chelsea is also dedicated to community engagement, having founded the Wokingham Youth Café, a local initiative aimed at providing a safe and supportive space for young people.
