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Speakers

Amanda Plusnin

Amanda Plusnin

Field Sales Manager QLD/WA
Terumo
View Bio
Angell Zhang

Angell Zhang

Managing Counsel
Oracle Health
View Bio
Dr Bassil Akra

Dr Bassil Akra

Chief Executive Officer
AKRA Team
View Bio
Brad Betty

Brad Betty

Senior Product Manager - Knee, Primary and Revision
Stryker
View Bio
Diana Kanecka

Diana Kanecka

Director International Affairs
MedTech Europe
View Bio
Erin Skuce

Erin Skuce

National Director
Medical Devices Compliance Program
View Bio
Harpreet Kaur

Harpreet Kaur

Post-Market Vigilance Manager
Medtronic
View Bio
Hasan Zarin Mehr

Hasan Zarin Mehr

Founder & CEO
Documedex
View Bio
Heyam Kalla

Heyam Kalla

Associate Director
Cencora
View Bio
Ian Burgess

Ian Burgess

Chief Executive Officer
MTAA
View Bio
Dr Jasjit Baveja

Dr Jasjit Baveja

Director
Regulatory and Industry Policy, MTAA
View Bio
Dr Jeff Brownscombe

Dr Jeff Brownscombe

Principal Medical Adviser
Medical Devices Authorisation Branch, Therapeutic Goods Administration (TGA)
View Bio
Assoc Prof Jiao Jiao Li

Assoc Prof Jiao Jiao Li

Associate Professor
University of Technology Sydney
View Bio
Jillianne McKenzie

Jillianne McKenzie

Vice President Regulatory Affairs
Field Orthopaedics
View Bio
John Jamieson

John Jamieson

Assistant Secretary
Medical Devices Authorisation Branch, Therapeutic Goods Administration (TGA)
View Bio
Kellie Shaw

Kellie Shaw

Senior Regulatory Affairs Associate
Olympus Australia and New Zealand
View Bio
Dr Kelly Tsang

Dr Kelly Tsang

Director, Devices Post-Market Monitoring Section
Therapeutic Goods Administration (TGA)
View Bio
Dr Kenneth Cavanaugh

Dr Kenneth Cavanaugh

Associate Director
International Policy and Strategy
View Bio
Leanne Etherington

Leanne Etherington

Head of Regulatory Affairs ANZ
Device Technologies Australia
View Bio
Ludger Moeller

Ludger Moeller

Chief Executive Officer
MDSS GmbH
View Bio
Mahesh Datar

Mahesh Datar

Senior Regulatory Affairs Manager
Medtronic Australasia
View Bio
Dr Marcelle Noja

Dr Marcelle Noja

Assistant Secretary
Medical Devices Surveillance Branch, Therapeutic Goods Administration (TGA)
View Bio
Michael Marquez

Michael Marquez

UDI Support Team Lead
Therapeutic Goods Administration (TGA)
View Bio
Michelle Stewart

Michelle Stewart

Director of People, Brand & Innovation
Device Technologies Australia
View Bio
Minta Chen

Minta Chen

Head of RAQA and Compliance
Harrison.ai
View Bio
Nada Alkhayat

Nada Alkhayat

European Commission (EU)
View Bio
Pravin Siriwardena

Pravin Siriwardena

Policy Manager
MTAA
View Bio
Sue Lynch

Sue Lynch

Director
Humonics
View Bio
Thaniya Panapiti

Thaniya Panapiti

Senior Regulatory Affairs Specialist
Medtronic Australasia
View Bio
Tracey Duffy

Tracey Duffy

First Assistant Secretary
Medical Devices and Product Quality Division, Therapeutic Goods Administration (TGA)
View Bio
Xin-Lin Goh

Xin-Lin Goh

Director
Therapeutic Goods Administration (TGA)
View Bio
Yuhua Tan

Yuhua Tan

Deputy Director
Health Sciences Authority
View Bio

Amanda Plusnin
Field Sales Manager QLD/WA, Terumo

With more than 25 years of experience in the healthcare industry, Amanda Plusnin has built a diverse career spanning clinical, technical and commercial leadership roles. Beginning her career in 1999 as a Cardiac Scientist, she has worked across Cardiac Pacing, Interventional Cardiology, Surgical Cardiology and Pharmaceuticals, developing deep expertise in both patient care and healthcare innovation. Today, Amanda is the Field Sales Manager at Terumo Australia, leading a team of six sales professionals across Queensland and Western Australia. She is passionate about developing people, building strong customer partnerships and helping healthcare organisations deliver better outcomes for patients. Her extensive clinical background and commercial experience enable her to connect effectively with healthcare professionals and lead high-performing teams. Outside of work, Amanda is a proud mother of three and a devoted grandmother to baby Archie. She values family, connection and authenticity, bringing these principles into both her leadership style and everyday life.

Angell Zhang
Managing Counsel, Oracle Health

Angell Zhang is Managing Counsel (JAPAC) at Oracle, with over a decade of legal and regulatory experience spanning private practice and senior in-house roles. She specialises in the regulation of SaMD, digital health and emerging healthcare technologies, advising on legal and regulatory strategy across the product lifecycle and the introduction of innovative healthcare solutions in the JAPAC markets. Angell works at the intersection of law, regulation, healthcare and technology, bringing a practical and commercially focused approach to navigating complex regulatory environments and enabling responsible innovation.

Dr Bassil Akra
Chief Executive Officer, Akra Team

Dr Bassil Akra is a distinguished leader in medical device and in vitro diagnostic device regulation, with extensive expertise spanning R&D, manufacturing, testing, conformity assessment, and standards development. As Chief Executive Officer of AKRA TEAM since July 2021, he supports the various stakeholders in developing and executing compliant regulatory, clinical, and quality strategies in the EU, effectively bridging the language between legislators, notified bodies, and industry stakeholders. He also supports the various due diligence activities and court cases which require his independent and impartial subject matter expertise.

Brad Betty
Senior Product Manager - Knee, Primary and Revision, Stryker

Brad is the Senior Product Manager for Knee, Primary & Revision at Stryker Australia, where he leads marketing and product strategy for the knee replacement portfolio. His prior experience covers health economics, market access and commercial strategy. Brad holds a Bachelor of Engineering (Honours) in Biomedical Engineering from the University of Sydney and is a Member of the Institution of Engineers Australia, where he serves as an office bearer for the Biomedical College Group, Sydney Division. He is also a mentor in CSIRO’s STEM Professionals in Schools program.

Diana Kanecka
Director International Affairs, MedTech Europe

Diana Kanecka is Director of International Affairs at MedTech Europe and Co-Chair of the Global Medical Technology Alliance (GMTA). She leads MedTech Europe’s international affairs activities, with a particular focus on advancing regulatory convergence, facilitating global trade and addressing barriers to patient access to medical technologies. Diana brings extensive experience in regulatory affairs, including the EU Medical Devices and in vitro Diagnostic Medical Devices Regulations, as well as international trade policy. Her experience in the medical technology sector and policy work underpins her commitment to fostering policies and international cooperation that support timely and sustainable access to innovative medical technologies.

Ms Erin Skuce
National Director, Medical Devices Compliance Program

Erin Skuce is the National Director of the Medical Devices Compliance Program (MDCP) within the Regulatory Operations and Enforcement Branch at Health Canada. She leads Canada’s national post-market regulatory oversight of medical devices, overseeing compliance and enforcement activities, inspections, establishment licensing, and recall reporting to help protect the health and safety of Canadians. Erin holds an Honours Bachelor of Biomedical Science from the University of Guelph and has more than 23 years of experience in Canada’s federal public service. Erin has built extensive expertise in regulatory operations, beginning as a medical devices inspector before progressing through increasingly senior leadership positions across the medical devices, controlled substances, consumer product safety, and cannabis regulatory programs. Prior to her current role, she served as Director of the Strategic Program Support Division within the Cannabis Directorate and as National Director of the Consumer Product Safety Inspection Program. Throughout her career, Erin has been committed to advancing modern, risk-based regulatory oversight, strengthening compliance and enforcement programs, and collaborating with domestic and international partners to support public health and regulatory excellence.

Harpreet Kaur
Post-Market Vigilance Manager, Medtronic

Post-Market Vigilance Manager at Medtronic ANZ and Co-Chair of Medical technology Association of Australia (MTAA) Quality Assurance Forum with over 12 years of experience in the medical device industry, supporting patient safety, regulatory compliance, and quality outcomes across ANZ.

Hasan Zarin Mehr
Founder & CEO, Documedex

Hasan brings over 20 years of global MedTech experience, supporting more than 100 medical device companies, from early-stage start-ups to multinational manufacturers, across regulatory and quality pathways. He has held leadership roles as a QA/RA Director and Regulatory Compliance Consultant and served as a Lead Auditor and Medical Device Technical Documentation Assessor with EU Notified Bodies, overseeing the conformity assessment of more than 500 medical devices across all risk classes. As Founder & CEO of Documedex, Hasan now provides end-to-end Regulatory Compliance (QA/RA) support to MedTech innovators and manufacturers.
His expertise includes:
• Global regulatory strategy and market access across the EU (MDR/CE), Australia (TGA), US (FDA), and more than 110 markets worldwide.
• Technical and clinical documentation, including risk management, biological evaluation, software validation, usability, clinical evaluation, and clinical trials.
• QMS implementation (ISO 13485, EU MDR, MDSAP, EN 18286:2026).
• “QA/RA as a Service”, providing ongoing regulatory and quality management support.

Ms Heyam Kalla
Associate Director, Cencora

Heyam Kalla is an experienced medical device regulatory consultant with several years of industry experience, specializing in high-risk devices and clinical evaluation reports. She has expertise in regulatory pathways, planning, and strategy for ANZ and global markets, as well as preparing regulatory submissions, managing regulatory reviews, and supporting post-market compliance for a wide range of devices, including high-risk products. Heyam holds a Bachelor of Science from the University of New South Wales, with a double major in Pharmacology and Medical Microbiology & Immunology, and First Class Honours in Pathology.

Ian Burgess
Chief Executive Officer, MTAA

Ian is CEO of the Medical Technology Association of Australia, the peak national association representing companies in the medical device industry. Ian’s previous CEO roles have included commercial health organisations and also medical professional associations – the Australian Dental Association (NSW) and the Australian Orthopaedic Association. Ian holds an MBA from Macquarie University and a Bachelor of Economics from the Australian National University, and he is a member of the Australian Institute of Company Directors. Ian is also a non-executive director of Red Nose, formerly known as SIDS & Kids, a well-respected not-for-profit organisation that is dedicated to saving the lives of babies and children.

Dr Jasjit Baveja
Director, Regulatory and Industry Policy, MTAA

Jasjit Baveja is Director of Regulatory and Industry Policy at MTAA, where she leads regulatory policy development and industry engagement with the Therapeutic Goods Administration. She brings over a decade of hands-on experience in medical device regulation. A long-standing advocate for women in the medical technology industry, Jasjit has co-led women’s network employee resource groups at both Boston Scientific and Johnson & Johnson, and continues to champion gender diversity and inclusion across the sector through her work at MTAA.

Dr Jeff Brownscombe
Principal Medical Adviser, Medical DevicesAuthorisation Branch,
Therapeutic Goods Administration (TGA)

Dr Jeff Brownscombe is a public health physician, GP and medical manager who is currently the Principal Medical Advisor for the Medical Devices Authorisation Branch as Therapeutic Goods Administration (TGA). Jeff also maintains his clinical practice through remote GP telehealth. Jeff’s background includes primary health care, health systems development, clinical governance, medical management, legal medicine, health technology assessment and regulation.

Assoc Prof Jiao Jiao Li
Associate Professor, University of Technology Sydney

Dr Jiao Jiao Li FRSN FRSB FIEAust is a biomedical engineer and Associate Professor at University of Technology Sydney (UTS). Her research in regenerative medicine develops new approaches including stem cells, bioactive materials, and nanotechnology to treat chronic diseases, particularly bone and joint disorders. National recognitions of her research include 2024 Eureka Prize for Emerging Leader in Science and 2023 Metcalf Prize for Stem Cell Research. Professionally, she serves as a Member of Australian Research Council (ARC) Advisory Committee, Board Director of Australian Institute of Policy & Science (AIPS), and Biomedical College Board of Engineers Australia. Beyond research, she is passionate about promoting STEM education, policy, and engagement, and helping young people become interested in STEM careers.

Jillianne McKenzie
Vice President Regulatory Affairs, Field Orthopaedics

Jillianne McKenzie, RAC (EU) Vice President, Regulatory Affairs, Field Orthopaedics Jillianne McKenzie is VP of Regulatory Affairs at Field Orthopaedics, a Brisbane-based medical device start-up developing innovative solutions for hand and wrist surgery. She leads regulatory strategy across multiple jurisdictions, spanning the full product lifecycle. With regulatory affairs experience encompassing medical devices and diagnostics, Jillianne has held roles with global responsibilities at organisations including Alere (now Abbott), Cook Medical and Panbio, and served as Australia’s IVD industry representative to the GHTF, contributing to guidance that continues to underpin regulatory systems used today. A long-time guest lecturer at the University of Queensland and a member of MTAA’s Regulatory Affairs Committee (RAC), she shares insights here from an Australian manufacturer’s perspective for EU MDR Meets Australia.

John Jamieson
Assistant Secretary, Medical Devices Authorisation Branch,
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.

Ms Kellie Shaw
Senior Regulatory Affairs Associate, Olympus Australia and New Zealand

With more than 20 years of experience in the medical device industry, Kellie brings a unique perspective to regulatory affairs, having built her career across marketing, product management, and regulatory functions. Her broad industry experience enables her to understand the regulatory landscape, as well as the practical realities of bringing innovative healthcare solutions to clinicians and patients. Kellie‘s passion for patient outcomes is deeply personal. Growing up with a brother living with a chronic illness gave her an early appreciation of the importance of safe and effective treatment options. That understanding became even more meaningful when her youngest child was diagnosed with type 1 diabetes. Kellie takes great pride in the role regulatory affairs plays in ensuring patients have access to safe, effective, and high-quality medical technologies. She is passionate about making a difference and is a strong advocate for keeping patient needs at the centre of every decision.

Dr Kelly Tsang
Director, Devices Post-Market Monitoring Section, Therapeutic Goods Administration (TGA)

Kelly Tsang is Director of the Post-Market Monitoring Section within the Medical Devices Surveillance Branch at Australia’s Therapeutic Goods Administration (TGA). He leads multidisciplinary teams responsible for post-market surveillance of medical devices, including the detection and investigation of safety signals, analysis of device performance and adverse event data, management of emerging supply disruptions, and regulatory responses to protect public health. Prior to joining the TGA, Kelly spent more than a decade in medical device research and development, specialising in biomaterials, medical device coatings and tissue engineering. He holds a Bachelor of Science, Bachelor of Engineering (Hons) and PhD from Monash University and has conducted research at Monash University, CSIRO, Brigham and Women’s Hospital and the Massachusetts Institute of Technology. Kelly was awarded the Fulbright BHP Billiton Postgraduate Scholarship in Science and Technology in 2011 and regularly speaks on medical device regulation, post-market surveillance, risk management, research translation and the safe adoption of innovative health technologies.

Dr Kenneth Cavanaugh
Associate Director, International Policy and Strategy

Dr Kenneth J. Cavanaugh Jr. has been employed at the U.S. Food and Drug Administration Center for Devices and Radiological Health since 2003 and is currently the Associate Director for International Policy and Strategy. In this role, he oversees the international affairs activities for medical devices and represents the Center on the Management Committee of the International Medical Device Regulators Forum (IMDRF), as co-chair of the IMDRF Good Regulatory Review Practices Working Group, and in multiple international consensus standards development committees. Prior to his current role, he spent over 20 years in FDA’s Office of Cardiovascular Devices as a scientific reviewer, supervisor, and Deputy Office Director.

Mrs Leanne Etherington
Head of Regulatory Affairs ANZ, Device Technologies Australia Pty Ltd

Leanne Etherington is Head of Regulatory Affairs ANZ at Device Technologies, with more than 20 years’ experience in regulatory strategy, applications, and compliance within the medical technology sector. She leads regulatory affairs across Australia and New Zealand, supporting over 1,300 ARTG inclusions and enabling access to innovative medical technologies. Leanne provides strategic leadership across Device Technologies and its group companies, partnering with commercial and operational teams to navigate complex regulatory environments while supporting business growth and patient access. She is recognised for translation of evolving regulatory requirements into practical solutions that deliver both compliance and commercial outcomes. As Chair of the Medical Technology Association of Australia (MTAA) Regulatory Affairs Forum, Leanne works closely with industry and the Therapeutic Goods Administration (TGA) on key regulatory initiatives, including implementation of Australia’s Unique Device Identification (UDI) system. She is passionate about regulatory excellence, mentoring future professionals, and advancing collaboration across the healthcare sector.

Mr Ludger Moeller
Chief Executive Officer, MDSS GmbH

Ludger Moeller is the CEO and owner of MDSS GmbH and the founder of several affiliated organizations including MDSS Consulting GmbH, ITN Holding GmbH, MDSS-UK RP Ltd, MDSS CH GmbH, MDSS USA LLC, MDSS Impex GmbH, MDSS AU PTY LTD, and MDSS NZ Ltd.
With a distinguished career spanning over three decades in the medical device regulatory sector, he has played a pivotal role in shaping compliance strategies and influencing regulatory frameworks across global markets.
Key Roles and Achievements:
  • Founding Member of the European Association of Authorized Representatives (EAAR); long-standing member of the Executive Board, Vice Chair since 2002, and Chair since November 2022
  • Founding Member of the UK Responsible Person Association (UKRPA)
  • Member of the Ethics Committee of the Medical Council for Lower Saxony since 2015
  • Member of the Regulatory Affairs Professional Society (RAPS), USA
  • Founding Member of the RAPS Germany Chapter

Mr Mahesh Datar
Senior Regulatory Affairs Manager, Medtronic Australasia

Professional with 30 years of experience in Medical Device & Pharmaceutical Industry with expertise in Regulatory Affairs, Quality Assurance and Operations.

Dr Marcelle Noja
Assistant Secretary, Medical Devices Surveillance Branch,
Therapeutic Goods Administration (TGA)

Dr Marcelle Noja is Assistant Secretary of the Medical Device Surveillance Branch at the Therapeutic Goods Administration (TGA). She leads national activities relating to medical device safety, post-market surveillance, adverse event investigations and reviews, and regulatory responses to emerging risks. With extensive experience across public health, health protection and therapeutic goods regulation, Marcelle is passionate about fostering collaboration between regulators, industry and healthcare providers to support innovation, patient safety and confidence in Australia’s medical technology sector.

Michael Marquez
UDI Support Team Lead, Therapeutic Goods Administration (TGA)

Michael Marquez is the UDI Support Team Lead within the Therapeutic Goods Administration’s UDI Program, supporting the implementation and ongoing operation of the Australian Unique Device Identification Database (AusUDID). He works closely with industry, healthcare organisations, regulators and international partners to improve medical device traceability, data quality and the adoption of UDI across Australia. Mic’s interest in this work is shaped by his previous experience as a Registered Nurse and as a Statewide Clinical Product Manager, where he saw firsthand the importance of accurate device information in supporting patient care and safety. He is passionate about helping realise the benefits of UDI for patients, healthcare providers and regulators, and enjoys working collaboratively with stakeholders to drive practical and meaningful outcomes.

Ms Michelle Stewart
Director of People, Brand & Innovation, Device Technologies Australia Pty Ltd

Michelle Stewart is a senior marketing and digital leader with more than 19 years of experience driving growth, innovation, and digital transformation. Since joining Device Technologies in 2018, she has played a key role in expanding the company’s digital presence and delivering customer-focused marketing strategies across the MedTech sector. Known for fostering collaboration and enhancing customer experience, Michelle has also led initiatives in social responsibility, community engagement, and diversity, equity, inclusion, and belonging (DEIB). She serves on the Medical Technology Association of Australia (MTAA) Code Monitoring and Women in MedTech Committees and holds an advisory role with the B2B eCommerce Association. A recognised thought leader, Michelle is a sought-after speaker at major industry events. Promoted to General Manager of Marketing & Digital in 2019 and Director of Marketing & Digital in 2023, she continues to lead innovation in marketing, digital strategy, and enterprise data, supporting Device Technologies’ ongoing growth and success.

Minta Chen
Head of RAQA and Compliance, Harrison.ai

Minta Chen leads Regulatory Affairs, Quality Assurance, and Compliance globally at Harrison.ai, taking AI/ML medical device software through the US, EU, UK, Australian and Asian frameworks. She is passionate in enabling innovative technology in healthcare, and a believer in applying AI to regulatory and quality work itself.

Nada Alkhayat
European Commission (EU)

Nada Alkhayat is a Policy Officer at the European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE). In her team, Nada holds a horizontal role in the implementation of the medical devices regulations, leading the work on international and chairs the Medical Device Coordination Groups on New Technologies, Nomenclature and International Matters. Her special interest areas include medical device software, Artificial intelligence and in vitro diagnostic medical devices. Prior to joining the European Commission, Nada was a Regulations & Industrial Policy Officer at MedTech Europe.

Pravin Siriwardena
Policy Manager, MTAA

Pravin Siriwardena is Policy Manager at the Medical Technology Association of Australia (MTAA), leading policy and advocacy initiatives across environmental, social and governance (ESG), procurement, and industry development. With extensive experience engaging government, healthcare providers and industry leaders, he works to advance policy reforms that support a sustainable, innovative and resilient MedTech sector. Pravin, on behalf of the Australian MedTech industry, has led national industry policy engagement on sustainable healthcare, modern slavery, battery stewardship, circular economy and medical plastics policy. He represents Australia on the Global Medical Technology Alliance (GMTA) Sustainability Committee and is an industry partner on the Solving Plastic Waste Cooperative Research Centre (CRC). In procurement, Pravin has spearheaded MTAA’s policy and advocacy with Australian state health procurement agencies to improve procurement frameworks, contracting practices and market access pathways. He regularly presents on the intersection of sustainability, procurement and innovation, helping organisations develop awareness and capability to engage on ESG policy developments while ensuring suppliers can continue to deliver outcomes for patients and the health system.

Ms Sue Lynch
Director, Humonics

Sue Lynch is an award-winning product developer and the founder and director of Humonics, a human factors and usability engineering consultancy. She has contributed to end-to-end medical device development across start-ups and global companies, spanning CPAP machines, ventilators, wearables, and surgical devices, with 650+ patents to her name.
Throughout her career, Sue has worked across industrial design, user interface design, systems engineering, team leadership, global product management, and program management. Her background as an ICU nurse gives her a unique cross-disciplinary perspective, having spent 25+ years designing the devices she once depended on. She has led user research, human factors engineering, usability evaluations, validation studies, and human factors submissions.
Sue is passionate about simplicity, designing healthcare experiences that make it easier for patients to self-manage and clinicians to deliver care, and helping companies navigate design, development, and regulation to bring game-changing products to market

Thaniya Panapiti
Senior Regulatory Affairs Specialist, Medtronic Australasia

I am a regulatory affairs professional, working in the industry for 11 years. I studied Chemical Engineering and Masters in Biomedical Engineering at UNSW, which is where my interest in medical devices was really fostered. Since my time at University, I’ve had the privilege of working in tech service at Ecomed, then in regulatory affairs at Device Technologies and now continuing work in Regulatory Affairs at Medtronic. Being able to shape access to medical devices through registrations, participating in TGA consultations and working groups has been a fulfilling journey.

Tracey Duffy
First Assistant Secretary, Medical Devices and Product Quality Division,
Therapeutic Goods Administration (TGA)

Tracey leads the Medical Devices and Product Quality Division at the Therapeutic Goods Adminitration (TGA). Her team is responsible for the pre-market assessment and post-market monitoring of medical devices, laboratory testing of therapeutic goods, GMP licencing and inspections, and national therapeutic goods recalls.

Xin-Lin Goh
Director, Therapeutic Goods Administration (TGA)

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 for Medical Devices is a comprehensive, three-part strategy to strengthen Australia’s medical device regulatory framework while maintaining a strong focus on patient safety, transparency and public confidence. It sets out a programme of reforms to enhance the safety, performance and quality of medical devices, improve access to information, and ensure Australia’s regulatory system remains responsive to the needs of patients, healthcare professionals and industry.

Ms Yuhua Tan
Deputy Director, Health Sciences Authority

Yuhua is Deputy Director of the Quality Systems, Adverse Events and Compliance Branch at the Medical Devices Cluster, Health Sciences Authority, Singapore. With over 15 years of experience in medical device regulation, she oversees adverse event reporting, dealers licensing, compliance programmes, and ISO 13485 and GDPMDS witness audit programmes. She has been actively involved in international regulatory harmonisation through the International Medical Device Regulators Forum (IMDRF), including work on Unique Device Identification (UDI), Quality Management Systems and Foundational Documents. She contributed to the development of the IMDRF UDI Application Guide and leads Singapore’s UDI implementation. She also serves on Singapore’s National Mirror Working Group for ISO/TC 210 Quality Management.

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