Speakers Introduction

Ms Wong Woei Jiuang currently holds the position of Assistant Group Director at Singapore's Health Sciences Authority (HSA), where she heads the Medical Devices Cluster. Her portfolio encompasses the oversight of several critical branches, including Therapeutic Devices, Diagnostic Devices, Digital Health, and Quality System, Adverse Events and Compliance.

In her capacity as Assistant Group Director, Ms Wong spearheads the implementation of a comprehensive life-cycle approach to medical device regulation, encompassing both pre-market assessment and post-market surveillance. This systematic methodology ensures the maintenance of stringent standards for safety, quality and performance of medical devices within Singapore's healthcare ecosystem.

At the international level, Ms Wong serves as Singapore's representative to the International Medical Device Regulators Forum (IMDRF), where she contributes significantly to global harmonisation initiatives in medical device regulations. Her participation facilitates the alignment of Singapore's regulatory framework with international standards whilst ensuring responsiveness to local healthcare requirements.

In the ASEAN context, Ms Wong maintains a prominent position within the ASEAN Medical Device Committee (AMDC), where she advances regional regulatory convergence and enhances collaborative efforts among ASEAN member states in medical device regulation. This international cooperation is fundamental to facilitating trade whilst upholding rigorous standards for medical device safety and efficacy across Southeast Asia.

Her expertise has been particularly instrumental in developing and implementing regulatory frameworks for emerging technologies, with specific emphasis on the rapidly evolving domains of digital health and medical software.

Since 2023, Ms Wong has served as a member of the Strategic and Technical Advisory Group on Medical Devices (STAG MEDEV) for World Health Organization (WHO). She has made substantial contributions to global regulatory frameworks, notably through her involvement in the development of the World Health Organization's Global Regulatory Framework for Medical Devices and in vitro diagnostics. Furthermore, her expertise has been crucial in the formulation of the WHO Global Benchmarking Tool for medical devices, thereby strengthening international regulatory standards.