CUHK
News Centre

The “Hong Kong International Medical Device Regulatory Forum”, co-organised by The Chinese University of Hong Kong (CUHK)’s Faculty of Medicine (CU Medicine) and the Department of Health (DH) of the HKSAR government, was held today at the Hong Kong Science Park’s Charles K. Kao Auditorium. The Forum, themed “Navigating the Future of Innovation and Artificial Intelligence (AI) in Medical Device regulation”, attracted over 200 global regulators, academic leaders, and industry innovators gather to discuss the challenges and opportunities of medical device regulation in an evolving landscape of innovation and AI.  

During the opening ceremony, Dr Ronald Lam Man-kin, Director of Health, said in his speech: “The HKSAR Government is committed to developing Hong Kong as a hub for health and medical innovation. The soon-to-be established Hong Kong Centre for Medical Products Regulation will conduct independent evaluations on the safety, efficacy and quality of medical products based on clinical data. In addition, with the development of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone, Hong Kong will leverage our unique advantages under the ‘One Country, Two Systems’ principle and serve as a ‘super connector’, linking Mainland China and the global market. This will create opportunities for entrepreneurs to thrive while supporting our country in enhancing its new quality productive forces in the health field.”

Professor Philip Chiu Wai-yan, Dean of CU Medicine, said: “With the deep integration of AI and medical technology, the emergence of innovative medical devices is bringing revolutionary changes to the global healthcare industry. As medical devices and AI-driven healthcare solutions advance at an unprecedented pace, the regulatory frameworks will have to move with the times to ensure patient safety and to match this momentum. Through multinational and cross-border collaborations, together we establish international regulatory trends, pathways for innovation, and strategies for compliance. Hong Kong, as an international health and medical innovation hub, is in a privileged position to promote discussion and practice in the field. We are greatly pleased to partner with the Department of Health hosting this Forum where we can engage with leaders and pioneers in the field to strengthen cooperation in medical innovation to enhance global health and the standards of the medical industry.”

The Forum features three core topics, namely “The regulatory pathways for AI and machine learning medical devices”, “Cross-border cooperation and regulatory coordination”, and “The challenges of translating medical robotics technology”. A number of prominent local, national and overseas speakers were invited, including representatives from National Medical Products Administration (NMPA) of The People’s Republic of China, the Medical Device Authority under the Ministry of Health in Malaysia, the Saudi Food and Drug Authority (SFDA), the Hungarian Academy of Sciences, and some outstanding local medtech enterprises.

Professor Chiu said: “This Forum has provided an efficient dialogue platform for regulators, academics and the industry. Our discussions today reaffirmed our shared goal: to build a patient-centered medical technology ecosystem that emphasizes both ethics and innovation. . CU Medicine shall continue to promote safe and effective medical technologies for the betterment of the world through clinical research and industry collaboration.