On 9 April 2025, The 2nd GHWP Innovative Medical Device Symposium was successfully held in Shanghai during the 91st China International Medical Equipment Fair (CMEF). Jointly organized by Reed Sinopharm Exhibitions and the Global Harmonization Working Party (GHWP), the symposium brought together over 300 professionals, including representatives from regulatory authorities and industry experts from GHWP member economies.
The event commenced with opening remarks by the head of the Department of Medical Device Regulation, National Medical Products Administration (NMPA), China, GHWP Vice Chair (Industry) Ms. EunHee Cho, and Mr. Li Chao, Managing Director of Reed Sinopharm Exhibitions. The symposium was co-chaired by Ms. Tran Quan, GHWP Strategic Advisory Board Member and Capacity Building Lead, and Mr. Ir Bryan SO, Executive Secretary of GHWP. Notable attendees included Mr. Gao Guobiao, GHWP Strategic Advisory Board Member; Ms. Miang Tankasemsub, GHWP TC Co-Chair (Industry); Mr. Hideki Asai, GHWP TC Advisor; Ms. Sunny Woo, Team Leader of Korea Medical Devices Industry Association; Mr. Amir Azfar Bin Miskon, Science Officer of the Policy and Strategic Planning Division, Medical Device Authority, Ministry of Health Malaysia; and representatives from the Department of Medical Device Regulation, NMPA and the Center for Medical Device Evaluation (CMDE).
Centered on the hot themes of “Innovation” and “Artificial Intelligence and Digital Medical Technology,” the symposium served as a high-level platform for in-depth dialogue among global government regulators, evaluation experts, and industry leaders from around the world. It aimed to promote harmonization, coordination, and mutual trust among international regulatory bodies, while offering insights into global policy trends, innovation developments, and emerging market opportunities. The event also sought to establish a cross-border dialogue platform that supports the entire innovation chain from R&D to commercialization.
At the opening of the symposium, Ms. EunHee Cho, GHWP Vice Chair (Industry), emphasized that the symposium aims to enhance regulatory coordination in the field of innovative medical devices and further advance innovation across the industry. By fostering collaboration at a global level, the event was dedicated to developing an more efficient and science-based global regulatory framework to ensure sustainable industry growth, ultimately contributing to the sustainable growth of the global medical device sector.
In her opening remarks, the Head of the Department of Medical Device Regulation at the National Medical Products Administration (NMPA), China, highlighted the country’s latest regulatory policies in the medical device sector. As one of the most established and widely represented international organizations in the field, the Global Harmonization Working Party (GHWP) remains the only global platform jointly driven by both regulators and industry stakeholders to advance regulatory dialogue and cooperation.
Grounded in the latest developments in regulatory science, GHWP's vision and mission focus on fostering open, trust-based collaboration between global regulatory authorities and industry leaders. The organization is dedicated to strengthening regulatory capabilities across its member countries and regions, while promoting convergence, harmonization, and reliance in the global medical device regulatory landscape.
In 2023, Dr. Xu Jinghe, Vice Commissioner of NMPA, China, was elected Chair of GHWP. He has placed strong emphasis on the advancement of innovative medical devices and the importance of international communication, actively working to establish high-level platforms for global collabration. On 22 November 2023, Reed Sinopharm Exhibitions and GHWP signed a strategic cooperation agreement, which led to the successful co-hosting of the First GHWP Innovative Medical Device Symposium on 12 April 2024.
Moreover, China issued a guideline on 30 December 2024 aimed at comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry. The document, issued by the General Office of the State Council, aims to accelerate the construction of a unified national market and foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a pharmaceutical powerhouse, while better meeting the public's growing demand for high-quality medical products.
Mr. Li Chao, Managing Director of Reed Sinopharm Exhibitions, noted that CMEF continues to serve as a world-class platform facilitating international collaboration across the entire medical device value chain. This year’s CMEF will attract over 300,000 professionals and nearly 5,000 manufacturers from more than 150 countries and regions. With more than 100 forums and conferences held, CMEF demonstrates its pivotal role in promoting knowledge exchange, technology advancement, and global partnerships. He also reaffirmed CMEF’s commitment to supporting GHWP’s mission in advancing regulatory excellence and industry growth.
In response to the rapidly evolving global regulatory landscape, the symposium also provided timely updates on the latest international regulatory developments, with a focus on differentiated approval pathways for innovative products. These discussions offered valuable guidance for companies seeking to navigate market entry in emerging regions.
The head of the General Affairs Department of the Center for Medical Device Evaluation under the NMPA outlined a series of initiatives aimed at advancing the reform of the evaluation and approval system while fostering innovation. These efforts include the establishment of fifteen regulatory mechanisms, the implementation of multi-channel and diversified communication strategies, the launch of the “CMDE Cloud Classroom,” and a strategic shift of regulatory focus toward earlier stages of product development. In recent years, CMDE has made significant progress in encouraging medical device innovation and supporting the high-quality development of the industry through process optimization, institutional innovation, and resource integration.
Mr. Gao Guobiao, GHWP Strategic Advisory Board Member, deeply engaged in the development of global medical device regulatory policies for many years. His deep expertise and lomgstanding contribution have significantly advanced GHWP’s mission and strengthened international regulatory collaboration, establishing him as a key figure in elevating the organization's global impact. At the symposium, he delivered a comprehensive presentation on global trends in innovative medical device regulation, offering insights into recent developments across the United States, Europe, Japan, Korea, Saudi Arabia, and other regions. He also highlighted recent advancements in regulatory frameworks aimed at accelerating the growth of the innovative medical device industry worldwide.
Mr. Hideki Asai, HWP TC Advisor, shared Japan’s practical experience in regulating innovative medical devices. He emphasized that the core of Japan’s review system lies in assessing product safety and performance based on the intended use statement, with a careful balance between risk and benefit. However, for breakthrough innovations, the traditional evidence-based approach may prolong the approval timeline, potentially delaying patient access to critical technologies. Striking a balance between robust evidence and patient accessibility remains a key challenge in regulatory science. To address this, Japan has introduced new mechanisms such as accelerated review pathways for innovative medical devices, streamlining evaluation processes to ensure both safety and faster access to cutting-edge technologies, offering valuable insights for global regulatory systems.
Ms. Sunny Woo, Team Leader of Korea Medical Devices Industry Association, touched on regulatory pathway for innovative medical devices in South Korea. The global digital health market has grown rapidly, and in response to the market growth, MFDS established regulatory management system for digital health devices including innovative medical devices and digital medical products. According to innovative medical devices regulation policies in Korea, if a product is designated as an innovative medical device, the device is subjected to priority review over other medical devices applications. She also provided an overview of the Digital Medical Products Act in Korea, detailing the definition of digital medical products and explaining the rationale and process behind the Act's establishment.
Mr. Amir Azfar Bin Miskon, Science Officer of the Policy and Strategic Planning Division, Medical Device Authority, Ministry of Health Malaysia, provided an overview of Malaysia’s strategic initiatives to support R&D and market access for innovative devices. He emphasized the importance of aligning innovation with clinical needs and outlined Malaysia’s vision of becoming a regional innovation hub.
The afternoon session was moderated by Mr. Ir Bryan So, GHWP Executive Secretary.
Cutting-edge technologies such as AI, medical robotics, and telemedicine are increasingly converging with medical devices, driving significant advancements in clinical workflows and improving access to healthcare. Leading global enterprises and innovation-driven institutions are leveraging these technologies to address unmet clinical needs and reshape the future of the medical industry. In the afternoon session, a reviewer from the Second Review Division of CMDE, delivered a practical presentation on the evaluation of safety and effectiveness for AI-powered medical devices and surgical robots, sharing valuable regulatory insights and real-world approaches.
Industry representatives then took the stage to showcase cutting-edge applications of artificial intelligence and digital health technologies. GE Healthcare presented its progress in building a localized AI ecosystem; Mindray shared its experience in developing AI-powered in vitro diagnostic products; Siemens Healthineers introduced its comprehensive “Intelligent Core Hub” medical ecosystem; MicroPort highlighted its application of AI in coronary intervention systems; Shukun Technology delivered a presentation titled “When Medicine Meets Foundation Models: Development and Application of Medical Foundation Models”; Deepwise shared its vision of an AI-driven intelligent medical workflow powered by multimodal foundation models; and TrueHealth provided an in-depth look into its innovative work on robotic systems for puncture procedures.
At the conclusion of the symposium, Ms. Miang, GHWP TC Co-Chair (Industry), emphasized that this event has truly embodied its vision of establishing a comprehensive and diversified platform for regulatory collaboration and trust, driving global innovation and development within the medical device industry. Together, we have explored critical themes such as “Global Policy Synergy in Innovation” and “Breakthroughs in Artificial Intelligence Technology,” fostering meaningful dialogue across governmental, industrial, academic, and research sectors.
In addition, a dedicated GHWP-themed exhibition area of approximately 100 square meters was set up in the central area of the 91st CMEF. It highlighted GHWP’s vision centered on “Convergence, Harmonization, and Reliance,” and showcased 66 technical guidelines issued by the Technical Committee (TC), covering the entire lifecycle management of medical devices, including clinical evaluation, cybersecurity, and quality management systems. It also featured major conferences organized by GHWP in recent years. As GHWP continues to expand, now encompassing 38 member countries, and as its technical guidelines grow in depth and breadth, the organization remains committed to strengthening collaboration with international partners and members. GHWP will continue to support the optimization of global regulatory systems and the development of an innovative medical device ecosystem, contributing to the advancement of global health.
The successful convening of The 2nd GHWP Innovative Medical Device Symposium not only provided an efficient platform for in-depth dialogue among the government, industry, academia and research, but also injected new momentum into driving innovation and high-quality development across the sector. Looking ahead, GHWP and CMEF will continue to deepen international cooperation, advance regulatory convergence, and accelerate the development and clinical adoption of innovative medical technologies, promoting that cutting-edge solutions benefit patients around the world.