Jointly Promoting Global Medical Device Regulatory Convergence, Harmonization, and Reliance
(Dr. Xu Jinghe, GHWP Chair)
Representatives from GHWP member countries and regions,
GHWP liaison members,
Distinguished guests, ladies and gentlemen!
Good morning!
It seems like only yesterday that we were in Riyadh in 2023, where the new GHWP leadership was elected. You honored me with your trust and support as the Chair. It is now my duty to present the work report of GHWP over the past three years.
The mission and vision of GHWP are the driving force and ultimate goal of everything we do. Let us restate it clearly: advancing global medical device regulatory convergence, harmonization, and reliance, so as to empower member to strengthen regulatory capacity, facilitate international trade; and ultimately, to fulfill our commitment to global public health.
Three years have passed in a flash, yet the milestones remain vivid. GHWP, under a united and determined leadership, has made significant progress over the last three years. We have advanced our mission, sharpened our focus on emerging fields, streamlined operations, and fostered greater vitality, guiding the organization to robust growth. Throughout this period, we have consistently implemented the Strategic Framework Toward 2026. Led by the Leadership and driven by a project-based approach, we ensured progress through regular monitoring, delivering tangible results year after year.
Over the past three years, we have continuously expanded GHWP membership, fueling our growth. We have actively promoted GHWP's mission and principles, attracting like-minded members. At the 27th GHWP Annual Meeting held in Shanghai, China, the accession of Egypt and Cuba were approved. At the 28th Annual Meeting in Kuala Lumpur, Malaysia, Botswana, Ghana, Macao SAR, and Uzbekistan joined. At this Annual Meeting, we will continue to review new membership applications, bringing new voices into GHWP. To date, GHWP comprises 38 member countries and regions across Asia, Africa, North America, and South America—representing nearly 60% of the global population.
Over the past three years, we have continuously strengthened GHWP's institutional framework, laying a solid foundation for its sustainable growth. First, we established the GHWP Strategic Advisory Board (SAB) to guide long-term development of GHWP and enhance decision-making. Second, we empowered the Capacity Building Committee to enhance member countries and regions regulatory capacities. Third, we formed the Common Evaluation Reliance Practice (CERP) Special Working Task Group to advance evaluation reliance. Fourth, we launched the GHWP (China) Academy, dedicated to global market access for innovative medical devices. To date, the Academy has organized four successful training programs, earning high marks from attendees. Furthermore, we implemented institutional reforms, adding leadership positions to engage more members in decision-making and foster broader ownership of our collective future.
Over the past three years, we have accelerated the formulation and revision of GHWP technical guidance documents, providing strong support for global regulatory convergence, harmonization, and reliance. Technical guidance documents serve as the cornerstone of GHWP's work in promoting regulatory convergence, harmonization and reliance worldwide. We have issued standard specifications for drafting technical guidance, approved 17 technical guidance documents, initiated 24 new projects. To date, 66 documents are active and in effect. The true value of these efforts lies in implementation. To this end, GHWP has continuously encouraged members to transform and implement guidance documents, thereby strengthening their regulatory capacity and laying a stronger foundation for global regulatory convergence, harmonization and reliance.
Over the past three years, we have successfully hosted GHWP Annual Meetings and Technical Committee (TC) Meetings, opening up new horizons for GHWP's development. In June 2023, the TC Meeting was held in Shenzhen, China. In November 2023, the 27th GHWP Annual Meeting convened in Shanghai, China. In June 2024, the TC Meeting took place in Bali, Indonesia. In December 2024, the 28th GHWP Annual Meeting was held in Kuala Lumpur, Malaysia. In June 2025, the TC Meeting was successfully organized in Cairo, Egypt. Now, here in Bangkok, we are adding a legendary chapter to our story. The TC leadership and its working groups have actively shaped this success, showcasing GHWP's vitality and collaborative spirit.
Over the past three years, we have also hosted GHWP Innovative Medical Device Symposiums, projecting a dynamic new profile for GHWP. We built a partnership with Sinopharm and networked with regional associations worldwide (including the Asia-Pacific, Middle East, Africa, and South America) to present global innovations at the China International Medical Equipment Fair (CMEF) and held 2 symposiums, serving as a powerful platform to display the innovative technologyoutputs of our members.
Over the past three years, we have deepened engagement with liaison partners and stakeholders worldwide while actively expanding GHWP's global partnerships through sustained international exchange and cooperation. We maintained an ongoing dialogue with the World Health Organization (WHO) and African Medical Devices Forum (AMDF). We successfully integrated the World Health Organization (WHO) as an Official Observer, and promoted the African Medical Devices Forum (AMDF) and Middle East Medical Devices Association (MECOMED) as a liaison partners. In addition, we have enhanced harmonization with standards issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), thereby fostering a more favorable international environment for GHWP's development. The successful launch of our new official GHWP website under the domain www.ghwp.org clearly reflects GHWP’s identity as an international organization. With its dynamic design, improved user experience, and robust cybersecurity, the website now serves as a more effective platform for sharing the latest news and developments in global medical device regulation.
Over the past three years, we have made significant advancements in GHWP's governance, focusing on greater transparency and deploying new measures to make voting and decision-making more efficient. The development and launch of an electronic voting system provide an alternative to in-person voting at annual meetings, enabling year-round participation. This system has accelerated our decision-making process and streamlined the endorsement of documents through majority votes by eligible members.
None of these achievements would have been possible without the dedicated individuals behind them. It is to them that we owe our success, and it is with great gratitude that we acknowledge --all my fellow GHWP leadership colleagues: Ms. Eka and Mr. Lupi, from Medical Devices Control, Ministry of Health, Indonesia; Ms. EunHee Cho from Abbott Medical Korea; Dr. Mohammed and Dr. Abdullatif from Saudi Food and Drug Authority (SFDA); Ms. Miang from Johnson & Johnson Vision; my colleague Ms. Li Jun from China NMPA; Mr. Bryan So and Dr. Xie Tingting from the GHWP Secretariat in Hong Kong SAR.
My gratitude goes to our strategic advisors--Dr. Jeong-Rim Lee, Mr. Gao Guobiao, Ms. Quan Tran, and Mr. Alfred Kwek.
My deep appreciation also goes to all representatives from 38 GHWP members; to Chairs, Co-Chairs, advisory experts, and members from the 9 Working Groups; to Academician Wang Yingjun, President of the GHWP (China) Academy, and her team; and to all contributing experts. Finally, I thank the GHWP Secretariat and the GHWP TC Secretariat for their dedication!
Ladies and gentlemen, dear friends!
Over the past three years, GHWP has pursued a balanced focus on guidance development and capacity building, alongside internal strengthening and international cooperation. This multi-pronged approach has fueled our steady progress, enabling the organization to advance its mission with measured growth and substantive outcomes.
Reflecting on our three-year journey, we see what truly powers GHWP. The regulator-industry synergy is our greatest asset; the participation from all member countries and regions economies is our core drive; investing in long-term development and capacity-building is our key to growth; equal partnership with international organizations enhances our standing and extends our reach; and a confident voice on the world stage strengthens our resolve to move forward.
Our foremost focus over the last three years has been on how to advance global regulatory convergence, harmonization, and reliance more effectively. Convergence is the trend, harmonization the path, and reliance the destination. As one of the global world's only international organization represented co-constituted by regulatory and industry representatives, GHWP's defining strength is this close partnership. Our commitment is clear: By confronting critical sector issues head-on; by heeding the voices of both regulators and industry; by uniting broader wisdom and resources; by tackling major challenges proactively; and by ensuring that regulation and industry advance together.
Our greatest investment over the past three years has been in accelerating the development and revision of more advanced and applicable technical guidance documents. Since the majority of GHWP members are developing economies, the most practical and impactful documents are those that address their pressing challenges. Diversity, while posing challenges, also serve as the strongest driver for convergence, harmonization, and reliance. To this end, GHWP TC Working Groups have diligently consider input from every member countries and regions. In GHWP today, we see a spectrum of contributions—some members are catching up, others are running alongside, and several are setting the pace. This diversity creates a vibrant and organic ecosystem of shared progress.
Our most transformative initiatives over the past three years have been in pioneering new pathways for innovative products to reach the world. Robust regulatory capacity is the foundation for convergence, harmonization, and reliance. The Capacity Building Committee has actively strengthened the regulatory capabilities of GHWP members. The GHWP (China) Academy has launched four advanced training programs to date. A large number of industry participants that have not only gained cutting-edge knowledge but also broadened their professional horizons. These efforts have built tangible momentum for regulatory convergence and reliance. GHWP firmly believes that only a thriving medical device industry leads to effective regulation and ultimately secures public health and well-being.
GHWP stands as one of the most established and inclusive global organizations in the medical device sector. It upholds the values of equality, openness, robustness, and shared success. It forges genuine partnerships with all the like-minded from international organizations, countries and regions, as well as liaison partners. Through sustained capacity building and global regulation exchanges, GHWP looks to the future, focusing on critical issues in medical device regulation and industry development. its platforms and methods to actively serve its members and contribute to global public health.
While celebrating our achievements, we must also see clearly the challenges that remain. Our work calls for deeper engagement from all members, high sharper quality in guidance development, stronger implementation across member countries and regions, and more substantive partnerships. This is our shared mission, and it requires our persistent dedication. Dear friends, due to limited time and resources, some ideas are still taking shape, some work is still in progress, and some goals still require extra effort. I am passing the baton, fully trusting the next Leadership team to bring GHWP to new height achieve even more.
Ladies and gentlemen, and all friends!
Vision sets our ceiling, attitude determines our state, and foresight shapes our final outcome. Today, the global medical device industry is experiencing unprecedented opportunities. With the continuous emergence of new technologies, materials, processes, products, and business models, the industry is thriving, and the global market continues to expand. According to Frost & Sullivan, the global medical device market reached USD 623 billion in 2024, growing 5.7% year-on-year. Mordor Intelligence reports that it will reach USD 681.57 billion in 2025 and is expected to reach USD 955.49 billion by 2030, with a compound annual growth rate of 6.99%. Innovative fields such as AI, biomaterials, 3D printing, nanotechnology, and high-throughput gene sequencing have become new engines of growth—powering the industry's exciting trajectory.
In a time of industry transformation and growing public health needs, GHWP must strengthen its unity and resolve, Our answer to the challenges of this era must be decisive and practical. There is an old saying in China: “People come and go with grand aspirations, times shift and flow with lofty accomplishments” At this Annual Meeting, GHWP will elect a new leadership team. We trust them to champion our mission and dreams. We count on them to advance our cause with renewed purpose and action, safeguarding global health with greater dedication.
Allow me to share several suggestions for GHWP's future development:
First, GHWP must always be driven by the reform vision of "Structure as our Framework, Efficiency as our Engine."
Through dedicated planning and extensive discussion, GHWP has added new leadership roles—Vice Chair, TC Co-Chair, and WG Co-Chair—to encourage broader participation. This platform empowers every member to engage deeply on the global stage. Through this diverse leadership and closer collaboration, we are enabling GHWP to respond faster to regulatory challenges and take harmonization and reliance to the next level.
Second, GHWP must always set its course by the stars of "Guidelines as our Compass, Training as our Anchor."
GHWP should continue streamline our management to deliver better guidance and faster, ensure timely and effective implementation. To keep pace with our dynamic industry, we must commit to continuous learning, professional growth, and the advancement of regulatory science. GHWP should expand the GHWP Academy network and reinvent empower our Capacity Building Committee. Through "Curriculum 2.0" and an expanded training platform, we will create a powerful system dedicated to elevating the skills of every regulator in our membership.
Third, GHWP must always embrace the responsibility of "Frontiers as our Beacons, Innovation as our Catalyst."
GHWP should target areas such as medical robotics, advanced imaging, AI-powered devices, and new biomaterials, to accelerate the release of white papers. GHWP should actively co-create global standards, and author the definitive technical guides. In partnership with industry, we will forge the path toward smarter regulation, filling unmet needs and building a more resilient future.
Fourth, GHWP must always be illumined by the light of "Evaluation Reliance as the Flame we guard, Common Success as the Beacon it lights for all."
Through the Common Evaluation Reliance Practice (CERP), GHWP will navigate the evaluation of medical devices for rare disease, urgent needs, and breakthrough innovations--sharing insights, aligning information, and moving toward mutual recognition. When one rigorous review opens multiple markets, we ease the burden on industry and, more importantly, deliver hope faster to waiting patients. This is the ultimate reward of regulatory trust.
Fifth, GHWP must always be architected on the strategy of "Good Law and Governance as our Cornerstone, High-level of Coordination as our Keystone."
Anchored to the Model Law on Global Medical Device Regulation, GHWP could assemble a world-class Working Group of global legal, regulatory, and technical experts. Through a global vision, solution-oriented innovation, and scientific rigor, we shall harmonize regulatory rules at the highest level, striving to compose a more definitive, unified legal reference for the world.
Ladies and gentlemen, dear friends,
We are living in a great era that calls us outward and drives us forward—a world driven by dreams, fueled by innovation. In the spirit of the Thai adage, “Joined forces are stronger than the mightiest elephant”, we answer the urgent need for regulatory harmony and the profound hope for human well-being. Let us stand shoulder-to-shoulder. Let our collective action be the irresistible force that drives global regulatory convergence harmonization and reliance, forging a new and greater chapter for global public health.
Thank you!