Submitted by admin on Mon, 05/27/2024 - 03:25

Speech at the First GHWP (Guangzhou) Academy Training

GHWP Chair: Dr. Xu Jinghe

(09:00-09:15 May 27, 2024 Guangzhou)


Distinguished Guests, Ladies and gentlemen,

Good morning!

In this bright and vibrant season, we are gathering here in Guangzhou, the beautiful City of Flowers, to participate in the first Global Harmonization Working Party (Guangzhou) Academy Training, themed “Collaborative EmpowermentInnovative Medical Devices Embrace the World”. On behalf of GHWP, I would like to express my warm congratulations on the successful opening of the training. I would also like to express our sincere welcome and our deepest gratitude to you for your  consistent support and commitment to promoting global medical device regulatory convergence, harmonization, and reliance.

Established in 1997, GHWP is one of the longest-standing and most inclusive international organizations in the global medical device sector. It is the only international platform that is collaboratively advanced by representatives both from regulatory authorities and the industry for the exchange of medical device regulations. Formerly known as the Asian Harmonization Working Party (AHWP), GHWP underwent a historic transformation in 2021 when it rebranded its name, signifying its evolution from a regional to a global organization. Currently, the members of GHWP have expanded from Asia to South America and Africa, covering 34 countries and regions, and accounting for nearly 60% of the world’s population. To date, GHWP has issued 56 technical guidance documents and conducted over 40 online and offline trainings, all aimed at enhancing the regulatory capabilities of its member countries and regions.

In the context of deepening globalization and rapid technological development, GHWP, as an international organization with increasingly prominent global influence, always adheres to the principles of openness, cooperation, robustness, and win-win. Great efforts have been made to strengthen communication and cooperation between medical device regulatory authorities and the industry, to facilitate regulatory harmonization and coordination among member countries and regions, and to promote global convergence, harmonization and reliance of medical device regulations. We are firmly confident that our lofty belief and persevering endeavors will constantly open new chapters for the medical device industry in the new era and give an impetus to protecting and promoting global public health.

Since its establishment, the new GHWP leadership has shown exceptional efficiency and a pragmatic approach to our work. Each year, we identify ten key tasks to ensure steady progress towards the goals outlined in our Global Harmonization Working Party Strategic Framework towards 2026. In 2024, we have prioritized the training on technical guidance documents. Through meticulous planning, our working groups are set to roll out a series of online technical guidance documents trainings for our member countries and regions.

At this moment, a latest round of scientific and technological revolution and industrial transformation is gaining momentum, rapidly reshaping the global economy and driving the medical device industry towards explosive growth. Analyses released by relevant organizations indicate that the global medical device market reached USD 616 billion in 2023 and is projected to surge to USD 699.9 billion by 2025. As living standards continue to improve, the general public’s demand for personalized, high-end, and intelligent medical devices has become increasingly diverse. More attentions are attached on the safety, effectiveness, accessibility, and applicability of medical devices. With global trade expansion, the medical device industry is eagerly seeking regulatory convergence, harmonization, and reliance. There is also a pressing desire to see innovative medical devices reach the global market in a more affordable, convenient, and streamlined manner, bringing more hope and well-being to global public health.

At present, as the global regulatory and legal systems for medical devices are continuously evolving, themes regarding the comprehensive prevention and control of risks, the full implementation of responsibilities, the overall advancement of systems, and the holistic enhancement of capabilities will never step down . The global medical device industry faces numerous risks and challenges, among which the perspectives of regulatory authorities and policymakers in addressing issues, their attitudes towards problems, the frameworks they use to analyze issues, and their ability to solve problems may also pose risks that demand particular attention. In the face of emerging technologies, processes, materials, products, and new business formats as well as new models, inadequate governance capacity is one of the most significant risks confronted by regulators and policymakers across many countries and regions. An effective measure to prevent and control the risk is to fully improve regulatory and governance capabilities. Global medical device professionals should enthusiastically embrace the new era, eagerly acquire new knowledge, and diligently cultivate new skills. Thus, with broader vision and greater excellence, they will approach the world, the future, and success with greater confidence.

To respond to regulatory needs and expectations from the industry, GHWP decided in 2023 to establish an offline training academy. Its mission is to offer face-to-face training and communication opportunities for regulatory authorities and industry professionals in member countries and regions, to accelerate the improvement of medical device regulatory and governance capabilities, and to lay a more solid foundation for global medical device regulatory convergence, harmonization and reliance. Through a stringent selection process, South China University of Technology was designated as the host institution for the world’s first GHWP Academy. With strong support from communities, GHWP (Guangzhou) Academy is operating very well and its first training is opening today. The academy has been making great efforts to make it happen. Let’s express our heartfelt gratitude to everyone who has been making great contribution.

Over the next five days, we will delve into understanding GHWP’s vision, mission, and goals, as well as its organizational structure, strategic development, operational mechanisms, and technical guidance documents. We will jointly explore review and approval regulations and policies of international medical devices, exchange insights on the innovative achievements in this field, engage in discussions on innovating the legal system for medical device governance, and collectively envision the bright future of innovative development in the global medical device industry.

Ladies and gentlemen,

Chinese President Xi Jinping noted that “People's health is the foundation of social civilization and progress and an important symbol of national prosperity.” “In this world, countries have been more interconnected and interdependent than ever before. Human beings live in the same global village, as well as the same time and space where history and reality meet, are becoming a community with a shared future.” “We should expand our global vision and develop keen insight into the trends of human development and progress, respond to the general concerns of people of all countries, and play our part in resolving the common issues facing humankind.”

Ancient Greek philosopher Plato said, “The human goods are said to be health, beauty, strength, and wealth in that order”. French thinker Montaigne also raised, “Health is the most precious gift that nature can prepare for us the most fair.” Humanity has never ceased to pursue health and happiness. For practitioners dedicated to safeguarding people’s health, we need to constantly develop professionalism and abilities so as to better fulfill our lofty mission of protecting public health.

To meet high expectations, GHWP will stay true to its founding mission and make every effort to further improve the technical guidance documents system, enhance regulatory capacity building and improve the level of health protection. In the middle of June, the 28th GHWP Technical Committee (TC) Leadership Meeting will be held in Indonesia, aiming to further advance the formulation and application of technical guidance documents. We will meticulously organize two offline trainings and several online trainings through the GHWP Academy, ensuring that regulatory authorities and the industry are better equipped to navigate this era of rapid change. We will organize the annual exchanges on innovative medical device industry between GHWP and China International Medical Equipment Fair (CMEF) to fully demonstrate the vitality of the industry. Moreover, we will accelerate the development of Common Evaluation Reliance Practice (CERP) to make the first key step towards regulatory reliance. We will convene the Strategic Advisory Board (SAB) meeting to delve into the future strategic development of GHWP. Furthermore, we will organize the annual meeting in Malaysia at the end of this year to discuss and plan key tasks for the next year. We will actively expand GHWP membership and make regulatory harmonization and reliance benefit more countries and regions. In addition, we will strengthen exchanges and cooperation with other international organizations to promote global medical device regulatory convergence, harmonization and reliance.

Knowledge shapes one’s future and education may change one’s life. With its profound academic attainments, strong academic atmosphere and excellent transformation capacity, South China University of Technology has built a high-end training platform for us. I sincerely hope all participants can value this precious opportunity and receive fruitful gains. First, I strongly encourage you to listen attentively to the experts and scholars to ensure a fruitful learning experience. We are privileged to have renowned international experts and authoritative speakers from regulatory authorities at this training, who have carefully crafted a comprehensive and multidimensional curriculum that promises to be enlightening. Second, please actively engage with your peers to learn industry experience, reflecting deeply on what you learn. The academy has organized several exchange sessions where everyone has the opportunity to both share and learn. I encourage you to proactively contribute your insights and wisdom, for a thinking mind is a sharp mind. I hope that each of you will leave the training with more questions than when you arrived, as these questions are the signs of true learning and insight. Third, try to understand more about the call of the times and the general public, and put what you have learned into practice so as not to squander your youth. As the global public increasingly seeks a higher quality of life, it is imperative that we keep abreast of global developments, broaden our international perspectives, and apply our knowledge into practice. Let us work together to bring medical device products to the global stage, to be tested and embraced by customers worldwide.

Last but not the least, I wish the training a complete success and a brighter future for GHWP Academy. Let’s join hands to pursue our dreams and make greater contributions to protecting and promoting global public health.

Thank you!