走近 GHWP：凝聚全球智慧，构建医疗器械监管协调新生态

走近全球医疗器械法规协调会GHWP：汇聚全球智慧，共建医疗器械监管协调新生态

全球医疗器械法规协调会——Global Harmonization Working Party，简称GHWP，是目前全球唯一由医疗器械监管机构代表与产业界代表共同参与的国际医疗器械法规协调平台。自1997年成立以来，GHWP始终致力于推动全球医疗器械法规趋同、监管协调与信赖，已成为连接各国监管机构、产业界、国际组织与专业力量的重要桥梁。

当前，人工智能医疗器械、数字医疗、体外诊断、先进生物材料等创新技术加速涌现，全球医疗器械监管面临更加复杂、多元的挑战。如何在保障产品安全、有效的基础上，提升监管体系的科学性、适应性与协同性，促进创新医疗技术在全球范围内有序应用，已成为国际社会共同关注的重要课题。

面对新形势，GHWP持续汇聚全球监管智慧和产业力量，推动监管知识共享、技术协作与能力建设，为医疗器械创新发展和全球公众健康提供重要支撑。本文将从发展历程、组织架构、核心使命和重点工作等方面介绍GHWP及其在全球医疗器械监管合作中的重要作用。

01发展历史：从区域协作走向全球合作

GHWP是由医疗器械监管机构代表和产业界代表共同参与的非营利国际组织，致力于研究和推动全球医疗器械法规及监管体系的趋同、协调与信赖。

 GHWP前身为亚洲医疗器械法规协调会（AHWP），形成于20世纪90年代中后期。随着成员范围、技术合作和国际影响力不断扩大，组织逐步由区域性法规协调平台发展为面向全球的医疗器械监管合作机制，自2021年起，亚洲法规协调会（AHWP）更名为全球医疗器械法规协调会（GHWP），标志着组织完成了由区域性平台向全球性平台的战略升级。

经过近三十年的持续发展，GHWP已经成为全球医疗器械领域历史悠久、代表广泛的国际合作平台之一。

目前，GHWP拥有来自亚洲、非洲、北美洲和南美洲等地区的39个成员国家和地区，汇聚监管机构、技术专家、行业组织和医疗器械企业等多方力量。2026年，世界卫生组织正式成为GHWP官方观察员，进一步深化了GHWP与全球公共卫生体系之间的交流与合作。

02核心工作：以趋同、协调与信赖连接全球监管体系

GHWP以推动医疗器械监管体系的国际协调为愿景，倡导在尊重各成员法规制度、监管能力和发展阶段差异的基础上，加强规则交流、技术协作与经验共享。

其核心工作围绕三个相互衔接的方向展开：

趋同（Convergence），推动各成员在监管理念、技术原则和制度框架方面逐步形成共识；协调（Harmonization），促进监管要求、技术标准和审评实践之间的衔接，减少不必要的制度差异和重复工作；信赖（Reliance），鼓励监管机构在充分评估的基础上，科学借鉴和利用其他监管机构的审评成果、专业能力与监管经验，提高监管资源配置和产品评价效率。 GHWP并非追求对各国法规体系的简单统一，而是通过建立共同原则、技术指南和交流机制，在多样化的监管环境中寻找具有科学基础、国际共识和实践价值的协调路径。 其愿景和使命始终指向同一目标：在保障患者安全的同时，促进公众及时获得安全、有效和高质量的医疗器械。03组织架构：以专业机制推动监管科学与技术协作

GHWP建立了由组织领导层、技术委员会、战略咨询机制、能力建设体系、秘书处及相关工作组共同组成的国际协作架构，并通过监管机构与产业界共同参与的治理模式，使监管需求、技术发展和产业实践能够在同一平台上充分交流。

GHWP技术委员会下设多个专业工作组，研究领域涵盖医疗器械上市前申报与通用申报资料、体外诊断医疗器械、软件作为医疗器械、上市后监管、临床证据、质量管理体系、标准、唯一器械标识与医疗器械命名，以及共同评价与监管信赖实践等医疗器械全生命周期重点环节。

依托各工作组及全球专家网络，GHWP持续开展法规比较研究、技术指南制定、白皮书编写、监管实践交流和前沿课题研究，为成员完善监管制度、提升技术审评能力、应对新技术监管挑战提供专业支持。

截至2025年底，GHWP已有66项技术和制度文件处于有效状态，形成了较为系统的国际医疗器械监管知识成果体系。

04GHWP（中国）学院：以能力建设促进共同发展

监管协调不仅依赖规则和文件，更依赖专业人才、组织能力与实践经验的长期积累。

GHWP持续通过年度会议、技术委员会会议、专题研讨、国际培训、成员国培训及GHWP学院等多种形式，为不同发展阶段的成员提供有针对性的能力建设支持。通过监管政策解读、技术审评培训、案例研讨和经验共享，GHWP帮助成员不断完善监管体系，提升监管人员专业能力，增强对创新医疗器械和新兴技术的科学评价水平。

2023年11月，华南理工大学经申报答辩，成功获批建设全球首个GHWP学院，学院正式落户广州。时任GHWP主席、国家药品监督管理局副局长徐景和博士为学院授牌，华南理工大学副校长许勇担任学院首届理事会理事长，王迎军院士担任首任院长。

2025年，学院正式更名为GHWP（中国）学院。学院作为GHWP能力建设体系的重要组成部分，为全球监管人才培养、法规交流、技术合作和创新医疗器械国际化搭建了新的专业平台，还将继续向其他成员国家和地区拓展，推动形成更加开放、系统和可持续的国际监管能力建设机制。

05愿景：促进创新发展，守护全球公众健康

医疗器械监管的最终目的，是保障公众健康，同时为真正具有临床价值的创新技术创造科学、透明和可预期的发展环境。

通过推动监管规则交流、技术指南制定、评价实践共享和成员能力提升，GHWP有助于减少全球市场准入过程中的信息壁垒与重复投入，提升医疗器械监管效率，促进创新成果在不同国家和地区更加安全、有序地应用。其工作不仅服务于监管体系建设和产业创新，也为国际贸易合作、医疗资源可及性和全球公共卫生治理提供重要支撑。相关定位与发展方向亦与现有GHWP介绍材料保持一致。

面向人工智能、医疗机器人、先进医学影像、数字医疗、新型生物材料等快速发展的前沿领域，GHWP将持续加强监管科学研究与国际协作，探索更加敏捷、科学和适应创新发展的监管模式，推动技术创新与监管创新协同前进。

06展望未来：携手共创全球医疗器械监管合作新未来

从亚洲起步到连接全球，从法规交流到技术协调，从能力建设到监管信赖，GHWP始终坚持开放、平等、合作、共享的发展理念，凝聚不同国家和地区监管机构、产业界与专业组织的智慧和力量。

未来，GHWP将继续围绕全球医疗器械监管趋同、协调与信赖，深化国际规则交流和技术合作，完善能力建设网络，积极回应新技术、新产品和新业态带来的监管挑战，推动建立更加科学、高效、包容和可持续的全球医疗器械监管生态。

Getting to Know the Global Harmonization Working Party: Bringing Global Expertise Together to Build a New Ecosystem for Medical Device Regulatory Harmonization

The Global Harmonization Working Party, or GHWP, is currently the world's only international platform for medical device regulatory harmonization jointly composed of regulatory authorities and industry representatives. Since its establishment in 1997, GHWP has remained committed to advancing global convergence, harmonization, and reliance in medical device regulation. It has become an important bridge connecting regulatory authorities, industry stakeholders, international organizations, and professional communities around the world.

Today, as emerging technologies such as AI-enabled medical devices, digital health, in vitro diagnostics, and advanced biomaterials continue to advance at an unprecedented pace, medical device regulatory systems worldwide are facing increasingly complex and multifaceted challenges. How to enhance the scientific rigor, adaptability, and coordination of regulatory systems while ensuring product safety and effectiveness has become a shared priority for the international community.

In response to this evolving landscape, GHWP continues to bring together regulatory expertise and industry insight from across the globe. Through regulatory knowledge sharing, technical collaboration, and capacity building, GHWP provides important support for medical device innovation and global public health. This article introduces GHWP by examining its history, organizational structure, core mission, and key areas of work, highlighting its important role in global medical device regulatory cooperation.

Image Source: Global Harmonization Working Party 

 Official Website

01History: From Regional Collaboration to Global Cooperation

GHWP is a non-profit international organization jointly composed of regulatory authority and industry representatives in the medical device sector. It is dedicated to studying and promoting the convergence, harmonization, and reliance of medical device regulations and regulatory systems worldwide.

 GHWP originated from the Asian Harmonization Working Party, or AHWP, which was formed in the mid-to-late 1990s. As its membership, technical cooperation, and international influence continued to expand, the organization gradually evolved from a regional regulatory harmonization platform into a global mechanism for medical device regulatory cooperation. In 2021, AHWP was renamed the Global Harmonization Working Party, marking its strategic transformation from a regional platform into a global one.After nearly three decades of sustained development, GHWP has become one of the world's most long-standing and broadly representative international platforms for cooperation.At present, GHWP has 39 member countries and regions across Asia, Africa, North America, and South America. It brings together regulatory authorities, technical experts, industry organizations, and medical device enterprises. In 2026, the World Health Organization joined GHWP as Official Observer, further strengthening engagement and cooperation between GHWP and the global public health system.02Core Area of Work: Connecting Global Regulatory Systems Through Convergence, Harmonization, and Reliance

GHWP envisions stronger international coordination of medical device regulatory systems. While respecting differences in regulatory frameworks, regulatory capacities, and stages of development among its members, GHWP encourages exchange of knowledge and expertise of regulatory, technical collaboration, and experience sharing.

Its core work focuses on three closely connected areas:Convergence: promoting gradual consensus among members in regulatory approaches, technical principles, and institutional frameworks;Harmonization: facilitating alignment among regulatory requirements, technical standards, and review practices, while reducing unnecessary regulatory differences and duplicative work;Reliance: encouraging regulatory authorities, based on sound assessment, to make scientific use of the review outcomes, technical expertise, and regulatory experience of other authorities, thereby improving the allocation of regulatory resources and the efficiency of product evaluation.GHWP does not seek to simply binding on regulatory systems of different countries. Instead, by developing common principles, technical guidelines, and mechanisms for dialogue and exchange, it explores scientifically grounded, internationally recognized, and practically valuable pathways for coordination within diverse regulatory environments.Its vision and mission ultimately serve one shared goal: to safeguard patient safety while promoting timely public access to safe, effective, and high-quality medical devices.03Organizational Structure: Advancing Regulatory Science and Technical Collaboration Through Professional Mechanisms

GHWP has established an international cooperation framework consisting of organizational leadership, a Technical Committee, strategic advisory mechanisms, a capacity-building system, a secretariat, and relevant working groups. Through a governance model jointly involving regulatory authorities and industry, GHWP enables regulatory needs, technological developments, and industry practices to be fully discussed on the same platform.

Under the GHWP Technical Committee, multiple specialized working groups focus on key areas across the full life cycle of medical devices. These areas include pre-market submissions and common submission dossiers for medical devices, in vitro diagnostic devices, Software as a Medical Device, post-market surveillance, clinical evidence, quality management systems, standards, unique device identification and nomenclature, as well as common evaluation and regulatory reliance practices.With the support of its working groups and global expert network, GHWP continues to carry out comparative regulatory studies, develop technical documents, prepare white papers, facilitate the exchange of regulatory practices, and conduct research on emerging topics. These efforts provide professional support for members to improve regulatory systems, enhance technical review capabilities, and respond to regulatory challenges brought by new technologies.By the end of 2025, GHWP had 66 technical and institutional documents currently in effect, forming a relatively systematic body of international knowledge on medical device regulation.Diagram from

04GHWP (China) Academy: Advancing Shared Development Through Capacity Building

Regulatory harmonization depends not only on rules and documents, but also on the long-term accumulation of future-ready regulatory professionals, institutional capacity, and practical experience.

GHWP has continued to provide targeted capacity-building support to members at different stages of development through annual meetings, Technical Committee meetings, thematic seminars, international training programs, training programs for member countries, and GHWP Academies. Through interpretation of regulatory policies, technical review training, case studies, and experience sharing, GHWP helps members continuously improve their regulatory systems, strengthen the professional capabilities of regulatory authorities, and enhance the scientific evaluation of innovative medical devices and emerging technologies.In November 2023, South China University of Technology successfully obtained approval to establish the world's first GHWP Academy following an application and review process, with the Academy officially established in Guangzhou. Dr. XU Jinghe, then GHWP Chair and Deputy Commissioner of the National Medical Products Administration, presented the plaque to the Academy. Professor XU Yong, Vice President of South China University of Technology, served as the first Chair of the Academy's Council, and Academician WANG Yingjun served as its founding President.In 2025, the Academy was officially renamed as GHWP (China) Academy. As an important component of GHWP's capacity-building system, the Academy has created a new professional platform for global regulatory talent development, regulatory exchange, technical cooperation, and the international market access for innovative medical devices. It will continue to expand to other member countries and regions, helping build a more open, systematic, and sustainable international mechanism for regulatory capacity building.05Vision: Promoting Innovation and Protecting Global Public Health

The ultimate purpose of medical device regulation is to protect public health while creating a scientific, transparent, and predictable environment for innovative technologies with genuine clinical value.

By promoting regulatory dialogue, developing technical guidelines, sharing evaluation practices, and strengthening member capacity, GHWP helps reduce information barriers and duplicative investment in global market access. It improves regulatory efficiency and supports the safer and more orderly adoption of innovative medical technologies across countries and regions. Its work serves not only regulatory system development and industrial innovation, but also international trade cooperation, access to medical resources, and global public health governance.

Looking ahead to rapidly evolving frontier areas such as artificial intelligence, medical robotics, advanced medical imaging, digital health, and new biomaterials, GHWP will continue to strengthen regulatory science research and international collaboration. It will explore more agile, scientific, and innovation-responsive regulatory models, promoting the coordinated advancement of technological and regulatory innovation.

06Looking Ahead: Shaping the Future of Global Medical Device Regulatory Cooperation TogetherFrom its origins in Asia to its growing global reach, from regulatory exchange to technical coordination, and from capacity building to regulatory reliance, GHWP has consistently upheld the principles of openness, equality, cooperation, and sharing. It continues to bring together the expertise and resources of regulatory authorities, industry stakeholders, and professional organizations from different countries and regions.In the future, GHWP will continue to focus on global convergence, harmonization, and reliance in medical device regulation. It will deepen international regulatory dialogue and technical cooperation, strengthen its capacity-building network, and actively respond to regulatory challenges arising from emerging technologies, new product categories, and evolving business models. Through these efforts, GHWP will help build a more scientific, efficient, inclusive, and sustainable global ecosystem for medical device regulation.

参考来源Reference

“GHWP Academy | GHWP.” n.d. Accessed July 8, 2026.

“Home | GHWP.” n.d. Accessed July 8, 2026.

徐景和. 2023. “坚持开放、合作、稳健、共赢 积极推动全球医疗器械监管趋同、协调与信赖.” 中国食品药品监管, no. 8: 4–11.

来源：高端医械院