Dear GHWP members and GHWP partners,

With your vigorous support and concerted efforts, the 27th GHWP Annual Meeting and TC Meeting was successfully held in Shanghai, China from November 27 to 30, 2023. More than 600 representatives from 25 countries and regions attended the meeting, jointly writing a new chapter of the GHWP endeavor. On behalf of GHWP leadership, I would like to express my heartfelt gratitude to all representatives, experts, and friends.

This is the first annual meeting after the election of the new GHWP leadership. Plentiful achievements have been made.

Firstly, we summarized the work achievements of GHWP in the past 9 months. The work achievements mainly included (1) improving the drafting procedures of GHWP guidance documents for medical devices to advance the quality and efficiency, (2) setting up the Strategic Advisory Board (SAB) to strengthen the research of forward-looking regulatory strategy, (3) establishing the first GHWP Academy to enhance the regulatory capacity building of GHWP member countries and regions, (4) building the first GHWP global industry exchange platform to promote the achievement through exhibition and exchange of innovative medical devices, and (5) intensifying communication with relevant international organizations to foster global medical device regulatory convergence, harmonization, and reliance.

Secondly, we delivered extensive and in-depth exchanges and discussions around cutting-edge technologies for medical device innovation. Focused on the opportunities and challenges brought by new technologies, innovative products and new regulatory approaches, multiple topics were designed for this annual meeting, at which academic discussions were profoundly delivered on cutting-edge technologies, regulatory pathways for innovation, regulatory tools fostering innovation, risk management of innovative medical devices, and application practice of unique device identifier (UDI). Owing to novel topics and advanced views, this annual meeting was highly praised by both regulatory authorities and industry representatives.

Thirdly, relevant international organizations, partners, and representatives from some countries and regions reported the latest progress in medical device regulation. Specifically, the International Medical Device Regulators Forum (IMDRF), World Health Organization (WHO), Africa Medical Devices Forum (AMDF), Asia Pacific Medical Technology Association (APACMed), Global Medical Technology Alliance (GMTA), Global Medical Device Nomenclature (GMDN), Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA), Globe Standard 1 (GS1), and Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector (IACRC) reported the latest work progress. Representatives from 11 countries and regions reported the latest progress of regulatory work, including Chile, the European Commission, Indonesia, Japan, Kingdom of Saudi Arabia, Laos PDR, Malaysia, People’s Republic of China, Republic of Korea, Thailand, and Vietnam.

Fourthly, a series of important collective decisions were made at this Annual Meeting. Such decisions included (1) approving 8 GHWP guidance documents, (2) approving to set up a special task group to conduct research on common evaluation reliance practice, (3) approving to accept Egypt and Cuba as new GHWP members, (4) approving the membership withdrawal request from the U.S. FDA, and (5) approving Medical Device Authority (MDA), Malaysia to host the 28th GHWP Annual Meeting.

Besides busy work, all representatives attended the city tour, visited the beautiful night scene of the Huangpu River, enjoyed the elegance and charm of Shanghai, and experienced the wonderful integration of traditional art and modern music at the Gala Dinner.

Looking back on the extraordinary course that GHWP has gone through in the past 27 years, all representatives resonate with common viewpoints and feelings. 

GHWP has our distinct features. With the joint participation of medical device regulatory authorities and industry representatives, GHWP has always directly confronted major issues in the medical device regulatory field, adhered to the coordinated development and growth for both regulators and the industry and actively cope with big challenges in medical device industry.

GHWP is open and inclusive. At present, GHWP has 34 member countries and regions. With SAB, Capacity Building Committee (CBC), and Technical Committee, GHWP can deliver extensive and in-depth discussions on major issues. In this big family, all GHWP member countries and regions consult on an equal footing and pool their wisdom, striving to seek common development and create a bright future together.

GHWP is enterprising and pioneering. Over the years, GHWP has always focused on the major topics of medical device regulation and industry development, endeavoring to actively serve GHWP member countries and regions and contribute to global public health by constantly innovating platforms and carriers.

GHWP upholds laws and regulations. Major decisions of GHWP are made according to its Terms of Reference and House Rules. GHWP member countries and regions, regardless of large or small, communicate on an equal footing, and are strongly encouraged to contribute more wisdom and strength to global medical device regulatory convergence, harmonization, and reliance by making full use of their resources.

During the annual meeting, representatives from regulatory authorities and industry repeatedly talked about regulatory convergence, harmonization and reliance. Convergence is the trend of development, harmonization is the consistency of action, and reliance is the goal of endeavor.

We must be aware that achieving global medical device regulatory convergence, harmonization, and reliance is a common expectation, and at the meanwhile, it is a gradual process of growth that takes time. The world is diverse. GHWP member countries and regions are at different stages of development, embrace different resources and with different regulatory capacities. In this context, it is impossible to accomplish regulatory convergence, harmonization, and reliance overnight. Instead, we must go forward step by step.

We must be aware that we should not be only aiming high and looking far, but also be down-to-earth to achieve global medical device regulatory convergence, harmonization, and reliance. In the face of a new round of scientific and technological revolution and industrial transformation, we must focus on the present and plan for the future in the long term. We should proceed from consensus, grasp critical links, go ahead steadily and firmly, and consolidate at every step. Practical results will further foster the in-depth participation of all GHWP member countries and regions and build a stronger sense of accomplishment and fulfillment.

We must be aware that we should not only adhere to our own good traditions but also actively draw on others' successful experiences to achieve global medical device regulatory convergence, harmonization, and reliance. In addition to mission and vision, every organization has its strengths and weaknesses. An organization can only achieve better development through open communication. GHWP has established its strategic focus and work priorities. We will be problem-oriented and goal-driven to concentrate on doing our work. Insisting on the principles of equality, openness, robustness, and win-win, GHWP will continue to cordially cooperate with international organizations, relevant countries and regions, and partners that are committed to fostering regulatory convergence, harmonization, and reliance.

Profound insight brings new height, sound mindset brings best condition and broad layout brings wonderful outcome. Looking into the future, GHWP will continue to expedite the achievement of medical device regulatory convergence, harmonization, and reliance with more united strength, more open mind, more enterprising attitude, and more pragmatic style, striving to make new and greater contributions to the protection and promotion of global public health.

Best regards,

Xu Jinghe 

GHWP Chair

GHWP成员国家和地区代表、GHWP合作伙伴：

在大家的鼎力支持和共同努力下，第27届全球医疗器械法规协调会（GHWP）年会暨技术委员会会议于11月27日至30日在中国上海成功召开。来自25个国家和地区的600多位代表参加此次盛会，共同续写了GHWP奋进跨越的新篇章。我代表GHWP领导团队，向各位代表、各位专家、各位朋友，表示衷心的感谢。

这次大会是GHWP新领导团队组建以来召开的第一次大会，取得了丰硕的成果：

一是对GHWP9个多月来的工作成果进行了全面总结。通过完善医疗器械技术指南制定程序，保障技术指南制定的质量与效率；通过建立战略咨询委员会，加强监管前瞻性战略研究；通过建立全球第一家GHWP培训学院，推进成员国家和地区监管能力建设；通过搭建全球第一家产业交流平台，推进创新医疗器械成果展示交流；通过加强与相关国际组织沟通，推动全球医疗器械监管趋同、协调和信赖。

二是围绕医疗器械前沿技术和创新产品进行广泛深入的交流研讨。大会设立多个专题，聚焦新技术、新产品和新模式带来的新挑战，就医疗器械前沿技术、创新医疗器械监管路径、支持创新的监管工具、创新医疗器械风险管理、UDI应用实践、数字化监管等进行了学术研讨，主题新颖、观点前卫，深受监管机构和业界的欢迎。

三是GHWP合作伙伴、相关国际组织和部分国家、地区代表通报了医疗器械监管最新进展。世界卫生组织（WHO），国际医疗器械监管机构论坛（IMDRF），非洲医疗器械论坛（AMDF），亚太医疗技术协会（APACMed），全球医疗技术联盟（GMTA），全球医疗器械术语系统（GMDN），全球诊断影像、医疗IT和放射治疗行业协会（DITTA），国际物品编码组织（GS1），美洲医疗技术监管趋同联盟（IACRC）等组织通报了相关领域最新工作进展。智利、欧盟、印尼、日本、沙特、老挝、马来西亚、中国、韩国、泰国、越南等11个国家和地区报告了最新监管工作情况。

四是大会集体审议共同决策作出了系列重要安排。审议通过8项技术指南文件；审议设立特别工作组开展审评共识实践；审议批准埃及、古巴为GHWP新成员；审议同意美国FDA退出GHWP；审议同意马来西亚医疗器械管理局举办第28届GHWP年会。

在紧张而繁忙的工作之余，我们共同游览了美丽的黄浦江夜景，领略了“东方明珠”上海这座国际化现代化大都市的风采和魅力；我们共同参加了Gala Dinner，在欢快喜庆的氛围中共享了传统艺术与现代音乐的美好交融。

回顾GHWP27年来走过的不平凡历程，与会代表畅叙了共情同感：

GHWP是一个优势鲜明的国际组织。作为全球唯一的由医疗器械监管者代表和产业界代表共同组成的国际组织，GHWP始终直面医疗器械领域的突出问题，坚持监管和行业协同发展、共同成长，积极应对医疗器械领域的重大挑战。

GHWP是一个开放包容的国际组织。目前GHWP有34个成员国家和地区，设有战略咨询委员会、能力建设委员会、TC专家委员会，对重大事项进行广泛而深入的研讨。在这个大家庭中，各成员国家和地区平等协商、集思广益、共谋发展、共创未来。

GHWP是一个开拓进取的国际组织。多年来，GHWP始终面向未来，聚焦医疗器械监管和产业发展的重大课题，不断创新平台和载体，积极为成员国家和地区服务，努力为全球公众健康服务。

GHWP是一个崇法尚规的国际组织。GHWP的重大决策均按照GHWP章程、规则进行。大小国家和地区平等交流。同时，GHWP鼓励各成员国家和地区充分利用自身资源，为全球医疗器械监管趋同、协调和信赖贡献更多的智慧和力量。

会议期间，各监管部门和业界代表提到最多的是监管的趋同、协调和信赖。趋同是发展大势、协调是一致行动、信赖是奋斗目标。

必须看到，实现全球医疗器械监管趋同、协调和信赖，既是大家的美好期待，也是一个渐进的成长过程。当今的世界是多样的世界，各成员国家和地区发展阶段不同、资源禀赋不同、监管能力不同，推进监管趋同、协调和信赖，不可能一蹴而就，必须循序渐进。

必须看到，实现全球医疗器械监管趋同、协调和信赖，既要登高望远，也要脚踏实地。面对新一轮科技革命和产业变革，我们必须立足当前、谋划长远，从共识出发，抓关键领域，稳扎稳打、步步为营，以实实在在的成效让所有的成员国家和地区深入参与，拥有更多的成就感和获得感。

必须看到，实现全球医疗器械监管趋同、协调和信赖，既要努力坚守自身的优秀文化，也要积极吸纳他人的成功经验。任何组织都有其独特的使命和愿景，也都有其自身的优势和不足，只有开放交流互鉴，才能实现向上发展。GHWP已确立了发展的战略重点和优先事项，我们将坚持问题导向和目标导向，集中力量办好自己的事情。GHWP将继续秉持平等、开放、稳健、共赢的原则，同热心致力于推动医疗器械监管趋同、协调和信赖的国际组织、相关国家和地区以及合作伙伴开展真诚的合作。

眼界决定境界、心态决定状态、格局决定结局。展望未来，GHWP将以更加团结的力量、更加开放的胸怀、更加奋进的姿态、更加务实的作风，加快推进全球医疗器械监管趋同、协调和信赖，为保护和促进全球公众健康作出新的更大的贡献。

全球医疗器械法规协调会主席

徐景和

2023年12月5日