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

Fostering Openness,Cooperation,Stability,and Mutual Benefit:Advancing Global Medical Device Regulatory Convergence,Harmonization and Reliance

全球医疗器械法规协调会(GHWP)是目前全球唯一的由监管机构代表和行业代表共同参与的国际医疗器械监管法规交流平台。本文介绍了GHWP基本情况,剖析了当前国际医疗器械监管面临的严峻挑战和良好机遇,并梳理了GHWP九大重点工作项目。相信未来GHWP基于开放、合作、稳健、共赢原则,将持续深化国际交流与合作,强化监管能力建设,共同推动全球医疗器械监管的趋同、协调与信赖,为保护和促进全球公众健康作出更大贡献。

Global Harmonization Working Party(GHWP)is currently the only international platform for communication between regulatory agencies and industry representatives on medical device regulations.This article provides an overview of GHWP,analyzes the challenges and opportunities confronting international medical device regulation,and categorizes the nine key work projects of GHWP.Based on the principles of openness,cooperation,stability,and mutual benefit,we believe that GHWP will continue to deepen international communication and cooperation in the future,strengthen regulatory capacity building,promote convergence,harmonization and reliance of global medical device regulation,and make greater contributions to safeguarding and advancing global public health.