中国医疗器械产业正进入全球化发展的关键阶段，海外布局已从“可选项”转变为实现长期增长的战略必选。在国内价格持续下行、政策改革深化以及竞争格局重塑的背景下，领先企业正加速从以规模驱动为主的发展模式，转向以创新驱动和全球化布局为核心的增长路径。本白皮书由新加坡经济发展局（EDB）与L.E.K.联合发布，并结合在新加坡及东南亚运营的中国医疗器械企业的一线实践经验。
在此趋势下，东南亚正成为中国企业出海的首选区域。该地区具备需求增长迅速、医疗基础设施持续完善以及准入环境相对友好的特点，为企业构建国际化能力提供了现实且可行的切入点。
在区域布局中，新加坡逐步成为企业全球化战略的关键支点。其在监管效率、先进制造、研发能力以及国际连接方面的综合优势，使企业能够以此为区域总部，统筹多国运营、提升市场进入效率，并加快向更广泛国际市场的拓展。
在企业层面，出海路径呈现出明显的差异化特征。领先企业根据产品复杂度、服务需求及长期战略目标，选择从以经销为主的轻资产模式到深度本地化运营等不同路径。如何实现运营模式与能力建设的匹配，正成为决定全球化成败的关键因素。
总体而言，本报告从战略与执行两个层面，为企业管理层提供了清晰的决策框架，对市场优先级选择、运营模式设计以及资源配置具有直接的实践指导意义。
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China’s medical device industry is entering a new phase of globalization in which international expansion is no longer optional but a strategic imperative for sustained growth. As domestic pricing pressure intensifies and policy reforms reshape the competitive landscape, leading companies are accelerating the shift from volume-driven growth to innovation-led, globally diversified models. Developed in collaboration with the Singapore Economic Development Board, this report draws on frontline perspectives from Chinese medtech companies operating in Singapore and across Southeast Asia.
Against this backdrop, Southeast Asia is emerging as a natural first location for international expansion. The region offers a compelling combination of strong demand growth, improving healthcare infrastructure and relatively accessible regulatory pathways, which creates a pragmatic entry point for companies building global capabilities.
Within Southeast Asia, Singapore stands out as a critical anchor for regional and global strategy. Its integrated ecosystem — spanning regulatory efficiency, advanced manufacturing, R&D capabilities and strong international connectivity — enables companies to centralize regional operations, streamline market entry and scale more effectively across multiple markets.
At the company level, the path to globalization is increasingly differentiated. Leading medtech players are adopting a range of operating models, from distributor-led approaches to fully localized platforms, depending on product complexity, service requirements and long-term strategic ambition. The ability to align operating model choices with capability development is emerging as a key determinant of success.
This report provides a practical lens for executives navigating this transition, with clear implications for how to prioritize markets, design operating models and allocate resources in building a sustainable global footprint.
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