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Objectives:   This article aimed to discuss the emergence of medical device sector in China from a sectoral innovation system perspective, to explore the drivers and barriers to the successful building of an innovation system of medical devices, and to highlight the policy implications and suggestions for sustainable innovation of medical devices.Methods:   A theoretical framework of sectoral systems of innovation was applied in the analysis of data, and materials were collected from multiple sources with particular attention paid to the evolutionary phases, structure, and function of the innovation system.Results:   The evolution of medical device sector in China could be divided into four phases: initialization (1960s–1970s); exploration (1980s); steady growth (1990s); and rapid growth (since 2000). Through analyzing the innovation system’s structural components of technology, actors, and networking, as well as institutions, this study indicated that the government policy decision was the most important driver that affected the virtuous cycle of the Chinese medical device innovation system, followed by market demand and entrepreneurial activities. However, barriers against the innovation cycle such as knowledge base development and diffusion, legitimacy, and resource mobilization still remained.Conclusion:   In its endeavor to build an innovation system, the Chinese medical device sector had made some progress in meeting the local medical demands and improving its industrial competence. Although a Chinese innovation system for medical devices was initiated under the guidance of the government, knowledge advancement and diffusion had become the main challenges for the sustainability of innovation in this sector. The future development depends on China’s effort and ability to establish education and health research systems specific to medical devices.

Building an innovation system of medical devices in China: Drivers, barriers, and strategies for sustainability