In recent years，Fujian Province has achieved rapid development in medical device industry under the guidance and promotion of policies，such as “Healthy China 2030” Planning Outline and “Made in China 2025” action plan. The number of manufacturing enterprises and registered products is continuously growing. It has formed several advantageous subdivided specialties like in vitro diagnostic reagent. It also formed industry agglomeration areas in Fuzhou，Xiamen，Changting and Quanzhou. Fujian Province has made progresses in the research and development of innovative medical devices. The work of Unique Device Identification is also satisfying. However，there are still some problems in the medical device industry in Fujian Province，such as the small scale of enterprises，the incomplete product category，the lack of skilled person，the short of research investment，the lack of ability to appraisal，approve，verify and test medical device. In the long run，it’s necessary to develop advantageous subdivided specialties，optimize the function of industrial park，strengthen the basic science research，establish flexible talent policy，strengthen the functions of government，increase the ability to verify and test medical device.