目的：对医疗器械检验体系现状和新时期的发展机遇进行分析，以期为医疗器械检验体系发展提供指导。方法：深入分析我国54家医疗器械检验机构的现状和发展趋势，剖析促进我国医疗器械检验体系发展的政策法规。结果与结论：我国医疗器械检验机构已经形成了成熟的体系，2015年和2016年我国连续出台政策鼓励制造业升级和科技创新。面对新形势，医疗器械检验体系将借助我国经济快速发展和科技创新发展的机遇，在制度、技术和观念上实现创新发展。

Objective: To discuss the current status and the development opportunities of medical device inspection system in the new era, and to provide analytical guidance for the development of the medical device inspection system. Methods: The current situation and development trend of 45 medical device inspection institutes in China were thoroughly analyzed. Moreover, policies and regulations for promoting the development of medical device inspection system in China were also analyzed. Results and Conclusion: The medical device inspection system was successfully established in China. Policies were continuously enacted to encourage the upgrading of manufacturing industry and innovation of science and technology in 2015 and 2016 in China. Medical device inspection system should seize the opportunities of rapid economic development and the innovation of science and technology in China and achieve the innovative development in the system, technology, as well as ideas.