医疗器械领域涉及国计民生，发展潜力巨大，但我国医疗器械产业中低端产品较多，高端产品缺乏原创性，发展面临重重困难和挑战。作为快速增长的新兴技术领域，发展新型穿戴式医疗设备具有重要意义。为此，中国工程院启动了“我国全民健康与医药卫生事业发展战略研究”重大咨询项目，其中“医疗器械与新型穿戴式医疗设备的发展战略研究”作为八个重点课题之一，围绕医疗器械与新型穿戴式医疗设备的发展现状和战略需求，研究我国医疗器械产业与新型穿戴式医疗设备领域的现状及特点，分析我国医疗器械国产化与新型穿戴式医疗设备领域健康发展的关键问题，研究该领域的相关政策，理清我国医疗器械发展过程中的重点问题、需求、已有优势和特点，并在此基础上提出了对策建议。

China is facing great difficulties and challenges in its quest to transition from the low end to the high end of the medical devices industry. In the burgeoning field of new wearable medical devices, we are encountering many more opportunities to catch up with the leaders in the field, although challenges still exist. The Chinese Academy of Engineering recently organized a major advisory project: the National Health and Medical & Health Industry Development Strategy. Research on the Development Strategies of Medical Devices and New Wearable Medical Devices is one of the eight key subjects in this project. As a result, this paper studies and systematically analyzes the subject of research into medical devices, and the requirements, characteristics, focus, and politics of this field have been assessed. This paper reports on the results of this project regarding research into medical devices and new wearable devices. This paper includes suggestions and proposals to clarify critical issues affecting the development of wearable medical devices.