Abstract：With the rapid development of internet technology, new technologies and new methods, such as
internet technology, mobile internet, big data and cloud computing and so on, are rapidly developed and
widely applied in medical equipment industry. The emergence of mobile medical devices APP software is
making revolutionary changes to the traditional healthcare from the aspects of diagnosis, monitoring, and
treatment. An intelligent medical era is approaching. Along with the emergence of new medical products,
how to effectively control its safety and effectiveness raised new challenges to regulatory agencies. Based
on the definition and features of mobile medical APP software, this paper combined the regulation ideas
and methods of the United States, the European Union and China, and performed an in-depth analysis on
the challenge of software update regulation, and proposed regulatory advice and faced the challenge for
the mobile medical APP software, expected to provide support and help for the regulation work.
王晨希，李澍，王浩，罗维娜，
任海萍. 移动医疗器械APP软件监管技术探讨[J]. 中国医疗设备, 2017, 32(6): 12-15.
WANG Chen-xi, LI Shu,
WANG Hao, LUO Wei-na,
REN Hai-ping. Study on the Regulation of Mobile Medical Devices APP Software. China Medical Devices, 2017, 32(6): 12-15.
