Recently, software has an important role in hospitals and clinics. However, the concept of "medical device" in apanese law is limited on the form of instruments. Therefore, software as a stand-alone type is not recognized as "medical devices". This paper discusses several points of problems on medical device software which arises from the point that medical device software as a stand-alone type is not recognized as "medical devices" in Japan, from the view point of patient safety related to the medical application software.

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