Abstract
Software cannot be submitted independently for the pre-market approval review under the Pharmaceutical Affairs Law (PAL) in Japan even if the software has the functions that meet the definition of Medical devices. Software must be installed into multipurpose hardware like personal computers (PCs) for the pre-market approval review. Consequently, the negative effects from this irrational pre-market review manner have been occurring in the clinical sites such as in healthcare facilities. The reason why such a pre-market approval review manner has been established, the situation of the negative effects on the clinical sites, and the pre-market approval review manner in the advanced foreign countries like EU and US is explained.
