Approval Review of Software as a Medical Device

Abstract

In addition to software with tangible medical device, software itself has been defined as medical device since PMD Act amended in 2013. In addition, medical device software classified as Class I is not subjected to restrictions on the PMD-Act. To review SaMD, it is important to determine the role of the SaMD in clinical practice. The role of the software affects whether the software is medical device or not, and how we review. Effective regulatory pathway, consultation service for good communications with applicants and discussion with experts are necessary for regulators.