The clinical trials act of Japan, enforced April 2018, which allows only medical doctor license holders to perform clinical trials using unauthenticated medical devices had a strong impact to medical device development researches which are mainly performed by engineering researchers. The authors conducted online survey for understanding impact of the act on medical device development researches in November 2021. The total number of responses was 46, 35% of them are forced to modify or abort their original research plan, although most of them has no need to do so. This survey result clarifies that education for review board members about medical device development researches and slight amendment of the act to enable medical device development researches are required for promotion of medical device development researches.
