A Safety Review of Medical Device Robots in JAPAN

  • Yuichiro Tsuji


In Japan, the robot evolution in the medical field has been remarkable, robots now often perform actions that are difficult for humans including assisting with elderly care and conducting medical operations that require specific techniques, and Japanese medical robot technology is among the best in the world. As the workforce population decreases in Japan's ageing society, the demand for robots will be ever-increasing, the use of robots will reduce the increasing medical costs. Unfortunately, there has been insufficient research by Japanese law researchers on medical robots. This paper examines whether the law in Japan is a barrier to the development of robot technology. In Japan, medical treatments that utilise robots are promoted by the government and by private organisations, including the Center of Assistive Robotics and Rehabilitation for Longevity and Good Health and the Japan Agency for Medical Research and Development, which are similar to the National Science Foundation and the National Institutes of Health in the U.S. In Europe, the SPARC robot project promotes the private development of robots. One side effect of robot technology is the challenge they present within legal systems because laws commonly lag behind the rapid technological developments. To address this, we may need to modify existing interpretations by the executive branch and revise statues in parliament; otherwise, judges must interpret the meaning of statutes that competing parties dispute. This paper focuses on the legal issues regarding medical robots, including how the government approves the use of medical devices for older people, and proposes a legal framework that encourages the safe implementation of robots in the medical field.