Education and training in regulatory science for medical device development.

Regulatory science can be defined as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. In addition to engineering researches that create novel medical devices, scientific methods for evaluating efficacy, safety and quality of medical devices are necessary to enable rational and scientific evaluation of the device in device approval process. Engineers and medical doctors involving research and development of novel medical devices are required to have basic knowledge on medical device safety standard, medical device regulation, and relevant methodologies. In Japan, several graduate schools in Japan have started educational programs on regulatory sciences in collaboration of Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2012, program for researches for development of evaluation guidelines for novel medical device products started where personnel exchanges between academic researches institutes and PMDA. Example of these programs will be introduced in the presentation and its impact on improvement of medical device research and development process will be discussed.