Abstract
To apply outcomes from researches into clinical practices, translational researches have been done from the early part of this century. Our division is doing the researches as well to develop methods for evaluating safety and efficacy of new medical devices and clarify factors necessary for the evaluation, some of which are shown in this presentation.For example, our division plays a role as secretariats of working groups for developing guidelines for evaluating efficacy and safety of emerging medical devices. Currently, nineteen guidelines have been open to public and some of these have been already utilized for reviews of the medical devices for approving their marketing by PMDA.Standardization of technologies and evaluation methods for new medical devices is another important factor for developing the medical devices for clinical practices. To notify its importance to stakeholders, we are trying to put out summarized information on current activities on medical device standardization.
