抄録
Since ventricular assist devices became smaller and more durable in this decade, patients can go out of hospital and return to jobs. To promote research and development (R&D) and to accelerate the approval review processes of medical devices the METI published in 2007 the R&D Guidance for artificial hearts, and the MHLW published in 2008 a Notification by Director regarding the evaluation criteria for artificial hearts. Then two kinds of implantable ventricular assist devices were approved in 2010 and simultaneously the doctor/facility qualification system was initiated by the academia. The role of academia has been recognized through these approval process.
