Industry wants change to IVD (in vitro diagnostics) regulation in Japan:
This article was originally published in Clinica
Japanese industry is hoping it can persuade the Ministry of Health and Welfare to establish a new regulatory category for in vitro diagnostics and related instrumentation. Currently IVDs are regulated in the same way as pharmaceuticals in Japan, while the equipment they run on is subject to the medical device approval process. Japan's IVD industry association, the JACR, believes that diagnostic products should be evaluated as a total system.