Effective Use of Foreign Clinical Data in Approvals for Medical Devices in Japan

Abstract

Initial clinical development of medical devices occurs mainly in the USA and EU, with many medical devices registered in Japan afterwards. As the clinical performance of medical devices is less sensitive to ethnicity than the efficacy and safety of a drug, the performance of such devices can often be evaluated using foreign clinical data. The factors affecting the requirement for Japanese clinical data was investigated in the Japanese approvals of 103 high-risk devices, occurring between April 2005 and March 2015. The requirement for Japanese clinical data was associated with no approval in the USA and EU and the absence of foreign clinical data in the submission (p<0.001). Our results suggest that Japanese clinical data are not an essential requirement when foreign clinical data are included in the Japanese data package for approval, although, for 50% of devices with approval in the USA or EU, Japanese clinical data were still required for the Japanese approval. Reasons for this included the possibility that the performance of the device was sensitive to ethnicity associated with the medical environment, and that the device had been updated from the original one.