Introduction

Japan suffers from a severe medical device lag, including in vitro diagnostic products (IVDs). This lag is conventionally understood as the absence of treatment and procedures that are available to patients in Europe and the United States on average three to five years earlier than in Japan. The lag can alternatively be described as treatment obtained only after considerable delays. To remedy this deficit, the Japanese government has engaged in building regulatory capacity, reorganizing existing regulatory structures, and bettering its medical-clinical infrastructures through a variety of initiatives, programs, and actions since 2005. Reform is ongoing.