Japan PMDA Pre-Submission for Medical Devices

A foreign manufacturer considering introducing a medical device to the Japanese market may have already placed the same device on the market in their home country and/or major markets such as the U.S. and EU. They may, therefore, anticipate that the same (clinical or non-clinical) data sets submitted for registrations outside of Japan would be sufficient to fulfill requirements in Japan without adding or modifying anything.

In this whitepaper we identify how medical devices are authorized in Japan, the challenges foreign manufacturers face, and the types of pre-sub consultations.