Medical Device Premarket Review and Challenge for Acceleration of the Review Process

Abstract

Pharmaceutical and Medical Device Agency (PMDA), Japan is responsible for the pre-market review of high-risk medical devices including highly-controlled (Class III and IV) devices. This article explains medical device regulation and premarket review based on the Japanese Pharmaceutical Affairs Law. Additionally, the PMDA review process and its expediting initiative. This information would make it possible to elaborate comprehensive strategy for the marketing approval from an early development phase, and thus lead to improve the medical device research and development.