Overview of medical device regulation in Japan as it relates to orthopedic devices

摘要

Pharmaceuticals and medical devices (PMDs) are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) under a system that grants marketing approval only when it is indicated that effectiveness and safety are guaranteed [1].Medical devices (MDs) have been used to treat, diagnose, and prevent disease since ancient times. MDs are classified by design complexity, use characteristics, and, importantly, risk assessment. Currently, a new classification system has been adopted [2]. The level of control, supervision, and data content needed to support the product depends on its classification [3] (Table 1).