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

Abstract

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). To register and market a class I device, the marketing authorization holder (MAH) need only file a pre-market notification with the PMDA without an assessment. To register and market a class II device, the MAH must file a pre-market approval application with a registered certification body and obtain certification [4]. This procedure is very similar to the European Conformity marking from a notified body [5]. If no applicable certification standard has been established or if the device is deemed a new MD, the MAH is required to submit an application to the PMDA to obtain approval. To register and market a class III or class IV device, the MAH must file a pre-market approval application with the PMDA and obtain approval.