Regulation of prosthetic and orthotic devices and their clinical studies : Registration of clinical studies/trials in Japan and overseas

Abstract

Markets of prosthetic and orthotic devices, used for therapeutic and welfare purposes, are rapidly growing and their research and development are also being increasingly called for more than ever before. This article aims to introduce an overview of the regulations on these devices in Japan, the EU, and the US, which define the cases where clinical studies/trials are necessary for product approval. Then, after explaining the registration of clinical studies, which is required by law or guidelines, a picture of clinical studies conducted recently on prostheses and orthoses is presented. Implications of those studies for the development and quality of products (devices) are discussed.