17 - Biological evaluation and regulation of medical devices in Japan

Abstract

In Japan, unified and original guidelines for biological safety evaluation based on ISO 10993 of medical devices have been implemented since 1995. Since then, the Japanese authorities issued and revised Japanese guidelines, but there have been no marked changes in the basic way of thinking. In recent years international mutual understanding has progressed, Japan’s safety evaluation way such as exhaustive extraction method has been introduced into various parts of the ISO 10993 series, and the latest ISO 10993 has been adopted for Japanese guidance. The basic test methods used in Japan do not differ from those used outside Japan for most test items. However, there is a perception gap in sample preparation applied to these tests. In Japan, the basic stance is to eliminate all risks systematically. This stance is especially prominent in cytotoxicity tests, sensitization tests and genotoxicity tests. In addition, there is a perception gap also in classification of medical devices. Focusing on these points, this chapter outlines the Japanese guidance for biological safety tests of medical devices.