Biological evaluation and regulation of medical devices in Japan

  title={Biological evaluation and regulation of medical devices in Japan},
  author={K Kojima},
  journal={Biocompatibility and Performance of Medical Devices},
  • K. Kojima
  • Published 2020
  • Medicine
  • Biocompatibility and Performance of Medical Devices
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… 
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