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Overview of Japan Medical Device Regulation

Contents

Overview of Japan Medical Device Regulation

  • Medical Device Legislation
  • Economic Operators in Japan
  • Japan Medical Device Nomenclature (JMDN)
  • Classification System
  • Comparison of Device Classifications
    • Japan QMS Overviews
    Marketing Authorization of Medical Devices in Japan
    Foreign Manufacturer Registration (FMR)
    Changes to a Medical Device
    Medical Device Adverse Events and Recalls