Japan Medical Device Regulations – A Comprehensive Overview

About This eLearning

This two-hour course provides a comprehensive overview of regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Japan is utilizing MDSAP.

Key Learning Objectives

By the end of this course, you will be able to:

  • Identify the legal and regulatory framework for medical devices in Japan
  • Understand classification of medical devices in Japan
  • Understand the Medical Device Single Audit Program (MDSAP) and its function in Japan
  • Understand the pre-market pathway(s) and requirements for medical devices in Japan
  • Understand the quality management system regulations required to market a medical device in Japan
  • Understand the post-market requirements for medical devices and IVDs in Japan

Who Should Attend

This course is essential for anyone wanting to bring a medical device or IVD to market in Japan, and also for employees in R&D, regulatory, quality and compliance functions.


By completing/passing this Japan medical device regulations course, you will attain the Medical Device Certificate.