In Depth: Japan Medical Device Approval and Compliance


Japan is the second largest medical device market, representing about 10% of the world total. While the population of Japan continues to decline, the potential for medical device manufacturers continues to be promising. Why? Japan has a rapidly aging population and those people are much larger consumers of healthcare than younger citizens. But this potentially lucrative market has what may be one of the most complicated registration processes in the world.

We'll explain the Japanese approval process step by step in this free video. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of March 2015.

In this slidecast:

  • Overview of the regulatory process in Japan [runtime = 3:35]
  • Determining your medical device classification [runtime = 3:11]
  • Key players in the PMDA approval process [runtime = 3:12]
  • Japanese Quality Management System Requirements [runtime = 2:53]
  • Pre-market Applications [runtime = 2:33]
  • Final Steps [runtime = 2:15]