Introduction to Japan's Medical Device Approval Process

Japan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend more on healthcare. An aging population and high per-capita spending make it an attractive and potentially lucrative market for medical device manufacturers. Interested in entering this market? This short video tells you how.

Topics covered include:

  • the Pharmaceuticals and Medical Devices Agency (PMDA)
  • quality system requirements
  • classification of medical devices according to risk
  • JMDN code
  • appointing a Marketing Authorization Holder (MAH), testing reports
  • the technical file
  • and more.

You may also like:

Free detailed chart about the medical device approval process in Japan (includes a timeline of how long it takes to gain approval in Japan).


Watch this short video and learn about registering your device in Japan Watch an in-depth video about the regulatory process in Japan [Runtime: 17 minutes]


Download medical device regulations for Japan.