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.

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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 an in-depth video about the regulatory process in Japan [Runtime: 17 minutes]

Download medical device regulations for Japan.