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.