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In 2024, the production value of medical devices in Japan stood at approximately **** trillion Japanese yen. The figure increased compared to around two trillion yen in 2014. The average production value of medical devices per month in 2024 amounted to about *** billion yen. 

The domestic medical device industry

Medical devices accounting for the biggest shares of the overall production value were artificial internal organs, cannulae or catheters of assorted tip configurations as well as medical mirror. The authorization of medical devices in Japan is strictly regulated by the Pharmaceuticals and Medical Devices Agency, PMDA for short, which is a subsidiary of the Ministry of Health, Labour and Welfare (MHLW) and was established in 2004. The ministry’s responsibilities include registration of manufacturers, licensing certain actors, and authorizing medical devices, whereas the PMDA surveils the market and inspects manufacturers. To warrant the safety of medical devices produced domestically and imported from abroad, the PMDA has defined certain guidelines, including a comprehensive list of design and manufacturing requirements. There is also a certain license for Japanese companies that intend to market an imported medical device.

Import and export of medical devices

While the regulations by the PMDA pose certain challenges for the import and disposal of medical technology and pharmaceuticals, Japan does not raise custom duties on medical devices. The import value of medical devices has reached over 2.9 trillion yen in 2022, with medical devices from the United States accounting for the largest share. In the same year, the United States was the region receiving the biggest share of Japanese medical device exports.