Number of newly approved medical devices Japan FY 2014-2022, by category

In the fiscal year 2022, over 900 medical devices were newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, of which 603 were generic medical devices. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices and works with Japan's health ministry.

Medical device industry in Japan

With a diverse array of products ranging from diagnostic equipment to therapeutic devices, Japan's medical device industry has solidified its position as a key player in the sector. Following the United States, China, and Germany, Japan currently ranks among the top four global players concerning revenue in the medical device industry.
At the forefront of Japan's medical device manufacturing are companies like Olympus Corporation and Terumo Corporation. While Olympus is renowned for its dominance in the gastrointestinal endoscope field and commands a significant share of the global market, cardiac and vascular solutions represent Temuro's largest business segments.

 Research spending and market position

In recent years, the import value of medical devices to Japan has exceeded its exports. Leading trading partners were key markets such as the United States, China, and Germany.
Japan's dedication to research and development is exemplified by initiatives such as the Japan Agency for Medical Research and Development (AMED) which fosters innovation in medical devices. In recent years, the research and development expenditure of the AMED increased to over 185 billion Japanese yen. Furthermore, the production value of medical devices in Japan grew to close to 2.6 trillion Japanese yen in recent years. The market is likely to grow further in the future, as the country continues to focus on investments in research and development.