Japan: newly approved medical devices by category| ��ƽ��

Number of medical devices newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2015 to 2024, by category

Characteristic	New medical devices	Improved medical devices (with clinical data)	Improved medical devices (without clinical data)	Generic medical devices	Re-manufacturing single-use devices (R-SUD)
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Release date

July 2025

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Region

Japan

Survey time period

fiscal year 2015 to 2024; the Japanese fiscal year starts on April 1 of the stated year and ends on March 31 of the following year

Supplementary notes

Classification of medical devices according to the source:
1. New medical devices: devices that have a clearly different structure, usage, indications, performance, etc., compared with those for which marketing approval has been granted.
2. Improved medical devices: devices that do not fall under “new medical devices” or “generic medical devices” and are not so novel as to be subject to re-examination, nor are they substantially equivalent to existing medical devices in terms of structure, usage, indications, performance, etc. (as defined under the PMD Act).
3. Generic medical devices: devices that are regarded as substantially equivalent to existing approved medical devices in terms of structure, usage, indications, performance, etc. (as defined under the PMD Act).

Citation formats

In the fiscal year 2024, ** medical devices were newly approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, of which *** 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 **, , and **, 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 **** and Terumo Corporation. While ** 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

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 fiscal 2023, the research and development expenditure of the AMED amounted to over ****billion Japanese yen. Japan's medical device market is likely to grow further in the future, as the country continues to focus on investments in research and development.