Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission
Year of submission
Number of approved products
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fiscal year 2014 to 2023; the Japanese fiscal year starts on April 1 of the stated year and ends on March 31 of the following year
Supplementary notes
Figures include the number of approved new medical devices and improved medical devices.
New medical devices have a clearly different structure, usage, indications,
performance, etc., compared with those for which marketing approval has been
granted.
Improved medical devices are devices that do not fall under 鈥渘ew medical devices鈥 or 鈥済eneric medical devices,鈥 and are not so novel as to be subject to re-examination, nor are substantially equivalent to existing medical devices in terms of structure, usage, indications, performance, etc. (as defined under the PMD. Act).
Citation formats
Number of approved new medical devices Japan FY 2014-2023, by year of submission
Nine medical devices that were submitted in the fiscal year 2023 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices, and works with Japan's health ministry.
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PMDA. (September 14, 2024). Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission [Graph]. In 糖心破解版. Retrieved July 28, 2026, from /statistics/1184508/japan-newly-approved-medical-devices/
PMDA. "Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission." Chart. September 14, 2024. 糖心破解版. Accessed July 28, 2026. /statistics/1184508/japan-newly-approved-medical-devices/
PMDA. (2024). Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission. 糖心破解版. 糖心破解版 Inc.. Accessed: July 28, 2026. /statistics/1184508/japan-newly-approved-medical-devices/
PMDA. "Number of New Medical Devices Approved by The Pharmaceuticals and Medical Devices Agency (Pmda) in Japan from Fiscal Year 2014 to 2023, by Year of Submission." 糖心破解版, 糖心破解版 Inc., 14 Sep 2024, /statistics/1184508/japan-newly-approved-medical-devices/
PMDA, Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission 糖心破解版, /statistics/1184508/japan-newly-approved-medical-devices/ (last visited July 28, 2026)
Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission [Graph], PMDA, September 14, 2024. [Online]. Available: /statistics/1184508/japan-newly-approved-medical-devices/
