In fiscal year 2023, 471 generic medical devices submitted were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working with Japan's health ministry.
Number of generic medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission
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
Generic medical devices are 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).
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PMDA. (September 14, 2024). Number of generic 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 Statista. Retrieved May 04, 2025, from https://www.statista.com/statistics/1185950/japan-newly-approved-generic-medical-devices/
PMDA. "Number of generic 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. Statista. Accessed May 04, 2025. https://www.statista.com/statistics/1185950/japan-newly-approved-generic-medical-devices/
PMDA. (2024). Number of generic medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission. Statista. Statista Inc.. Accessed: May 04, 2025. https://www.statista.com/statistics/1185950/japan-newly-approved-generic-medical-devices/
PMDA. "Number of Generic Medical Devices Approved by The Pharmaceuticals and Medical Devices Agency (Pmda) in Japan from Fiscal Year 2014 to 2023, by Year of Submission." Statista, Statista Inc., 14 Sep 2024, https://www.statista.com/statistics/1185950/japan-newly-approved-generic-medical-devices/
PMDA, Number of generic medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023, by year of submission Statista, https://www.statista.com/statistics/1185950/japan-newly-approved-generic-medical-devices/ (last visited May 04, 2025)
Number of generic 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: https://www.statista.com/statistics/1185950/japan-newly-approved-generic-medical-devices/
