Eight medical devices that were submitted in the fiscal year 2022 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.
Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2013 to 2022, by year of submission
fiscal year 2013 to 2022; 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 “new medical devices” or “generic medical devices,” 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).
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PMDA. (September 14, 2023). Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2013 to 2022, by year of submission [Graph]. In Statista. Retrieved October 31, 2024, from https://www.statista.com/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 2013 to 2022, by year of submission." Chart. September 14, 2023. Statista. Accessed October 31, 2024. https://www.statista.com/statistics/1184508/japan-newly-approved-medical-devices/
PMDA. (2023). Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2013 to 2022, by year of submission. Statista. Statista Inc.. Accessed: October 31, 2024. https://www.statista.com/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 2013 to 2022, by Year of Submission." Statista, Statista Inc., 14 Sep 2023, https://www.statista.com/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 2013 to 2022, by year of submission Statista, https://www.statista.com/statistics/1184508/japan-newly-approved-medical-devices/ (last visited October 31, 2024)
Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2013 to 2022, by year of submission [Graph], PMDA, September 14, 2023. [Online]. Available: https://www.statista.com/statistics/1184508/japan-newly-approved-medical-devices/