32 medical devices that were submitted in the fiscal year 2020 were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan so far, down from 99 approved products applied in fiscal 2014. The PMDA functions as a regulatory agency for pharmaceutical products and medical devices, and works together with the health ministry in Japan.
Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2011 to 2020, by year of submission
fiscal year 2011 to 2020; 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. (June 23, 2021). Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2011 to 2020, by year of submission [Graph]. In Statista. Retrieved January 28, 2022, 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 2011 to 2020, by year of submission." Chart. June 23, 2021. Statista. Accessed January 28, 2022. https://www.statista.com/statistics/1184508/japan-newly-approved-medical-devices/
PMDA. (2021). Number of new medical devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2011 to 2020, by year of submission. Statista. Statista Inc.. Accessed: January 28, 2022. 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 2011 to 2020, by Year of Submission." Statista, Statista Inc., 23 Jun 2021, 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 2011 to 2020, by year of submission Statista, https://www.statista.com/statistics/1184508/japan-newly-approved-medical-devices/ (last visited January 28, 2022)
