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Japan NEW Notification

■2022/05/19, Yakuseikishinhatsu 0519, dai2go[Online submission]


Online application to PMDA can be done by the gateway system is started.

-Notification: Already started

-Submission for approval: From July 1st, 2022

-Business license: From October 1st, 2022

Original:   薬生機審発0519第1号 令和4年5月19日「申請書等のオンライン提出に係る・・・

Ref Translation: Please contact IM Japan for full translation.


■2022/01/26, JIMURENRAKU [Consultation window for Program MD]


For applying MHLW consultation request if your program is regarded as medical devices, consultation form is prepared. Please note that Class I device is not required submission.

Original:   事務連絡 令和4年1月26日「プログラムの医療機器該当性の相談窓口」における・・・

Ref Translation: JIMURENRAKU 2022/1/26 "Consultation window for program medical devices"・・・








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