IM ジャパン

Japan NEW Notification

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

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Note：

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

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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.

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

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Note：

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.

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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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