Japan NEW Notification

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

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

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]

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.

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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■欧州指令が改訂されました。

①EMC指令ガイド

  https://ec.europa.eu/docsroom/documents/33601

②無線機器指令ガイド 

  https://ec.europa.eu/docsroom/documents/29782

・参考和訳をご希望の方はお問い合わせください。

・薬事プロ(欧州薬事経験10年以上)が翻訳する、理解しやすい文章です。