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.
//////////////////////////////////////////////////////////////////////////////////////////////////////////
■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"・・・
//////////////////////////////////////////////////////////////////////////////////////////////////////////

■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。