Japan NEW Notification
■2023/03/31, YAKUSEIKISHINHATSU 0331, dai8go [Cybersecurity]
Note:
For medical devices that use programs, it is necessary to perform risk management relative to the medical device software life cycle according to JIS T 2304 to ensure safety and basic performance. In addition, JIS T 81001-5-1 must be used to implement cyber security measures throughout the product lifecycle, reduce risks to an acceptable level, and prevent the occurrence and spread of harm to patients. In other words, when applying for product approval of Class III and IV medical devices, it is necessary to demonstrate conformity to JIS T 81001-5-1, etc.
Original:薬生機審発0331第8号 令和5年3月31日「医療機器の基本要件基準第 12 条第3項の適用について」
Ref Translation: Please contact IM Japan for full translation.
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■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。