IM ジャパン

■2023/03/31, YAKUSEIKISHINHATSU 0331, dai8go [Cybersecurity]

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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.

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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]

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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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