[Seminar] Recent Regulatory Trends in Software as a Medical Device (SaMD)

Ministry of Health, Labour and Welfare: Initiatives for Further Practical Application

Our company will hold a seminar on "Recent Regulatory Trends in Software as a Medical Device (SaMD)." Medical devices are regulated in their manufacturing and sales under the "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices." Since 2014, standalone software intended for the diagnosis and treatment of diseases has also been subject to regulation as medical devices, leading to many software medical devices receiving manufacturing and sales approvals. The Ministry of Health, Labour and Welfare aims to further practical application and international expansion of software medical devices and, in September 2023, jointly with the Ministry of Economy, Trade and Industry, announced the "Package Strategy for Promoting Practical Application of Software Medical Devices 2 (commonly known as 'DASH for SaMD2')." Various initiatives are being undertaken, including early identification of nascent seeds and the publication of review concepts. This presentation will provide a detailed explanation of recent regulatory trends regarding software medical devices. 【Seminar Details】 ■ Date and Time: September 27 (Friday) 13:30-15:30 (Doors open at 13:00) ■ Speaker: Ministry of Health, Labour and Welfare, Pharmaceutical and Medical Device Agency, Medical Device Review Management Division, Head of Software Medical Device Review Management Office, Ph.D. (Pharmacy) Reiko Mizutani *For more details, please refer to the PDF document or feel free to contact us.

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