Japan’s MHLW Announces New SaMD Reimbursement Updates; Event to Focus on Products Covered from June

Overview: On May 13, Japan’s Ministry of Health, Labour and Welfare newly announced the following information related to insurance coverage. 【Category C2】 ・Product name: SUSMED Insomnia App Medcle 　Company: SUSMED, Inc. 　Reimbursement price: JPY 24,100 ・Product name: ENDEAVORRIDE 　Company: Shionogi & Co., Ltd. 　Reimbursement price: JPY 14,500 【Decision on evaluation-based medical care for software as a medical device】 ・Product name: Lifton D 　Intended purpose and method of use: Relief of psychiatric symptoms in patients with depression who continue to have moderate or more severe depressive symptoms despite receiving pharmacotherapy. Reference: Insurance coverage for medical devices, scheduled for listing on June 1, 2026. In response, the event program will be partially revised to deliver the latest topic quickly, with a primary focus on “SaMD newly covered by insurance from June.” The initially planned content on trends in the FY2026 medical fee revision will be omitted this time in light of the above news. The event will feature Kohei Takeshita, who has experience in price-setting operations at the MHLW and also practical experience with SaMD reimbursement from the corporate side. Together with moderator Eiji Takeda of Software Regulation Inc., the session will discuss insurance coverage for software as a medical device, covering both practical points and recent cases. Date and venue: Date and time: Thursday, May 21, 2026, 18:00 to 19:30. Online access will cover part of the program only. Venue: Beyond Next Ventures Event Space, 3F MFPR Nihonbashi Honcho Building, 3-7-2 Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023 Online: Zoom planned. The URL will be sent to those who register by the day of the event. Fee: Free Organizers: Software Regulation and Beyond Next Ventures Program: 【Online and offline】 18:00 to 18:05 Introduction 18:05 to 18:20 Basic knowledge of medical device insurance coverage 18:20 to 18:35 Overview of SaMD products to be covered by insurance from June 【Offline only】 18:40 to 19:00 Case study and Q&A on SaMD products to be covered by insurance from June 19:00 to 19:30 Networking Speakers and panelists: Kohei Takeshita, Lecturer, Department of Advanced Medical Information Technology, The Jikei University School of Medicine. He spent four and a half years reviewing medical devices at the PMDA, gaining broad evaluation experience from clinical trials to in vitro testing. He also served as an instructor for new staff education and regulatory training seminars. He was later seconded to the MHLW, where he handled pricing decisions for medical devices, in vitro diagnostics, and regenerative medicine products. After leaving government service, he worked on insurance listing for a medical device app at a medical IT startup and on product development strategy at a major medical device manufacturer. In his current role at The Jikei University School of Medicine, he conducts research on medical IT and medical devices while supporting startup development and advising medical device manufacturers. Eiji Takeda, Representative Director, Software Regulation Inc. He previously handled regulatory submissions for therapeutic apps at a startup that developed Japan’s first therapeutic app. After leaving CureApp, he founded a company that supports regulatory submissions for software as a medical device, assisting SaMD developers with domestic and international regulatory affairs for therapeutic apps, diagnostic AI software, and related products. Advance questions: Registration for this event requires submission of advance questions. Participants are asked to fill in the relevant form fields. Selected questions will be addressed during the session. Questions may also be submitted through the online tool on the day of the event. Please note that not all questions may be answered due to time constraints.