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  6. [Seminar] Regulatory Framework Surrounding Medical Device Programs and Healthcare Apps

[Seminar] Regulatory Framework Surrounding Medical Device Programs and Healthcare Apps

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last updated:Oct 30, 2024

日本計画研究所
日本計画研究所
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Points that related businesses should be aware of - Personal Information Protection Law, insurance coverage, transactions with medical institutions, research and development, etc.

Our company will hold a business seminar. With the arrival of a super-aged society and the increasing public interest in healthcare and medical issues due to the COVID-19 pandemic, various healthcare-related applications and software products have been developed and released in recent years thanks to advancements in IT technology. Among these program products, those aimed at the diagnosis and treatment of diseases are subject to regulation under the Pharmaceuticals and Medical Devices Act (PMDA) as medical device programs, just like tangible medical devices and hardware. Whether or not a program falls under the PMDA regulations significantly affects the effort and costs for businesses in obtaining licenses and complying with regulations, while determining whether a program qualifies as a medical device program is not straightforward. This seminar will provide a detailed explanation of the points that relevant businesses should pay attention to, including the applicability of medical device programs, the Personal Information Protection Act, and other related considerations. [Seminar Details] ■ Date and Time: November 21 (Thursday) 16:30-18:30 (Doors open at 16:00) ■ Speaker: Yasutaka Tokuda, Partner, Lawyer at Mori Hamada & Matsumoto *For more details, please refer to the PDF document or feel free to contact us.

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[Seminar] Regulatory Framework Surrounding Medical Device Programs and Healthcare Apps

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  • Related Link - https://www.jpi.co.jp/seminar/17117?utm_medium=ipr…

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【Lecture Items】 ■Introduction ■Overview of Regulations on Medical Device Programs under the Pharmaceutical and Medical Device Act ■Eligibility Determination for Medical Device Programs ■Personal Information Protection ■Others ■Related Q&A ■Business Card and Information Exchange Meeting *For more details, please refer to the PDF materials or feel free to contact us.

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Regulatory Framework Surrounding Medical Device Programs and Healthcare Apps, and Key Points for Related Businesses to Consider

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日本計画研究所

日本計画研究所

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JPI Corporation (Japan Planning Institute) has been providing valuable information for executives and senior management involved in the execution of national policies and national projects, supporting the dissemination of knowledge as a 'bridge of wisdom' between 'politics,' 'government,' and 'the public' in a limited-participant, real seminar format for half a century, aiming to create national knowledge.

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