Practical measures for entry into the healthcare industry Part 2 - Medical device regulations based on the Pharmaceuticals and Medical Devices Law -
2023/1/24
[Webinar] Initial Response to Corporate Scandals - Four Skills Required of Legal and Compliance Officers - Part 4
2023/1/24
Mori Hamada & Matsumoto
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In recent years, the trend of making full use of cutting-edge technologies such as IoT, AI, and big data to innovate existing industries has spread to the healthcare industry. There is an increasing number of companies from other industries entering the healthcare industry.
On the other hand, since this is an area that can directly affect the lives and bodies of citizens, there are laws and regulations that can be said to be unique to the industry, and it is not easy to understand the details of these regulations compared to laws and regulations in other industries.In addition to regulations based on laws and regulations, there are many regulations based on soft laws such as administrative notices and voluntary industry standards, and in recent years there have been many revisions due to regulatory reforms, making this a rapidly moving field.
Therefore, this time, we will explain the main legal points that should be kept in mind, focusing on digital health and health tech-related products and services, which are often entered from other industries, in four parts, based on the latest situation. . The theme of Part 4 is "Overview of Healthcare Legal Affairs and Countermeasures."
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Mori Hamada & Matsumoto
You can download the materials from the form at the bottom of the page.
In recent years, the trend of making full use of cutting-edge technologies such as IoT, AI, and big data to innovate existing industries has spread to the healthcare industry. There is an increasing number of companies from other industries entering the healthcare industry.
On the other hand, since this is an area that can directly affect the lives and bodies of citizens, there are laws and regulations that can be said to be unique to the industry, and it is not easy to understand the details of these regulations compared to laws and regulations in other industries.In addition to regulations based on laws and regulations, there are many regulations based on soft laws such as administrative notices and voluntary industry standards, and in recent years there have been many revisions due to regulatory reforms, making this a rapidly moving field.
Therefore, this time, we will explain the main legal points that should be kept in mind, focusing on digital health and health tech-related products and services, which are often entered from other industries, in four parts, based on the latest situation. . The theme of Part 4 is "Overview of Healthcare Legal Affairs and Countermeasures."
Mori Hamada & Matsumoto
Senior Associate Yasutaka Tokuda Lawyer
While he has worked on many large-scale M&A projects and organizational restructurings in Japan, he has also used his experience of being seconded to the Pharmaceutical and Environmental Health Bureau of the Ministry of Health, Labor and Welfare to help pharmaceutical companies, medical device manufacturers, and businesses from other industries entering the healthcare-related business. We provide legal advice and crisis management related to pharmaceutical affairs and medical care, and strive to provide effective and efficient advice based on the latest trends and the actual situation of each company.
Related publications include “Health Tech Legal Q&A (2nd Edition)” (co-authored by Shojihomu), “Regarding the Establishment of a Legal Compliance System Based on the Amended Pharmaceuticals and Medical Devices Law”, PHARM TECH JAPAN Volume 37, No. 10, “Getting the Deal Through - Healthcare M&A 2022 - Japan Chapter”, etc.
Graduated from the University of Tokyo Faculty of Law in 2007, completed the University of Tokyo Law School in 2010, and joined Mori Hamada & Matsumoto Law Office in 2012. In 2018, she graduated from Cornell University Law School and worked at Kirkland & Ellis LLP (Chicago office) for about a year from 2018. In 1, he was admitted to the New York State Bar. For two years from 2019, he worked as a public employee with a fixed term at the Pharmaceutical and Environmental Health Bureau of the Ministry of Health, Labor and Welfare (Monitoring and Guidance and Narcotic Control Division, Pharmaceutical Evaluation and Management Division, Medical Device Evaluation and Management Division, etc.).
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Mori Hamada & Matsumoto Law Firm has a "Firm of Choice", i.e., when clients face the most important problems, when they face the most complex problems, when they need the fastest solutions. First of all, we aim to be an office that is relied on and contacted.
Above all, from the perspective of international operations, we aim to be the No. 7 Regional Firm in Asia with seven overseas bases, and contribute to the construction of a legal infrastructure that allows domestic and overseas companies to be active globally. is our mission.
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