Institute for Medical Regulatory Science –

Institute for Medical Regulatory Science

Research Theme

The Institute for Medical Regulatory Science promotes research on the regulation of medical devices, pharmaceuticals, and regenerative medicine products, as well as on non-clinical testing, clinical trials, evaluation methods, and the appropriate use of therapeutic medical devices in real-world clinical settings. In particular, we are advancing research and development on experimental systems and evaluation methodologies that simulate human pathological conditions to accelerate the development of Class IV therapeutic medical devices. Additionally, in collaboration with academia and startups, we are engaged in regulatory science initiatives that facilitate the societal implementation of Class IV therapeutic medical devices, playing a key role in fostering an ecosystem that transitions basic research into practical applications. Our efforts focus on the global development of innovative Class IV therapeutic medical devices, such as tissue regenerative devices based on decellularized tissue, which promote in vivo autologous tissue construction. Together with researchers from diverse fields and invited experts, we are also addressing the regulation of “Software as a Medical Device” for medical and health applications, driving innovation through regulatory science research.

Research Director

IWASAKI, Kiyotaka

Faculty of Science and Engineering, Graduate School of Advanced Science and Engineering

 Research Director Database

Project Members

Advisor

KASANUKI, Hiroshi
UMEZU, Mitsuo

Researchers

AYABE, Hironori Professor, Faculty of Science and Engineering, School of Creative Science and Engineering
HASUIKE, Takashi Professor, Faculty of Science and Engineering, School of Creative Science and Engineering
HATTORI, Kaoru Associate Professor (non-tenure-track), Faculty of Science and Engineering, Graduate School of Advanced Science and Engineering
HIGASHIDE, Hironori Professor, Faculty of Commerce, Graduate School of Business and Finance
IMAI, Shinya Research Associate, Faculty of Science and Engineering, Graduate School of Advanced Science and Engineering
ISHII, Hiroyuki Professor, Faculty of Science and Engineering, School of Creative Science and Engineering
IWASAKI, Kiyotaka Professor, Faculty of Science and Engineering, Graduate School of Advanced Science and Engineering
KOMATSUBARA, Akinori Professor, Faculty of Science and Engineering, School of Creative Science and Engineering
NOGUCHI, Haruko Professor, Faculty of Political Science and Economics, School of Political Science and Economics
SHIOZAKI, Yuji Research Associate, Comprehensive Research Organization
TAKANISHI, Atsuo Professor, Faculty of Science and Engineering, School of Creative Science and Engineering
TAKEOKA, Shinji Professor, Faculty of Science and Engineering, School of Advanced Science and Engineering
YAMAGUCHI, Nariaki Professor, Faculty of Law, School of Law
YOKONO, Megumu Associate Professor, Faculty of Social Sciences, School of Social Sciences
ZHU, Xiaodong Junior Researcher (Assistant Professor), Faculty of Science and Engineering, Waseda Research Institute for Science and Engineering

Guest Researcher / Adjunct Researcher

ARUGA, Atsushi
DEGUCHI, Atsuko
ECHIGO, Masahiro
HANAMURA, Nobuyuki
HIKICHI, Yutaka
HIRANO, Asao
IIJIMA, Kazuo
IKENO, Fumiaki
INOUE, Tomoko
ITO, Masafumi
ITOU, Junya
IWAISHI, Chie
JOKURA, Yoji
KATO, Tsugiko
KAWAKAMI, Akihiko
KAWAMOTO, Yukiyoshi
KEARON, Emi Matsuoka
KOJIMA, Shigehiro
KOKUBO, Akira
KOMINE, Teruo
KONDO, Hideyuki
KUNO, Takatoshi
MASAMUNE, Ken
MATSUMOTO, Keisuke
MATSUMOTO, Toru
MATSUMOTO, Toru
MATSURA, Yuka
MIYAJIMA, Atsuko
MORI, Mitsuko
MURAGAKI, Yoshihiro
MURASE, Gen
NAKAO, Koji
NAKAOKA, Ryusuke
NAKAYAMA, Masafumi
NOMURA, Kenichi
NOMURA, Yusuke
OKAMOTO, Yoshihiro
OKAMURA, Takayuki
ONO, Mao
ONOMURA, Akira
ORIBE, Yusuke
OTAKE, Masanori
OTSU, Hiroshi
OTSU, Ryoji
SAKODA, Hideyuki
SASE, Kazuhiro
SORIMACHI, Kazuko
TAKEDA, Keiichi
TAMURA, Manabu
TANAKA, Yutaka
TANIGUCHI, Yasuhiro
TSUBOKO, Yusuke
TSUYUKI, Kenichiro
UEMATSU, Miyuki
UEMURA, Nobuo
YAJIMA, Toshitaka
YAMADA, Naoki
YAMAMOTO, Eiichi
YAMAMOTO, Tadashi
YAMATO, Masayuki
YAMAWAKI, Masahiro
YUBA, Mitsuru

 Research Keywords
 Research Summary
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 Contact

Research Keywords

Regulatory Science, Evaluation Science, Human Pathological Simulator and System, Medical Innovation, Social Implementation

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Research Summary

The Institute for Medical Regulatory Science promotes research on the regulation of medical devices, pharmaceuticals, and regenerative medicine products, as well as non-clinical testing, clinical trials, evaluation methods, and the appropriate use of therapeutic medical devices in real-world clinical settings.
In particular, we advance research and development on experimental systems and evaluation methodologies that simulate human pathological conditions. These systems are applied to:
(1) The development of First-in-Class Class IV therapeutic medical devices
(2) The assessment of efficacy and safety in regulatory approval applications
(3) The safe and effective post-approval use of novel medical devices

Through the development and application of human pathological simulator and systems, we play a pivotal role in fostering an ecosystem that promotes both the research and development of innovative therapeutic medical devices and their societal implementation.
Furthermore, we accelerate the research and development of Class IV therapeutic medical devices, including biological decellularized tissues that are replaced by autologous tissues in vivo, driving regulatory science research to support their integration into society.
We also conduct research on the regulation of “Software as a Medical Device” (SaMD), which is expected to improve health and medical care outcomes.
Our institute includes researchers from diverse fields such as engineering, medicine, pharmacy, law, economics, ethics, business, and social sciences, along with invited researchers from academia, clinical hospitals, medical-related companies, national research institutes, government agencies, and startups.
Together, we engage in regulatory science research aimed at shaping policies for medical technologies that will contribute to a better global future.

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