Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States
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ORIGINAL ARTICLE Others
Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States Sara Takahashi1,2 · Kiyotaka Iwasaki1,3,4 · Haruki Shirato2 · Mami Ho2 · Mitsuo Umezu1,3,4 Received: 21 June 2020 / Accepted: 9 September 2020 © The Author(s) 2020
Abstract Further development of medical devices for children is required in Japan, but the development of such devices is delayed compared to that of medical devices for adults. Herein, we investigated policies for advancing the development of pediatric medical devices in Japan and the United States. Considering the achievements of each policy, we proposed a strategy to promote further development of pediatric medical devices in Japan. We investigated policies for supporting the development of pediatric medical devices and approved cases in Japan and the United States by searching contents of websites of regulatory bodies and other related administrations, and scientific papers. We found the main six policies in Japan and nine main policies in the United States for the development of pediatric medical devices. In the United States, various measures have initiated mainly in the 2000s, while in Japan, the main measures have been in place since 2013. Similarities were found in both countries, such as subsidies for application fees and research and development expenses, exemption of requirements for regulatory approval, and priority review and consultation by the regulatory body. Our study revealed that there are similarities in initiatives by both countries. To promote further development of pediatric medical devices in the future, improvements to expediting the review process to approval by the regulatory body, global development, and implementation of alternative measures to ensure the efficacy and safety of the device instead of large-scale clinical trials should be anticipated through cooperation among industry, government, and academia. Keywords Pediatric medical device · Regulatory measure · Regulatory science
Introduction * Sara Takahashi [email protected] * Kiyotaka Iwasaki [email protected] 1
Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women’s Medical University and Waseda University, Waseda University, 2‑2 Wakamatsucho, Shinjuku, Tokyo 1628480, Japan
2
Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Shin‑Kasumigaseki Building, 3‑3‑2, Kasumigaseki, Chiyoda‑ku, Tokyo 100‑0013, Japan
3
Department of Modern Mechanical Engineering, Graduate School of Creative Science and Engineering, Waseda University, 2‑2 Wakamatsucho, Shinjuku, Tokyo 1628480, Japan
4
Department of Integrative Bioscience and Biomedical Engineering, Graduate School of Advanced Science and Engineering, Waseda University, 2‑2 Wakamatsucho, Shinjuku, Tokyo 1628480, Japan
In Japan, the birthrate is declining, and further development of medical devices for children is needed. It is often difficult for companies to dedicate efforts on the development of pediatri
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