Takahashi Sara, Iwasaki Kiyotaka, Shirato Haruki, Ho Mami, Umezu Mitsuo
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.
Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
J Artif Organs. 2021 Mar;24(1):90-101. doi: 10.1007/s10047-020-01216-6. Epub 2020 Oct 20.
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.
日本需要进一步发展儿童医疗设备，但与成人医疗设备相比，此类设备的开发有所延迟。在此，我们调查了日本和美国推进儿童医疗设备开发的政策。考虑到各项政策的成果，我们提出了促进日本儿童医疗设备进一步发展的策略。我们通过搜索监管机构和其他相关管理部门的网站内容以及科学论文，调查了日本和美国支持儿童医疗设备开发的政策及获批案例。我们发现日本有六项主要政策，美国有九项主要政策用于儿童医疗设备的开发。在美国，各项措施主要始于21世纪初，而在日本，主要措施自2013年起实施。两国存在相似之处，例如申请费和研发费用补贴、免除监管批准要求以及监管机构的优先审评和咨询。我们的研究表明两国的举措存在相似性。为了未来促进儿童医疗设备的进一步发展，预计应通过行业、政府和学术界的合作，改进加快监管机构审批的审评流程、全球开发以及实施替代措施以确保设备的有效性和安全性，而非进行大规模临床试验。
