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.
Highlights
In Japan, the birthrate is declining, and further development of medical devices for children is needed
We investigated the purpose of each policy and the status of utilization for approval of pediatric medical devices based on public information including the Food and Drug Administration (FDA) website
As for the pediatric medical device designated in the “SAKIGAKE Designation System”, a domestic clinical trial for the pediatric medical device has started to obtain evidence for regulatory approval [22]
Summary
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 pediatric medical devices because of the small number of patients in the pediatric field, complicated disease conditions, difficulties in assessing efficacy and safety of pediatric medical devices, and the necessity of multiple device variations. For class II devices, no review standard exists, while for medium-risk (class III), and high-risk (class IV) medical devices, a marketing holder requires marketing approval from the Minister of Health, Labour and Welfare (MHLW). Medical devices reviewed by the PMDA are classified as “Brandnew,” “Improved,” and “Me-too” medical devices. Brandnew medical devices are defined as those that have a novel structure, usage, indication, or performance compared to other medical devices approved in Japan regardless of their class. In the United States, the Center for Devices and Radiological Health in the Food and Drug Administration (FDA) is responsible for the review of all medical devices [2]
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