A Comparative Analysis of the Regulatory Framework and Collaborative Environment for Pediatric Medical Device Development in Japan and the United States: Identifying Challenges, Support Mechanisms, and Emerging Opportunities

Author:

T R Priyanka,Kumar Sudheer,R Kamaraj

Publisher

Springer Science and Business Media LLC

Reference24 articles.

1. CDRH management directory by organization. (2020). Accessed. June 17, 2020: https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization.

2. Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States;Takahashi S;J Artif Organs,2021

3. Pediatric medical device development and regulation: current state, barriers, and opportunities;Espinoza J;Pediatrics,2022

4. Partnership between Japan and the United States for early development of pediatric medical devices-harmonization by doing for children;Takahashi S;Circ J,2020

5. List of approved new medical devices. (2020). Accessed. June 17, 2020: https://www.pmda.go.jp/review-services/drug-reviews/review-information/devices/0018.html.

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