2025 Volume 95 Issue 4 Pages 432-445
The Japanese Ministry of Health, Labour and Welfare established a new system for the remanufacturing of single-use devices (SUDs) on July 31, 2017, and issued a notice under the Pharmaceutical Affairs Law. However, the use of remanufactured SUDs has not yet become widespread in Japan. To identify issues related to remanufactured SUDs, a questionnaire survey was conducted among medical institutions and medical device companies. The survey revealed various issues, such as concerns about the quality and safety of remanufactured SUDs and the perception that the process is cumbersome and has few advantages. Based on these findings, an additional fee for the use of remanufactured SUDs was included in the 2024 revision of medical fees to provide financial incentives for medical institutions. However, many challenges remain, and efforts to promote the adoption of remanufactured SUDs will continue to be crucial.
