International Comparison of Reporting Systems for Medical Device Malfunctions

Abstract

 When using medical devices in clinical practice, there are limits to the ability to ensure the safety of patients and users with the safety risk information obtained before marketing, subject to conditions regarding target patients and usage conditions. Malfunction reporting systems allow post-marketing malfunctions of medical devices or health effects on patients from approved medical devices to be reported to regulatory authorities. Such systems are established by law not only in Japan, but also in other countries and require marketing authorization holders to report to regulatory authorities according to certain criteria. Compared with overseas systems, reporting criteria for malfunction reports were found to be fragmented in Japan.