Utilization of Clinical Research in Regulatory Application for Medical Devices: Current Status and Considerations

Abstract

 This study investigates the current utilization of clinical research data in regulatory applications for medical devices and analyzes trends in products that were utilized clinical trial data. The goal is to provide insights into the potential for using clinical research data as an alternative for products that currently require clinical trials and to discuss the direction of their use. The research focused on products approved between April 2013 and March 2023 that conducted clinical evaluation for approval. Products listed on the PMDA website that utilized clinical data for regulatory applications, the number of products approved based on clinical research in Japan tended to be few. Products approved through clinical trials tend to be either high-risk with relative novelty or improved medical devices not novel in treatment but considered for trials due to changes in raw materials or similar modifications with relatively minor clinical added value, indicating no prior human use. For the latter, clinical research data conducted with sufficient consideration for reliability assurance may be an alternative to confirm efficacy and safety. The study suggests that by Ministry of Health, Labour and Welfare presenting examples of utilization according to each type of clinical evidence (clinical trials, clinical research, literature, etc.), it could facilitate the use of clinical research data in regulatory applications.