Utilization of Clinical Evaluation Reports in Japan's Medical Device Approvals: Insights from Review Data on Approved...

Clinical Evaluation Reports (CERs) have been an accepted pathway for medical device regulatory approval in Japan, yet their utilization and the characteristics of literature included in CERs remain poorly understood. This study aimed to describe CER utilization patterns and identify characteristics to inform manufacturers and regulators about acceptable CER-based regulatory applications.

We analyzed 898 medical devices approved in Japan between FY2009 and FY2021 using clinical evidence based on PMDA public data. We compared characteristics between devices approved based on CERs and those approved based on clinical trial data among formally deliberated new devices (CER: n = 18; clinical trial: n = 125). For the 18 CER-based devices, we further analyzed cited literature characteristics.

Of the 898 devices, 257 (28.6%) were approved based on CERs, with the proportion exceeding 20% annually since FY2011. Among formally deliberated new devices, CER-based approvals were significantly more likely to be designated as high medical need devices (55.6% vs. 24.0%; p = 0.010), while regulatory review periods were comparable between groups (median 12.1 vs. 12.3 months). In the literature analysis, 7 of 18 CERs included no articles reporting clinical studies conducted in Japan, 3 lacked high-level evidence literature (systematic reviews, meta-analyses, or RCTs), and 6 utilized literature on prior-generation or similar devices.

CER-based approvals have increased steadily since FY2009. The literature cited showed diversity in source and level of evidence, suggesting that PMDA evaluates submissions based on device characteristics. These findings provide a descriptive reference for manufacturers planning CER-based submissions and regulators in Japan.