Sample Size and Test Environment Requirements for PMDA HFE Submission: A Practical Guide for Validation Studies in Japan
PMDA’s overall HFE mindset is aligned with international regulatory frameworks, but expectations in certain areas can differ. In particular, PMDA takes a distinct approach to topics such as sample size determination and test environment considerations. This guide outlines key points based on the implementation of JIS T 62366-1:2022 and current PMDA expectations. Sample Size PMDA does not […]