JIS T 62366 1

Healthcare professional conducting simulated usability testing with a patient mannequin in a conference room environment for PMDA human factors engineering validation in Japan
Medical Research

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 […]

Read More →
Medical device usability testing session in a simulated clinical environment with researchers observing a healthcare professional interacting with monitoring equipment
Medical Research

For International Manufacturers: Key Usability Points for Japanese PMDA Submissions 

What is Required to Market a Medical Device in Japan?  If your company is planning to introduce a medical device to the Japanese market, you may be asking questions such as:  In recent years, the PMDA has placed a clearer and stricter emphasis on usability engineering. They now require manufacturers to demonstrate compliance with JIS T 62366-1:2022, which […]

Read More →