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 […]
Human Factors for Medical Devices in Japan: What Global Manufacturers Need to Know
As Human Factors Engineering (HFE), commonly referred to as Usability Engineering (UE) in Japan and the EU, becomes a core pillar of safe and effective medical device design worldwide, international manufacturers may find themselves asking, “How is usability evaluated in Japan?” In the US, the FDA requires a formal HFE/UE report* for most Class II […]