Beyond the Guidance: Lessons from Applying Two Years of NMPA HFE Guidance

Since October 2024, China’s National Medical Products Administration has formally applied its Human Factors Engineering (HFE) guidance across medical device submissions. Two years later, manufacturers are still navigating how those expectations translate into documentation, testing strategies and regulatory outcomes.

This webinar goes beyond theory to share what has actually happened inside submissions reviewed by NMPA. Drawing on Emergo’s direct experience supporting HFE submissions across device categories, we will break down how the guidance is being interpreted, where reviewers are focusing their feedback, and what successful documentation looks like.

About our presenters

Yvonne Limpens, Managing human factors specialist

Yvonne Limpens is a Managing Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Arnhem, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device, pharmaceutical, and laboratory equipment industries. Yvonne leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations across the globe, including in the United States, Europe, China, and Japan. Yvonne holds a B.S. in Industrial Design and an M.S. in Human Technology Interaction, both from Eindhoven University of Technology (NL).

Julee Henry, Lead human factors specialist

Julee Henry is a lead human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Raleigh, North Carolina. She has been with the team since 2022 and has 12 years of experience leading HFE activities, user interface design, conducting user research, and leading multidisciplinary user experience teams in the US and in China. Julee advises clients on global regulatory strategies, conducts user research and usability testing, and develops key human factors analyses and documentation for regulatory submission. Having lived in Shanghai, China for three years, developing digital and physical user interfaces, she understands the challenges and complexities of global product development and regulatory compliance. She holds an M.S. in Human Factors Engineering from Virginia Tech.