THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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.
What you will learn
How NMPA reviewers are applying HFE expectations and trends across submissions
What HF documentation should look like for China submissions
Common challenges manufacturers encounter when aligning HF programs with China‑specific expectations
Practical tips to address gaps, reduce review cycles and strengthen submissions
Watch now: Beyond the guidance: Lessons from applying two years of NMPA HFE guidance
Webinar date
May 29, 2026
Speakers
Yvonne Limpens, Managing human factors specialist
Julee Henry, Lead human factors specialist
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This webinar is designed for regulatory affairs professionals supporting China market access, Human Factors and usability engineering teams, quality and compliance leaders overseeing global submissions, product development and clinical teams involved in usability validation, and manufacturers planning or preparing NMPA submissions under the HF guidance.
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