Insights and expertise gained from a year of applying the 2024 HF guidance

China’s medical product regulator, the National Medical Product Administration (NMPA), finalized their Human Factors (HF) guidance “Guidelines for the review of medical device usability engineering registration” in March 2024. The guidance came into effect on October 8, 2024, after a 6-month grace period. As such, manufacturers that want to market their medical products in China must meet NMPA’s HF expectations set forth in their finalized HF guidance document.

In this presentation, the presenters will briefly review the HF expectations and activities set forth in NMPA’s 2024 HF finalized guidance and share their experiences in meeting NMPA’s HF expectations during the guidance document’s inaugural year. 

The presentation will enable attendees to:

• Understand NMPA’s HF expectations and the implications for HFE practitioners regarding the scope and nature of activities and documentation work.
• Learn about various considerations that will help HFE practitioners to appropriately and efficiently scale NMPA’s HF efforts. 
• Learn from our leading HF expert’s first-hand experience in meeting NMPA expectations for a variety of products.

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.