NMPA Expectations for Applying Human Factors Engineering (HFE) to Medical Devices

March 18, 2021 | 8am CDT

Yvonne Limpens and Ryan Zhang from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the NMPA’s HFE Guideline and its implications for medical device manufacturers. During the webinar, the presenters will also cover key HFE considerations when marketing medical devices in China, US and Europe. Webinar attendees will come away with a greater understanding of how the NMPA’s HFE guidelines impact the HFE work that manufacturers must complete and will receive a "road-map to NMPA compliance" from a human factors perspective.

The webinar will include discussions of:

  • An introduction to the Chinese medical device registration process and regulation requirements.
  • The NMPA’s organizational structure, and an introduction to its recently released HFE guideline.
  • A comparison between the requirements set forth in NMPA’s HFE Guideline HFE, FDA’s HFE guidance document, and IEC62366-1

Note: This is a pre-recorded webinar.

March 18, 2021

Yvonne Limpens is a Managing Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team. 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, including use-related risk analyses. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Yvonne holds a B.S. in Industrial Design and an M.S. in Human Technology Interaction, both from Eindhoven University of Technology.

Ryan Zhang is Aisa Pacific Business Development and Marketing Manager with Emergo by UL’s Human Factors Research & Design (HFR&D) team. He has over 15 years' experience being committed to finished product strategy deployment and market expansion for medical device industry. With the plentiful business experience, Ryan owns the comprehensive view on medical device total life cycle, from protype design, market access to regulatory compliance, supporting products not only meeting markets' expectation but also regulators'. Now, Ryan is joining in Emergo by UL HFRD team, specializing in advising and training clients on how to meet regulators' expectations. He also leads co-building HFE labs in Shanghai bonded zone with CMTC, as well as  leads NMPA government affairs. Ryan holds M.S. in MBA from Shanghai Jiaotong University, and B.S. in Biomedical Engineering from Zhejiang University.