Conducting Usability Tests in China for NMPA: An Overview of Considerations Based on Past Learnings

Watch this webinar to learn about planning and conducting usability tests in China for the National Medical Products Administration (NMPA) based on past learnings.

The presenters share insights about NMPA’s human factors engineering (HFE) guidelines and their implications for medical device manufacturers. During the webinar, the presenters also share tips for conducting usability tests in China for NMPA, as well as pitfalls to avoid based on recent experience.

Gain a greater understanding of how the NMPA’s HFE guidelines impact HFE work and the best ways to plan and conduct usability tests in China for NMPA.

Key topics covered:

  • An introduction to NMPA’s HFE guidelines
  • An overview of the HFE requirements outlined in the NMPA’s HFE guidelines
  • Considerations and best practices on conducting usability tests in China for NMPA based on past learnings

Presenters:

Ken Yoshida

Ken Yoshida is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Tokyo, Japan. He has been with the team since 2015 and specializes in medical device technology. Yoshida occasionally delivers public seminars to advocate the importance of applying HFE to medical device development in Japan. Yoshida holds a bachelor’s degree in computer science and psychology from Indiana University Bloomington, a Master of Education in community counseling from Loyola University Chicago, and a doctorate in Kinesiology specializing in human factors from the University of Minnesota.


Yvonne Limpens

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device, pharmaceutical and laboratory equipment industries. Limpens leads and oversees research activities and helps customers develop key HFE documents for their design history files. Furthermore, she advises and trains customers to apply HFE during product development to meet regulators' expectations. Limpens holds a bachelor’s in Industrial Design and a master’s in human technology interaction, both from Eindhoven University of Technology (NL).

This webinar was recorded on April 20, 2022.

 

Additional resources:

New medical device usability testing rules from China NMPA

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

China regulatory roundup: Latest guidelines for medical device and IVD compliance