Watch now: China NMPA Human Factors Engineering finalized guidelines
Trace the history of NMPA’s initiative to provide the industry with guidance on HFE, and learn more about the technical work that manufacturers must perform to satisfy NMPA’s expectations set forth in the guidance.
Webinar date
Apr. 10, 2024
Speakers
Yvonne Limpens, MS. Managing Human Factors Specialist with Emergo by UL's Human Factors Research & Design (HFR&D)
Michael Wiklund, CHFP, PE. Principal Consultant with Emergo by UL's Human Factors Research & Design (HFR&D)
Jiakun Niu, Usability Testing Engineer, Shanghai Center for Medical Testing and Inspection (CMTC)
On March 19, 2024, China’s National Medical Products Administration (NMPA) Center For Medical Device Evaluation (CMDE) released a finalized version of its guidance pertaining to the application of human factors engineering (HFE)/usability engineering. The Chinese version of the document, titled “Guideline of usability engineering review for medical devices” is available here.
Webinar participants will include representatives from Emergo by UL’s human factors team, which has China-based operations in addition to expansive ones in the U.S., EU, and U.K. A representative from Emergo by UL’s partner, the Shanghai Center for Medical Testing and Inspection (CMTC), will also participate in the webinar. CMTC is a strategic partner of Emergo by UL. We have been working together for several years to accomplish the following goals:
- Conduct in-country usability tests of medical technologies (including combination products and IVDs) under development by both domestic and foreign manufacturers to satisfy local needs. (Note: NMPA expects an HF-experienced third-party test team to conduct the summative usability test).
- Serve the needs of China-based companies that seek to meet the HFE requirements that prevail in other regions, particularly the U.S., U.K., and EU.
- Support multi-national companies that seek to meet today’s standard of care when applying HFE to medical technologies and NMPA’s human factors expectations, originally communicated in draft form but now finalized.
About the presenters
Yvonne Limpens, MS. Managing Human Factors Specialist with Emergo by UL's Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. Broadly experienced in helping companies meet international standards on HFE to gain market entry.
Michael Wiklund, CHFP, PE. Principal Consultant with Emergo by UL's Human Factors Research & Design (HFR&D) team based in the Boston, Massachusetts area. An internationally-recognized human factors expert who has contributed to multiple HFE standards followed today. Author of 10 books on human factors. Professor of the Practice at Tufts University.
Jiakun Niu, Usability Testing Engineer, Shanghai Center for Medical Testing and Inspection (CMTC). Experienced in the evaluation of multiple medical technologies in conjunction with China’s evolving HFE expectations.
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