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.
NMPA Expectations for Applying Human Factors Engineering (HFE) to medical devices
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
Yvonne Limpens | Managing Human Factors Specialist
Ryan Zhang | Business Development & Marketing Manager