German UPA Publication Repository
Published August 13, 2025 | Version 1.0.0
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Unofficial Commented Translation: Guideline for Registration Review of Usability Engineering of Medical Devices (NMPA)

Creators

  • 1. ROR icon Erbe Elektromedizin (Germany)
  • 2. USE-Ing. GmbH
  • 3. EMPIANA GmbH
  • 4. ROR icon Dräger (Germany)
  • 5. ROR icon Furtwangen University
  • 6. ROR icon Spiegel Institut (Germany)
  • 7. Bayer Pharmaceuticals
  • 8. Use-lab GmbH
  • 9. ROR icon Stryker (Germany)

Description

This document (especially the commented part) is intended for human factors and regulatory professionals who need support on interpreting NMPA’s original guideline and the associated expectations when planning to register their products in China and complying with the expectations there.

This unofficial commented translation is intended to support understanding of the original Chinese content, but manufacturers are advised to use the original NMPA guideline as their reference for deriving NMPA’s expectations. In case of uncertainties and need for clarifications, readers are asked to refer to the original NMPA documents and further official sources by the NMPA.

Files

Unofficial Commented Translation Guideline for Registration Review of Usability Engineering of Medical Devices (NMPA) V1.0.0.pdf

Files (2.5 MB)

Additional details

References

  • Announcement of the Center for Medical Device Evaluation of the National Medical Products Administration on Issuing the Guidelines for Registration Review of Usability Engineering of Medical Devices (No.13, 2024) https://www.ydcmdei.org.cn/article/401accessed on Aug. 7, 2025