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Unofficial Commented Translation: Guideline for Registration Review of Usability Engineering of Medical Devices (NMPA)

Year: 2025

Type: article

Abstract: 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.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.16758440

Authors: Homans, Hendrik, Janny, Benedikt, Engler, Michael, Haeusler, Andrea, Pfeffer, Stefan, Reisemann, Matthias, Schauderna, Florian, Schwenke, Stephanie, Stangenberg, Martin

Institutions: Erbe Elektromedizin (Germany), Dräger (Germany), Furtwangen University, Spiegel Institut (Germany), Stryker (Germany)

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

Open Access status: green

OpenAlex ID: W6930818783

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