NMPA’s New Standard Brings Devices Usability Engineering in Line with Global Practices

NMPA issued the draft standard “Medical Devices – Part 1: Application of Usability Engineering to Medical Devices” on August 28, 2025 for feedback. Feedbacks need to be submitted by October 27, 2025. The document represents China’s adoption of the internationally recognized IEC 62366-1:2020 framework and FDA guidance of “Applying Human Factors and Usability Engineering to Medical Devices”.

The draft standard defines a process that integrates human factors into design, connects usability to risk management, and demands clear evidence of compliance through documentation and evaluation.

While the immediate goal is to minimize safety risks from use errors, the standard also promotes broader usability benefits that improve efficiency, accuracy, and user satisfaction. Its strong alignment with international norms facilitates global collaboration and supports manufacturers seeking to enter the China market.

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For NMPA’S Interpretation on Device Usability Engineering Guideline, click HERE

Scope of Application

The standard specifies a structured process that manufacturers must follow to analyze, specify, develop, and evaluate the usability of medical devices in relation to safety. The focus is on normal use, including both correct use and foreseeable use errors. The framework does not cover deliberate misuse outside manufacturer control.

While the primary focus is safety, the methodology can also contribute to broader usability goals such as efficiency, task accuracy, and user satisfaction, which often overlap with commercial advantages in competitive markets.

Key Principles

The document sets out several core principles for usability engineering:

1. Usability Engineering Process – Manufacturers must implement a defined process covering user needs, interface design, evaluation, and documentation. The outcome should be an evidence-based usability engineering file.
2. Risk Control in User Interface Design – Hazards linked to device use must be controlled in priority order: inherent safe design, protective measures in the device or process, and—only if necessary—safety information and training.
3. Safety Information – When safety information is used as a risk control measure, it must be perceptible, understandable, and effective in guiding correct use for the intended users and environments.
4. Documentation – Results of usability activities must be captured in a usability engineering file, which may be integrated into design or risk management documentation.
5. Customization of Workload – The depth and methods of usability work may vary depending on device complexity, risk severity, scope of use, and whether the device incorporates interfaces of unknown provenance (UOUP).

Usability Engineering Process

The standard outlines a step-by-step process that manufacturers are required to follow:

1. Use Specification – Define intended medical indications, patient populations, body sites, user characteristics, use environments, and device principles. This is sometimes called the “intended use statement.”
2. Identification of User Interface Characteristics and Use Errors – Determine aspects of the interface that affect safety and anticipate potential errors based on foreseeable conditions.
3. Hazard and Hazardous Situation Identification – Link potential use errors to possible hazards, such as loss or degradation of clinical performance.
4. Use Scenarios – Describe foreseeable sequences of user tasks and device responses, including those related to hazardous situations.
5. Selection of Scenarios for Summative Evaluation – Choose representative scenarios that must be tested to validate usability under realistic conditions.
6. User Interface Specification – Develop comprehensive and forward-looking requirements for the user interface.
7. Evaluation Planning – Prepare a strategy including formative evaluation (iterative testing during design) and summative evaluation (final validation).
8. Design, Implementation, and Formative Evaluation – Iteratively build and test prototypes to refine usability.
9. Summative Evaluation – Confirm that final design meets usability objectives, especially those related to safety.
10. User Interfaces of Unknown Provenance (UOUP) – Apply special evaluation procedures to legacy or inherited interfaces where documentation is incomplete.

Risk Management

The usability engineering process is explicitly connected to the broader risk management system described in GB/T 42062—2022. Hazards are prioritized and mitigated through design, protective measures, or information. Residual risks must be evaluated, documented, and integrated into overall risk assessment.

Importantly, the usability process does not only focus on safety. It also creates opportunities for better task performance, efficiency, and user satisfaction, which can support broader goals of innovation and competitiveness.

Supporting Information

The standard includes several annexes:

• Annex A provides general principles and rationale behind requirements, aiding correct interpretation and future adaptation.
• Annex C describes evaluation of user interfaces of unknown provenance.
• Annex D categorizes types of device use, with illustrative examples.
• Annex E cross-references the standard’s clauses with the essential safety and performance principles of ISO 16142-1 and ISO 16142-2, ensuring consistency with international frameworks.