Usability Validation (or user error evaluation)

Since 2024 there is a new challenging for high risk medical device (16 product types) to make a usability (human factor) test in CHina. For other middle and low risk medical device either a existing home country evidence of usability report or a kind of user error evaluation is for Chinese registration essential.

Usability  is not just a test or a report for registration — it is embedded throughout the entire medical‑device lifecycle. It is closely linked to risk management, design inputs and outputs, verification and validation, clinical evaluation, post‑market surveillance, complaint handling, and real‑world use analysis. Manufacturers are expected to use usability engineering to identify user‑related risks, design safer and more intuitive interfaces, and ensure that devices support user‑friendly operation. Ultimately, companies that treat usability as a strategic design element can even position it as a differentiating product feature.

Which product is applied for Chinese usability validation?

The usability guidance of medical device is valid as of Oct.2024. So far only for 16 product codes it is obligatory to have a Chinese usability study:

Category Code | Product Name

01-03-02 01-03-04 Cardiac Radiofrequency Ablation Equipment; Cardiac Radiofrequency Ablation Catheter; Cardiac Surgical Radiofrequency Ablation Equipment; Cardiac Surgical Radiofrequency Ablation Forceps/Pen

01-07-01 Surgical Navigation and Positioning System (with robotic arm and end effector)

01-07-03 Endoscopic Surgical System; Vascular Interventional Surgical Control System

08-01-01 Therapeutic Ventilator

08-01-04 Home Ventilator

08-03-01 External Defibrillator

10-03-01 Hemodialysis Equipment

10-03-02 Continuous Blood Purification Equipment

10-03-04 Artificial Liver Equipment

12-04-02 Implantable Circulatory Assist Devices

12-04-03 Implantable Drug Infusion Devices

14-01-01 Infusion Pump (Class III)

14-01-03 Needle-free injector

14-02-01 Infusion pump (Class III)

14-03-02 Insulin pump (Class III)

Here are the chapter in template of usability report after study in China:

• Basic information
• Level of use risk including justification
• Core elements (e.g., users, use scenarios, and user interfaces)
• Usability engineering process
• User interface requirements specification
• Risk management based on post market
• Verification and validation of the user interface 
• Traceability analysis of user interface
• User training protocol
• Conclusion

User error validation for non high risk device

At least for initial registration of middle and low risk medical device either existing usability report or a kind of evaluation of use error must be submitted, here are main chapters for Chinese user error evaluation:

• Basic information
• Level of use risk including justification
• Core elements (e.g., users, use scenarios, and user interfaces)
• Analysis of post-market use problems of similar medical devices
• Risk management based on post market
• Conclusion

Pathway of usability evidence in China

Below is a deciding tree which usability evidence is needed for.manufacturers willing to have market access of medical device in China:

When to revise usability evidence at change registration?

Substantial changes to the users, usage scenarios, or user interface of medical devices typically involve one or more changes to matters stated in the registration certificate, such as the scope of application, structural composition, or product technical requirements. An application for change registration should be submitted in such cases.

There is no need to submit any usability data at renewal every 5 years.

What is equivalent international standards or guidance?

The chinese usability requirement is not invented. It is derived from many international standards as below:

IEC 62366-1:2015+A1:2020, Medical devices - Part 1: Application of usability engineering to medical devices

FDA: Applying Human Factors and Usability Engineering to Medical Devices, 2016

International comparison:

China, the United States, and the European Union all regulate medical‑device usability based on product risk, but they differ in how they define user groups, critical tasks, and documentation requirements. The U.S. relies on detailed FDA human‑factors guidance and ANSI standards, while the EU primarily uses IEC 62366 and IEC 60601‑1‑6 without issuing its own dedicated usability guideline. China has now issued its own 2024 usability engineering guideline, which is more detailed than the EU approach and was introduced earlier than the U.S. risk‑based submission framework, with stricter distinctions by risk level and a narrower focus on medical users.

Important definition among Chinese usability validation

The following definitions are key to understand Chinese usability and more or less similar to FDA guidance Applying Human Factors and Usability Engineering to Medical Devices, 2016.

Medical device usability engineering refers to the comprehensive application of knowledge about human anatomy, physiology, psychology, behavior, and culture to design and develop medical devices to enhance their usability.

Usability refers to the user interface characteristics that ensure the safety, effectiveness, and ease of use of a medical device when used normally by the intended user in the intended use scenario. The core elements of usability include the user, the use scenario, and the user interface, focusing on the safety and effectiveness of the medical device's normal use.

Users refer to all personnel who interact with the medical device as specified by the registration applicant, and can be divided into multiple user groups based on user characteristics. The guiding principles focus on users/user groups who operate the medical device to achieve its intended purpose, including medical personnel, patients, and home care workers, as well as personnel involved in medical device sterilization and disinfection.

Usage scenarios refer to the actual use scenario factors of the medical device as specified by the registration applicant, including the use environment and operational tasks. The use environment refers to the actual environment in which the user operates the medical device, including the place of use and environmental conditions. Operational tasks refer to the actions or sequences of actions taken by the user to achieve a specific goal, which can be divided into critical tasks, urgent tasks, and routine tasks. The guiding principles focus on operational tasks related to medical activities, based on critical tasks, especially critical tasks that are also urgent or routine tasks. The user interface refers to all objects and methods by which a user interacts with a medical device, including but not limited to the device's shape, size, weight, display, feedback, connection, assembly, operation, control, instruction manual, labels, packaging, and user training materials.

Considering the difficulty in statistically assessing the probability of injury caused by usage risks at the implementation level, medical device usage risks are categorized into three levels based on the severity of the injury: high, middle, and low. These represent levels where incorrect use may result in serious injury or death, may result in minor injury, and is unlikely to result in injury, respectively.

The user interface (i.e., the user interface) refers to all objects and methods of human-machine interaction between the user and the medical device.

Critical tasks are operational tasks where user action or lack of action may lead to serious injury or death.

Urgent tasks are operational tasks that require immediate user intervention for medical intervention; conversely, non-urgent tasks are those that do not require immediate user intervention.

Contact us to make a usability test in China, edit usability report for high risk device and edit user error report for middle and low device.

We speak global compliance and can easily find gap and switch form your existing usability data. Otherwise use our template, we have non finding guarantee till product approval.