Access to the Chinese medical device market offers great potential—but it also comes with specific requirements, particularly in the area of usability. The National Medical Products Administration (NMPA) places great emphasis on human factors engineering (HFE) and usability testing to ensure the safe use of medical devices.
In this article, we outline the key aspects you need to consider in order to understand and successfully implement the NMPA’s requirements.
Among other things, we answer the following questions:
- For which products must usability studies be conducted?
- What are the requirements for demonstrating usability?
- Does the NMPA provide any assistance in meeting these requirements?
- What are the requirements regarding labeling and training?
Read on to learn how you can meet the NMPA’s usability requirements and thereby support your product’s approval for the Chinese market.
What is the NMPA, and what role does it play in usability?
The National Medical Products Administration (NMPA) is China’s central regulatory authority for the approval and oversight of medical devices and pharmaceuticals. It ensures that all medical devices placed on the market in China meet strict safety and efficacy standards.
The NMPA plays a significant role in usability studies for medical devices: It requires manufacturers to implement detailed human factors engineering (HFE) processes to ensure the usability and safety of medical devices. This often includes specific usability tests that must be conducted with Chinese users to ensure that products are safe and effective for Chinese users under real-world conditions. The NMPA evaluates these studies as part of the approval process and requires comprehensive documentation demonstrating that potential user errors have been minimized and that the products have been adapted to the specific requirements of the Chinese market.
Where can I find information on usability requirements for the Chinese market?
Information on the NMPA’s usability requirements for the Chinese market can be found in the “Guideline of Usability Engineering Review for Medical Devices.” These guidelines explain the usability and safety requirements for medical devices on the Chinese market and the documentation required for human factors engineering (HFE). They cover the entire process, from risk analysis to formative and summative evaluation. The requirements are based on international standards such as IEC 62366-1, but include additional country-specific adaptations, such as conducting evaluations in China with Chinese users and the minimum requirement of 15 participants per user group.
There is no official English translation of this guideline issued by the NMPA, but unofficial translations can be found online. Please note that these are for informational purposes only and do not have official status.
Is there an NMPA pre-submission process similar to the one at the FDA?
Similar to the FDA, the NMPA offers pre-submission meetings where manufacturers can ask questions about the requirements of the approval process. These pre-submission meetings are particularly helpful for clarifying questions regarding the applicability of usability requirements and specific study requirements. During these meetings, manufacturers can discuss the study requirements with NMPA representatives and receive formal feedback.
As with the FDA, these meetings are generally free of charge. However, there are a few rules to follow to ensure that the meeting goes smoothly. These include, among other things, planning well in advance, thorough preparation, a solid understanding of current guidelines, and appropriate behavior during the meetings.
Do I always have to conduct a usability study?
Whether it is necessary to conduct usability studies for the Chinese market depends on several factors. These include the product’s risk classification, the possible existence of equivalent products, or whether relevant product changes have been made to an already approved product.
The NMPA attaches particular importance to Human Factors Engineering (HFE) for medical devices that pose a high risk of misuse – that is, products where incorrect operation could lead to serious injury or death.
If equivalent medical devices are already available on the Chinese market and their usability has been demonstrated, it may be possible to waive the requirement for separate usability studies under certain conditions. However, this requires that equivalence be demonstrated from a technical, biological, and clinical standpoint and that there be unrestricted access to the technical documentation of the reference product.
For existing products that are already approved for the Chinese market, new studies may be required if substantial changes are made to the product design, user interface, or user group. Changes that pose new risks during use must be tested to ensure that the changes do not have a negative impact on safety during use.
Therefore, it is not always absolutely necessary to conduct usability studies; however, manufacturers should carefully assess whether their product falls into one of the categories listed above in order to meet the NMPA’s requirements.
Do I need to conduct usability studies in China?
Yes and no. For imported products that pose a high risk of misuse, the NMPA generally requires that usability studies be conducted in China to ensure that the product is suitable for the Chinese market. This is particularly true when cultural differences or adaptations for Chinese user groups are relevant.
It is not necessary to conduct a study in China if the manufacturer can demonstrate that the product is safe even when cultural differences are taken into account and that user behavior in the target market does not require any significant adaptation. To this end, comprehensive international data and analyses must be submitted to demonstrate that the safety and usability requirements of the Chinese market are fully met.
For products that do not pose a high risk of use and for which no unacceptable risks have been identified, studies conducted in the manufacturer’s country may be sufficient.
Who is responsible for organizing the study program in China?
Usability testing for products with a high risk of use is typically organized by certified local partners or authorized third-party providers who are familiar with the NMPA’s requirements. These partners coordinate and conduct the usability tests, often in collaboration with the manufacturer, to ensure that all tests and documentation meet the requirements.
Manufacturers often collaborate with CROs (Contract Research Organizations) that specialize in the Chinese market and hold the necessary certifications to conduct clinical trials. These organizations ensure that all trials are conducted in accordance with NMPA guidelines and that the results are properly documented.
Usability studies—including those for products with a moderate risk of use—must not be conducted by the manufacturer’s stakeholders. In such cases, manufacturers often turn to specialized usability agencies, such as Custom Medical, for study planning, coordination, and support.
What is the required scope of usability studies in China?
Usability studies for the Chinese market must be comprehensive enough to cover all relevant user groups and minimize critical usage errors. The NMPA specifies the number of participants (e.g., at least 15 participants for simple user groups) and requires that all critical and frequently used use cases be covered. These studies must also focus on the specific context and requirements of Chinese users.
How do I define the right user group for the Chinese market?
To obtain approval, you must demonstrate that the target audience can use your product safely. The Chinese market regulatory authority expects a broad test group that represents the country’s diversity in terms of age and education. For products used by healthcare professionals, you should also define user profiles and recruit appropriate test subjects.
For consumer products, it is particularly important to assemble a representative test group that includes users with less technical experience. Custom Medical is happy to assist you in recruiting the right users to ensure that your target audience is represented in the test.
What kind of usage environment is required for usability testing in the Chinese market?
A realistic environment is crucial for testing your product’s usability under realistic conditions. For example, if your product is used in a busy environment such as an urban hospital, you should ensure that comparable noise levels and distractions are present during testing. Keep in mind that requirements for the usage environment in the Chinese market are, in some cases, stricter than in other countries.
What specific labeling requirements for my medical device do I need to consider for China?
All labels and instructions for use must be written in simplified Chinese to ensure that they are understandable to the target audience. The information should be precise and easy to understand to avoid misinterpretations. This includes the use of clear symbols and pictograms that are internationally recognized and interpreted in a culturally appropriate manner.
Since cultural differences influence user behavior and expectations, manufacturers should be aware of whether specific colors, symbols, or terminology are interpreted differently in China and how this might affect usability.
In addition, the labeling must comply with the NMPA’s specific requirements, including the product name, model, manufacturer information, date of manufacture, expiration date, and relevant warnings.
What are the requirements for training materials?
The NMPA requires that training materials for medical devices be written entirely in simplified Chinese to ensure that the target audience can use them clearly and easily.
These materials must include all safety-related information, such as instructions for operation, maintenance, and troubleshooting, as well as specific safety warnings. In addition, cultural adaptation is necessary to ensure that symbols and examples are easily understandable and appropriate for Chinese users.
The materials must also comply with current NMPA guidelines and should be updated regularly to ensure smooth and safe product use.
Are there any specific requirements for documenting usability tests for the NMPA?
The NMPA requires comprehensive documentation of the usability engineering process, covering all phases from planning through implementation to evaluation. Manufacturers must prepare detailed test plans that clearly define tasks, methods, and success criteria, and maintain records that transparently document the course of the study and its results.
The selection of test participants must be representative of potential Chinese users to ensure that the results are applicable to the target audience. The test results must be analyzed in a structured report that describes usability issues, their causes, and proposed measures for risk mitigation, and these findings must be incorporated into the product’s risk management.
Cultural and linguistic aspects must also be taken into account in the documentation, as the tests are intended to reflect the conditions of the Chinese market as realistically as possible.
Conclusion
Access to the Chinese market offers significant potential for medical device manufacturers, but requires a thorough understanding of the NMPA guidelines on usability testing and human factors engineering.
Although the NMPA’s requirements for usability studies are closely based on international standards such as IEC 62366-1, they include specific adaptations that must be taken into account. Among other things, this includes the requirement that usability tests be conducted with Chinese users in order to account for cultural, linguistic, and system-related differences. Labeling, documentation, and training materials are also subject to clear requirements that go beyond international standards.
For manufacturers, this means:
- Planning usability tests early on is crucial to avoiding delays in the approval process.
- Selecting the right user groups is essential—for testing to be successful, the tests must be representative of the Chinese target audience.
- The study should be conducted with the support of local experts or specialized agencies to ensure that the NMPA’s requirements are fully met.
- Pre-submission meetings with the NMPA can be useful for clarifying open questions and coordinating study requirements at an early stage.
- The documentation must be complete and transparent, as the NMPA requires a detailed review of all supporting evidence.
Those who address NMPA requirements early on, develop a well-founded usability strategy, and collaborate with the right partners can not only streamline the approval process but also ensure that the product is optimally tailored to the needs of Chinese users.
Do you need assistance in implementing the NMPA usability requirements? We’d be happy to help you plan, conduct, and document your usability studies for the Chinese market.
