New NMPA Human Factors Guidelines for Medical Devices in China: What Manufacturers Need to Know
Jul 27, 2022
Introduction
Updated August 2024
The National Medical Products Administration (NMPA) is the Chinese agency that regulates medical devices and drugs. On October 8, 2024, China's National Medical Products Administration (NMPA) will implement new guidelines on the application of human factors and usability engineering to medical devices in China. This article provides an overview of the NMPA guidelines, and highlights differences between the Chinese NMPA guidelines and the 2016 FDA human factors guidance.
Note: This summary is based on translations of the guidelines provided by Cisema and Microsoft Word's translation feature.
Purpose of the NMPA Draft Human Factors Guidance
The Chinese NMPA guidelines is intended to provide a framework for the human factors design process and the necessary submission information for medical device manufacturers. These guidelines also emphasize the importance of considering cultural, educational, and medical practice differences in China when designing medical devices. These human factors guidelines are based on current standards and FDA guidance:
IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices.
IEC/TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices.
ANSI/AAMI HE75:2009/(R2018) Human factors engineering – Design of medical devices.
FDA, Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff, 2016.
The new NMPA guidelines additionally expands on these existing human factors standards and FDA guidance with some details specific to the Chinese market.
Human Factors Process in the Chinese NMPA Draft Guidance
The NMPA defines “human factors” as the use of knowledge around human, “anatomy, physiology, psychology, behavior, and other human factors” [2] to design medical devices with enhanced usability.
The overall human factors process outlined in the NMPA guidelines has many parallels to the FDA human factors guidance. The NMPA guidelines suggest that manufacturers should consider the users, user interfaces, and the use environments. These considerations align with the FDA guidance as shown in Figure 1.
Figure 1. Human Factors Considerations from FDA Guidance [1].
Human Factors Tools and Methods in the NMPA Draft Guidance
There are various human factors tools and methods that the NMPA guidelines recommends for manufacturers to use throughout the device design process. The following tools and methods can be used to help ensure human factors engineering considerations are incorporated into the medical device design:
Interviews and questionnaires of the target users or users of a similar device.
Task analyses to determine the tasks required for the users to operate the device and any possible risks associated with these tasks (Failure Modes Effects Analysis (FMEA) and Fault Tree Analysis (FTA) are recommended tools for task analysis in the Chinese NMPA draft human factors guidance).
Expert reviews of the design by human factors and/or clinical experts.
Usability testing to gain feedback on potential use errors earlier in the design process.
The NMPA guidelines recommends that the specific human factors tools and methods used should be chosen to best fit the medical device being developed. Many of the tools and methods in the NMPA guidelines are also recommended in the FDA guidance. In both guidance documents, a final summative or validation study is required once the device design is finalized to exhibit it is safe and effective before it is approved for use on the market.
Four (4) Key Differences between the Draft NMPA and FDA Human Factors Guidance
1. Device and User Scope
The updated NMPA guidance includes all medical devices, including combination products, while excluding in vitro diagnostics (IVDs). The NMPA guidelinesstate that only Class II and Class III medical devices are in scope, whereas the FDA human factors guidance does not specifically state which types of devices are in scope. Additionally, the NMPA guidelines state that personnel who install, maintain, or dispose of devices are not currently in scope of the guidance. In contrast, the FDA guidance states that device users can include users such as a(n) “installer, maintenance staff member, reprocessor, [or] disposer” [1]. Therefore, there may be some medical devices or users covered by the FDA human factors guidance that would not be in scope of the Chinese NMPA draft human factors guidance.
2. Sample Sizes for Usability Studies
The NMPA guidelines have slightly different recommendations than the FDA guidance around sample size for both formative, and summative or validation studies. See Table 1 for specifics on the sample sizes between the two human factors guidance documents.
Table 1. Sample Size Recommendations for Human Factors Studies
3. Comparative Evaluation
The Chinese NMPA guidelines contain a section on performing comparative evaluations on new and existing medical devices. Equivalent devices are defined in the guidelines as having the same or equivalent intended use, target population, user groups, user characteristics, use environments, tasks, user interfaces, etc. The purpose of the comparative evaluation is to leverage human factors data for existing medical devices on the Chinese market when submitting for a new device. The two steps in the process of a comparative evaluation include:
Determining what the differences are, if any, between the devices being compared.
Gathering information on any adverse events, recalls, or post-market problems with the existing on-market medical device to determine if there are any new risks associated with that device that need to be considered with the new device.
Different levels of documentation are required based on the device differences and risks, as outlined in Table 2.
Table 2. Documentation Requirements for Comparative Evaluation
The FDA human factors guidance recommends researching known use problems of similar devices to help guide the design process. Leveraging existing validation study data can only be done for direct modifications of an existing device under the FDA guidance.
4. Testing with Chinese Users
The Chinese NMPA guidelines state that the medical device is not guaranteed to be safe and effective in China because the use environment, users, and applications may be different in China than in other countries. Furthermore, the device may not be safe and effective when introduced in the Chinese market even if it has been proven as such in other countries.
The NMPA guidelines recommends performing human factors validation testing in China with Chinese users unless detailed proof can be provided that the differences between countries do not impact human factors. In contrast, the FDA human factors guidance requires that the participants of human factors validation testing be U.S. residents, so this could be an important consideration for manufacturers looking to transfer an existing product from the U.S. (or another country) into the Chinese market.
NMPA Draft Guidance vs. FDA Guidance
There are many similarities between the FDA human factors guidance and the NMPA guidelines. The two guidance documents largely follow the same processes to incorporate human factors concepts into the medical device design process. However, there are some differences that manufacturers should consider when taking a device into the Chinese market. Manufacturers should consider the users and use environments that may be specific to a medical device’s use in China.
Next Steps
With the October 8, 2024 implementation date approaching, manufacturers should prioritize obtaining a translated copy of the regulations and verifying device classification in China. An external human factors specialist, on-site studies in China and a report submitted in Chinese, are critical, but not all encompassing, steps for compliance with the new NMPA guidelines.
Q&A Session with Louisa Harvey, Principal and Founder at ClariMed
What are your thoughts on China releasing their own human factors medical device guidance?
It is important manufacturers to know their intended population and use environment. It’s therefore not surprising that countries expect to see evidence of this, and I can imagine that there will be more countries who decide to go down this route. Patient safety is critical, and usability has a major part to play in this. Cultural and educational differences can be huge and combined with different medical practices means that one product which can fly (in terms of preference, usability, and safety) in one country yet might not in another. We see this time and time again through low sales adoption, customer complaints and product recalls.
With the October 8, 2024 effective date for the new NMPA Guidelines, what should manufacturers focus on to ensure they are fully compliant?
There are some key differences manufacturers need to be aware of in the China guidelines versus the FDA guidance, FDA regulations, and IEC 62366-1. For example, checking how your device is classified in China is very important. If you don’t know, we’d suggest asking the NMPA because the device classification is imperative to your success in submitting what is required and will hopefully prevent manufacturers falling into costly pitfalls. The China regulations include all medical devices, including combination products, but not in vitro diagnostics. If required, Summative research if required must be conducted in China by a human factors specialist who is not an employee of the client company unless you can prove that they had no involvement in the design and development of that device. All documents must be translated and submitted in Chinese. There are also new terms in there, such as the use of ‘high use risk’ and ‘high risk’, it is important manufacturers understand the difference. There are also other important considerations such as where the device was designed and where and when it has previously been launched since this will impact the human factors effort required.
Overall, the new China regulations are clear about what is expected from manufacturers. I would firstly get hold of a translated copy – feel free to get in touch with us and we’ll happily provide one! The guidelines have a similar feel to the FDA guidelines but have supplementary information similar to IEC 62366 part 2.
Could you share insights on the practical challenges of conducting human factors studies in China, particularly regarding participant recruitment and cultural considerations?
Over the years, ClariMed has worked on a multitude of studies in China. We also have fantastic, trusted partners who we work with. Recruitment for any research is imperative and can completely derail the study objectives and timeline when recruiters don’t have a proactive attitude. When interviewing on your home ground or overseas, you need to be aware of cultural etiquette and be mindful to thoroughly research the country you will be interviewing in. ClariMed actually runs a great training on this.
Where are Validation/Summative studies conducted?
We conduct studies in a facility in Beijing or Shanghai depending on our clients’ preferences. Contrary to some beliefs, the released guidelines do not state you must conduct the study in a government-run testing facility. We’ve seen this myth spread in the human factors world, so it’s critical to be aware of this. In the section titled “Summative Testing,” the guidelines clearly explain that you may use simulation testing based on simulated use scenarios and self-built usability laboratories, on-site testing based on real use scenarios and other methods, or a third-party usability laboratory including testing agencies, universities, research institutions, or other similar agencies to conduct the simulation testing.
Are manufacturers able to observe on-site?
Of course! We love clients joining us on site. As the studies will be conducted in Mandarin Chinese by a Human Factors Expert, we would ensure that we have a simultaneous translator in the back room translating to any language the client prefers, so they can hear and appreciate the sessions real-time.
Conclusion
While there are similarities between the FDA human factors guidance and the NMPA guidelines, manufacturers must carefully consider the specific requirements for the Chinese market. Understanding and adapting to these differences will be crucial for successfully introducing medical devices in China.
Need help navigating the new NMPA guidelines? Contact ClariMed for expert assistance in international human factors standards compliance.
References
[1] Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff, FDA. (February 3, 2016).
[2] Technical Review Guidelines of Human Factors Design (Draft), Cisema translation. https://www.cisema.com/wp-content/uploads/2020/06/Guideline-of-Human-Factors-Design-of-Medical-Devices-Draft-EN.pdf
