Human Factors regulatory expectations across different markets

Over the last few years, part of my work has involved making sure Human Factors activities and evidence are aligned with the regulatory expectations of different markets. That sounds straightforward until you start working across regions. IEC 62366-1 gives us a common usability engineering process, but regulators do not all look at Human Factors in exactly the same way. Some have developed their own guidance, submission expectations, or local requirements that go beyond simply showing compliance with IEC 62366-1.

This article highlights a few of those differences and some of the jurisdictions I think are worth paying attention to when planning a global Human Factors strategy. It is not an exhaustive list of every country or every applicable requirement. It is a selection of examples that show how local expectations can differ from the traditional IEC 62366-1 approach. The applicable requirements will always depend on the device, risk profile, regulatory pathway, and sometimes the type of evidence already available.

IEC 62366-1 should guide the process

IEC 62366-1 gives medical device manufacturers a common framework for usability engineering. It provides a process for understanding intended users and use environments, identifying foreseeable use errors and use-related hazards, developing the user interface iteratively, and evaluating whether the final interface can be used safely.

For medical device development, that is usually the logical starting point, but IEC 62366-1 does not tell you everything a regulator may expect to see. Over the years, several authorities have developed their own Human Factors requirements, guidance, or submission expectations. Some are closely aligned with IEC 62366-1. Others introduce additional concepts, evidence expectations, or documentation requirements.

That means two manufacturers can follow essentially the same usability engineering process and still need to present quite different evidence depending on where the device is submitted. Below are some examples I would keep in mind when preparing for a global medical device submission.

FDA has one of the most developed Human Factors review frameworks

The US is probably one of the markets where Human Factors expectations are most explicit, both for medical devices and combination products. FDA’s Applying Human Factors and Usability Engineering to Medical Devices guidance is the document most people associate with medical device Human Factors in the US, and sometimes globally. It explains how Human Factors and usability engineering should be integrated into device development and risk management, with the objective of reducing use-related risks and supporting safe and effective use. The guidance was first issued in draft in 2011, finalized in 2016, and revised again in August 2026.

FDA also has a second guidance, Content of Human Factors Information in Medical Device Marketing Submissions, finalized in May 2026. This guidance focuses on what Human Factors information should be included in a marketing submission and introduces a risk-based framework for determining the amount of information FDA expects to review. In practice, FDA now makes a much clearer distinction between conducting an appropriate Human Factors process and preparing the Human Factors evidence needed for a regulatory submission.

For combination products, there is an additional guidance called Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, finalized in September 2023. This document addresses how Human Factors principles apply to combination products and clarifies how characteristics associated with their different constituent parts can affect the HF process.

Those three documents are only the most obvious examples. In my own review, I have identified around 92 FDA guidance documents that contain HF-related recommendations for certain device categories or references to use error, Human Factors activities, use-related problems, or risk controls associated with device use. I would not call all of them “Human Factors guidances”. That would be misleading. But together they show how deeply Human Factors concepts are embedded across FDA’s regulatory framework.

Several FDA concepts are also more specific than IEC 62366-1 alone. FDA places particular emphasis on critical tasks, known use problems, representative intended users, realistic conditions of use, root-cause analysis of observed use errors, and demonstrating that implemented risk controls are adequate. The 2026 submission guidance also introduces three HF Submission Categories to determine the level of Human Factors information expected in a marketing submission.

For FDA, following IEC 62366-1 is a good foundation, but it is not enough to simply show compliance with the standard. The evidence needs to address FDA’s expectations around use-related risk, critical tasks, validation, observed use errors, root-cause analysis, and the adequacy of final risk controls.

This is also where experienced Human Factors specialists can make a substantial difference. FDA’s expectations go beyond conducting a usability study. The URRA, study strategy, validation design, interpretation of findings, and regulatory narrative all need to work together.

It is also worth looking at some of FDA’s own historical data. In a CDRH presentation reporting 2019 Human Factors engineering review activity, FDA reported 542 HF engineering reviews, but only 23 were considered “first time right”. For 510(k) reviews specifically, 11 out of 228 were reported as first time right.

That does not mean Human Factors was the reason the overall submission was rejected. But it does show how frequently the Human Factors portion of a submission required additional work or interaction with FDA.

For me, that is the practical reminder. Human Factors for FDA is not simply an IEC 62366-1 compliance exercise. It is a specialized regulatory discipline, and weaknesses in the Human Factors strategy or documentation can create significant submission delays.

China adds another question: does the evidence apply to Chinese users?

China has moved toward a much more explicit Human Factors framework. In 2024, NMPA’s Center for Medical Device Evaluation published its Medical Device Usability Engineering Registration Review Guideline. The framework addresses intended users, use scenarios, user interfaces, foreseeable use errors, formative activities, and confirmation of the final interface.

One of the most important differences appears when a manufacturer wants to use Human Factors evidence generated outside China. The manufacturer needs to consider whether differences between Chinese and overseas users, use scenarios, and regulatory requirements could affect use safety. Language, labeling, training, clinical practice, user characteristics, and use environments can all become relevant.

Known use-related problems also need to be considered in relation to the Chinese population and conditions of use. A known use issue identified in another market may still be relevant, but Chinese users, clinical workflows, labeling conventions, training practices, or use environments could introduce additional use problems or affect how existing ones manifest. For higher use-related risk devices, those differences may lead to additional user-interface confirmation activities in China.

So a successful FDA validation study does not automatically become sufficient NMPA evidence. The manufacturer needs to demonstrate transferability. If there are meaningful differences between the population or conditions tested and those expected in China, additional evidence may be needed.

That does not necessarily mean repeating the same study locally. The better first question is whether the existing evidence is transferable, and where the actual gaps are.

The UK has dedicated Human Factors guidance, but a different review model

The MHRA published Applying human factors to medical devices in 2017 and updated the guidance most recently in 2025. The guidance describes usability engineering as an iterative process involving design, testing, and validation. But it also emphasizes something that can sometimes be lost when Human Factors becomes too submission-focused: the lifecycle.

MHRA explicitly connects Human Factors with post-market experience. Use problems identified after launch may show that the design needs further improvement, and Human Factors methods can be used both to identify use-related risks before launch and to investigate incidents after the device reaches the market.

It is not the same as the FDA model. Manufacturers still need a defensible usability engineering process, but the expectation is more closely connected with design, risk management, lifecycle evidence, and post-market learning than with an FDA-style critical-task validation report.

Taiwan has its own dedicated Human Factors guidance

Taiwan is another market that is easy to overlook. TFDA published its Medical Device Human Factors/Usability Engineering Evaluation Guidance in 2020 to support manufacturers during device design, development, registration, and post-market activities.

The terminology will look familiar to anyone working with FDA or IEC 62366-1. The guidance addresses formative evaluation, Human Factors validation or summative evaluation, use error, and the user interface. It defines Human Factors validation as an evaluation performed at the end of user-interface development to obtain objective evidence that the interface can be used safely. But, for Taiwan, I would not treat IEC 62366-1 compliance as the end of the discussion. There is a local regulator document describing how Human Factors evidence is expected to support development and registration.

Canada makes Human Factors visible within the submission structure

Canada is interesting because its approach is less prescriptive than FDA’s, but still quite explicit. Health Canada does not have a dedicated HF guidance equivalent to FDA’s, but its current clinical evidence guidance discusses Human Factors and usability evidence, including the use of appropriate users and representative settings.

Its IMDRF-based submission structure also contains a dedicated Usability/Human Factors section for relevant applications. The dossier can include a summary of the Human Factors evidence, the test environment and its relationship to the intended use environment, the rationale for which testing was or was not performed, and a justification that the evidence is sufficient to support the application.

Canada is not telling every manufacturer to conduct an FDA-style validation study. It is asking the manufacturer to explain what Human Factors evidence is relevant and why the evidence generated is sufficient. That makes the regulatory argument important since a study can be omitted when it is not necessary, but the omission itself may need to be justified.

Japan embeds usability engineering into the conformity framework

Japan takes another approach. The Japanese Basic Requirements include usability-related requirements, and the PMDA has specific implementation material explaining application of JIS T 62366-1:2022, the Japanese adoption corresponding to IEC 62366-1:2015+A1:2020.

JIS T 62366-1 defines the usability engineering process for analyzing, specifying, developing, and evaluating safety-related usability. This is much closer to an IEC conformity model than FDA’s separate Human Factors review architecture. The usability engineering file becomes particularly important because it provides the evidence that the applicable Japanese Basic Requirements have been addressed.

South Korea makes usability part of the quality system

MFDS has incorporated usability requirements into its medical device manufacturing and quality management framework, alongside Korean adoption of IEC 62366-1 and regulator guidance. That means usability is not only something considered when preparing a market submission. It is connected with the manufacturer’s design and development system.

Companies treating Human Factors as a standalone regulatory report created at the end of development are likely to have a harder time demonstrating compliance. The usability work needs to connect with design inputs, design development, risk management, and design validation within the quality system.

Some local requirements apply only to particular devices or pathways

Not every specific Human Factors requirement applies to all medical devices, so I thought it would be a good idea to mention some of them.

Brazil is a good example. ANVISA's RDC 657/2022 for Software as a Medical Device contains explicit Human Factors and usability provisions and identifies IEC 62366-1 within the applicable regulatory framework.

Egypt provides another recent example. The Egyptian Drug Authority published a 2026 Usability Study document for an identified local-manufacturer pathway that references IEC 62366-1. That is a route-specific requirement. It should not be generalized to every Egyptian medical device submission.

Other jurisdictions have similarly specific requirements for IVDs, self-testing devices, home-use products, or particular software categories.

This is why I am increasingly reluctant to classify countries simply as “requiring Human Factors” or “not requiring Human Factors”. The more useful question is: What exactly creates the Human Factors expectation in that jurisdiction, and what evidence does it trigger for this particular device?

The EU is a useful counterexample

The EU MDR includes several binding requirements concerning ergonomic characteristics, intended users, use environment, and the reduction of risks related to use error. But the MDR does not contain an FDA-style Human Factors process or submission framework, and it does not prescribe a dedicated Human Factors validation study.

IEC 62366-1 is therefore extremely useful for generating the evidence needed to address those requirements, but I would not describe the MDR as simply “requiring IEC 62366-1”. The legal requirement comes from the MDR itself rather than from a dedicated European Human Factors guidance. In my experience, how deeply that evidence is challenged can also vary depending on the Human Factors experience of the Notified Body and the reviewers involved.

What I take from all of this

I would not interpret this list as a map of the only countries where Human Factors matters. The examples above are countries where I found specific Human Factors, usability, or use-error expectations that go beyond a generic statement of compliance with IEC 62366-1, or that add a local interpretation of how that evidence should be generated, justified, or submitted.

It is very visible that the absence of dedicated local Human Factors guidance does not necessarily mean that Human Factors is irrelevant. Other markets may still regulate usability, ergonomics, intended users, intended use, use environments, foreseeable use errors, or use-related risks through Essential Principles, design requirements, quality system requirements, device-specific rules, or regional frameworks.

What changes from one jurisdiction to another is how explicit the regulator is, what type of Human Factors evidence may be expected, and how that evidence is reviewed during submission, conformity assessment, or inspection.