Your PMDA Submission: An Integrated Approach to Usability (62366-1) and Risk (14971) 

As you prepare your submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and set your sights on the Japanese market, you may already be running into questions around usability evaluation requirements. These are questions we hear frequently from international teams: 

• “What’s the real relationship between the usability standard (JIS T 62366-1) and the risk management standard (JIS T 14971)?” 
• “How are we supposed to integrate our usability engineering process with our risk management activities?” 

These are questions we frequently hear from international manufacturers and service providers. 

Since April 2024, compliance with JIS T 62366-1:2022 (or its international equivalent, IEC 62366-1) has become a mandatory requirement in Japan. This means these questions are no longer just about understanding the theory; they’re about a critical factor that can determine the success of your submission. For PMDA, safety is not just about preventing device malfunction. It requires that risks arising from use error—mistakes made by the user—are also identified and properly managed. 

In practice, usability and risk management cannot be treated as separate activities. They must be designed and executed as a single, integrated system. 

In this article, we’ll break down the two core standards and related documents central to PMDA submissions and explain how to put them into practice as an integrated risk management model. 

Why You Need to Understand Both Standards at Once 

In the context of PMDA submissions, usability engineering is considered a part of your overall risk management activities. 

As of April 1, 2024, medical devices sold in Japan must, in principle, comply with JIS T 62366-1:2022 (Usability Engineering). This is now a practical necessity. And this standard cannot be applied in isolation from the medical device risk management standard, JIS T 14971:2020. 

The PMDA defines “safety” as having objective evidence that a device can be used safely, with all unacceptable risks eliminated or reduced. The key here is that “risk” isn’t limited to technical failures. Use errors, such as misinterpreting information or making a slip, are treated as equally critical risks that must be managed. In other words, even a device with brilliant functionality can be deemed “unsafe” if its interface is so complex that it invites errors. 

This is where the two standards work together to systematically address use-related risks: JIS T 14971 covers all reasonably foreseeable misuse, including “abnormal use,” while JIS T 62366-1 specifically hones in on use errors that can occur during “normal use.”  

This means you don’t run two separate processes. This requires an integrated risk management perspective that operates with a single, consistent logic. 

The Two Main Standards: Risk Management and Usability 

First, let’s get a clear understanding of the roles of the two core JIS standards for your PMDA submission. 

 1. JIS T 14971:2020 – The Foundation of Risk Management 

Based on ISO 14971, this standard establishes a systematic process for managing risks throughout the entire lifecycle of a medical device. It serves as the overarching framework for all safety-related activities, including usability. Here are three key takeaways: 

2. JIS T 62366-1:2022 – Usability Engineering for Human-Related Risks 

This standard, which is technically identical to IEC 62366-1:2015+AMD1:2020*, is a specialized process focused on mitigating risks arising from normal use (errors made while trying to use the device correctly), which were identified within the broader scope of JIS T 14971. In other words, within the overall safety framework set by risk management, usability engineering provides specific methods for analyzing and evaluating the particular domain of human-related risks. Its key components include: 

*The PMDA accepts compliance with internationally recognized standards like IEC 62366-1:2015+AMD1:2020, as long as you can logically explain how it meets Japan’s essential requirements. 

The Interplay between the Two Standards: An Integrated Risk Management Model 

The practical question, then, is how these two standards are integrated. The practical key is to treat 14971 as the master framework and embed 62366-1 as a subprocess within it. 

Usability activities don’t exist in a vacuum. They are an integral part of the risk management process, linking closely with the “Risk Analysis” and “Risk Control” phases. 

The specific point where they connect is the “Hazard-Related Use Scenario.”  

This flow—translating abstract risks into concrete use scenarios and validating them through evaluation—is the core of integrated risk management. 

Supporting “Related Standards and Guidelines” 

These two main standards alone might not always give you the “how-to” for every situation. In practice, you can get a clearer picture by referring to the following related documents: 

ISO 13485 (Quality Management Systems for Medical Devices) 
This is the international standard for a Quality Management System (QMS) specific to medical devices. It specifies the organizational structure and processes needed to ensure a product is consistently safe and meets regulatory requirements. The usability and risk management activities we’ve discussed are not one-off tasks. The resulting Usability Engineering File (UEF) must be formally integrated into your QMS as part of the design and development process, subject to design reviews and change control. 

A Special Case: Handling Existing Products (UOUP) 

A common challenge many manufacturers face is, “What do we do with products that were fully developed and commercialized before the major PMDA changes in April 2024?” 

An existing user interface that lacks development records compliant with the latest JIS standards is defined as a UOUP (User Interface of Unknown Provenance). For these, an alternative process outlined in Annex C of the standard is permitted. 

Instead of retroactively applying the full usability engineering process (Clause 5), you can demonstrate that the usability meets safety requirements by reviewing post-market data (complaints, adverse event reports), comparing it to equivalent devices, and conducting expert reviews (e.g., heuristic evaluations). 

However, if you make any modifications to a UOUP (e.g., design tweaks, feature additions), the modified parts and any affected areas must follow the standard usability engineering process. Furthermore, if a UI change is needed for risk control, the modified portion cannot be treated as UOUP. This isn’t a simple workaround, so careful planning is required. 

Conclusion: A Cohesive Logic and Usability Strategy for Successful PMDA Submissions 

PMDA does not evaluate only the final product—it evaluates the logic behind how safety has been ensured. They’re looking for a cohesive logic throughout your development process, backed by objective evidence. 

The key to success is to properly reference the family of standards centered around JIS T 62366-1 and JIS T 14971, execute all activities in accordance with your QMS, and document the entire process in your Usability Engineering File. 

At the same time, we see many companies run into practical challenges, such as: 

• Identifying the right use scenarios to evaluate. 
• Reflecting Japan-specific medical environments and user characteristics. 
• Ensuring documentation quality that meets PMDA standards. 

These are issues that can’t be solved by simply reading the standards; they require experience-based design and planning. 

As specialists in medical device usability evaluation in Japan, we can support you every step of the way—from planning and execution to documentation. We help you not only comply with regulations but also create a product that is truly safe and easy to use for Japanese users. 

If you are preparing for a PMDA submission or planning usability validation in Japan, feel free to reach out to discuss your project. 

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References

• JIS T 62366-1: 2022（Medical devices – Part 1: Application of usability engineering to medical devices） 
• JIS T 14971: 2020（Medical devices-Application of risk management to medical devices） 
• PMDA Usability of Medical Devices

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