What is Required to Market a Medical Device in Japan?
If your company is planning to introduce a medical device to the Japanese market, you may be asking questions such as:
- Can we follow the same Human Factors Engineering (HFE) approach used for FDA submissions?
- Are there Japan-specific regulatory requirements we should be aware of?
- Can we use the usability evaluation data we’ve already collected outside of Japan for our Japanese submission?
In recent years, the PMDA has placed a clearer and stricter emphasis on usability engineering. They now require manufacturers to demonstrate compliance with JIS T 62366-1:2022, which is harmonized with IEC 62366-1, and they closely scrutinize the validity of the entire process.
This article breaks down the key usability engineering points to help international manufacturers navigate the PMDA submission process smoothly.
PMDA Submissions and Usability Engineering
The Core Requirement: Compliance with JIS T 62366-1:2022
To market a medical device in Japan, approval or certification from the PMDA is mandatory. A critical part of this process involves addressing Human Factors/Usability Engineering.
Currently, the PMDA requires manufacturers to demonstrate compliance with JIS T 62366-1:2022 (Medical devices – Part 1: Application of usability engineering to medical devices). This standard is a Japanese Industrial Standard (JIS) harmonized with the international standard IEC 62366-1:2015+AMD1:2020.
This standard specifies a usability engineering process to systematically analyze, specify, develop, and evaluate the safety-related usability of a medical device. The main process steps include:
- Preparation of use specification
- Identification of user interface characteristics related to safety and potential use errors
- Identification of known or foreseeable hazards and hazardous situations
- Identification and description of hazard-related use scenarios
- Selection of hazard-related use scenarios for summative evaluation
- Establishment of user interface specification
- Establishment of user interface evaluation plan
- Performance of user interface design, implementation, and formative evaluation
- Performance of summative evaluation of the usability of the user interface
What Are PMDA Reviewers Looking For? Key Points of the Usability Process
In a PMDA review, it’s not enough to simply state that a summative evaluation was conducted. Reviewers will scrutinize whether the processes leading up to it are logically connected and consistent.
The coherence between the following processes is central to justifying your approach in the submission file:
- Use Specification:
The intended use, user groups, and use environments of the medical device must be clearly defined. This forms the foundation for all subsequent analyses.
- Identification of Hazard-Related Use Scenarios:
This step should not be a simple list of potential user errors. Instead, the analysis must explain why a use error may occur, based on characteristics of the user interface, and must be linked to hazards identified in the risk management process. - Selection of Hazard-Related Use Scenarios:
Not every scenario must be tested. However, scenarios must be selected based on risk severity identified through risk analysis, and the rationale for why the selected scenarios are sufficient must be clearly explained. - Formative Evaluation:
Formative studies must be conducted with the purpose of improving user interface design. Their role should not be confused with that of summative validation. - Summative Evaluation:
The final user interface must be evaluated against hazard-related use scenarios to confirm that residual risks associated with use errors are acceptable.
Formative vs. Summative Evaluation: Requirements by Device Class
The level of usability evaluation required depends on the risk classification of the device.
Evaluation Levels by Medical Device Class
| DEVICE CATEGORY | CLASS | REQUIREMENTS & OVERVIEW |
| General Medical Devices | Class I | Devices with extremely low risk. A summative evaluation is generally not required, but you must demonstrate in your risk analysis that the risks from use error are negligible. *¹ |
| Controlled Medical Devices | Class II | Devices with a relatively low risk, but where failure could impact health. A summative evaluation is generally required. |
| Specially Controlled Medical Devices | Class III | Devices with a relatively high risk, where failure could pose a serious threat to life or health. A summative evaluation is mandatory. The rationale for scenario selection and the acceptability of residual risk will be rigorously examined. |
| Class IV |
*¹: Exceptions exist for certain Class I devices, such as SaMD (Software as a Medical Device) and some consumer-facing devices. If there is little precedent, the risk analysis may be deemed insufficient, and a summative evaluation may be requested. In such cases, prior consultation with the PMDA is strongly recommended.
Key Considerations for Formative Evaluation
Formative evaluation is designed to identify problems early and improve the UI. The PMDA focuses on how the evaluation results were fed back into the design.
- The Goal is “Design Improvement”:
The purpose is strictly to refine the UI. If issues are found but no design changes are made, you must provide a sound rationale. - Keep Records Simple:
Formal protocols and statistical analysis are not required. Documentation that tracks “when we evaluated what, and how we improved the UI as a result” is sufficient. - Limited Cases where Summative Evaluation may not be Required:
In rare cases, summative evaluation may not be required if:- no hazards related to use errors can be identified
- UI changes from an existing device are extremely minor
- the interface qualifies as UOUP (User Interface of Unknown Provenance) and real-world safety evidence supports its usability *²
*²: Note that this is an exceptional circumstance and does not apply to new designs or significant redesigns. If you are unsure, consult with the PMDA beforehand.
Key Considerations for Summative Evaluation
The summative evaluation is arguably the most critical part of the submission, serving as objective evidence of your product’s safety.
- The Goal is “Validation”:
It is a validation activity that uses the final design to verify that use-related risks are acceptable. - What Matters in Evaluation Design:
- Justification Over Participant Count: PMDA does not specify a sample size. More important than the number of participants is your ability to justify why that number and their specific attributes (e.g., physicians with specific expertise, elderly users) are sufficient to validate the device’s usability for the intended user population.
- Representativeness over Fidelity: You don’t need to perfectly replicate the actual use environment. Even a conference room setup can be sufficient, as long as it accounts for environmental factors that could induce or allow for the observation of use errors in your hazard-related scenarios (e.g., lighting, noise, interruptions).
Practical Points Often Overlooked by International Manufacturers
Beyond understanding the standard, several practical issues can impact your submission. Addressing these early can prevent costly rework.
Handling of Evaluation Data from Overseas
You can leverage evaluation data from outside Japan, but simply translating the report into Japanese is not enough. You must analyze the gaps between the context of your original evaluation and the Japanese market by considering its unique medical environment, regulations, and user characteristics (physical, cultural, etc.).You need to logically demonstrate that the use conditions are equivalent and that localization (e.g., translation, UI changes) has not introduced new risks.
Need for Ethical (IRB) Review
While usability testing is often not classified as a “clinical study,” it is research involving human subjects, making ethical considerations essential. For summative evaluations, which serve as objective data for the submission, obtaining an ethical review from an Institutional Review Board (IRB) is strongly recommended.
Integration with Risk Management
Usability engineering is not a standalone activity. Use errors and hazards identified in the usability process must be closely integrated with your risk management process (JIS T 14971 / ISO 14971). The evaluation of residual risk based on your findings must also be reflected in the risk management file.
Post-Market Conformity Assessments
The PMDA review is not a one-time event. During QMS (Quality Management System) conformity assessments, regulators will verify that usability engineering is being systematically applied throughout the product lifecycle as an organizational process.
Conclusion: The Keys to Success are a Consistent Process and a Deep Understanding of the Japanese Market
Successfully navigating the PMDA’s usability requirements is not about just running a test. It requires establishing a consistent process aligned with JIS T 62366-1 and clearly documenting the rationale behind each step.
For international manufacturers, the key to a smooth submission goes beyond meeting regulatory demands. It involves integrating an understanding of the Japanese clinical context and user characteristics—the “unwritten rules”—into your design and evaluation process. Understanding the differences from FDA requirements and identifying Japan-specific challenges early is your fastest path to success.
Usability Evaluation Services to Support Your Entry into the Japanese Market
Drawing on our extensive experience in UX research and medical device usability evaluation in Japan, we provide robust support for your PMDA submission. We can tailor our services to your specific needs, including:
We can tailor our services to your specific needs, including:
- Planning and conducting formative and summative evaluations for the Japanese market.
- Analyzing the gaps in your existing overseas data and designing supplementary evaluations for your Japanese submission.
- Identifying hazard-related use scenarios that account for Japanese user characteristics and use environments.
If you are facing challenges with usability evaluation for your PMDA submission or need UX research for the Japanese market, please do not hesitate to contact us.
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 – “About Usability of Medical Devices” (in Japanese)
- MHLW Notification on Usability (No. 0930-1, Sept. 30, 2022) (in Japanese)
