{"id":8199,"date":"2026-03-18T02:22:34","date_gmt":"2026-03-17T17:22:34","guid":{"rendered":"https:\/\/uism.co.jp\/?p=6437"},"modified":"2026-04-13T14:00:37","modified_gmt":"2026-04-13T05:00:37","slug":"for-international-manufacturers-key-usability-points-for-japanese-pmda-submissions-2","status":"publish","type":"post","link":"https:\/\/uism.co.jp\/en\/blog\/for-international-manufacturers-key-usability-points-for-japanese-pmda-submissions-2\/","title":{"rendered":"For International Manufacturers: Key Usability Points for Japanese PMDA Submissions\u00a0"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">What&nbsp;is Required to Market a Medical Device in Japan?&nbsp;<\/span><\/h2>\n\n\n\n<p>If your company is planning to introduce a medical device to the Japanese market, you may be asking questions such as:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Can&nbsp;we follow the same Human Factors Engineering (HFE) approach used for FDA submissions?&nbsp;<\/li>\n\n\n\n<li>Are&nbsp;there Japan-specific regulatory requirements we should be aware of?&nbsp;<\/li>\n\n\n\n<li>Can&nbsp;we use the usability evaluation data&nbsp;we&#8217;ve&nbsp;already collected outside of Japan for our Japanese submission?&nbsp;<\/li>\n<\/ul>\n\n\n\n<p>In recent years, the PMDA has placed a clearer and stricter emphasis on usability engineering. They now require manufacturers to&nbsp;demonstrate&nbsp;compliance with JIS T 62366-1:2022, which is harmonized with IEC 62366-1, and they closely scrutinize the validity of the entire process.&nbsp;<\/p>\n\n\n\n<p>This article breaks down the key usability engineering points to help international manufacturers navigate the PMDA submission process smoothly.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">PMDA Submissions and Usability Engineering&nbsp;<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">The Core Requirement: Compliance with JIS T 62366-1:2022&nbsp;<\/span><\/h3>\n\n\n\n<p>To market a medical device in Japan,&nbsp;approval&nbsp;or certification from the PMDA is mandatory. A critical part of this process involves addressing Human Factors\/Usability Engineering.&nbsp;<\/p>\n\n\n\n<p>Currently, the PMDA&nbsp;<strong>requires manufacturers to&nbsp;demonstrate&nbsp;compliance with JIS T 62366-1:2022<\/strong>&nbsp;(Medical devices \u2013 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.&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<p>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:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-container smb-container c-container\"><div class=\"smb-container__body u-slim-width is-layout-constrained wp-block-snow-monkey-blocks-container-is-layout-constrained\">\n<ol start=\"1\" class=\"wp-block-list\">\n<li>Preparation of use specification&nbsp;<\/li>\n\n\n\n<li>Identification of user interface characteristics related to safety and potential use errors&nbsp;<\/li>\n\n\n\n<li>Identification of known or foreseeable hazards and hazardous situations&nbsp;<\/li>\n\n\n\n<li>Identification and description of hazard-related use scenarios&nbsp;<\/li>\n\n\n\n<li>Selection&nbsp;of hazard-related use scenarios for summative evaluation&nbsp;<\/li>\n\n\n\n<li>Establishment of user interface specification&nbsp;<\/li>\n\n\n\n<li>Establishment of user interface evaluation plan&nbsp;<\/li>\n\n\n\n<li>Performance of user interface design, implementation, and formative evaluation&nbsp;<\/li>\n\n\n\n<li>Performance of summative evaluation of the usability of the user interface&nbsp;<\/li>\n<\/ol>\n<\/div><\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">What Are PMDA Reviewers Looking For? Key Points of the Usability Process&nbsp;<\/span><\/h3>\n\n\n\n<p>In a PMDA review,&nbsp;it\u2019s&nbsp;not enough to simply&nbsp;state&nbsp;that a summative evaluation was conducted. Reviewers will scrutinize whether the processes leading up to it are logically connected and consistent.&nbsp;&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group has-border-color has-light-green-cyan-border-color has-background is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;border-top-left-radius:10px;border-top-right-radius:10px;border-bottom-left-radius:10px;border-bottom-right-radius:10px;background-color:#7bdbb51a\">\n<div class=\"wp-block-columns are-vertically-aligned-top is-not-stacked-on-mobile is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:15px\">\n<p class=\"has-text-align-center\" style=\"padding-top:0;padding-bottom:0\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"circle-check\" class=\"svg-inline--fa fa-circle-check fa-flip \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" style=\"font-size:1.8em\" color=\"#7bdcb5\"><path fill=\"currentColor\" d=\"M256 512A256 256 0 1 0 256 0a256 256 0 1 0 0 512zM369 209L241 337c-9.4 9.4-24.6 9.4-33.9 0l-64-64c-9.4-9.4-9.4-24.6 0-33.9s24.6-9.4 33.9 0l47 47L335 175c9.4-9.4 24.6-9.4 33.9 0s9.4 24.6 0 33.9z\"><\/path><\/svg><\/span><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"has-text-align-left\">The coherence between the following processes is central to justifying your approach in the submission file:&nbsp;<\/p>\n<\/div>\n<\/div>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Use Specification<\/strong>:&nbsp;<br>The intended use, user groups, and use environments of the medical device must be clearly defined. This forms the foundation for all&nbsp;subsequent&nbsp;analyses.&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Identification of Hazard-Related Use&nbsp;Scenarios:<\/strong>&nbsp;<br>This step should not&nbsp;be&nbsp;a simple&nbsp;list&nbsp;of&nbsp;potential&nbsp;user&nbsp;errors. Instead, the analysis must explain why a&nbsp;use&nbsp;error may occur, based on characteristics of the user interface, and must be linked to hazards&nbsp;identified&nbsp;in the risk management process.&nbsp;<\/li>\n\n\n\n<li><strong>Selection&nbsp;of Hazard-Related Use Scenarios:<\/strong>&nbsp;<br>Not every scenario must be tested. However, scenarios must be selected based on risk severity&nbsp;identified&nbsp;through risk analysis, and the rationale for why the selected scenarios are sufficient must be clearly explained.&nbsp;<\/li>\n\n\n\n<li><strong>Formative Evaluation:<\/strong>&nbsp;&nbsp;<br>Formative studies must be conducted with the purpose of improving&nbsp;user&nbsp;interface design. Their role should not be confused with that of summative validation.&nbsp;<\/li>\n\n\n\n<li><strong>Summative Evaluation:<\/strong>&nbsp;<br>The final user interface must be evaluated against hazard-related&nbsp;use&nbsp;scenarios to confirm that residual risks associated with&nbsp;use&nbsp;errors are acceptable.&nbsp;<\/li>\n<\/ul>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">Formative vs. Summative Evaluation: Requirements by Device Class&nbsp;<\/span><\/h2>\n\n\n\n<p>The level of usability evaluation&nbsp;required&nbsp;depends on the&nbsp;<strong>risk classification<\/strong>&nbsp;of the device.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">Evaluation Levels by Medical Device Class&nbsp;<\/span><\/h3>\n\n\n\n<figure class=\"wp-block-table is-style-regular\" style=\"padding-top:0\"><table class=\"has-sm-text-alt-background-color has-background\"><tbody><tr><td><span class=\"sme-font-size has-sm-s-font-size\">DEVICE CATEGORY&nbsp;<\/span><\/td><td><span class=\"sme-font-size has-sm-s-font-size\">CLASS<\/span>&nbsp;<\/td><td><span class=\"sme-font-size has-sm-s-font-size\">REQUIREMENTS &amp; OVERVIEW&nbsp;<\/span><\/td><\/tr><tr><td>General Medical Devices&nbsp;<\/td><td>Class I&nbsp;<\/td><td>Devices with extremely&nbsp;low risk. A summative evaluation is&nbsp;generally not&nbsp;required, but you must&nbsp;demonstrate&nbsp;in your risk analysis that the risks from&nbsp;use&nbsp;error are negligible. *\u00b9&nbsp;<\/td><\/tr><tr><td>Controlled Medical Devices&nbsp;<\/td><td>Class II&nbsp;&nbsp;<\/td><td>Devices with a relatively&nbsp;low risk, but where failure could&nbsp;impact&nbsp;health.&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">A summative evaluation is&nbsp;generally&nbsp;required<\/span><\/strong>.&nbsp;<\/td><\/tr><tr><td rowspan=\"2\">Specially Controlled Medical Devices&nbsp;<\/td><td>Class III&nbsp;<\/td><td rowspan=\"2\">Devices with a relatively&nbsp;high risk, where failure could pose a serious threat to life or health.&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">A summative evaluation is mandatory<\/span><\/strong>. The rationale for scenario&nbsp;selection&nbsp;and the acceptability of residual risk will be&nbsp;rigorously examined.&nbsp;<\/td><\/tr><tr><td>Class IV&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em><span class=\"sme-font-size has-sm-s-font-size\">*\u00b9: 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&nbsp;deemed&nbsp;insufficient, and a summative evaluation may be&nbsp;requested. In such cases, prior consultation with the PMDA is strongly recommended.&nbsp;<\/span><\/em><\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" src=\"https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/03\/image-2.png\" alt=\"\" class=\"wp-image-6421\"\/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">Key Considerations for Formative Evaluation&nbsp;<\/span><\/h3>\n\n\n\n<p>Formative evaluation is designed to&nbsp;identify&nbsp;problems early and improve the UI. The PMDA focuses on how the evaluation results were fed back into the design.&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group has-border-color has-sm-light-gray-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;box-shadow:var(--wp--preset--shadow--sharp)\">\n<ul class=\"wp-block-list\">\n<li><strong>The Goal is &#8220;Design Improvement&#8221;:<\/strong>&nbsp;<br>The&nbsp;purpose is strictly to refine the UI. If issues are&nbsp;found&nbsp;but no design changes are made, you must provide a sound rationale.&nbsp;<\/li>\n\n\n\n<li><strong>Keep Records Simple:&nbsp;<\/strong><br>Formal protocols and statistical analysis are not&nbsp;required. Documentation that tracks &#8220;when we evaluated what, and how we improved the UI as a result&#8221; is sufficient.&nbsp;<\/li>\n\n\n\n<li><strong>Limited&nbsp;Cases&nbsp;where Summative Evaluation&nbsp;may&nbsp;not&nbsp;be Required:&nbsp;<\/strong><br>In rare cases, summative evaluation may not&nbsp;be&nbsp;required&nbsp;if:&nbsp;\n<ul class=\"wp-block-list\">\n<li>no hazards related to use errors can be&nbsp;identified&nbsp;<\/li>\n\n\n\n<li>UI changes from an existing device are extremely minor&nbsp;<\/li>\n\n\n\n<li>the interface qualifies as UOUP (User Interface of Unknown Provenance)&nbsp;and real-world safety evidence supports its usability&nbsp;*\u00b2&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n\n\n\n<p><em><span class=\"sme-font-size has-sm-s-font-size\">*\u00b2:&nbsp;Note that this is an exceptional circumstance and does not apply to&nbsp;new designs&nbsp;or significant redesigns. If you are unsure, consult with the PMDA beforehand.&nbsp;<\/span><\/em><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">Key Considerations for Summative Evaluation&nbsp;<\/span><\/h3>\n\n\n\n<p>The summative evaluation is&nbsp;arguably the&nbsp;most critical part of the submission, serving as objective evidence of your product&#8217;s safety.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">The Goal is &#8220;Validation&#8221;<\/span><\/strong>:&nbsp;<br>It is a validation activity that uses the final design to verify that use-related risks are acceptable.&nbsp;<\/li>\n\n\n\n<li>What Matters in Evaluation&nbsp;Design:&nbsp;\n<ul class=\"wp-block-list\">\n<li><strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">Justification Over Participant Count<\/span>:<\/strong>&nbsp;PMDA does not specify a sample size.&nbsp;More important than the number of participants is your ability to justify why that number and their specific attributes (e.g., physicians with specific&nbsp;expertise, elderly users) are sufficient to&nbsp;validate&nbsp;the device&#8217;s usability for the intended user population.&nbsp;<\/li>\n\n\n\n<li><strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">Representativeness&nbsp;over Fidelity<\/span><\/strong>:&nbsp;You&nbsp;don&#8217;t&nbsp;need to perfectly replicate the actual use environment. Even a conference room setup can be sufficient,&nbsp;as long as&nbsp;it accounts for environmental factors that could induce or allow for the observation of&nbsp;use&nbsp;errors in your hazard-related scenarios (e.g.,&nbsp;lighting, noise, interruptions).&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed is-type-rich is-provider-wp-oembed-blog-card wp-block-embed-wp-oembed-blog-card\"><div class=\"wp-block-embed__wrapper\">\nhttps:\/\/uism.co.jp\/en\/blog\/sample-size-and-test-environment-requirements-for-pmda-hfe-submission-a-practical-guide-for-validation-studies-in-japan\n<\/div><\/figure>\n\n\n\n<figure class=\"wp-block-embed is-type-rich is-provider-wp-oembed-blog-card wp-block-embed-wp-oembed-blog-card\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"szc7V57WgL\"><a href=\"https:\/\/uism.co.jp\/en\/blog\/how-to-recruit-for-success-in-japanese-medical-research\/\">How to Recruit for Success in Japanese Medical Research<\/a><\/blockquote><div class=\"c-responsive-container-16-9\"><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"&#8220;How to Recruit for Success in Japanese Medical Research&#8221; &#8212; Uism\" src=\"https:\/\/uism.co.jp\/en\/blog\/how-to-recruit-for-success-in-japanese-medical-research\/embed\/#?secret=cPxWb0WTGO#?secret=szc7V57WgL\" data-secret=\"szc7V57WgL\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">Practical Points Often Overlooked by International Manufacturers&nbsp;<\/span><\/h2>\n\n\n\n<p>Beyond understanding the standard, several practical issues can&nbsp;impact&nbsp;your submission. Addressing these early can prevent costly rework.&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group has-border-color has-sm-lighter-gray-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;border-top-left-radius:15px;border-top-right-radius:15px;border-bottom-left-radius:15px;border-bottom-right-radius:15px\">\n<h4 class=\"wp-block-heading\">Handling of Evaluation Data from Overseas<\/h4>\n\n\n\n<p>You&nbsp;can&nbsp;leverage&nbsp;evaluation data from outside Japan, but&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">simply translating the report into Japanese is not enough<\/span><\/strong>.&nbsp;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&nbsp;demonstrate&nbsp;that the use conditions are&nbsp;equivalent&nbsp;and that localization (e.g., translation, UI changes) has not introduced new risks.&nbsp;<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-group has-border-color has-sm-lighter-gray-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;border-top-left-radius:15px;border-top-right-radius:15px;border-bottom-left-radius:15px;border-bottom-right-radius:15px\">\n<h4 class=\"wp-block-heading\">Need for Ethical (IRB) Review&nbsp;<\/h4>\n\n\n\n<p>While usability testing is often not classified as a &#8220;clinical study,&#8221; 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.&nbsp;<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-group has-border-color has-sm-lighter-gray-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;border-top-left-radius:15px;border-top-right-radius:15px;border-bottom-left-radius:15px;border-bottom-right-radius:15px\">\n<h4 class=\"wp-block-heading\">Integration with Risk Management&nbsp;<\/h4>\n\n\n\n<p>Usability engineering is not a standalone activity. Use errors and hazards&nbsp;identified&nbsp;in the usability process&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">must be&nbsp;closely integrated&nbsp;with your risk management process (JIS T 14971 \/ ISO 14971)<\/span><\/strong>. The evaluation of residual risk based on your findings must also be reflected in the risk management file.&nbsp;<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-group has-border-color has-sm-lighter-gray-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;border-top-left-radius:15px;border-top-right-radius:15px;border-bottom-left-radius:15px;border-bottom-right-radius:15px\">\n<h4 class=\"wp-block-heading\">Post-Market Conformity Assessments&nbsp;<\/h4>\n\n\n\n<p><strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">The PMDA review is not a one-time event<\/span><\/strong>. 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.&nbsp;<\/p>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #00795b\" class=\"sme-text-color\">Conclusion: The Keys to Success are a Consistent Process and a Deep Understanding of the Japanese Market&nbsp;<\/span><\/h2>\n\n\n\n<p>Successfully navigating the PMDA&#8217;s usability requirements is&nbsp;not about&nbsp;just running a test.&nbsp;It requires&nbsp;establishing&nbsp;a consistent process aligned with JIS T 62366-1 and clearly documenting the rationale behind each step.&nbsp;<\/p>\n\n\n\n<p>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\u2014the &#8220;unwritten rules&#8221;\u2014into your design and evaluation process. Understanding the differences from FDA requirements and&nbsp;identifying&nbsp;Japan-specific challenges early is your fastest path to success.&nbsp;<\/p>\n\n\n\n<p><span style=\"color: #00795b\" class=\"sme-text-color\"><strong><span class=\"sme-font-size has-sm-l-font-size\">Usability Evaluation Services to Support Your Entry into the Japanese Market&nbsp;<\/span><\/strong><\/span><\/p>\n\n\n\n<p>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:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group has-border-color has-light-green-cyan-border-color has-background is-layout-constrained wp-block-group-is-layout-constrained\" style=\"border-width:1px;border-top-left-radius:10px;border-top-right-radius:10px;border-bottom-left-radius:10px;border-bottom-right-radius:10px;background-color:#7bdbb51a\">\n<p><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"circle-check\" class=\"svg-inline--fa fa-circle-check fa-flip \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" style=\"font-size:1.8em\" color=\"#7bdcb5\"><path fill=\"currentColor\" d=\"M256 512A256 256 0 1 0 256 0a256 256 0 1 0 0 512zM369 209L241 337c-9.4 9.4-24.6 9.4-33.9 0l-64-64c-9.4-9.4-9.4-24.6 0-33.9s24.6-9.4 33.9 0l47 47L335 175c9.4-9.4 24.6-9.4 33.9 0s9.4 24.6 0 33.9z\"><\/path><\/svg><\/span> We can tailor our services to your specific needs, including:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Planning and conducting formative and summative evaluations for the Japanese market.&nbsp;<\/li>\n\n\n\n<li>Analyzing the gaps in your existing overseas data and designing supplementary evaluations for your Japanese submission.&nbsp;&nbsp;<\/li>\n\n\n\n<li>Identifying&nbsp;hazard-related use scenarios that account for Japanese user characteristics and use environments.&nbsp;<\/li>\n<\/ul>\n<\/div>\n\n\n\n<p>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.&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-sm-lightest-gray-color has-alpha-channel-opacity has-sm-lightest-gray-background-color has-background\" style=\"margin-top:var(--wp--preset--spacing--50);margin-bottom:var(--wp--preset--spacing--50)\"\/>\n\n\n\n<p><span style=\"color: #00795b\" class=\"sme-text-color\"><strong>References&nbsp;<\/strong><\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span class=\"sme-font-size has-sm-s-font-size\">JIS T 62366-1:2022 (Medical devices &#8211; Part 1: Application of usability engineering to medical devices)&nbsp;<\/span><\/li>\n\n\n\n<li><span class=\"sme-font-size has-sm-s-font-size\">JIS T 14971:2020 (Medical devices &#8211; Application of risk management to medical devices)&nbsp;<\/span><\/li>\n\n\n\n<li><span class=\"sme-font-size has-sm-s-font-size\">PMDA &#8211; &#8220;About Usability of Medical Devices&#8221; (in Japanese)&nbsp;&nbsp;<a href=\"https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/about-reviews\/devices\/0050.html\" target=\"_blank\" rel=\"noopener\" title=\"\ufffc\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"up-right-from-square\" class=\"svg-inline--fa fa-up-right-from-square \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><path fill=\"currentColor\" d=\"M352 0c-12.9 0-24.6 7.8-29.6 19.8s-2.2 25.7 6.9 34.9L370.7 96 201.4 265.4c-12.5 12.5-12.5 32.8 0 45.3s32.8 12.5 45.3 0L416 141.3l41.4 41.4c9.2 9.2 22.9 11.9 34.9 6.9s19.8-16.6 19.8-29.6V32c0-17.7-14.3-32-32-32H352zM80 32C35.8 32 0 67.8 0 112V432c0 44.2 35.8 80 80 80H400c44.2 0 80-35.8 80-80V320c0-17.7-14.3-32-32-32s-32 14.3-32 32V432c0 8.8-7.2 16-16 16H80c-8.8 0-16-7.2-16-16V112c0-8.8 7.2-16 16-16H192c17.7 0 32-14.3 32-32s-14.3-32-32-32H80z\"><\/path><\/svg><\/span><\/a>&nbsp;<\/span><\/li>\n\n\n\n<li><span class=\"sme-font-size has-sm-s-font-size\">MHLW Notification on Usability (No. 0930-1, Sept. 30, 2022) (in Japanese)&nbsp;&nbsp;<a href=\"https:\/\/www.jfmda.gr.jp\/wp\/wp-content\/uploads\/2024\/01\/Handling-of-JIS-concerning-requirements-for-usability-engineering-of-medical-devices-PSEHB-MDED-CND-Notification-No.0930-1-2022-09-30.pdf\" target=\"_blank\" rel=\"noopener\" title=\"\ufffc\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"up-right-from-square\" class=\"svg-inline--fa fa-up-right-from-square \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><path fill=\"currentColor\" d=\"M352 0c-12.9 0-24.6 7.8-29.6 19.8s-2.2 25.7 6.9 34.9L370.7 96 201.4 265.4c-12.5 12.5-12.5 32.8 0 45.3s32.8 12.5 45.3 0L416 141.3l41.4 41.4c9.2 9.2 22.9 11.9 34.9 6.9s19.8-16.6 19.8-29.6V32c0-17.7-14.3-32-32-32H352zM80 32C35.8 32 0 67.8 0 112V432c0 44.2 35.8 80 80 80H400c44.2 0 80-35.8 80-80V320c0-17.7-14.3-32-32-32s-32 14.3-32 32V432c0 8.8-7.2 16-16 16H80c-8.8 0-16-7.2-16-16V112c0-8.8 7.2-16 16-16H192c17.7 0 32-14.3 32-32s-14.3-32-32-32H80z\"><\/path><\/svg><\/span><\/a><\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Preparing a PMDA submission for a medical device in Japan? Learn the key usability engineering requirements, JIS T 62366-1 compliance, local study design, and use of overseas data.<\/p>\n","protected":false},"author":27,"featured_media":8252,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_locale":"en_US","_original_post":"https:\/\/uism.co.jp\/?p=6420","footnotes":"","wp-seo-meta-description":"Learn key usability engineering requirements for PMDA medical device submissions in Japan, including JIS T 62366-1 compliance, evaluation strategies, and practical tips for international manufacturers.","wp-seo-meta-robots":[]},"categories":[175],"tags":[269,403,411,412,413],"class_list":{"0":"post-8199","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-healthcare","8":"tag-usability-engineering","9":"tag-jis-t-62366-1","10":"tag-medical-device-japan","11":"tag-pmda","12":"tag-summative-evaluation","13":"en-US","14":"c-entry"},"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/8199","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/users\/27"}],"replies":[{"embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/comments?post=8199"}],"version-history":[{"count":4,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/8199\/revisions"}],"predecessor-version":[{"id":9367,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/8199\/revisions\/9367"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media\/8252"}],"wp:attachment":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media?parent=8199"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/categories?post=8199"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/tags?post=8199"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}