{"id":4626,"date":"2026-03-18T02:23:00","date_gmt":"2026-03-17T17:23:00","guid":{"rendered":"https:\/\/uism.co.jp\/?p=4626"},"modified":"2026-04-13T14:00:19","modified_gmt":"2026-04-13T05:00:19","slug":"human-factors-for-medical-devices-in-japan-what-global-manufacturers-need-to-know","status":"publish","type":"post","link":"https:\/\/uism.co.jp\/en\/blog\/human-factors-for-medical-devices-in-japan-what-global-manufacturers-need-to-know\/","title":{"rendered":"Human Factors for Medical Devices in Japan: What Global Manufacturers Need to Know\u00a0"},"content":{"rendered":"\n<p>As Human Factors Engineering\/Usability Engineering (HFE\/UE)&nbsp;*&nbsp;becomes a core pillar of safe and effective medical device design worldwide, international manufacturers may find themselves asking,&nbsp;<strong>&#8220;How is usability evaluated in Japan?&#8221;<\/strong>&nbsp;<\/p>\n\n\n\n<p>In the US, the FDA&nbsp;(Food and Drug Administration)&nbsp;requires&nbsp;a formal HFE\/UE report for most Class II and III medical devices. Japan, by contrast, did not mandate usability engineering practices to be embedded in medical device development until recently, leading to confusion or underestimation of usability engineering&#8217;s role in regulatory success.&nbsp;&nbsp;<\/p>\n\n\n\n<p>However, with the enforcement of&nbsp;<strong>JIS T 62366-1:2022<\/strong>&nbsp;(Japan&#8217;s usability engineering standard for medical devices, harmonized with IEC 62366-1:2015) beginning&nbsp;<strong>April 1, 2024<\/strong>, usability engineering has shifted from supplementary to&nbsp;<strong>mandatory for all device classes<\/strong>. The Pharmaceuticals and Medical Devices Agency (PMDA) now&nbsp;has&nbsp;significantly increased expectations for summative evaluation, particularly for Class II and above devices.&nbsp;&nbsp;<\/p>\n\n\n\n<p>This blog clarifies the current landscape in Japan and what it means for international teams preparing medical device submissions to PMDA.&nbsp;<\/p>\n\n\n\n<p><span class=\"sme-text-color has-sm-dark-gray-color\"><em>* Commonly referred to as \u201cusability engineering\u201d in Japan<\/em><\/span><\/p>\n\n\n\n<details class=\"wp-block-details has-sm-dark-gray-color has-text-color has-link-color wp-elements-bcc4ec461dfd91385b1f6371ab336cce is-layout-flow wp-block-details-is-layout-flow\"><summary>&lt;source&gt;&nbsp;&nbsp;<\/summary>\n<ul class=\"wp-block-list\">\n<li>FDA HF\/UE guidelines&nbsp;<a href=\"https:\/\/chrome-extension\/\/efaidnbmnnnibpcajpcglclefindmkaj\/https:\/\/www.fda.gov\/media\/80481\/download\" 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><\/li>\n\n\n\n<li>PMDA website (English)&nbsp;<a href=\"https:\/\/www.pmda.go.jp\/english\/\" 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><\/li>\n<\/ul>\n<\/details>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\"><strong>1. Japan&#8217;s Regulatory Approach to Usability<\/strong>&nbsp;<\/span><\/h2>\n\n\n\n<p>Japan&#8217;s medical device regulatory system is overseen by PMDA, under the Ministry of Health, Labour and Welfare (MHLW). While PMDA has published guidance documents and overview materials explaining JIS T 62366-1, these resources focus primarily on what is required rather than providing detailed implementation guidance or templates.<\/p>\n\n\n\n<p>PMDA applies key international standards to guide usability considerations:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>JIS T 62366-1:2022<\/strong> \u2013 Japan&#8217;s Industrial Standard for applying usability engineering to medical device design. Harmonized with IEC 62366-1:2015, this standard defines a structured process for\u00a0identifying\u00a0and minimizing use-related risks through user-centered design.\u00a0<\/li>\n\n\n\n<li><strong>JIS T 14971:2020<\/strong>\u00a0 \u2013 Japan&#8217;s harmonized standard based on ISO 14971:2019 for risk management of medical devices, which includes\u00a0identifying\u00a0and\u00a0evaluating\u00a0use-related hazards.\u00a0<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\"><strong>2. <\/strong>What Medical Devices are Subject to Usability Engineering?<\/span><\/h2>\n\n\n\n<p><strong>All medical devices are subject to usability engineering requirements.<\/strong>&nbsp;Like risk management under JIS T 14971, there are no exemptions from usability engineering compliance under JIS T 62366-1.&nbsp;<\/p>\n\n\n\n<p>This is an important distinction: while Class I devices in Japan are&nbsp;generally exempt&nbsp;from design control requirements, they are not exempt from risk management or usability engineering.&nbsp;&nbsp;<\/p>\n\n\n\n<p>A common misconception is that usability engineering only applies to software-based or electronically controlled devices.&nbsp;In reality, any&nbsp;medical device with user interaction falls under the scope,&nbsp;regardless of whether it&nbsp;contains&nbsp;software or electronics.&nbsp;For example,&nbsp;accompanying&nbsp;materials are also considered part of the interface and must be evaluated for use-related risks.&nbsp;<\/p>\n\n\n\n<p>Examples of accompanying materials include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Instructions for use\u00a0<\/li>\n\n\n\n<li>Package inserts\u00a0\u00a0<\/li>\n\n\n\n<li>Training materials\u00a0<\/li>\n\n\n\n<li>Maintenance and inspection manuals\u00a0<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\"><strong>3. Examples of accompanying materials include:\u00a0<\/strong><\/span><\/h2>\n\n\n\n<p>Understanding which submission pathway applies to your device is critical for\u00a0determining\u00a0the level of\u00a0usability engineering\u00a0documentation.\u00a0<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Submission Type<\/strong>&nbsp;<\/td><td><strong>Device Classification<\/strong>&nbsp;<\/td><td><strong>Review Authority<\/strong>&nbsp;<\/td><td><strong>Summative Evaluation Expectation<\/strong>&nbsp;<\/td><\/tr><tr><td><strong>Shonin (Approval)<\/strong>&nbsp;<\/td><td>New or significantly modified Class III or IV devices, and certain high-risk Class II devices&nbsp;<\/td><td>PMDA&nbsp;<\/td><td><strong>Required<\/strong>&nbsp;\u2013 Full summative validation expected&nbsp;<\/td><\/tr><tr><td><strong>Ninsho&nbsp;(Certification)<\/strong>&nbsp;<\/td><td>Standard Class II devices&nbsp;<\/td><td>PMDA-registered Third-Party Certification Body (RCB)&nbsp;<\/td><td><strong>Typically required<\/strong>&nbsp;\u2013 Extent depends on risk profile and user interface complexity&nbsp;<\/td><\/tr><tr><td><strong>Todokede&nbsp;(Notification)<\/strong>&nbsp;<\/td><td>Low-risk Class I devices&nbsp;<\/td><td>No review \u2013 notification&nbsp;only&nbsp;&nbsp;submitted&nbsp;to PMDA&nbsp;&nbsp;<\/td><td><strong>Generally&nbsp;not&nbsp;required<\/strong>&nbsp;&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<details class=\"wp-block-details has-sm-dark-gray-color has-text-color has-link-color wp-elements-d6902661dbf0aeb7bbaaf10d52cd8a2b is-layout-flow wp-block-details-is-layout-flow\"><summary>&lt;source&gt;&nbsp;&nbsp;<\/summary>\n<ul class=\"wp-block-list\">\n<li>PMDA Medical Devices(Japanese)\u00a0<a href=\"https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/about-reviews\/devices\/0028.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><\/li>\n\n\n\n<li>PMDA Regulations and Approval\/Certification of Medical Devices (English)\u00a0\u00a0<a href=\"https:\/\/www.pmda.go.jp\/english\/review-services\/reviews\/0004.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><\/li>\n<\/ul>\n<\/details>\n\n\n\n<p>For&nbsp;<strong>Class II devices and above<\/strong>, typical submission documents now include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Application form\u00a0<\/li>\n\n\n\n<li>Device summary and intended use description\u00a0<\/li>\n\n\n\n<li>Risk management file\u00a0(per JIS T 14971 \/ ISO 14971:2019)\u00a0<\/li>\n\n\n\n<li>Clinical evaluation and performance testing data\u00a0<\/li>\n\n\n\n<li>Labeling and\u00a0Instructions for Use (IFU) in Japanese\u00a0<\/li>\n\n\n\n<li>Quality Management System (QMS) documentation\u00a0<\/li>\n\n\n\n<li class=\"has-vivid-red-color has-text-color has-link-color wp-elements-c896b02fe14a84325b663a17cf6e5c78\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Usability engineering file\u00a0(UEF)\u00a0<\/strong>including:\u00a0<\/span>\n<ul class=\"wp-block-list\">\n<li class=\"has-text-color has-link-color wp-elements-a28b9b5ffed239cd8c3b91492ee2e970\" style=\"color:#ff6666\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Use specification<\/strong>: Who will use the device, where, and for what purpose\u00a0<\/span><\/li>\n\n\n\n<li class=\"has-text-color has-link-color wp-elements-a347a95562af0198e2b0b7be9b079f99\" style=\"color:#ff6666\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Use-related risk analysis (URRA)<\/strong>: User tasks, potential use errors, harms, hazard-related use scenarios, risk control\u00a0<\/span><\/li>\n\n\n\n<li class=\"has-text-color has-link-color wp-elements-43fda7d8c0a72bfd1989178d6c4a96c9\" style=\"color:#ff6666\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Formative evaluation summaries<\/strong>: Iterative testing results and design improvements\u00a0<\/span><\/li>\n\n\n\n<li class=\"has-text-color has-link-color wp-elements-5dbcc5e387fac499f2792e9ec61b5a76\" style=\"color:#ff6666\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Summative evaluation report<\/strong>: Final validation\u00a0demonstrating\u00a0safe and effective use\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\"><strong>4. <\/strong>What Global Manufacturers Should Know About Usability Engineering in Japan\u00a0\u00a0<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Rational Justification&nbsp;<\/h3>\n\n\n\n<p>Many global manufacturers with experience in&nbsp;FDA submissions or&nbsp;EU MDR&nbsp;compliance&nbsp;already conduct usability testing as a standard part of development. The good&nbsp;news is that&nbsp;<strong>existing HFE\/UE&nbsp;work can often be adapted for PMDA submissions<\/strong>.&nbsp;However,&nbsp;to use foreign HFE data, manufacturers must provide a rational justification for two key points:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Equivalence of Use Context:<\/strong>\u00a0Must prove that the intended users, use environments, and use scenarios in the foreign study are\u00a0essentially equivalent\u00a0to those in Japan.\u00a0<\/li>\n\n\n\n<li><strong>Localization Risk Assessment:<\/strong>\u00a0Must\u00a0demonstrate\u00a0that Japanese-specific\u00a0elements;\u00a0such as language displays, unit notations (e.g., specific medical units), and localized labeling\u00a0do not introduce new risks or use errors.\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Integration with Risk Management&nbsp;<\/h3>\n\n\n\n<p>In addition to the providing rationale for the above,&nbsp;usability engineering file must clearly link to your&nbsp;risk management file&nbsp;(per JIS T 14971). PMDA reviewers expect to see:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Traceability<\/strong>: Use-related hazards\u00a0identified\u00a0in risk analysis must be addressed\u00a0in summative\u00a0testing\u00a0<\/li>\n\n\n\n<li><strong>Outcome-Based Evaluation:\u00a0<\/strong>Summative evaluation is viewed as a confirmation of risk control effectiveness. Reviewers dislike conclusory statements like &#8220;safety was confirmed&#8221;; instead, documentation should\u00a0state\u00a0that the evaluation confirmed the design-based risk controls are effective for the identified hazard-related scenarios.\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Cases Requiring In-Country Studies&nbsp;<\/h3>\n\n\n\n<p>Additional&nbsp;studies in Japan may be necessary for:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient-facing Software as a Medical Device (SaMD):<\/strong>\u00a0Software intended for use by patients rather than healthcare professionals.\u00a0<\/li>\n\n\n\n<li><strong>High-impact display results:<\/strong>\u00a0Devices where the results shown on the display\u00a0directly\u00a0impact\u00a0diagnostic or treatment decisions.\u00a0<\/li>\n\n\n\n<li><strong>UI misinterpretation risks:<\/strong>\u00a0Any case where the\u00a0Japanese-language User Interface (UI)\u00a0might pose a risk of misinterpretation or lead to new use errors.\u00a0<\/li>\n<\/ul>\n\n\n\n<p><strong>Why is it important?<\/strong>&nbsp;<\/p>\n\n\n\n<p>Testing with Japanese users ensures that language, cultural context, and demographic factors are properly accounted for and may reveal use errors that\u00a0wouldn&#8217;t\u00a0surface in other testing environments abroad.\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\">5. How\u00a0We\u00a0Can Help<\/span><\/h2>\n\n\n\n<p>\u00a0At&nbsp;Uism,&nbsp;we specialize in helping international manufacturers navigate the Japanese regulatory landscape for medical device usability. Our services include:&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Local Usability Testing&nbsp;<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Planning and executing formative and summative usability studies with Japanese users\u00a0<\/li>\n\n\n\n<li>Recruiting hard-to-reach participants such as clinicians, elderly users, or patients with specific conditions\u00a0<\/li>\n\n\n\n<li>Testing in\u00a0simulated environments\u00a0that reflect actual use conditions in Japan\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Regulatory-Ready Documentation&nbsp;<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Structuring studies and reports to align with PMDA expectations and JIS T 62366-1 requirements\u00a0<\/li>\n\n\n\n<li>Developing\u00a0usability engineering\u00a0documents\u00a0<\/li>\n\n\n\n<li>Supporting\u00a0task analyses, URRA\u00a0\u00a0<\/li>\n\n\n\n<li>Formative\/summative evaluation reports\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Localization Support&nbsp;<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Evaluating Japanese-language IFU, labeling, and on-screen interfaces\u00a0<\/li>\n\n\n\n<li>Identifying\u00a0cultural or workflow-specific issues that may affect usability\u00a0<\/li>\n\n\n\n<li>Supporting UI\/UX refinements for the Japanese market\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Bilingual Expertise&nbsp;<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Providing bilingual researchers for seamless communication with global teams\u00a0<\/li>\n<\/ul>\n\n\n\n<p>While we do not directly manage regulatory submissions, our research provides the evidence and documentation you need to support your PMDA filing strategy.&nbsp;<\/p>\n\n\n\n<p>As a member of the&nbsp;<a href=\"https:\/\/resight.global\/\" target=\"_blank\" rel=\"noreferrer noopener\">ReSight Global<\/a>, which includes leading human factors firms such as&nbsp;<a href=\"https:\/\/boldinsight.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">Bold Insight<\/a>&nbsp;in the U.S. and&nbsp;<a href=\"https:\/\/www.uintent.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">uintent<\/a>&nbsp;in Germany, we bring not only local execution capabilities in&nbsp;Japan, but&nbsp;also shared&nbsp;expertise&nbsp;and best practices from some of the most experienced teams in the world. This global collaboration&nbsp;ensures&nbsp;our approach is consistent, rigorous, and informed by the&nbsp;latest&nbsp;regulatory trends.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\"><strong>Conclusion<\/strong>&nbsp;<\/span><\/h2>\n\n\n\n<p>Japan&#8217;s medical device market is evolving rapidly. While HFE\/UE&nbsp;resources and regulatory precedents&nbsp;remain&nbsp;more limited compared to the US or EU, usability is increasingly recognized as a critical element of medical device safety and effectiveness.&nbsp;<\/p>\n\n\n\n<p>For international manufacturers, the April 2024 enforcement of JIS T 62366-1:2022 means usability engineering is no longer optional. Whether&nbsp;you&#8217;re&nbsp;adapting existing HFE\/UE&nbsp;work for Japan or&nbsp;starting from scratch, testing with Japanese&nbsp;users&nbsp;and documenting use-related risks in a way that aligns with PMDA expectations is now essential.&nbsp;<\/p>\n\n\n\n<p>Uism is here to help.&nbsp;We offer end-to-end support for planning, executing, and documenting usability testing in Japan, bridging the gap between global standards and local regulatory requirements.&nbsp;<\/p>\n\n\n\n<p>Let&#8217;s&nbsp;connect and explore how we can support your human factors strategy in Japan.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Entering Japan\u2019s medical device market? See what PMDA expects for human factors, how overseas data can be adapted, and when local studies become essential.<\/p>\n","protected":false},"author":29,"featured_media":4623,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_locale":"en_US","_original_post":"https:\/\/uism.co.jp\/?p=4620","footnotes":"","wp-seo-meta-description":"Entering Japan\u2019s medical device market? See what PMDA expects for human factors, how overseas data can be adapted, and when local studies become essential.","wp-seo-meta-robots":[]},"categories":[175],"tags":[266,267,268,269],"class_list":{"0":"post-4626","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-healthcare","8":"tag-medical-device-regulation-japan","9":"tag-medical-device-ux","10":"tag-human-factors-engineering","11":"tag-usability-engineering","12":"en-US","13":"c-entry"},"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/4626","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\/29"}],"replies":[{"embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/comments?post=4626"}],"version-history":[{"count":9,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/4626\/revisions"}],"predecessor-version":[{"id":9365,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/4626\/revisions\/9365"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media\/4623"}],"wp:attachment":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media?parent=4626"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/categories?post=4626"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/tags?post=4626"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}