{"id":4626,"date":"2026-03-18T02:23:00","date_gmt":"2026-03-17T17:23:00","guid":{"rendered":"https:\/\/uism.co.jp\/?p=4626"},"modified":"2026-05-21T13:28:14","modified_gmt":"2026-05-21T04:28:14","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":"Medical Device Usability Engineering in Japan: What Global Manufacturers Need to Know About PMDA and JIS T 62366-1\u00a0"},"content":{"rendered":"<div class=\"smk-summary-box\">\n<h3 class=\"smk-summary-title\"><span class=\"smk-summary-icon\">\u2736<\/span>Article Summary<\/h3>\n<ul class=\"smk-summary-list\">\n<li><span class=\"TextRun SCXW134699999 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW134699999 BCX0\">Japan\u2019s enforcement of\u00a0<\/span><\/span><span class=\"TextRun SCXW134699999 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW134699999 BCX0\">JIS T 62366-1:2022<\/span><\/span><span class=\"TextRun SCXW134699999 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW134699999 BCX0\">\u00a0has made usability engineering increasingly important for medical device regulatory preparation.<\/span><\/span><span class=\"EOP SCXW134699999 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><span class=\"TextRun SCXW156709878 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW156709878 BCX0\">Global manufacturers may be able to adapt existing HFE\/UE data, but must justify Japan-specific use context, localization, and risk differences.<\/span><\/span><span class=\"EOP SCXW156709878 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><span class=\"TextRun SCXW223956778 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW223956778 BCX0\">Testing with Japanese users can help\u00a0<\/span><span class=\"NormalTextRun SCXW223956778 BCX0\">identify<\/span><span class=\"NormalTextRun SCXW223956778 BCX0\">\u00a0language, workflow, and cultural risks before PMDA submission.<\/span><\/span><span class=\"EOP SCXW223956778 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245417&quot;:false,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">For global medical device manufacturers, usability engineering is now an important part of regulatory preparation in Japan. With the enforcement of JIS T 62366-1:2022 from April 1,&nbsp;2024,&nbsp;usability&nbsp;engineering is expected to be addressed as part of the medical device development and risk management process.&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This&nbsp;article&nbsp;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<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 class=\"wp-block-paragraph\">Japan&#8217;s medical device regulatory system is overseen by&nbsp;<strong>PMDA<\/strong>, under the Ministry of Health,&nbsp;Labour&nbsp;and Welfare (MHLW). While PMDA has published guidance documents and overview materials explaining JIS T 62366-1, these resources focus primarily on&nbsp;what&nbsp;is&nbsp;required&nbsp;rather than&nbsp;providing&nbsp;detailed implementation guidance or templates.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PMDA applies key international standards to guide usability considerations:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>JIS T 62366-1:2022<\/strong>&nbsp;\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&nbsp;identifying&nbsp;and minimizing use-related risks through user-centered design.&nbsp;<\/li>\n\n\n\n<li><strong>JIS T 14971:2020<\/strong>&nbsp;\u2013 Japan&#8217;s harmonized standard based on ISO 14971:2019 for risk management of medical devices, which includes&nbsp;identifying&nbsp;and&nbsp;evaluating&nbsp;use-related hazards.&nbsp;<\/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 class=\"wp-block-paragraph\">Usability engineering should be considered for all medical devices with user interaction, with the level of documentation depending on the device\u2019s risk profile, user interface complexity, and submission pathway.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">Examples of accompanying materials include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Instructions for use&nbsp;<\/li>\n\n\n\n<li>Package inserts&nbsp;&nbsp;<\/li>\n\n\n\n<li>Training materials&nbsp;<\/li>\n\n\n\n<li>Maintenance and inspection manuals&nbsp;<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\"><strong>3. PMDA Submission Pathways: Shonin,&nbsp;Ninsho, and&nbsp;Todokede&nbsp;<\/strong><\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Understanding which submission pathway applies to your device is critical for&nbsp;determining&nbsp;the level of&nbsp;usability engineering&nbsp;documentation.&nbsp;<\/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-39756cff11efb873ad99093b3c153e75 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)&nbsp;<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)&nbsp;&nbsp;<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 class=\"wp-block-paragraph\">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&nbsp;<\/li>\n\n\n\n<li>Device summary and intended use description&nbsp;<\/li>\n\n\n\n<li>Risk management file&nbsp;(per JIS T 14971 \/ ISO 14971:2019)&nbsp;<\/li>\n\n\n\n<li>Clinical evaluation and performance testing data&nbsp;<\/li>\n\n\n\n<li>Labeling and&nbsp;Instructions for Use (IFU) in Japanese&nbsp;<\/li>\n\n\n\n<li>Quality Management System (QMS) documentation&nbsp;<\/li>\n\n\n\n<li class=\"has-vivid-red-color has-text-color has-link-color wp-elements-eb02e209581375985418150e99b75408\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Usability engineering file&nbsp;(UEF)&nbsp;<\/strong>including:&nbsp;<\/span>\n<ul class=\"wp-block-list\">\n<li class=\"has-text-color has-link-color wp-elements-30551ffb97e147128dc2f9f3ea25e822\" 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&nbsp;<\/span><\/li>\n\n\n\n<li class=\"has-text-color has-link-color wp-elements-a96409ab9a4c93323e6cb4ad465c7b12\" 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&nbsp;<\/span><\/li>\n\n\n\n<li class=\"has-text-color has-link-color wp-elements-44ab4aa6caa67d0d143d82da1d6347e9\" style=\"color:#ff6666\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Formative evaluation summaries<\/strong>: Iterative testing results and design improvements&nbsp;<\/span><\/li>\n\n\n\n<li class=\"has-text-color has-link-color wp-elements-d15e33a8dbb5efea004083c271a00b6c\" style=\"color:#ff6666\"><span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>Summative evaluation report<\/strong>: Final validation&nbsp;demonstrating&nbsp;safe and effective use&nbsp;<\/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>Can Foreign HFE\/UE Data Be Used for Japan?&nbsp;<\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Rational Justification<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">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,&nbsp;it is important to&nbsp;provide&nbsp;the following:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Equivalence of Use Context:<\/strong>&nbsp;Must prove that the intended users, use environments, and use scenarios in the foreign study are&nbsp;essentially equivalent&nbsp;to those in Japan.&nbsp;<\/li>\n\n\n\n<li><strong>Localization Risk Assessment:<\/strong>&nbsp;Must&nbsp;demonstrate&nbsp;that Japanese-specific&nbsp;elements;&nbsp;such as language displays, unit notations (e.g., specific medical units), and localized labeling&nbsp;do not introduce new risks or use errors.&nbsp;<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Integration with Risk Management&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">In addition to providing rationale for the above,\u00a0usability engineering file must clearly link to your\u00a0risk management file\u00a0(per JIS T 14971). PMDA reviewers expect to see:\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Traceability<\/strong>: Use-related hazards&nbsp;identified&nbsp;in risk analysis must be addressed&nbsp;in summative&nbsp;testing&nbsp;<\/li>\n\n\n\n<li><strong>Outcome-Based Evaluation:&nbsp;<\/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&nbsp;state&nbsp;that the evaluation confirmed the design-based risk controls are effective for the identified hazard-related scenarios.&nbsp;<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Cases Requiring In-Country Studies&nbsp;<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">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>&nbsp;Software intended for use by patients rather than healthcare professionals.&nbsp;<\/li>\n\n\n\n<li><strong>High-impact display results:<\/strong>&nbsp;Devices where the results shown on the display&nbsp;directly&nbsp;impact&nbsp;diagnostic or treatment decisions.&nbsp;<\/li>\n\n\n\n<li><strong>UI misinterpretation risks:<\/strong>&nbsp;Any case where the&nbsp;Japanese-language User Interface (UI)&nbsp;might pose a risk of misinterpretation or lead to new use errors.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Why is it important?<\/strong>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testing with Japanese users ensures that language, cultural context, and demographic factors are properly accounted for and may reveal use errors that&nbsp;wouldn&#8217;t&nbsp;surface in other testing environments abroad.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\">Conclusion&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Japan\u2019s medical device market is evolving rapidly. While HFE\/UE 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 class=\"wp-block-paragraph\">For international manufacturers, the April 2024 enforcement of JIS T 62366-1:2022 means usability engineering now needs to be considered as part of medical device development and regulatory preparation in Japan. Whether you are adapting existing HFE\/UE work for Japan or&nbsp;starting from scratch, it is important to document use-related risks in a way that aligns with PMDA expectations and, where needed, evaluate the device with Japanese users.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Uism&nbsp;supports international medical device manufacturers with usability testing and research documentation in Japan. We help teams plan formative and summative studies, recruit Japanese healthcare professionals and patients, evaluate Japanese-language interfaces and IFUs, and prepare usability documentation aligned with JIS T 62366-1 and PMDA expectations.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If you are preparing a PMDA submission or assessing whether&nbsp;your&nbsp;existing HFE\/UE data can be used for Japan, our team can help you&nbsp;identify&nbsp;the most&nbsp;appropriate next&nbsp;steps.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #34775c\" class=\"sme-text-color\">FAQ<\/span><\/h2>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>Is usability engineering&nbsp;required&nbsp;for medical devices in Japan?<\/strong>&nbsp;&nbsp;<\/summary>\n<p class=\"wp-block-paragraph\"><strong>Yes.<\/strong>&nbsp;Conformance to&nbsp;<strong>JIS T 62366-1:2022<\/strong>&nbsp;is mandatory for all medical device approvals and certifications in Japan as of&nbsp;<strong>April 1, 2024<\/strong>. This requirement ensures compliance with the&nbsp;requirements&nbsp;(specifically Articles 9 and 16)&nbsp;established&nbsp;by the Ministry of Health,&nbsp;Labour&nbsp;and Welfare (MHLW), which dictate that risks from&nbsp;use&nbsp;errors must be reduced as far as possible.&nbsp;<\/p>\n<\/details>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>Does JIS T 62366-1 apply to Class I medical devices?<\/strong>&nbsp;&nbsp;<\/summary>\n<p class=\"wp-block-paragraph\"><strong>Yes.<\/strong>&nbsp;The standard applies to&nbsp;<strong>all medical device classes.&nbsp;<\/strong>While the level of documentation and the need for a final summative test may vary based on risk, the manufacturer must still follow a systematic usability engineering process to meet Japanese regulatory standards.&nbsp;<\/p>\n<\/details>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>Is summative usability testing always&nbsp;required&nbsp;for PMDA submissions?<\/strong>&nbsp;&nbsp;<\/summary>\n<p class=\"wp-block-paragraph\">Summative evaluation is&nbsp;<strong>generally required&nbsp;for Class II, III, and IV devices<\/strong>. For&nbsp;<strong>Class I devices<\/strong>, summative testing is typically&nbsp;<strong>not mandatory<\/strong>, provided the manufacturer can rationally explain through risk analysis (JIS T 14971) that use-related risks are negligible. However, summative testing&nbsp;may still be suggested for&nbsp;Class I products if they are&nbsp;<strong>Software as a Medical Device (SaMD)<\/strong>&nbsp;or intended for&nbsp;<strong>general consumer\/home use<\/strong>.&nbsp;<\/p>\n<\/details>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>Can FDA or EU HFE\/UE data be used for PMDA submissions?<\/strong>&nbsp;&nbsp;<\/summary>\n<p class=\"wp-block-paragraph\"><strong>Yes, but translation alone is insufficient<\/strong>. Overseas evaluation data can be&nbsp;leveraged&nbsp;if the manufacturer provides two specific rationales in the dossier:&nbsp;<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li><strong>Equivalence of Use Context:<\/strong>&nbsp;Proving that the intended users, environments, and scenarios in the foreign study are&nbsp;essentially equivalent&nbsp;to those in Japan.&nbsp;<\/li>\n\n\n\n<li><strong>Localization Risk Assessment:<\/strong>&nbsp;Confirming that&nbsp;<strong>Japanese language displays<\/strong>, specific unit notations, or cultural differences do not introduce new use-related risks.&nbsp;<\/li>\n<\/ol>\n<\/details>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>When should usability testing be conducted with Japanese users?<\/strong>&nbsp;&nbsp;<\/summary>\n<p class=\"wp-block-paragraph\">Additional&nbsp;validation studies involving&nbsp;<strong>Japanese participants<\/strong>&nbsp;may be&nbsp;required&nbsp;in the following scenarios:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>For&nbsp;<strong>patient-facing SaMD<\/strong>&nbsp;or devices intended for home use by lay users.&nbsp;<\/li>\n\n\n\n<li>When device&nbsp;display&nbsp;results (e.g., AI-aided diagnostics)&nbsp;<strong>directly&nbsp;impact&nbsp;clinical decisions<\/strong>.&nbsp;<\/li>\n\n\n\n<li>Where the&nbsp;<strong>Japanese-language UI<\/strong>&nbsp;or localized labeling poses a unique risk of misinterpretation.&nbsp;<\/li>\n<\/ul>\n<\/details>\n\n\n\n<details class=\"wp-block-details is-layout-flow wp-block-details-is-layout-flow\"><summary><strong>Are IFUs and labeling included in usability engineering?&nbsp;<\/strong><\/summary>\n<p class=\"wp-block-paragraph\"><strong>Yes.<\/strong>&nbsp;The &#8220;user interface&#8221; is broadly defined to include&nbsp;<strong>all means of interaction<\/strong>&nbsp;between the user and the device. This explicitly includes&nbsp;<strong>Instructions for Use (IFUs)<\/strong>, labels, packaging, training materials, and any other accompanying documentation. Because these are considered&nbsp;<em>information&nbsp;for safety<\/em>, their effectiveness must be verified during the usability engineering process.&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\"\/>\n<\/details>\n","protected":false},"excerpt":{"rendered":"<p>Learn what global manufacturers need to know about medical device usability engineering in Japan, including PMDA expectations, JIS T 62366-1, foreign HFE data, and Japanese user testing. <\/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":["post-4626","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-healthcare","tag-medical-device-regulation-japan","tag-medical-device-ux","tag-human-factors-engineering","tag-usability-engineering","en-US","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":13,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/4626\/revisions"}],"predecessor-version":[{"id":10325,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/4626\/revisions\/10325"}],"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}]}}