{"id":10630,"date":"2026-07-08T10:48:28","date_gmt":"2026-07-08T01:48:28","guid":{"rendered":"https:\/\/uism.co.jp\/?p=10630"},"modified":"2026-07-08T10:48:28","modified_gmt":"2026-07-08T01:48:28","slug":"your-pmda-submission-an-integrated-approach-to-usability-62366-1-and-risk-14971","status":"publish","type":"post","link":"https:\/\/uism.co.jp\/en\/blog\/your-pmda-submission-an-integrated-approach-to-usability-62366-1-and-risk-14971\/","title":{"rendered":"Your PMDA Submission: An Integrated Approach to Usability (62366-1) and Risk (14971)\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>PMDA submissions: Don&#8217;t treat usability (62366-1) and risk management (14971) as separate tasks. <\/li>\n<li>Integrated framework: Treat the usability standard (62366-1) as a subprocess within the main risk framework (14971).<\/li>\n<li>Practical workflow: Translate abstract risks from 14971 into concrete, testable use scenarios for 62366-1 validation. <\/li>\n<\/ul>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">As you prepare your submission to Japan&#8217;s Pharmaceuticals and Medical Devices Agency (PMDA) and set your sights on the Japanese market,&nbsp;you may already be running into questions around usability evaluation requirements.&nbsp;These are questions we hear&nbsp;frequently&nbsp;from international teams:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>&#8220;What\u2019s the real relationship between the usability standard (JIS T 62366-1) and the risk management standard (JIS T 14971)?&#8221;&nbsp;<\/li>\n\n\n\n<li>&#8220;How are we supposed to integrate our usability engineering process with our risk management activities?&#8221;&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These are questions we&nbsp;frequently&nbsp;hear from international manufacturers and service providers.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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&nbsp;just about understanding&nbsp;the theory;&nbsp;they&#8217;re about&nbsp;a critical factor that can&nbsp;determine&nbsp;the success of your submission.&nbsp;For PMDA, safety is not just about preventing device malfunction. It requires that risks arising from&nbsp;use&nbsp;error\u2014mistakes made by the user\u2014are also&nbsp;identified&nbsp;and&nbsp;properly managed.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In practice, usability and risk management cannot be treated as separate activities.&nbsp;They must be designed and executed as a single, integrated system.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this article,&nbsp;we&#8217;ll&nbsp;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.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Why You Need to Understand Both Standards at Once&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In the context of PMDA submissions,&nbsp;usability engineering is considered a part of your overall risk management activities.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As of April 1, 2024, medical devices sold in Japan must, in principle,&nbsp;comply with&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">JIS T 62366-1:2022<\/span><\/strong>&nbsp;(Usability Engineering). This is now a practical necessity. And this standard cannot be applied in isolation from the medical device risk management standard,&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">JIS T 14971:2020<\/span><\/strong>.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The PMDA defines &#8220;safety&#8221; as having objective evidence that a device can be used safely, with all unacceptable risks eliminated or reduced. The key here is that &#8220;risk&#8221;&nbsp;isn&#8217;t&nbsp;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&nbsp;deemed&nbsp;&#8220;unsafe&#8221; if its interface is so complex that it invites errors.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is where the two standards work together to systematically address use-related risks: JIS T 14971 covers all&nbsp;reasonably foreseeable&nbsp;misuse, including &#8220;abnormal use,&#8221; while JIS T 62366-1 specifically&nbsp;hones in&nbsp;on use errors that can occur during &#8220;normal use.&#8221;&nbsp;&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-grid smb-grid smb-grid--columns:columns smb-grid--rows:rows\" style=\"--smb-grid--gap:var(--wp--preset--spacing--30);--smb-grid--columns:2;--smb-grid--rows:1\">\n<p class=\"has-border-color has-background wp-block-paragraph\" style=\"border-color:#0693e3;border-width:1px;border-top-left-radius:20px;border-top-right-radius:20px;border-bottom-left-radius:20px;border-bottom-right-radius:20px;background-color:#e8f1ff\"><strong><span class=\"sme-font-size has-sm-l-font-size\">JIS T 14971<\/span><\/strong><br>Defines the overall framework for risk management.&nbsp;<\/p>\n\n\n\n<p class=\"has-border-color has-background wp-block-paragraph\" style=\"border-color:#1aa270;border-width:1px;border-top-left-radius:20px;border-top-right-radius:20px;border-bottom-left-radius:20px;border-bottom-right-radius:20px;background-color:#e5ffe0\"><strong><span class=\"sme-font-size has-sm-l-font-size\">JIS T 62366-1<\/span><\/strong><br>Provides the specialized process for handling&nbsp;the human-related risks within that framework.&nbsp;<\/p>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">This means you&nbsp;don&#8217;t&nbsp;run two separate processes.&nbsp;This requires an integrated risk management perspective&nbsp;that&nbsp;operates&nbsp;with a single, consistent logic.&nbsp;<\/span><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">The Two Main Standards: Risk Management and Usability&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">First,&nbsp;let&#8217;s&nbsp;get a clear understanding of the roles of the two core JIS standards for your PMDA submission.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">&nbsp;1.&nbsp;JIS T 14971:2020 \u2013 The Foundation of Risk Management&nbsp;<\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Based on ISO 14971, this standard&nbsp;establishes&nbsp;a systematic process for managing risks throughout the entire lifecycle of a medical device.&nbsp;It serves as&nbsp;the&nbsp;overarching framework&nbsp;for all safety-related activities, including usability. Here are three key takeaways:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--background-opacity:1;--smb-box--border-width:1px\"><div class=\"smb-box__background\"><\/div><div class=\"smb-box__body is-layout-constrained wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<h4 class=\"wp-block-heading\">\u2160.<strong>The&nbsp;Overall Risk Management Framework<\/strong>&nbsp;<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">It defines the end-to-end process:&nbsp;identifying&nbsp;hazards (potential sources of harm),&nbsp;estimating&nbsp;and evaluating the associated risks, implementing risk controls, and verifying their effectiveness\u2014from product concept to disposal.&nbsp;<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--background-opacity:1;--smb-box--border-width:1px\"><div class=\"smb-box__background\"><\/div><div class=\"smb-box__body is-layout-constrained wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<h4 class=\"wp-block-heading\"><strong>\u2161. Identification of Reasonably Foreseeable Misuse<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The standard requires a comprehensive analysis of potential misuse. This includes not only unintentional use errors but also intentional &#8220;abnormal use,&#8221; like a user ignoring a warning in the instructions for use. This analysis becomes the starting point for your usability engineering efforts.&nbsp;<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--background-color:var(--_color-white);--smb-box--background-opacity:1;--smb-box--border-width:1px\"><div class=\"smb-box__background\"><\/div><div class=\"smb-box__body is-layout-constrained wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<h4 class=\"wp-block-heading\"><strong>\u2162. Clarifying the Causal Chain: Hazard, Hazardous Situation, and Harm<\/strong>&nbsp;<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This is the process of logically linking cause and effect to answer, &#8220;Why does this action lead to harm?&#8221; For example, you would map out a chain like: <\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"border-left-color:var(--wp--preset--color--vivid-red);border-left-width:4px;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">Small text on a display (Hazard) \u2192 User misreads the setting value (Hazardous Situation occurs) \u2192 Medication is overdosed (Harm).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"> Clarifying this chain helps you target your risk control measures effectively.&nbsp;<\/p>\n<\/div><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">2.&nbsp;JIS T 62366-1:2022 \u2013 Usability Engineering for Human-Related Risks&nbsp;<\/span><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">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&nbsp;identified&nbsp;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&nbsp;particular domain&nbsp;of human-related risks. Its key components include:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--background-opacity:1;--smb-box--border-width:1px\"><div class=\"smb-box__background\"><\/div><div class=\"smb-box__body is-layout-constrained wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<h4 class=\"wp-block-heading\">\u2160. <strong>The Usability Engineering Process (Clause 5)<\/strong>&nbsp;<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This systematic process consists of nine main steps, starting from &#8220;Preparing the Use Specification&#8221; to &#8220;Identifying Hazard-Related Use Scenarios,&#8221; and running through &#8220;Formative Evaluation&#8221; and &#8220;Summative Evaluation.&#8221; Adherence to this process itself serves as objective evidence for the PMDA.&nbsp;<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--background-opacity:1;--smb-box--border-width:1px\"><div class=\"smb-box__background\"><\/div><div class=\"smb-box__body is-layout-constrained wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<h4 class=\"wp-block-heading\"><strong>\u2161. Design Improvement through Formative Evaluation<\/strong>&nbsp;<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This is an iterative process&nbsp;conducted repeatedly during design and development. By having real users test prototypes, you can&nbsp;identify&nbsp;issues early and refine the design.&nbsp;It\u2019s&nbsp;a crucial step for improving the quality of your user interface.&nbsp;<\/p>\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--background-opacity:1;--smb-box--border-width:1px\"><div class=\"smb-box__background\"><\/div><div class=\"smb-box__body is-layout-constrained wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<h4 class=\"wp-block-heading\"><strong>\u2162. Safety Verification through Summative Evaluation<\/strong>&nbsp;<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">This serves as the final validation step.&nbsp;Using the final user interface, you evaluate the hazard-related use scenarios to obtain objective evidence that the usability for safety is adequate. For a PMDA submission, this evaluation is the core evidence&nbsp;demonstrating&nbsp;that your risk control measures have been effective.&nbsp;<\/p>\n<\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--30);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\"><em>*The PMDA accepts compliance with internationally recognized standards like IEC 62366-1:2015+AMD1:2020,&nbsp;as long as&nbsp;you can logically explain how it meets Japan&#8217;s essential requirements.&nbsp;<\/em><\/p>\n\n\n<div class=\"smk-related-card\" data-url=\"https:\/\/uism.co.jp\/en\/blog\/for-international-manufacturers-key-usability-points-for-japanese-pmda-submissions\/\">\n  <img decoding=\"async\" class=\"smk-thumb\" src=\"\" alt=\"\" \/><\/p>\n<div class=\"smk-thumb-placeholder\">\ud83d\udcc4<\/div>\n<div class=\"smk-content\">\n<p class=\"smk-label\">Related Article<\/p>\n<p>    <a class=\"smk-title\" href=\"#\">Loading&#8230;<\/a><\/p>\n<p class=\"smk-caption\">For an overview of PMDA usability requirements, see this related article. It explains key points for international manufacturers, including PMDA expectations, use of overseas data, and evaluation design rationale.<\/p>\n<p>    <a class=\"smk-readmore\" href=\"#\">Read more \u2192<\/a>\n  <\/div>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">The Interplay&nbsp;between the Two Standards: An Integrated Risk Management Model&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The practical question, then, is how these two standards are integrated.&nbsp;The practical key is to treat 14971 as the master framework and embed 62366-1 as a subprocess within it.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Usability activities&nbsp;don&#8217;t&nbsp;exist in a vacuum. They are an integral part of the risk management process, linking closely with the &#8220;Risk Analysis&#8221; and &#8220;Risk Control&#8221; phases.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The specific point where they connect is the &#8220;Hazard-Related Use Scenario.&#8221;<\/strong><strong>&nbsp;<\/strong>&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-f69f6e3a wp-block-group-is-layout-constrained\" style=\"border-top-left-radius:10px;border-top-right-radius:10px;border-bottom-left-radius:10px;border-bottom-right-radius:10px;border-top-color:#0576b7;border-top-width:4px;border-right-color:var(--wp--preset--color--sm-light-gray);border-right-width:1px;border-bottom-color:var(--wp--preset--color--sm-light-gray);border-bottom-width:1px;border-left-color:var(--wp--preset--color--sm-light-gray);border-left-width:1px;padding-top:var(--wp--preset--spacing--40);padding-right:var(--wp--preset--spacing--40);padding-bottom:var(--wp--preset--spacing--40);padding-left:var(--wp--preset--spacing--40)\">\n<p class=\"wp-block-paragraph\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>Step 1<\/strong><\/span> <span style=\"\n  display: inline-block;\n  background: #E8F1FF;\n  color: #0046AD;\n  padding: 8px 20px;\n  border-radius: 25px;\n  font-weight: bold;\n  font-size: 14px;\n  letter-spacing: 0.05em;\n\">14971<\/span><\/p>\n\n\n\n<ul style=\"margin-top:var(--wp--preset--spacing--20);margin-bottom:var(--wp--preset--spacing--20)\" class=\"wp-block-list is-style-default\">\n<li>Conduct a risk analysis to identify &#8220;hazardous situations&#8221; that could lead to harm.&nbsp;\n<ul class=\"wp-block-list\">\n<li>Example: For an infusion pump,&nbsp;identify&nbsp;the hazardous&nbsp;situation&nbsp;&#8220;over-infusion of medication.&#8221;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-font-awesome-icon wp-font-awesome-icon\" style=\"display:flex;justify-content:center\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"chevron-down\" class=\"svg-inline--fa fa-chevron-down \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><path fill=\"currentColor\" d=\"M233.4 406.6c12.5 12.5 32.8 12.5 45.3 0l192-192c12.5-12.5 12.5-32.8 0-45.3s-32.8-12.5-45.3 0L256 338.7 86.6 169.4c-12.5-12.5-32.8-12.5-45.3 0s-12.5 32.8 0 45.3l192 192z\"><\/path><\/svg><\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-f69f6e3a wp-block-group-is-layout-constrained\" style=\"border-top-left-radius:10px;border-top-right-radius:10px;border-bottom-left-radius:10px;border-bottom-right-radius:10px;border-top-color:#00795b;border-top-width:4px;border-right-color:var(--wp--preset--color--sm-light-gray);border-right-width:1px;border-bottom-color:var(--wp--preset--color--sm-light-gray);border-bottom-width:1px;border-left-color:var(--wp--preset--color--sm-light-gray);border-left-width:1px;padding-top:var(--wp--preset--spacing--40);padding-right:var(--wp--preset--spacing--40);padding-bottom:var(--wp--preset--spacing--40);padding-left:var(--wp--preset--spacing--40)\">\n<p class=\"wp-block-paragraph\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>Step<\/strong><\/span> <strong><span class=\"sme-font-size has-sm-l-font-size\">2 <span style=\"\n  display: inline-block;\n  background: #E5FFE0;\n  color: #00795B;\n  padding: 8px 20px;\n  border-radius: 25px;\n  font-weight: bold;\n  font-size: 14px;\n  letter-spacing: 0.05em;\n\"><span style=\"color: #288a66\" class=\"sme-text-color\">62366-1<\/span><\/span><\/span><\/strong><\/p>\n\n\n\n<ul style=\"margin-top:var(--wp--preset--spacing--20);margin-bottom:var(--wp--preset--spacing--20)\" class=\"wp-block-list is-style-default\">\n<li>Analyze and define the specific sequence of user actions (scenario) that could lead to that hazardous situation.&nbsp;\n<ul class=\"wp-block-list\">\n<li>Example: Create a scenario: &#8220;On the dose setting screen, the user overlooks the unit (mg\/mL) and inputs a value 10 times what was intended.&#8221;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-font-awesome-icon wp-font-awesome-icon\" style=\"display:flex;justify-content:center\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"chevron-down\" class=\"svg-inline--fa fa-chevron-down \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><path fill=\"currentColor\" d=\"M233.4 406.6c12.5 12.5 32.8 12.5 45.3 0l192-192c12.5-12.5 12.5-32.8 0-45.3s-32.8-12.5-45.3 0L256 338.7 86.6 169.4c-12.5-12.5-32.8-12.5-45.3 0s-12.5 32.8 0 45.3l192 192z\"><\/path><\/svg><\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-f69f6e3a wp-block-group-is-layout-constrained\" style=\"border-top-left-radius:10px;border-top-right-radius:10px;border-bottom-left-radius:10px;border-bottom-right-radius:10px;border-top-color:#00795b;border-top-width:4px;border-right-color:var(--wp--preset--color--sm-light-gray);border-right-width:1px;border-bottom-color:var(--wp--preset--color--sm-light-gray);border-bottom-width:1px;border-left-color:var(--wp--preset--color--sm-light-gray);border-left-width:1px;padding-top:var(--wp--preset--spacing--40);padding-right:var(--wp--preset--spacing--40);padding-bottom:var(--wp--preset--spacing--40);padding-left:var(--wp--preset--spacing--40)\">\n<p class=\"wp-block-paragraph\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>Step<\/strong><\/span> <strong><span class=\"sme-font-size has-sm-l-font-size\">3 <span style=\"\n  display: inline-block;\n  background: #E5FFE0;\n  color: #00795B;\n  padding: 8px 20px;\n  border-radius: 25px;\n  font-weight: bold;\n  font-size: 14px;\n  letter-spacing: 0.05em;\n\">62366-1<\/span><\/span><\/strong><\/p>\n\n\n\n<ul style=\"margin-top:var(--wp--preset--spacing--20);margin-bottom:var(--wp--preset--spacing--20)\" class=\"wp-block-list is-style-default\">\n<li>Test this scenario in a summative evaluation to gather objective evidence that the user interface can be used safely.&nbsp;<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-font-awesome-icon wp-font-awesome-icon\" style=\"display:flex;justify-content:center\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"chevron-down\" class=\"svg-inline--fa fa-chevron-down \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><path fill=\"currentColor\" d=\"M233.4 406.6c12.5 12.5 32.8 12.5 45.3 0l192-192c12.5-12.5 12.5-32.8 0-45.3s-32.8-12.5-45.3 0L256 338.7 86.6 169.4c-12.5-12.5-32.8-12.5-45.3 0s-12.5 32.8 0 45.3l192 192z\"><\/path><\/svg><\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-f69f6e3a wp-block-group-is-layout-constrained\" style=\"border-top-left-radius:10px;border-top-right-radius:10px;border-bottom-left-radius:10px;border-bottom-right-radius:10px;border-top-color:#0576b7;border-top-width:4px;border-right-color:var(--wp--preset--color--sm-light-gray);border-right-width:1px;border-bottom-color:var(--wp--preset--color--sm-light-gray);border-bottom-width:1px;border-left-color:var(--wp--preset--color--sm-light-gray);border-left-width:1px;padding-top:var(--wp--preset--spacing--40);padding-right:var(--wp--preset--spacing--40);padding-bottom:var(--wp--preset--spacing--40);padding-left:var(--wp--preset--spacing--40)\">\n<p class=\"wp-block-paragraph\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>Step 4<\/strong><\/span> <span style=\"\n  display: inline-block;\n  background: #E8F1FF;\n  color: #0046AD;\n  padding: 8px 20px;\n  border-radius: 25px;\n  font-weight: bold;\n  font-size: 14px;\n  letter-spacing: 0.05em;\n\">14971<\/span><\/p>\n\n\n\n<ul style=\"margin-top:var(--wp--preset--spacing--20);margin-bottom:var(--wp--preset--spacing--20)\" class=\"wp-block-list is-style-default\">\n<li>Feed the results back into the overall residual risk assessment to make a final judgment on the device&#8217;s safety.&nbsp;<\/li>\n<\/ul>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">This flow\u2014translating abstract risks into concrete use scenarios and&nbsp;validating&nbsp;them through evaluation\u2014is the core of integrated risk management.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Supporting &#8220;Related Standards and Guidelines&#8221;&nbsp;<\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/06\/middle-1024x683.png\" alt=\"\" class=\"wp-image-10549\" style=\"aspect-ratio:1.499256480062227;width:1070px;height:auto\" srcset=\"https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/06\/middle-1024x683.png 1024w, https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/06\/middle-300x200.png 300w, https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/06\/middle-768x512.png 768w, https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/06\/middle.png 1536w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">These two main standards alone might not always give you the &#8220;how-to&#8221; for every situation. In practice, you can get a clearer picture by referring to the following related documents:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-grid smb-grid smb-grid--columns:columns smb-grid--rows:rows\" style=\"--smb-grid--gap:var(--wp--preset--spacing--40);--smb-grid--columns:2;--smb-grid--rows:1\">\n<p class=\"has-background wp-block-paragraph\" style=\"background-color:#fcb90012\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>IEC 60601-1-6 (Collateral Standard for Usability of Medical Electrical Equipment)<\/strong>&nbsp;<\/span><br>For medical electrical (ME) equipment, this standard acts as a bridge between the basic safety standard (JIS T 0601-1) and the usability standard (JIS T 62366-1). Be aware: simply following the 62366-1 process&nbsp;isn&#8217;t&nbsp;enough to meet this collateral standard&#8217;s unique requirements for the instructions for use, so you must review it as well.&nbsp;<\/p>\n\n\n\n<p class=\"has-background wp-block-paragraph\" style=\"background-color:#9b51e012\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>IEC TR 62366-2 (Guidance on the Application of Usability Engineering)<\/strong>&nbsp;<\/span><br>While JIS T 62366-1 focuses on safety, this technical report (TR) is a practical textbook that covers broader usability topics like efficiency and satisfaction, along with detailed evaluation methods.&nbsp;<\/p>\n\n\n\n<p class=\"has-background wp-block-paragraph\" style=\"background-color:#0792e312\"><strong><span class=\"sme-font-size has-sm-l-font-size\">JIS TR T 24971 (Guidance on the Application of Risk Management)<\/span><\/strong>&nbsp;<br>This guidance document provides detailed, practical methods for implementing JIS T 14971 in the field. Its in-depth explanations of&nbsp;use&nbsp;error analysis and risk estimation are especially helpful for improving the quality of your risk analysis.&nbsp;<\/p>\n\n\n\n<p class=\"has-background wp-block-paragraph\" style=\"background-color:#cf2d2d12\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>Particular Product&nbsp;Standards (e.g., ISO 15197 for Blood-Glucose Monitoring Systems)<\/strong>&nbsp;<\/span><br>For certain product categories like blood-glucose meters, particular standards may contain their own unique usability requirements.&nbsp;It is essential to&nbsp;check for&nbsp;any particular standards relevant to your device.&nbsp;<\/p>\n<\/div>\n\n\n\n<p class=\"has-background wp-block-paragraph\" style=\"background-color:#00d18412\"><span class=\"sme-font-size has-sm-l-font-size\"><strong>ISO 13485 (Quality Management Systems for Medical Devices)<\/strong>&nbsp;<\/span><br>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&nbsp;we\u2019ve&nbsp;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.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">A Special Case: Handling Existing Products (UOUP)&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A common challenge many manufacturers face is, &#8220;What do we do with products that were fully developed and commercialized before the major PMDA changes in April 2024?&#8221;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">An existing user interface that lacks development records compliant with the latest JIS standards is defined as a&nbsp;<strong><span style=\"background-image: linear-gradient(transparent 60%, rgba(255, 240, 151, 0.5) 60%)\" class=\"sme-highlighter\">UOUP (User Interface of Unknown Provenance)<\/span><\/strong>. For these, an alternative process outlined in Annex C of the standard is&nbsp;permitted.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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).&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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&nbsp;portion&nbsp;cannot be treated as UOUP. This&nbsp;isn&#8217;t&nbsp;a simple workaround, so careful planning is&nbsp;required.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Conclusion: A Cohesive Logic and Usability Strategy for Successful PMDA Submissions&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PMDA does not evaluate only the final product\u2014it evaluates the logic behind how safety has been ensured.&nbsp;They&#8217;re&nbsp;looking for&nbsp;a cohesive&nbsp;logic throughout your development process, backed by objective evidence.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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&nbsp;in accordance with&nbsp;your QMS, and document the entire process in your Usability Engineering File.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">At the same time, we see many companies run into practical challenges, such as:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Identifying&nbsp;the right use scenarios to evaluate.&nbsp;<\/li>\n\n\n\n<li>Reflecting Japan-specific medical environments and user characteristics.&nbsp;<\/li>\n\n\n\n<li>Ensuring documentation quality that meets PMDA standards.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These are issues that&nbsp;can&#8217;t&nbsp;be solved by simply&nbsp;reading&nbsp;the standards; they&nbsp;require&nbsp;experience-based design and planning.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As specialists in medical device usability evaluation in Japan, we can support you every step of the way\u2014from planning and execution to documentation. We help you not only&nbsp;comply with&nbsp;regulations but also create a product that is truly safe and easy to use for Japanese users.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If you are preparing for a PMDA submission or planning usability validation in Japan, feel free to reach out to discuss your project.&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\n\n<a href=\"https:\/\/uism.co.jp\/en\/human-factors-research\/\" class=\"service-border-card-en\">\n  <h3 class=\"border-title-en\">Human Factors Research<\/h3>\n  <p class=\"border-description-en\">Learn more about Uism\u2019s UX research services.<\/p>\n  <div class=\"border-link-en\">\n    <span>Learn More<\/span>\n    <svg width=\"16\" height=\"16\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\">\n      <path d=\"M5 12h14M12 5l7 7-7 7\"\/>\n    <\/svg>\n  <\/div>\n<\/a>\n\n\n<p class=\"wp-block-paragraph\"><strong><span style=\"color: #4c9f87\" class=\"sme-text-color\">References<\/span><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>JIS T 62366-1: 2022\uff08Medical devices &#8211; Part 1: Application of usability engineering to medical devices\uff09&nbsp;<\/li>\n\n\n\n<li>JIS T 14971: 2020\uff08Medical&nbsp;devices-Application of risk management to medical devices\uff09&nbsp;<\/li>\n\n\n\n<li>PMDA Usability of Medical Devices <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><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-section smb-section smb-section--fit\" style=\"padding-top:var(--wp--preset--spacing--40);padding-bottom:var(--wp--preset--spacing--40)\"><div class=\"smb-section__inner\"><div class=\"c-container c-container--no-padding\"><div class=\"smb-section__contents-wrapper\"><div class=\"smb-section__body is-layout-constrained wp-block-snow-monkey-blocks-section-is-layout-constrained\">\n<p class=\"wp-block-paragraph\"><strong><span class=\"sme-font-size has-sm-l-font-size\"><strong><span style=\"color: #4c9f87\" class=\"sme-text-color\">Related Articles:<\/span><\/strong><\/span><\/strong><\/p>\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=\"177AK2wiwO\"><a href=\"https:\/\/uism.co.jp\/en\/blog\/for-international-manufacturers-key-usability-points-for-japanese-pmda-submissions\/\">For International Manufacturers: Key Usability Points for Japanese PMDA Submissions\u00a0<\/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=\"\u201cFor International Manufacturers: Key Usability Points for Japanese PMDA Submissions\u00a0\u201d \u2014 Uism\" src=\"https:\/\/uism.co.jp\/en\/blog\/for-international-manufacturers-key-usability-points-for-japanese-pmda-submissions\/embed\/#?secret=cGIIyonzbM#?secret=177AK2wiwO\" data-secret=\"177AK2wiwO\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/div>\n<\/div><figcaption class=\"wp-element-caption\"><em>If you are planning a PMDA submission, this related article will help you understand what usability evidence is expected in Japan, how overseas data may be used, and where evaluation design often requires careful justification.<\/em><\/figcaption><\/figure>\n<\/div><\/div><\/div><\/div><\/div>\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=\"ejtpIajWez\"><a href=\"https:\/\/uism.co.jp\/en\/blog\/human-factors-for-medical-devices-in-japan-what-global-manufacturers-need-to-know\/\">Medical Device Usability Engineering in Japan: What Global Manufacturers Need to Know About PMDA and JIS T 62366-1\u00a0<\/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=\"\u201cMedical Device Usability Engineering in Japan: What Global Manufacturers Need to Know About PMDA and JIS T 62366-1\u00a0\u201d \u2014 Uism\" src=\"https:\/\/uism.co.jp\/en\/blog\/human-factors-for-medical-devices-in-japan-what-global-manufacturers-need-to-know\/embed\/#?secret=vwt9PfBQdY#?secret=ejtpIajWez\" data-secret=\"ejtpIajWez\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/div>\n<\/div><figcaption class=\"wp-element-caption\"><em>Before applying HFE\/UE practices developed overseas to a Japanese submission, it is important to understand Japan-specific expectations. This article explains where localization, user characteristics, and testing with Japanese users can affect your strategy.<\/em><\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Understand key usability evaluation requirements for PMDA submissions, including how JIS T 62366-1 and JIS T 14971 work together in medical device risk management.<\/p>\n","protected":false},"author":27,"featured_media":10548,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_locale":"en_US","_original_post":"https:\/\/uism.co.jp\/?p=10543","footnotes":"","wp-seo-meta-description":"Understand key usability evaluation requirements for PMDA submissions, including how JIS T 62366-1 and JIS T 14971 work together in medical device risk management.","wp-seo-meta-robots":[]},"categories":[175],"tags":[407,416,425,443,444],"class_list":["post-10630","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-healthcare","tag-risk-management","tag-pmda-submission","tag-jis-t-62366-1-3","tag-usability-evaluation","tag-jis-t-14971","en-US","c-entry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/10630","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=10630"}],"version-history":[{"count":20,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/10630\/revisions"}],"predecessor-version":[{"id":10780,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/10630\/revisions\/10780"}],"wp:attachment":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media?parent=10630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/categories?post=10630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/tags?post=10630"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}