{"id":10293,"date":"2026-05-21T16:25:45","date_gmt":"2026-05-21T07:25:45","guid":{"rendered":"https:\/\/uism.co.jp\/?p=10293"},"modified":"2026-05-21T16:25:46","modified_gmt":"2026-05-21T07:25:46","slug":"irb-requirements-for-medical-device-usability-testing-in-japan-key-triggers-timelines-and-documentation","status":"publish","type":"post","link":"https:\/\/uism.co.jp\/en\/blog\/irb-requirements-for-medical-device-usability-testing-in-japan-key-triggers-timelines-and-documentation\/","title":{"rendered":"IRB Requirements for Medical Device Usability Testing in Japan: Key Triggers, Timelines, and Documentation"},"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 SCXW251948191 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW251948191 BCX0\">IRB approval for medical device usability testing in Japan is\u00a0<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">not always\u00a0<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">required<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">, but is\u00a0<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">determined<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">\u00a0through a\u00a0<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">risk-based approach<\/span><span class=\"NormalTextRun SCXW251948191 BCX0\">, considering factors such as patient involvement, clinical settings, invasive prototypes, or physician participation in treatment decisions.<\/span><\/span><span class=\"EOP SCXW251948191 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 SCXW72730053 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW72730053 BCX0\">Early planning is critical in Japan<\/span><span class=\"NormalTextRun SCXW72730053 BCX0\">, as IRB processes typically take 6\u20138 weeks, with fixed monthly review cycles and strict submission timelines.\u00a0<\/span><\/span><span class=\"EOP SCXW72730053 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 SCXW16997170 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW16997170 BCX0\">Regardless of the decision, teams must\u00a0<\/span><span class=\"NormalTextRun SCXW16997170 BCX0\">clearly document the rationale for obtaining or not obtaining IRB approval<\/span><span class=\"NormalTextRun SCXW16997170 BCX0\">, ensuring alignment with regulatory expectations and smoother review processes.<\/span><\/span><span class=\"EOP SCXW16997170 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;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">At&nbsp;Uism, we&nbsp;frequently&nbsp;receive questions from clients about whether their specific usability study requires IRB*&nbsp;approval.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">While IRB review is&nbsp;required&nbsp;for clinical research, its applicability to usability testing is less straightforward&nbsp;and&nbsp;often&nbsp;sits in a gray zone.&nbsp;In this guide, we outline how&nbsp;to&nbsp;determine&nbsp;whether IRB approval&nbsp;is&nbsp;required, based on practical considerations and risk.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><span class=\"sme-font-size has-sm-xs-font-size\"><strong>*IRB (Institutional Review Board)<\/strong>&nbsp;is an ethics committee that reviews research involving human subjects to ensure participant safety, rights, and welfare are protected. In Japan, IRB oversight is guided by ethical guidelines for research involving humans.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Why Usability Testing May Require IRB&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Medical device usability testing is&nbsp;generally&nbsp;<strong>not&nbsp;considered clinical research<\/strong>. However, specific study characteristics may require ethical review.&nbsp;<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">1. Testing with Patients&nbsp;<\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Studies involving&nbsp;<strong>actual patients<\/strong>&nbsp;require the most careful consideration.&nbsp;You must assess whether participation introduces any risk&nbsp;(physical or psychological)&nbsp;to the patient\u2019s health or treatment. This is especially important when working with vulnerable populations such as:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-ecb84aab wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"margin-top:0;margin-bottom:0;padding-top:14px;padding-right:0;padding-bottom:14px;padding-left:0;--smb-box--box-shadow:5px 0px 5px 1px rgba(255, 255, 255, 1);--smb-box--background-color:var(u002du002d_lightest-color-gray);--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-container-snow-monkey-blocks-box-is-layout-90a3cc8b wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<p class=\"has-text-align-center wp-block-paragraph\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"hospital-user\" class=\"svg-inline--fa fa-hospital-user \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\" style=\"font-size:2.5em\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M48 0C21.5 0 0 21.5 0 48V256H144c8.8 0 16 7.2 16 16s-7.2 16-16 16H0v64H144c8.8 0 16 7.2 16 16s-7.2 16-16 16H0v80c0 26.5 21.5 48 48 48H265.9c-6.3-10.2-9.9-22.2-9.9-35.1c0-46.9 25.8-87.8 64-109.2V271.8 48c0-26.5-21.5-48-48-48H48zM152 64h16c8.8 0 16 7.2 16 16v24h24c8.8 0 16 7.2 16 16v16c0 8.8-7.2 16-16 16H184v24c0 8.8-7.2 16-16 16H152c-8.8 0-16-7.2-16-16V152H112c-8.8 0-16-7.2-16-16V120c0-8.8 7.2-16 16-16h24V80c0-8.8 7.2-16 16-16zM512 272a80 80 0 1 0 -160 0 80 80 0 1 0 160 0zM288 477.1c0 19.3 15.6 34.9 34.9 34.9H541.1c19.3 0 34.9-15.6 34.9-34.9c0-51.4-41.7-93.1-93.1-93.1H381.1c-51.4 0-93.1 41.7-93.1 93.1z\"><\/path><\/svg><\/span><\/p>\n\n\n\n<p class=\"has-text-align-center wp-block-paragraph\">Patients with serious\/terminal conditions&nbsp;&nbsp;<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"margin-top:0;margin-bottom:0;padding-top:14px;padding-right:0;padding-bottom:14px;padding-left:0;--smb-box--box-shadow:5px 0px 5px 1px rgba(255, 255, 255, 1);--smb-box--background-color:var(u002du002d_lightest-color-gray);--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-container-snow-monkey-blocks-box-is-layout-90a3cc8b wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<p class=\"has-text-align-center wp-block-paragraph\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"brain\" class=\"svg-inline--fa fa-brain \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" style=\"font-size:2.5em\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M184 0c30.9 0 56 25.1 56 56V456c0 30.9-25.1 56-56 56c-28.9 0-52.7-21.9-55.7-50.1c-5.2 1.4-10.7 2.1-16.3 2.1c-35.3 0-64-28.7-64-64c0-7.4 1.3-14.6 3.6-21.2C21.4 367.4 0 338.2 0 304c0-31.9 18.7-59.5 45.8-72.3C37.1 220.8 32 207 32 192c0-30.7 21.6-56.3 50.4-62.6C80.8 123.9 80 118 80 112c0-29.9 20.6-55.1 48.3-62.1C131.3 21.9 155.1 0 184 0zM328 0c28.9 0 52.6 21.9 55.7 49.9c27.8 7 48.3 32.1 48.3 62.1c0 6-.8 11.9-2.4 17.4c28.8 6.2 50.4 31.9 50.4 62.6c0 15-5.1 28.8-13.8 39.7C493.3 244.5 512 272.1 512 304c0 34.2-21.4 63.4-51.6 74.8c2.3 6.6 3.6 13.8 3.6 21.2c0 35.3-28.7 64-64 64c-5.6 0-11.1-.7-16.3-2.1c-3 28.2-26.8 50.1-55.7 50.1c-30.9 0-56-25.1-56-56V56c0-30.9 25.1-56 56-56z\"><\/path><\/svg><\/span><\/p>\n\n\n\n<p class=\"has-text-align-center wp-block-paragraph\">Individuals with severe mental health conditions<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"margin-top:0;margin-bottom:0;padding-top:26px;padding-right:0;padding-bottom:26px;padding-left:0;--smb-box--box-shadow:5px 0px 5px 1px rgba(255, 255, 255, 1);--smb-box--background-color:var(u002du002d_lightest-color-gray);--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-container-snow-monkey-blocks-box-is-layout-ebe776ca wp-block-snow-monkey-blocks-box-is-layout-constrained\">\n<p class=\"has-text-align-center wp-block-paragraph\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"person-cane\" class=\"svg-inline--fa fa-person-cane \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 448 512\" style=\"font-size:2.5em\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M272 48a48 48 0 1 0 -96 0 48 48 0 1 0 96 0zm-8 187.3l47.4 57.1c11.3 13.6 31.5 15.5 45.1 4.2s15.5-31.5 4.2-45.1l-73.7-88.9c-18.2-22-45.3-34.7-73.9-34.7H177.1c-33.7 0-64.9 17.7-82.3 46.6l-58.3 97c-9.1 15.1-4.2 34.8 10.9 43.9s34.8 4.2 43.9-10.9L120 256.9V480c0 17.7 14.3 32 32 32s32-14.3 32-32V352h16V480c0 17.7 14.3 32 32 32s32-14.3 32-32V235.3zM352 376c0-4.4 3.6-8 8-8s8 3.6 8 8V488c0 13.3 10.7 24 24 24s24-10.7 24-24V376c0-30.9-25.1-56-56-56s-56 25.1-56 56v8c0 13.3 10.7 24 24 24s24-10.7 24-24v-8z\"><\/path><\/svg><\/span><\/p>\n\n\n\n<p class=\"has-text-align-center wp-block-paragraph\">Elderly individuals with cognitive impairment<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"margin-top:0;margin-bottom:0;padding-top:38px;padding-bottom:38px;--smb-box--box-shadow:5px 0px 5px 1px rgba(255, 255, 255, 1);--smb-box--background-color:var(u002du002d_lightest-color-gray);--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<p class=\"has-text-align-center wp-block-paragraph\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"children\" class=\"svg-inline--fa fa-children \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 640 512\" style=\"font-size:2.5em\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M160 0a64 64 0 1 1 0 128A64 64 0 1 1 160 0zM88 480V400H70.2c-10.9 0-18.6-10.7-15.2-21.1l31.1-93.4L57.5 323.3c-10.7 14.1-30.8 16.8-44.8 6.2s-16.8-30.7-6.2-44.8L65.4 207c22.4-29.6 57.5-47 94.6-47s72.2 17.4 94.6 47l58.9 77.7c10.7 14.1 7.9 34.2-6.2 44.8s-34.2 7.9-44.8-6.2l-28.6-37.8L265 378.9c3.5 10.4-4.3 21.1-15.2 21.1H232v80c0 17.7-14.3 32-32 32s-32-14.3-32-32V400H152v80c0 17.7-14.3 32-32 32s-32-14.3-32-32zM480 0a64 64 0 1 1 0 128A64 64 0 1 1 480 0zm-8 384v96c0 17.7-14.3 32-32 32s-32-14.3-32-32V300.5L395.1 321c-9.4 15-29.2 19.4-44.1 10s-19.4-29.2-10-44.1l51.7-82.1c17.6-27.9 48.3-44.9 81.2-44.9h12.3c33 0 63.7 16.9 81.2 44.9L619.1 287c9.4 15 4.9 34.7-10 44.1s-34.7 4.9-44.1-10L552 300.5V480c0 17.7-14.3 32-32 32s-32-14.3-32-32V384H472z\"><\/path><\/svg><\/span><\/p>\n\n\n\n<p class=\"has-text-align-center wp-block-paragraph\">children<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">In such cases, IRB approval is strongly recommended.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A key principle is minimizing unnecessary exposure to risk. Therefore, you must clearly justify&nbsp;<strong>why patients are&nbsp;required<\/strong>&nbsp;instead of general users.&nbsp;&nbsp;<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">2. Other Factors That May Trigger IRB&nbsp;<\/span><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Even if patients are not involved, IRB may still be required depending on the&nbsp;study&nbsp;design. Key triggering factors include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Testing in real clinical environments (e.g., hospitals or clinics)&nbsp;&nbsp;<\/li>\n\n\n\n<li>Use of realistic or invasive prototypes (e.g., injectors)&nbsp;&nbsp;<\/li>\n\n\n\n<li>Physician involvement in diagnosis or treatment decisions&nbsp;&nbsp;<\/li>\n\n\n\n<li>Evaluation of medical effectiveness or safety&nbsp;&nbsp;<\/li>\n\n\n\n<li>Positioning the study as clinical evidence for regulatory submission&nbsp;<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">The Risk-Based Approach<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The decision to obtain IRB approval is&nbsp;<strong>risk-based<\/strong>.<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-ecb84aab wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group has-background is-layout-constrained wp-container-core-group-is-layout-dcd86f6d 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:#00ab36;border-top-width:6px;border-right-color:#00ab36;border-right-width:1px;border-bottom-color:#00ab36;border-bottom-width:1px;border-left-color:#00ab36;border-left-width:1px;background-color:#f5fff2;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<p class=\"wp-block-paragraph\" style=\"padding-top:var(--wp--preset--spacing--20);padding-right:0;padding-bottom:0;padding-left: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 \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" color=\"#00ab36\"><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> <strong><span style=\"color: #01942f\" class=\"sme-text-color\">Low-Risk Studies&nbsp;<\/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>No involvement of vulnerable populations&nbsp;&nbsp;<\/li>\n\n\n\n<li>Use of mock devices or simulated environments&nbsp;&nbsp;<\/li>\n\n\n\n<li>Conducted outside clinical settings&nbsp;&nbsp;<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile has-background\" style=\"background-color:#fffff2;grid-template-columns:15% auto\"><figure class=\"wp-block-media-text__media\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/04\/\u633f\u5165\u753b\u50cf_\u6b63\u65b9\u5f62\uff08500\u00d7500\uff09-9.png\" alt=\"\" class=\"wp-image-9836 size-full\" srcset=\"https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/04\/\u633f\u5165\u753b\u50cf_\u6b63\u65b9\u5f62\uff08500\u00d7500\uff09-9.png 500w, https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/04\/\u633f\u5165\u753b\u50cf_\u6b63\u65b9\u5f62\uff08500\u00d7500\uff09-9-300x300.png 300w, https:\/\/uism.co.jp\/wp-content\/uploads\/2026\/04\/\u633f\u5165\u753b\u50cf_\u6b63\u65b9\u5f62\uff08500\u00d7500\uff09-9-150x150.png 150w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"wp-block-paragraph\">If IRB is not pursued, you must <strong>document the rationale<\/strong> clearly.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-group has-background is-layout-constrained wp-container-core-group-is-layout-dcd86f6d 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:var(--wp--preset--color--vivid-red);border-top-width:6px;border-right-color:var(--wp--preset--color--vivid-red);border-right-width:1px;border-bottom-color:var(--wp--preset--color--vivid-red);border-bottom-width:1px;border-left-color:var(--wp--preset--color--vivid-red);border-left-width:1px;background-color:#ffe9e9;padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<p class=\"wp-block-paragraph\" style=\"padding-top:var(--wp--preset--spacing--20);padding-right:0;padding-bottom:0;padding-left:0\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"triangle-exclamation\" class=\"svg-inline--fa fa-triangle-exclamation \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\" color=\"#cf2e2e\"><path fill=\"currentColor\" d=\"M256 32c14.2 0 27.3 7.5 34.5 19.8l216 368c7.3 12.4 7.3 27.7 .2 40.1S486.3 480 472 480H40c-14.3 0-27.6-7.7-34.7-20.1s-7-27.8 .2-40.1l216-368C228.7 39.5 241.8 32 256 32zm0 128c-13.3 0-24 10.7-24 24V296c0 13.3 10.7 24 24 24s24-10.7 24-24V184c0-13.3-10.7-24-24-24zm32 224a32 32 0 1 0 -64 0 32 32 0 1 0 64 0z\"><\/path><\/svg><\/span> <span style=\"color: #cf2e2e\" class=\"sme-text-color\"><strong>High-Risk Studies&nbsp;<\/strong><\/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>Testing in real clinical environments&nbsp;&nbsp;<\/li>\n\n\n\n<li>Use of invasive prototypes&nbsp;<\/li>\n\n\n\n<li>Physician involvement in diagnosis or treatment&nbsp;<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<h4 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Why IRB is Recommended for Summative Evaluations&nbsp;<\/span><\/h4>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-top is-layout-flex wp-container-core-columns-is-layout-ecb84aab 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\">\n<div class=\"wp-block-snow-monkey-blocks-box smb-box\" style=\"--smb-box--box-shadow:0px 0px 1px 1px rgba(5, 118, 183, 0.4);--smb-box--background-color:var(u002du002d_lightest-color-gray);--smb-box--background-opacity:0;--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<p class=\"wp-block-paragraph\"><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\">IRB approval is strongly recommended for summative (validation) studies because:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Results are often used in submissions to PMDA&nbsp;&nbsp;<\/li>\n\n\n\n<li>PMDA may question the absence of IRB approval where risk is present&nbsp;&nbsp;<\/li>\n\n\n\n<li>It&nbsp;demonstrates&nbsp;ethical oversight and due diligence&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\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\" style=\"font-size:1em\"><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-snow-monkey-blocks-box smb-box\" style=\"--smb-box--box-shadow:0px 0px 1px 1px rgba(5, 118, 183, 0.4);--smb-box--background-color:var(u002du002d_lightest-color-gray);--smb-box--background-opacity:0;--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<p class=\"wp-block-paragraph\"><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\">Recommended Actions:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Conduct and document a risk assessment for every study&nbsp;&nbsp;<\/li>\n\n\n\n<li>Include IRB timelines in project planning (typically 6\u20138 weeks)&nbsp;&nbsp;<\/li>\n\n\n\n<li>Consult an external IRB early if there is uncertainty&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">IRB Application&nbsp;Overview&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Japan has a unique IRB process, which often requires more time from submission to final decision. It is therefore important to&nbsp;plan ahead&nbsp;and consider the following elements when preparing your IRB application.&nbsp;<\/p>\n\n\n<div class=\"smk-table-wrap\">\n<table class=\"smk-table-both\" style=\"border-collapse: collapse; width: 100%; border: 1px solid #cfcfcf;\">\n<tbody>\n<tr>\n<th style=\"background: #f3f3f3; border: 1px solid #cfcfcf;\">\u00a0<\/th>\n<th style=\"background: #f3f3f3; border: 1px solid #cfcfcf;\">Details<\/th>\n<\/tr>\n<tr>\n<th style=\"text-align: left;\">IRB meeting frequency<\/th>\n<td style=\"text-align: left;\">Varies by institution (typically once a month)<\/td>\n<\/tr>\n<tr>\n<th style=\"text-align: left;\">Document submission<\/th>\n<td>~14 days before meeting<\/td>\n<\/tr>\n<tr>\n<th style=\"text-align: left;\">Review outcomes<\/th>\n<td>\n<ul>\n<li>Approved<\/li>\n<li>Conditionally Approved<\/li>\n<li>Revise and Resubmit<\/li>\n<li>Disapproved<\/li>\n<li>Not applicable<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<th style=\"text-align: left;\">IRB types<\/th>\n<td>\n<ul>\n<li><strong>Internal\/Hospital-based IRB:<\/strong>Strong for single-site research; rigorous process<\/li>\n<\/ul>\n<ul>\n<li><span style=\"color: #e53935;\"><strong>External\/Independent IRB:<\/strong><\/span> Better for multi-site and industry-sponsored research; typically\u00a0faster<\/li>\n<li>University hospitals: Most stringent; heavy procedures<\/li>\n<li>Private hospitals: More flexible; increasing use of external IRBs<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<th style=\"text-align: left;\">Typical total timeline<\/th>\n<td>6-8 weeks with revisions; expect more for higher-risk studies<\/td>\n<\/tr>\n<tr>\n<th style=\"text-align: left;\">Cost<\/th>\n<td style=\"text-align: left;\">Budget \u00a5100,000-\u00a5200,000 minimum per review<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">*Terms apply as each IRB has different&nbsp;timeline&nbsp;and difficulty levels.&nbsp;&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Core IRB Application&nbsp;Documents&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Document requirements differ by review board, so&nbsp;please&nbsp;refer to your selected IRB&#8217;s website for&nbsp;a&nbsp;complete list.&nbsp;Please note that it is essential to&nbsp;use&nbsp;consistent wording across all documents&nbsp;to clearly&nbsp;state&nbsp;that the study is not clinical research. Typical documents include:<\/p>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-dcd86f6d 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-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<p class=\"wp-block-paragraph\" style=\"padding-top:var(--wp--preset--spacing--20);padding-right:0;padding-bottom:var(--wp--preset--spacing--20);padding-left:0\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"file\" class=\"svg-inline--fa fa-file \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 384 512\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M0 64C0 28.7 28.7 0 64 0H224V128c0 17.7 14.3 32 32 32H384V448c0 35.3-28.7 64-64 64H64c-35.3 0-64-28.7-64-64V64zm384 64H256V0L384 128z\"><\/path><\/svg><\/span> <strong><span style=\"color: #0576b7\" class=\"sme-text-color\"><strong>1. IRB Application Form<\/strong>&nbsp;<\/span><\/strong><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-dcd86f6d 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-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<p class=\"wp-block-paragraph\" style=\"padding-top:var(--wp--preset--spacing--20);padding-right:0;padding-bottom:0;padding-left:0\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"flask-vial\" class=\"svg-inline--fa fa-flask-vial \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 640 512\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M175 389.4c-9.8 16-15 34.3-15 53.1c-10 3.5-20.8 5.5-32 5.5c-53 0-96-43-96-96V64C14.3 64 0 49.7 0 32S14.3 0 32 0H96h64 64c17.7 0 32 14.3 32 32s-14.3 32-32 32V309.9l-49 79.6zM96 64v96h64V64H96zM352 0H480h32c17.7 0 32 14.3 32 32s-14.3 32-32 32V214.9L629.7 406.2c6.7 10.9 10.3 23.5 10.3 36.4c0 38.3-31.1 69.4-69.4 69.4H261.4c-38.3 0-69.4-31.1-69.4-69.4c0-12.8 3.6-25.4 10.3-36.4L320 214.9V64c-17.7 0-32-14.3-32-32s14.3-32 32-32h32zm32 64V224c0 5.9-1.6 11.7-4.7 16.8L330.5 320h171l-48.8-79.2c-3.1-5-4.7-10.8-4.7-16.8V64H384z\"><\/path><\/svg><\/span> <strong><span style=\"color: #0576b7\" class=\"sme-text-color\"><strong>2. <strong>Research Protocol<\/strong><\/strong><\/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>Study objectives&nbsp;<\/li>\n\n\n\n<li>Methodology and procedures&nbsp;<\/li>\n\n\n\n<li>Participant selection criteria&nbsp;<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-dcd86f6d 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-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<p class=\"wp-block-paragraph\" style=\"padding-top:var(--wp--preset--spacing--20);padding-right:0;padding-bottom:0;padding-left:0\"><span class=\"wp-rich-text-font-awesome-icon wp-font-awesome-icon\"><svg aria-hidden=\"true\" focusable=\"false\" data-prefix=\"fas\" data-icon=\"handshake-simple\" class=\"svg-inline--fa fa-handshake-simple \" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 640 512\" color=\"#0576b7\"><path fill=\"currentColor\" d=\"M323.4 85.2l-96.8 78.4c-16.1 13-19.2 36.4-7 53.1c12.9 17.8 38 21.3 55.3 7.8l99.3-77.2c7-5.4 17-4.2 22.5 2.8s4.2 17-2.8 22.5l-20.9 16.2L550.2 352H592c26.5 0 48-21.5 48-48V176c0-26.5-21.5-48-48-48H516h-4-.7l-3.9-2.5L434.8 79c-15.3-9.8-33.2-15-51.4-15c-21.8 0-43 7.5-60 21.2zm22.8 124.4l-51.7 40.2C263 274.4 217.3 268 193.7 235.6c-22.2-30.5-16.6-73.1 12.7-96.8l83.2-67.3c-11.6-4.9-24.1-7.4-36.8-7.4C234 64 215.7 69.6 200 80l-72 48H48c-26.5 0-48 21.5-48 48V304c0 26.5 21.5 48 48 48H156.2l91.4 83.4c19.6 17.9 49.9 16.5 67.8-3.1c5.5-6.1 9.2-13.2 11.1-20.6l17 15.6c19.5 17.9 49.9 16.6 67.8-2.9c4.5-4.9 7.8-10.6 9.9-16.5c19.4 13 45.8 10.3 62.1-7.5c17.9-19.5 16.6-49.9-2.9-67.8l-134.2-123z\"><\/path><\/svg><\/span> <strong><span style=\"color: #0576b7\" class=\"sme-text-color\"><strong>3. <strong><strong>Informed Consent Documents&nbsp;<\/strong>&nbsp;<\/strong><\/strong><\/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>Study purpose&nbsp;&nbsp;<\/li>\n\n\n\n<li>Personal information and video recording handling&nbsp;(what is&nbsp;recorded, why&nbsp;it&nbsp;is&nbsp;necessary, who will&nbsp;access&nbsp;it, storage period, third-party&nbsp;sharing, etc.)&nbsp;<\/li>\n\n\n\n<li>Participant&nbsp;rights (withdrawal without disadvantage, compensation policy)&nbsp;<\/li>\n<\/ul>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Critical Documentation: Distinguish from Clinical Research&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Your documentation (protocol, application, consent forms) should explicitly state that the study:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-snow-monkey-blocks-container smb-container c-container\"><div class=\"smb-container__body is-layout-constrained wp-block-snow-monkey-blocks-container-is-layout-constrained\">\n<ul class=\"wp-block-list is-style-sme-list-check\">\n<li>Is&nbsp;<strong>not a clinical trial<\/strong>&nbsp;&nbsp;<\/li>\n\n\n\n<li>Is conducted as&nbsp;<strong>design verification\/validation under JIS T 62366-1<\/strong>&nbsp;&nbsp;<\/li>\n\n\n\n<li>Does&nbsp;<strong>not involve diagnosis or treatment decisions<\/strong>&nbsp;&nbsp;<\/li>\n\n\n\n<li>Does&nbsp;<strong>not evaluate medical effectiveness or safety<\/strong>&nbsp;&nbsp;<\/li>\n\n\n\n<li>Is&nbsp;<strong>not intended as clinical evidence for regulatory approval<\/strong>&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">In Japan, IRBs often do not distinguish between clinical trials and usability studies in their processes. Clear positioning is therefore critical to avoid delays.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span style=\"color: #4c9f87\" class=\"sme-text-color\">Conclusion&nbsp;<\/span><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A risk-based approach should be applied to both formative and summative evaluations. However, IRB approval is strongly recommended for summative studies, as it supports regulatory submission and&nbsp;demonstrates&nbsp;ethical rigor.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If you are planning medical device usability testing in Japan, we recommend evaluating your study carefully against these criteria. When in doubt, consult with an experienced external IRB early to ensure a smooth and compliant 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\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<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=\"50lje8r2bH\"><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=Nm5GWgNTNq#?secret=50lje8r2bH\" data-secret=\"50lje8r2bH\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/div>\n<\/div><figcaption class=\"wp-element-caption\">Explore the practical overview of how PMDA expectations, usability engineering, and human factors requirements shape medical device development in Japan.<\/figcaption><\/figure>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Understand IRB requirements for medical device usability testing in Japan, including risk factors, review timelines, and key documentation considerations.  <\/p>\n","protected":false},"author":29,"featured_media":10297,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_locale":"en_US","_original_post":"https:\/\/uism.co.jp\/?p=10224","footnotes":"","wp-seo-meta-description":"","wp-seo-meta-robots":[]},"categories":[175],"tags":[266,410,414],"class_list":["post-10293","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-healthcare","tag-medical-device-regulation-japan","tag-usability-testing","tag-medical-device-usability","en-US","c-entry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/10293","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=10293"}],"version-history":[{"count":6,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/10293\/revisions"}],"predecessor-version":[{"id":10350,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/posts\/10293\/revisions\/10350"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media\/10297"}],"wp:attachment":[{"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/media?parent=10293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/categories?post=10293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uism.co.jp\/wp-json\/wp\/v2\/tags?post=10293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}