{"id":167,"date":"2019-02-12T09:02:23","date_gmt":"2019-02-12T09:02:23","guid":{"rendered":"https:\/\/cde.nus.edu.sg\/bme\/?page_id=167"},"modified":"2026-10-02T15:03:42","modified_gmt":"2026-10-02T07:03:42","slug":"gc-mdra","status":"publish","type":"page","link":"https:\/\/cde.nus.edu.sg\/bme\/graduate\/gc-mdra\/","title":{"rendered":"Graduate Certificate (MDRA)"},"content":{"rendered":"\n\n\t\t\t\t\t<ul id=\"menu-graduate\"><li id=\"menu-item-13942\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/overview\/\">Overview<\/a><\/li>\n<li id=\"menu-item-13943\"><a aria-expanded=\"false\" href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate-research-programmes\/\">Graduate Research Programmes<\/a>\n<ul>\n\t<li id=\"menu-item-13935\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/admission-requirements\/\">Admission Requirements<\/a><\/li>\n\t<li id=\"menu-item-13936\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/applicationprocess\/\">Application Process<\/a><\/li>\n\t<li id=\"menu-item-13937\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/coursework-requirements\/\">Coursework Requirements<\/a><\/li>\n\t<li id=\"menu-item-13947\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/research-modules\/\">Research Courses<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-13944\"><a aria-expanded=\"false\" href=\"https:\/\/cde.nus.edu.sg\/bme\/master-of-science-msc-in-biomedical-engineering\/\">Master of Science (MSc) in Biomedical Engineering<\/a>\n<ul>\n\t<li id=\"menu-item-14327\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/overview\/\">Overview<\/a><\/li>\n\t<li id=\"menu-item-14326\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/admission\/\">Admission<\/a><\/li>\n\t<li id=\"menu-item-14325\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/curriculum\/\">Curriculum<\/a><\/li>\n\t<li id=\"menu-item-14324\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/fees-and-financial-information\/\">Fees and Financial Information<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-16531\"><a aria-expanded=\"false\" href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/nus-bme-tsu-bme-dual-masters-degree-program-master-plus-programme\/\">NUS BME &#8211; TSU BME Dual Master&#8217;s Degree Program (Master Plus Programme)<\/a>\n<ul>\n\t<li id=\"menu-item-16534\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/nus-bme-tsu-bme-dual-masters-degree-program-master-plus-programme\/admission-copy\/\">Admission &#8211; Master Plus Programme<\/a><\/li>\n\t<li id=\"menu-item-16533\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/nus-bme-tsu-bme-dual-masters-degree-program-master-plus-programme\/curriculum-copy\/\">Curriculum &#8211; Master Plus Programme<\/a><\/li>\n\t<li id=\"menu-item-16532\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/nus-bme-tsu-bme-dual-masters-degree-program-master-plus-programme\/fees-and-financial-information-copy\/\">Fees and Financial Information &#8211; Master Plus Programme<\/a><\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-13939\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/gc-mdra\/\">Graduate Certificate (MDRA)<\/a><\/li>\n<li id=\"menu-item-13938\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/graduate-certificate-amdr\/\">Graduate Certificate (AMDR)<\/a><\/li>\n<\/ul>\t\n\t<h2>\n\t\t\tGraduate Certificate (MDRA)\t<\/h2>\n\t<h3><strong>Graduate Certificate in Medical Device Regulatory Affairs<\/strong><\/h3>\n<p>GCMDRA aims to build a pipeline of executives, managers and directors to meet the immediate and long-term requirements of the Medical Technology Manufacturing industry. This part-time and year-long programme is tailored for busy working professionals who wish to equip themselves with knowledge and skills in the global regulatory framework of the medical device (MD) industry.<\/p>\n<p>The programme is well suited for those with portfolio in MD regulation and strategy development. It will further equip participants with a global outlook in which the role of a MD regulatory professional is examined systematically from the context of different regions.<\/p>\n\n<h3><strong>Programme Structure<\/strong><\/h3>\n<table>\n<tbody>\n<tr>\n<td width=\"29%\"><strong>Programme Completion Requirements<\/strong><\/td>\n<td width=\"69%\">\n<ul>\n<li>Complete all 4 courses (16 Units*)<\/li>\n<li>Minimum GPA of 2.50 (equivalent to an average grade of C+)<\/li>\n<li>At least 75% attendance<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td width=\"29%\"><strong>Maximum Candidature<\/strong><\/td>\n<td width=\"69%\">Part-time: 3 Year\nFull-time: not offered<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong><em>*<\/em><a href=\"http:\/\/www.nus.edu.sg\/registrar\/academic-information-policies\/graduate\/modular-system\"><em>Units\u00a0<\/em><\/a><\/strong><\/p>\n\n<h3>Admission<\/h3>\n<table>\n<tbody>\n<tr>\n<td width=\"212\"><strong>Eligibility*<\/strong><\/td>\n<td width=\"495\">\n<ul>\n<li>Bachelor&#8217;s Degree or<\/li>\n<li>Diploma with relevant working experience<\/li>\n<\/ul>\nCandidates with other qualifications and experience may be considered on a case-by-case basis.<\/td>\n<\/tr>\n<tr>\n<td width=\"212\"><strong>Upcoming Intake<\/strong><em>\u00a0<\/em><\/td>\n<td width=\"495\">August 2025 (application period: 1 May &#8211; 15 July 2026) <a href=\"https:\/\/myapplications.nus.edu.sg\/\">Apply Now<\/a>\nProgramme will be run only if minimum number of participants is met.<\/td>\n<\/tr>\n<tr>\n<td width=\"212\"><strong>Application Portal<\/strong><\/td>\n<td width=\"495\"><a href=\"https:\/\/cde.nus.edu.sg\/bme\/wp-content\/uploads\/sites\/8\/2019\/06\/UserGuide_applyingOnOAP.pdf\">User Guide<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>* This is minimum requirement, which does not guarantee admission.\u00a0<\/em><em>Each application will be reviewed by the Admissions Committee.<\/em><\/p>\n\n<h3><strong>Fees\u00a0<\/strong><\/h3>\n<table>\n<thead>\n<tr>\n\n<th><strong>International students\/Non-SSG funded<\/strong><\/th>\n<th><strong>Singapore Citizens below 40 years old &amp; Singapore PRs<\/strong><\/th>\n<th><strong>Singapore Citizens aged 40 years &amp; above (MCES)<\/strong><\/th>\n<th><strong>Enhanced Training Support for SMEs (ETSS)<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"122\"><strong>Full Fee Per Course<br \/>\n(excluding GST)<\/strong><\/td>\n<td width=\"135\">S$5,400<\/td>\n<td width=\"122\">S$5,400<\/td>\n<td width=\"113\">S$5,400<\/td>\n<td width=\"112\">S$5,400<\/td>\n<\/tr>\n<tr>\n<td width=\"122\"><strong>SSG Funding Schemes<\/strong><\/td>\n<td width=\"135\">NA<\/td>\n<td width=\"122\">70% of the full fee per course (excluding GST)<\/td>\n<td width=\"113\">additional 20% of the full fee per course (excluding GST)<\/td>\n<td width=\"112\">additional 20% of the full fee per course (excluding GST)<\/td>\n<\/tr>\n<tr>\n<td width=\"122\"><strong>Nett Fee Per Course\u00a0<\/strong><\/td>\n<td width=\"135\">S$5,886<\/td>\n<td width=\"122\">S$1,765.80<\/td>\n<td width=\"113\">S$685.80<\/td>\n<td width=\"112\">S$685.80<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\">\n<ol>\n<li>All enrolled participants will also be required to pay the Student Services Fee of $25.7 (inclusive of prevailing GST) per semester.<\/li>\n<li>Academic Courses taken on an Audit Basis are not eligible for SSG funding.<\/li>\n<li>SSG will only fund a course once for each eligible participant. In the event that you have to retake a course, you will not be eligible for SSG funding again.<\/li>\n<li>Participant will not be eligible for SSG funding if:<\/li>\n<\/ol>\n<ul>\n<li>\n<ul>\n<li>Failure to fulfil a minimum attendance of 75% for the courses.<\/li>\n<li>Premature withdrawal from the course\/programme<\/li>\n<li>Failure to attain a GPA \u2265 2.5 and pass all prescribed coursework, examinations and\/or assessments for the courses.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>For details of the various schemes, please refer to:<\/p>\n<p><sup>1<\/sup>\u00a0<a href=\"https:\/\/www.tpgateway.gov.sg\/training-grants\/training-grants-from-government-agencies\/skillsfuture-mid-career-enhanced-subsidy\">Mid-Career Enhanced Subsidy (MCES)<\/a><\/p>\n<p><sup>2<\/sup>\u00a0<a href=\"http:\/\/www.ssg.gov.sg\/programmes-and-initiatives\/funding\/enhanced-training-support-for-smes1.html\">Enhanced Training Support for SMEs (ETSS)<\/a><\/p>\nThe University reserves the right to review and adjust the course fees and make changes to the programme structure and requirements as necessary and accordingly without prior notice.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<h3><strong>Courses<\/strong><\/h3>\n<table>\n<thead>\n<tr>\n<th><strong>Code<\/strong><\/th>\n<th><strong>Title &amp; Brief Description<\/strong><\/th>\n<th><strong>Units<\/strong><\/th>\n<th><strong>Semester Offered*<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>BN5511 (Stackable)<\/td>\n<td>Introduction to Global Medical Device Regulation<\/td>\n<td>4<\/td>\n<td>1<\/td>\n<\/tr>\n<tr>\n<td>BN5512 (Stackable)<\/td>\n<td>Medical Device Regulation in the US and EU<\/td>\n<td>4<\/td>\n<td>1<\/td>\n<\/tr>\n<tr>\n<td>BN5513 (Stackable)<\/td>\n<td>Medical Device Regulation in ASEAN and Asia-Pacific<\/td>\n<td>4<\/td>\n<td>2<\/td>\n<\/tr>\n<tr>\n<td>BN5514 (Stackable)<\/td>\n<td>Medical Device Regulatory Process Strategy and Planning<\/td>\n<td>4<\/td>\n<td>2<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em>* This is only a guide and is subject to changes without notice. For the latest updates, check the current timetable.<\/em><\/p>\n<p><strong>Syllabus\u00a0<\/strong><\/p>\n<p><a href=\"https:\/\/cde.nus.edu.sg\/bme\/wp-content\/uploads\/sites\/8\/2024\/04\/MDRA-Courses-Descriptions.pdf\">GC (MDRA) Courses<\/a><\/p>\n<h3><strong>Alternative Pathway: Admission to Master of Science (Biomedical Engineering) Programme<\/strong><\/h3>\n<ul>\n<li>Upon completion of the Graduate Certificate programme, graduates with overall GPA \u2265 3.5 may apply for MSc (BME), subject to approval by host department.<\/li>\n<li>Submission of MSc programme application is required.<\/li>\n<li>For the course in the completed Graduate Certificate to be credit transferred to MSc (BME), the grade attained has to be B and above.<\/li>\n<li>Up to 5 mapped Graduate Certificate courses (from MDRA and\/or AMDR) may be transferred to the MSc (BME), subject to credit transfer requirements.<\/li>\n<li>Units transfer within 5 years from award of Graduate Certificate.<\/li>\n<\/ul>\n<h3><strong><br \/>\nTimetable<\/strong><\/h3>\n<p>Tutorial sessions are on Wednesday from 6:30pm to 9:30pm. Seminars are on Saturdays from 8am to 6pm. Final exam is held during the last tutorial session of each course (dates may change with prior notice).<\/p>\n<h3><strong>Academic Year 2026\/2027 Tentative <\/strong>Class timetable &#8211;\u00a0<a href=\"https:\/\/cde.nus.edu.sg\/bme\/wp-content\/uploads\/sites\/8\/2026\/10\/MDRA-Timetable_AY26-27.pdf\">PDF\u00a0<\/a><\/h3>\n<h3><strong>Contact Information<\/strong><\/h3>\n<p>For inquiries, please contact:<\/p>\n<table>\n<thead>\n<tr>\n<th><strong>Name<\/strong><\/th>\n<th><strong>Email<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Assoc Professor Leo Hwa Liang<\/td>\n<td>\u00a0<a href=\"mailto:bielhl@nus.edu.sg\">bielhl@nus.edu.sg<\/a><\/td>\n<\/tr>\n<tr>\n<td>Senior Lecturer Mrinal Kanti Musib<\/td>\n<td><a href=\"https:\/\/cde.nus.edu.sg\/bme\/graduate\/graduate-certificate-amdr\/biemkm@nus.edu.sg\">biemkm@nus.edu.sg<\/a><\/td>\n<\/tr>\n<tr>\n\n\n<\/tr>\n<\/tbody>\n<\/table>\n\n","protected":false},"excerpt":{"rendered":"<p>Overview Graduate Research Programmes Admission Requirements Application Process Coursework Requirements Research Courses Master of Science (MSc) in Biomedical Engineering Overview Admission Curriculum Fees and Financial Information NUS BME &#8211; TSU BME Dual Master&#8217;s Degree Program (Master Plus Programme) Admission &#8211; Master Plus Programme Curriculum &#8211; Master Plus Programme Fees and Financial Information &#8211; Master Plus [&hellip;]<\/p>\n","protected":false},"author":29,"featured_media":0,"parent":157,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"rs_blank_template":"","rs_page_bg_color":"","slide_template_v7":"","site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-167","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/pages\/167","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/users\/29"}],"replies":[{"embeddable":true,"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/comments?post=167"}],"version-history":[{"count":4,"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/pages\/167\/revisions"}],"predecessor-version":[{"id":16581,"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/pages\/167\/revisions\/16581"}],"up":[{"embeddable":true,"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/pages\/157"}],"wp:attachment":[{"href":"https:\/\/cde.nus.edu.sg\/bme\/wp-json\/wp\/v2\/media?parent=167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}