Graduate Certificate (MDRA)

Graduate Certificate in Medical Device Regulatory Affairs

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.

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.

Programme Structure

Programme Completion Requirements
  • Complete all 4 courses (16 Units*)
  • Minimum GPA of 2.50 (equivalent to an average grade of C+)
  • At least 75% attendance
Maximum Candidature Part-time: 3 Year

Full-time: not offered

*Units 

Admission

Eligibility*
  • Bachelor’s Degree or
  • Diploma with relevant working experience

Candidates with other qualifications and experience may be considered on a case-by-case basis.
Upcoming Intake  August 2024 (application period: 1 May – 18 June 2024) Apply Now

Programme will be run only if minimum number of participants is met.
Application Portal User Guide

* This is minimum requirement, which does not guarantee admission. Each application will be reviewed by the Admissions Committee.

Fees 

International students/Non-SSG funded Singapore Citizens below 40 years old & Singapore PRs Singapore Citizens aged 40 years & above (MCES) Enhanced Training Support for SMEs (ETSS)
Full Fee Per Course
(excluding GST)		 S$5,400 S$5,400 S$5,400 S$5,400
SSG Funding Schemes NA 70% of the full fee per course (excluding GST) additional 20% of the full fee per course (excluding GST) additional 20% of the full fee per course (excluding GST)
Nett Fee Per Course  S$5,886 S$1,765.80 S$685.80 S$685.80
  1. All enrolled participants will also be required to pay the Student Services Fee of $25.46 (inclusive of prevailing GST) per semester.
  2. Academic Courses taken on an Audit Basis are not eligible for SSG funding.
  3. 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.
  4. Participant will not be eligible for SSG funding if:
    • Failure to fulfil a minimum attendance of 75% for the courses.
    • Premature withdrawal from the course/programme
    • Failure to attain a GPA ≥ 2.5 and pass all prescribed coursework, examinations and/or assessments for the courses.

For details of the various schemes, please refer to:

1 Mid-Career Enhanced Subsidy (MCES)

2 Enhanced Training Support for SMEs (ETSS)

The 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.

Courses

Code Title & Brief Description Units Semester Offered*
BN5511 Introduction to Global Medical Device Regulation 4 1
BN5512 Medical Device Regulation in the US and EU 4 1
BN5513 Medical Device Regulation in ASEAN and Asia-Pacific 4 2
BN5514 Medical Device Regulatory Process Strategy and Planning 4 2

* This is only a guide and is subject to changes without notice. For the latest updates, check the current timetable.

* BN5512's Final Exam Date & Time: 27th November 2024, 5:00pm.

 

Syllabus 

GC (MDRA) Courses

Timetable

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).

Academic Year 2024/2025 Tentative Class timetable – PDF

Contact Information

For inquiries, please contact:

Name Email
Assoc Professor Leo Hwa Liang  bielhl@nus.edu.sg
Senior Lecturer Mrinal Kanti Musib biemkm@nus.edu.sg