Graduate Certificate in Medical Technology Regulation
Date duration
Programme Period
1 Apr 2025 to 19 Sep 2025
Delivery mode
Program Description
The Graduate Certificate in Medical Technology Regulation program consists of 4 courses with a total of 16 units.
| Course |
Description |
|
GMS5008 |
Regulation and Clinical Evaluation of Medical Devices |
|
GMS5009 |
Manufacturing and Quality Management System for Medical Devices |
|
GMS5114 |
Post-Market for Medical Technologies |
|
GMS5106 |
Regulation of Digital Health Products
|
Course Description
GMS5008
Regulation and Clinical Evaluation of Medical Devices
This course describes the unique approaches for the product design and development, as well as regulation of medical devices and technology. Key concepts for assessing the clinical performance of medical devices will be introduced, facilitating the understanding of an optimal environment for health technology adoption.
GMS5009
Manufacturing and Quality Management System for Medical Devices
This course covers the production, quality management systems, and regulatory activities related to quality assurance of medical technology in regulated markets.
GMS5114
Post-Market for Medical Technologies
This course aims to equip students with the knowledge of the post-market regulatory requirements of medical devices, and the activities involved in managing adverse events and conducting Field safety corrective action.
GMS5106
Regulation of Digital Health Products
Through this course, students will learn to describe and differentiate the relevant standards and guidance required in Digital Health products verification and validation.
Admission Requirements
The Admissions Committee reviews all application material, reference letters, and interviewer comments carefully to better understand each applicant.
Applicants must have an undergraduate Bachelor’s degree or its equivalent in relevant discipline. Relevant work experience (i.e., in the fields of regulatory, healthcare or research) at the time of matriculation into Duke-NUS Medical School is desirable. Applicants from non-English speaking countries will be required to present documentary evidence of their competence in written and spoken English (TOEFL or ILS).
Fees
The following course fees are applicable for the Graduate Certificate Programmes.
Student Service Fee (SSF): Participants are required to pay an additional SGD25.70 per semester. In the event that participant do not take any courses that semester, they would not have to pay this fee.
With effect from 1 January 2024, individuals using credit/debit card and eWallet to make payment via NUSFastPay will have to pay a 1% processing fee.
No processing fee is charged for using PayNow QR and Convera in NUSFastPay.
All fees are in SGD.
|
39 years old
or younger
|
40 years old
or older
|
Refund Policy
All requests for withdrawal must be received
6 weeks before the start of the workshop for the course. Late withdrawals will be subjected to payment of the
FULL course fees.
Any access to learning materials (online preparatory materials and workshop materials) will be considered as participation and no refunds will be allowed.
For participants who are supported by SSGPlease note that if you have taken an SSG-funded course, you would be liable to pay back the SSG training grant plus the prevailing Goods and Services Tax (GST) to NUS if you have received the grant for the course and fall into any of the following categories:
- Failure to fulfil a minimum attendance of 75% for the course
- Premature withdrawal from the course
- Failure to pass all prescribed coursework, examinations and/or assessments for the course
- Please note that the Tuition Fee and Student Services Fee (SSF) are non-refundable and non-transferable.