Course Description

Singapore’s Regulatory System for Medical Devices

Course Description:

Note: This course is currently being updated.

This course offers a detailed outline of both Singapore’s health economy and their Regulatory System for Medical Devices. It includes an informative look into the Singapore Health Science Authority (HSA), its departments and structure, medical device regulations, and required licenses, as well as product registration, evaluation routes, Common Submission Dossier Templates (CSDT), and registration timelines.

In addition, this course provides essential information and insight on how to get to market in Singapore based on the your medical device risk classification , including where to find applicable guidance documents and links.

Please note that from 1 May 2012 to December 2015, a series of updates to the medical device regulatory framework were performed for medical device registration, dealer’s licenses, change notification submission for registered devices and special authorization route licenses. A briefing on these changes is included at the end of this course. 

 

Watch the Course Trailer:

 

 


Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Comprehend and identify the working fundamentals of Singapore’s health economy and Regulatory System for Medical Devices
  • Prepare and submit a medical device regulatory submission for Singapore
  • Understand how to use other market approvals as a support in getting to market in Singapore.

Who Should Enroll:

Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Affairs Director, Clinical Project Manager, Export Manager, and R&D Engineer dealing with product registration and compliance in Singapore are encouraged to enroll in this course.


Prerequisite Knowledge/Requirements:

Learners should understand the basic medical device regulatory principles outlined in the GHTF/IMDRF documents and explained in the series of courses GHTF/IMDRF:

  • pre-market Regulatory Model (ID N170).
  • Post market regulatory model (ID N171)
  • Supporting documents (ID N172)
  • International Implementation (ID N173)
  • Essential principles of safety and performance of medical devices (ID N182)
  • STED and its contents (ID N187)

Subject Matter Expert:
Hwee Ee Tan

Duration:
68 min

Release date:
06/24/2011

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 139.00
Premium Account: € 104.00

Last update - 02/12/2016:

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