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E-IMDS
Singapore Product Registration for Medical Device

ID: E001

Fee: SGD 54 (After 70% Discount, Original SGD 180)

Duration: 60 Mins

Course Overview

This course seeks to provide a basic understanding of the regulatory landscape in Singapore. It covers key areas such as product classification, risk classification, product grouping and registration pathways. It also includes information on dealer licensing and a quick introduction to Health Sciences Authority (HSA) MEDICS system. There will also be tips on product registration, potential job roles and other requirements.

Instructor Details

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Learning Objectives

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

  • Understand Singapore Medical Device Registration process, pathways and regulatory requirements

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  • Awareness of other requirements e.g. Digital Health, Dealer’s licensing, Consultation, Funding support

Key Benefits

  • Concise and quick introduction Singapore Product Registration course for professionals and fresh    graduates venturing in Medtech Industry

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  •  A certificate will be awarded upon completion of the course

Course Content

  1. Medtech industry in Singapore

  2. Basics of Product Registration for Medical Device and IVD

    • Definition

  3. Risk classification

  4. Product grouping

  5. Registration pathways

  6. Special Authorisation routes

  7. Change Notification

  8. Change of Registrant/Licence Transfer

  9. HSA MEDICS e-system

  10. Other requirements

  11. Digital health devices

  12. Dealer’s licensing

  13. Consultation

  14. Funding

  15. Tips to accelerate product registration

  16. Potential Medtech job roles

Certification Preview

Certificate Snip_20220427.PNG
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