[E001] Singapore Product Registration for Medical Device

What you’ll learn
  • Understand Singapore Medical Device Registration process, pathways and regulatory requirements
  • Awareness of other requirements e.g. Digital Health, Dealer’s licensing, Consultation, Funding support
  • No prior knowledge of regulatory is needed as this is introductory course

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.

This course will cover the following:
  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
Who this course is for:
  • Participants who need or are interested to learn about Singapore medical device regulatory
  • This course is designed for regulatory, non regulatory (such as commercial, R&D, Quality & Supply chain) and students
About the trainers/speakers

Approximate course length
  • 1hr
Current Status
Not Enrolled
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This course is currently closed