Singapore Medical Device Updates 2011 Webcast

Singapore passed the Health Products Act in February 2007. This Act has been implemented in stages throughout the past few years. Under this Act, all Class A-D products require Singapore medical device registration with the Singapore HSA. Also, manufacturers, dealers, importers and wholesalers of medical products require comprehensive government licensing in order to do business. Make sure you know the newest regulations in order to remain in compliance with Singapore law! Companies without the proper Singapore medical device registration or licensing will not be allowed to import, manufacture, or sell medical devices in Singapore.


To view the webcast presentation slides in PDF format, please click on Singapore Medical Device Regulatory Updates 2011 Webcast Slides.



  • Overview of Singapore
    • Economy
    • Demographics
    • Health Statistics
  • Overview of Singapore Medical Device Market (Size, Growth Rate, Key Sectors)
  • Profile of Singapore’s Health Sciences Authority (HSA)
    • Organization
    • Key Departments and People
  • Overview of Medical Device Regulatory Framework
  • Singapore Medical Device Registration Process
    • Definitions
    • Classification of Medical Devices
    • New Medical Device Registration Requirements and Upcoming Deadlines
    • Which Products Need to Be Registered and by When
    • Exemptions from Registration
    • Application Process
    • Common Submission Dossier Template (CSDT)
    • Medical Device Information and Communication System (MEDICS)
    • Submission Fees and Timeframes
    • How to Expedite the Registration Process
  • New Regulations for Importers, Wholesalers, and Manufacturers of Medical Devices
    • Good Distribution Practice for Medical Devices (GDPMDS)
    • Licensing Process for Importers, Wholesalers, and Manufacturers
  • Post-Marketing Surveillance Responsibilities
    • Adverse Event Reporting
    • Field Safety Corrective Action (FSCA) Reporting
    • Product Defect Reporting
    • Other Post-Marketing Surveillance Responsibilities
  • Advertisement and Promotion
  • Reimbursement
  • Future Regulatory Trends of Singapore’s Medical Device Market