Medical Device Regulatory Process in Singapore

Download white paper - Medical Device Regulation in SingaporeMedical Devices in Singapore are regulated by the Health Science Authority (HSA). The system for regulation shares many similarities with the regulatory process in the European Union. This is because Singapore's process is based on the ASEAN (Association of Southeast Asian Nations) harmonization framework, which is largely derived from the former Global Harmonization Harmonization Task Force (GHTF). However, there are a number of small differences in the classification rules between Singapore and the EU, which makes it necessary to independently classify your device against the Singapore regulations.

In this white paper:

  • Scope of the medical device regulations
  • Classification in Singapore
  • Routes to market entry
  • Grouping
  • Registration requirements
  • Fees and review times
  • Post market notifications
  • Change notifications
  • and more

About the Author:
Michael A. Siano is a Senior Global Regulatory Specialist at Emergo.