Recent Regulatory Changes
This page tracks recent significant changes to Singapore's medical device regulatory requirements, including new or revised guidance documents, regulatory amendments, and changes to HSA's processes.
How to stay current
The most reliable way to stay up to date with HSA regulatory changes is to:
- Monitor HSA announcements: hsa.gov.sg/announcements
- Subscribe to HSA e-newsletters (via the HSA website)
- Check the HSA guidance documents page periodically for new or updated documents: hsa.gov.sg/medical-devices/guidance-documents
- Watch for IMDRF guidance publications that HSA may adopt: imdrf.org
Quick Guide — April 2026
HSA published an updated Quick Guide to Medical Device Registration and Licensing in April 2026. This is the most current overview of the registration and licensing process and should be the starting point for any company new to Singapore registration:
This page is updated periodically. For the most current regulatory news, always refer directly to HSA's official announcements.