Forms, Portals and Application Links
SHARE — Primary submission portal
All regulatory applications (product registration, Class A notification, dealer's licence, change notification, AE reports, FSCA submissions) are submitted through SHARE:
hsa.gov.sg/medical-devices/e-services
Infosearch — Singapore Medical Device Register
Search the Singapore Medical Device Register (SMDR) to verify whether a device is registered and to find registration details:
hsa.gov.sg/e-services/infosearch
HSA online tools
| Tool | Purpose | Link |
|---|---|---|
| Is it a medical device? | Determine whether a product is a medical device | Link |
| Risk classification tool | Determine device class (A/B/C/D) | Link |
| Registration and licensing requirements tool | Check which registration route and licence type apply | Link |
| Medical device grouping tool | Determine the appropriate grouping type | Link |
Fees and turnaround times
hsa.gov.sg/medical-devices/fees