Useful Links & Official Resources
SFDA official portals
| Resource | Description |
|---|---|
| SFDA Website | Official SFDA website — regulatory news, announcements, guidance |
| GHAD Portal | Unified electronic system for MDMA, MDEL, UDI submissions |
| SFDA Medical Devices Sector | Medical devices regulatory section |
| NCMDR | National Centre for Medical Device Reporting — adverse event submission |
SFDA guidance documents (MDS-REQ series)
MDS-REQ and MDS-G guidance documents are available for download from the SFDA website under: Medical Devices → Regulations and Guidance → Guidance Documents
Key documents to download:
- MDS-REQ 1 — Requirements for MDMA (core registration document)
- MDS-REQ 5 — Post-Market Surveillance and Vigilance
- MDS-REQ 7 — UDI requirements
- MDS-G008 — Classification guidance
International reference resources
| Resource | Description |
|---|---|
| IMDRF | International Medical Device Regulators Forum |
| ISO 13485:2016 | QMS standard for medical devices |
| ISO 14971:2019 | Risk management for medical devices |
| IEC 62304 | Software lifecycle for medical devices |
| GS1 UDI | GS1 UDI issuing agency |
RAPath suite
- RAPath Hub — all jurisdiction sites
- Australia (TGA)
- European Union (MDR/IVDR)
- Canada (Health Canada)
- Singapore (HSA)
- United Kingdom (MHRA)
- United States (FDA)
Disclaimer
External links are provided for reference only. RAPath does not control the content of external sites. Always verify that you are using the most current version of any SFDA guidance document.