UDI Implementation — MDS-REQ 7 Requirements for Medical Devices
SFDA is implementing Unique Device Identification (UDI) requirements for medical devices under MDS-REQ 7. The UDI system aligns Saudi Arabia with the global IMDRF UDI framework and requires manufacturers to:
- Assign a UDI-DI (Device Identifier) and UDI-PI (Production Identifier) to all applicable devices.
- Label devices with the UDI in human-readable and machine-readable (barcode/2D code) format.
- Submit UDI data to the SFDA Medical Device Database (MDDB) through the GHAD portal.
🔖 Status: phased implementation by device class and risk level
Manufacturers placing devices on the Saudi market should review MDS-REQ 7 for their applicable device classes and compliance timelines. UDI labelling must be in place before the relevant implementation deadline for each device class. Work with your Saudi AR to ensure MDDB submissions are completed on time.
View official source (SFDA — Medical Devices) ↗