Medical Device Unique Device Identification (UDI)

What Is Unique Device Identification (UDI)?

The UDI system documents unique device codes for medical devices in Saudi Arabia based on accredited international standards, enabling all stakeholders to identify medical device information through the unique device identification code registered in the system.

Manufacturers and their authorized representatives are directly responsible for submitting, maintaining, and updating all unique device identification code data for their medical devices, in accordance with the SFDA guidance for UDI.

Benefits of Unique Device Identification (UDI)

• Standardized Identification: Ensures consistent device identification for streamlined processes.

• Device Traceability: Enhances monitoring and control of devices throughout their lifecycle.

• Fraud Prevention: Helps identify counterfeit devices, strengthening patient safety.

• Data Management: Supports effective management of recalls, corrective actions, and adverse events.

• Lifecycle Efficiency: Establishes controls for efficient device management from inception to disposal.

• Improved Safety: Promotes device safety for better healthcare outcomes.

^{**The Saudi FDA may request further information, updates, or data verification at any time.}

Bio-Standards manages Saudi-DI (UDI) submissions as part of our SFDA medical device registration services. Download the UDI e-book, or contact us to get UDI-ready.

‍