Medical Device - Unique Device Identification (UDI)

What is Unique Device Identification (UDI)?

UDI system aims to document unique devices codes for medical devices based on accredited international standards, with the purpose to allow all stakeholders to identify medical devices information through the unique device identification code that is registered on the system.

Manufacturers and their authorized representatives are directly responsible for submitting, maintaining, and modifying all data of unique device identification codes for their medical devices according to the SFDA guidance for UDI.
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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: Facilitates identification of counterfeit devices, bolstering 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.
• Achieving Safety: Promotes device safety for improved healthcare outcomes.

_{**Saudi FDA may ask for further information, updates, or data verification at any time.}