Extends Deadlines for Saudi Arabia SFDA Guidance on UDI

Saudi Arabia SFDA Guidance on UDI

A wide range of medical devices are available in the market. The rising concerns related to medical devices like patients’ safety and supply chain management has forced the introduction of a single, unique, globally harmonized identification system for every device.

UNIQUE IDENTIFICATION IDENTIFIER

The US FDA has established the unique identification system to every medical device, with a purpose to identify the device sold in the US market. The label of the medical device would include Unique Device Identifier (UDI) with numeric or alphanumeric code. The UDI system is adopted in various countries like China, Australia, Europe, Brazil, Japan, Saudi Arabia etc. Saudi Arabia SFDA guidance on UDI has captured attention these days due its new updates on extent ending deadlines for compliance.

GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUIDD)

The Global Unique Device Identification Database (GUDID) is a database by FDA that serves as a reference catalogue for the medical devices with unique device identifier. GUDID contains only the Device Identifier (DI) portion of the device and not the product Identifiers (PI).

PURPOSE OF UDI

• The UDI system provides single, unique and globally accepted device identification which makes it easy to trace the device through distribution and use.
• It helps in easy identification of devices in adverse events and taking corrective actions towards it.
• The system facilitates steps towards patients’ safety.
• It helps in reduction in medical errors by simplifying and integrating the information of the device.

Read More -  Saudi Arabia SFDA Guidance on UDI

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