Meeting SFDA UDI Requirements for Medical Devices in Saudi Arabia
Medical device manufacturers selling products in Saudi Arabia must meet the Saudi Food and Drug Authority (SFDA) Unique Device Identification (UDI) requirements for medical devices and in vitro diagnostic (IVD) devices. Device manufacturers have very little time to put UDIs on their products and submit device data to the Saudi Arabia UDI Database (SAUDI-D).
This on-demand webinar walks through what manufacturers need to do to be ready, covering the SFDA compliance requirements, an overview of SAUDI-D, and how compliance deadlines vary by device class.
What You'll Learn
- The SFDA UDI compliance requirements that apply to medical devices and IVDs sold in Saudi Arabia.
- How the Saudi Arabia UDI Database (SAUDI-D) works and what device data manufacturers must submit.
- How compliance deadlines differ based on device class, so you can prioritize your remediation timeline.
- Why the short timeframe to apply UDIs and submit data makes early planning essential.
What the Session Covers
The discussion included:
- Details on compliance requirements for SFDA UDI
- Overview of the Saudi Arabia UDI Database (SAUDI-D)
- Compliance deadlines based on device class
- Live Q&A with the presenter
UDI mandates like Saudi Arabia's SFDA program are part of a global wave of device traceability requirements, each with its own database, data attributes, and deadlines. USDM helps medical device and IVD manufacturers turn fragmented regional UDI obligations into a structured, audit-ready compliance program, so that the systems and processes managing device data stay validated and trustworthy as requirements expand. Building UDI readiness on a foundation of strong data integrity means your submissions hold up whether you are filing to SAUDI-D, the FDA's GUDID, or the EU's EUDAMED.
Frequently Asked Questions
What is the SFDA UDI requirement?
It is the Saudi Food and Drug Authority's Unique Device Identification mandate, which requires medical device and IVD manufacturers selling in Saudi Arabia to apply UDIs to their products and submit device data to the country's UDI database.
What is SAUDI-D?
SAUDI-D is the Saudi Arabia UDI Database. Manufacturers must submit their device data to this database as part of meeting SFDA UDI requirements, in addition to applying UDIs to the products themselves.
Do the same deadlines apply to every device?
No. As covered in the webinar, compliance deadlines are based on device class. Manufacturers should map their portfolio by class to understand which products must be UDI-compliant first.
Does the requirement apply to IVDs as well as medical devices?
Yes. The SFDA UDI requirements cover both medical devices and in vitro diagnostic (IVD) devices.
How can USDM help with UDI compliance?
USDM helps manufacturers interpret SFDA UDI requirements, prepare and validate device data for SAUDI-D submission, and keep the underlying systems compliant. Our work is grounded in regulatory and data integrity expertise so your UDI program stays audit-ready. Contact us to discuss your readiness.
Watch the On-Demand Webinar
Watch this on-demand session to learn what your organization needs to do to be ready for Saudi Arabia's SFDA UDI requirements before the compliance deadlines arrive. To talk through your specific UDI obligations and timeline, contact USDM.
About the Presenter
Jay Crowley, Vice President, Medical Device Solutions and Services