Phase 2 Scope
SFDA's UDI programme Phase 1, which covered Class D high-risk devices, achieved 91% manufacturer enrolment against a target of 85% by the June 2026 deadline. Phase 2 extends mandatory UDI implementation to Class B (moderate-low risk) and Class C (moderate-high risk) devices, representing approximately 74% of all medical devices registered in Saudi Arabia by volume.
Technical Requirements
Manufacturers must apply GS1 or HIBCC UDI carrier formats to device labels and register device identifiers in the SFDA's National Device Registry (NDR) platform. For Class C devices, Dynamic Device Identification (DI) data including production identifiers must be captured in the NDR. SFDA will provide free onboarding support through its GHAD registration assistance portal.
Import Licence Implications
From 01 January 2027, new import licence applications and renewal applications for Class B and C devices must include confirmed NDR registration numbers. Applications submitted without valid UDI NDR references will be returned as incomplete. SFDA has signalled that enforcement of the deadline will be strict given the 18-month lead time provided.
Pilot Programme Outcomes
The six-month pilot enrolled 340 manufacturers across 12 device categories. Key learnings incorporated into the Phase 2 implementation guide include simplified DI assignment rules for device families with multiple configurations and an exemption for custom-made devices manufactured in quantities of fewer than 50 units annually.