Resources Library

Important notice regarding Saudi Arabia UDI requirements

Saudi Arabia has allowed voluntary UDI registration since October 1, 2020, but mandatory compliance for all device classes doesn’t begin until September 1, 2022. These requirements apply to both labeling and database registration.

Medical devices imported before the compliance date can be distributed for up to 1 year after the compliance date without meeting UDI requirements. This exception does not apply to the Direct Marking (DM) requirement, which is a permanent marking of the UDI on the device itself.

All UDI Requirements:

  • Class D devices – 1 year after SAUDI-D is ready
  • Class B/C devices – 2 years after SAUDI-D is ready
  • Class A devices – 3 years after SAUDI-D is ready
  • For the Direct Mark requirements – 2 years after the applicable class compliance date
Saudi Arabia compliance timeline
Device risk class Compliance dates

(labeling and registration)

Class D (high risk) Sep 1, 2023
Class B & C (medium risk) Sep 1, 2023
Class A (low risk) Sep 1, 2024

For additional information, see the Saudi Arabia guidance on UDI requirements for medical devices.

The SFDA website

The SFDA Medical Device webpage

The SFDA Medical Device helpline e-mail address

Product Classification System (PCS)

SFDA established Product Classification System for companies to classify their products and get to know the eligibility of products and whether it is subject to registration. The classification exclusively based on the SFDA criteria and products classification guidance. It is an optional service for companies and does not replace registration for other SFDA electronic systems