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

The SFDA website www.sfda.gov.sa

The SFDA Medical Device webpage http://www.sfda.gov.sa/En/MedicalEquipments

The SFDA Medical Device helpline e-mail address MDS@sfda.gov.sa

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