May 17, 2019

The Saudi Food and Drug Authority (SFDA) has prepared adjustments to its medical device and IVD registration requirements in line with upcoming changes to European regulations, and has also drafted UDI guidance as well as a Brexit contingency plan.

SFDA, MDR and IVDR

According to Emergo by UL sources in Riyadh, Saudi Arabian market registrants currently relying on their CE Mark certification to the European Medical Devices Directives or In Vitro Diagnostics Directive to meet SFDA prior approval requirements will have to demonstrate compliance to the Medical Devices Directive (MDR) and In-vitro Diagnostic Devices Directive (IVDR) once those Regulations come into force in Europe.

SFDA will follow the same timelines established by the European Commission for transition to the new Regulations: May 26, 2020 for the MDR and May 2022 for the IVDR. From those dates on, medical device companies will have to show compliance to the MDR and/or IVDR if they intend to use their CE Marking for prior approval requirements in order to pursue registration in Saudi Arabia.

Brexit-related policies

Although the terms of a planned UK withdrawal from the European Union may now not be known until late October 2019, SFDA has announced to manufacturers and registrants that starting in 2020, the regulator will only recognize CE Mark certificates from Notified Bodies based in the EU. In addition, SFDA will require that registrants’ Authorized Representatives be based in the EU.

UDI guidance

SFDA has also issued guidance on establishing a Unique Device Identification (UDI) system in Saudi Arabia. The guidance covers all medical devices and accessories approved for sale in Saudi Arabia, with the exception of custom-made devices as well as investigational medical and IVD devices.

The Saudi regulators’ UDI requirements, generally in line with International Medical Device Regulators Forum (IMDRF) recommendations and systems implemented in the US and other markets, include the following:

  • A device identifier (UDI-DI) and a production identifier (UDI-PI) assigned to each device;
  • UDI data available in both plain text and AIDC technology formats;
  • Reusable devices should have permanent direct marking (DM) UDI information;
  • New UDI-DI data will be required when a device or its attributes undergo changes or modifications

SFDA’s UDI system will also entail a database, the Saudi Arabia UDI Database (SAUDI-D), into which manufacturers or their Authorized Representatives will be required to submit and maintain UDI-related data.

SFDA UDI compliance dates

UDI compliance deadlines for Saudi Arabian medical device market registrants will be contingent upon the launch of the SAUDI-D database, as well as their device classifications:

  • Class D devices: six months following implementation of SAUDI-D
  • Class B and C devices: one year following implementation of SAUDI-D
  • Class A devices: two years following implementation of SAUDI-D
  • DM requirements: one year following compliance date for device’s applicable class

Emergo by UL will follow up with SAUDI-D launch news as we learn more.

Related Saudi Arabia medical device regulatory information: