SAUDI ARABIA: UDI deadlines for Medical Devices postponed

Saudi Food and Drug Authority (SFDA) – Regulatory Authority of Medical Devices market in Saudi Arabia – aims to increase patients’ safety by optimizing devices traceability. As a consequence of this, SFDA decided to postpone UDI deadlines for Medical Devices, to give involved Operators more time to comply with Unique Medical Device Identifier System (UDI).

Saudi Arabia UDI deadlines for Medical Devices postponed
UDI deadlines for Medical Devices postponed

Which are the new UDI deadlines for Medical Devices?

UDI deadlines have been postponed as follow, according to medical devices risk class:

  • Class D (high risk): from August 1, 2021, to September 1, 2022.
  • Class B and C (medium risk): from February 1, 2022, to September 1, 2022.
  • Class A (low risk): from February 1, 2023, to September 1, 2023.

On September 2020, with regard to UDI requirements, SFDA published an update on the “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (MDS-G34)” document to offer Manufacturers and other stakeholders, useful information on UDI system main requirements. These need to be applied on devices authorised to be placed on Saudi Arabia market. The document also offers crucial information on UDI database (Saudi-DI) which is a fundamental element for unique devices identification system because it contains updated info on products.

Main goals of UDI system implementation

According to SFDA guideline, the main goals of the UDI system implementation are:

  • Providing accurate identification of Medical Devices and device-specific data.
  • Ensuring Medical Devices traceability.
  • Managing information in case of recalls, corrective measures, counterfeit devices, and adverse event reporting.
  • Establishing effective checks on Medical Devices during their life cycle.
  • Guaranteeing that products are use in effective and safe ways.

Do you need more information on Medical Devices Regulation in Saudi Arabia?

Thema experts are available for consultancy and to offer you information on regulatory scenario in Saudi Arabia. Additionally, if you want to register your devices, Thema experts will help during the whole registration process to market your products in full compliance with the Regulation.

Contact us for additional information!

Source:

UDI deadline extension for Medical Devices, SFDA, 2021

Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (MDS-G34), SFDA, 2020