SFDA UDI Requirements for Medical Devices

SFDA requires compliance with the Unique Device Identification (UDI) regulations on all medical device companies in Saudi Arabia. They must register their product’s UDI information in the SFDA UDI system. It is gradually enforced according to the device risk class and can be entered by authorized representatives in Saudi Arabia.

What is UDI?

Unique Device Identification UDI is a series of numeric or alphanumeric characters generated through a globally accepted coding system. It is an identifier that unambiguously identifies a device through its distribution and use. Comprised of Two Parts:

 1. A Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the specific Product Number of a device and the labeller of that device and

 2. A Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

• •The lot or batch within which a device was manufactured.
• The serial number of a specific device.
• The expiration date of a specific device.
• The manufacturing date of a specific device.

The UDI shall be placed on the label of the device and on all higher levels of the packaging materials and be presented in two forms:

• Easily readable plain-text (also known as HRI-Human Readable Interpretation), and
• AIDC technology (Automatic Identification and Data Capture).

The UDI Barcode- What is on the Label?

 

Scope

• All medical devices and their accessories, except custom-made for specific patients and investigational as well as research-use devices
• Manufacturers, authorised representatives

Recognised Issuing Agencies

UDI recognised issuing Agencies are the entities: GS1, HIBCC, ICCBBA

UDI Database

• The manufacturer, or its authorised representative, shall submit and maintain the appropriate data in the UDI database
• Shall be checked and maintained periodically by the manufacturer
• The data for new UDI-DI shall be available in database at the time the device is placed on the market.
• All specified (non-private) data in the database will be publicly available.
• All data in GHAD and Saudi-DI are accurate and valid, such as models name, GMDN code etc.

WHY UDI?

The purpose of SFDA’s UDI System is to provide standardized identification of medical devices (and their accessories). The UDI system aims to increasing patient safety and optimizing patient care by facilitating the following:

Increasing patient safety

• Increase patient’s safety: In adverse event reports and other post market surveillance activities, field safety corrective actions.
• Improving identification and traceability: Control at ports and during its life cycles, identification, and documentation at the point of patient use.
• Identification of counterfeits.
• Safe and effective use of devices and reduction of medical errors.
• Patient’s electronic health records.

Utilised in other aspects

• Purchasing and inventory management
• Medical insurance activities
• Cost control & monitor
• Replace in-house coding by UDI

Compliance Effedtive Dates

• Effective from July 2020 1st of Oct 2020
  Launching the UDI database and starting optional registration for all type of devices Compliance date Risk Class
• Enforcement plan will be based on the product’s risk class as follows:
  • High Risk (D) – 1 Aug 2021 1 September 2023
  • Medium Risk (B, C)1 Feb 2022 1 September 2023
  • Low Risk (Class A)-  1 Feb 2023 1 September 2024

How Do I Register my medical device product?

Through the SFDA UDI platform that it is available for access for Saudi authorized representatives. Contact us for support.

Read More:

• SFDA Medical Device Registration
• SFDA Registration & Market Regulations
• Medical Device Authorized Representative (SFDA AR)
• SFDA Classification