SFDA UDI Requirements for Medical Devices

Compliance with the Unique Device Identification (UDI) regulations is required by SFDA on all medical device companies in Saudi Arabia. They have to register their products’ UDI information in the SFDA UDI system. It is gradually enforced according to the device risk class and can be done by local companies who act as local distributors, medical devices authorized representatives and medical device consultancies 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?

 

UDI SFDA

Scope

  • All medical devcies and their accessories, except custom-made for specific patient 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
  • Enforcement plan will be based on the product’s risk class. Refer to SFDA announcment No 01/09/2020
    • High Risk (D) – 1 Aug 2021
    • Medium Risk (B, C)1 Feb 2022
    • Low Risk (Class A)-  1 Feb 2023
    • Direct Marking – 6 months after applicable compliance date

How Do I Register my medical device product?

Through the SFDA UDI platform that it is available for access by local companies in Saudi Arabia who act as local distributors or medical device authorized representatives.

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