The UDI regulations in Saudi Arabia are intended to play a role in health insurance and cost monitoring additionally to increase patient safety. However, the focus is on traceability, market surveillance, and various safety aspects.
Authority: Kingdom of Saudi Arabia Food and Drug Administration (SFDA).
Timeframe: The SFDA UDI regulation came into force by 01.08.2021. The database, SAUDI-D, is usable since 1 October 2020. For the different product classes (Class A-D), different deadlines must be met:
- Class D (high risk) 1 September 2023
- Class B and C (medium risk) 1 September 2023
- Class A (low risk) 1 September 2024
Products: All medical devices, except custom-made devices and investigational medical devices.
Issuing Agencies: GS1, HIBCC, and ICCBBA.
The UDI regulations in Saudi Arabia cover all medical devices distributed in the KSA market, as well as manufacturers, Authorised Representatives, and importers. The requirements cover various UDI types and regulations for affixing. In addition, there is the premise of making the corresponding UDIs accessible/readable over the entire life cycle of a product.
The Structure of the UDI in Saudi Arabia
The Saudi UDI code divides into two UDI types, the UDI-DI and the UDI-PI. Additionally, there is the DM UDI (Direct Marking) for reusable medical devices.
The UDI-DI identifies a specific product of a manufacturer and is the key to the corresponding data in the UDI database, SAUDI-D. Accordingly, manufacturers must ensure to assign globally unique UDI-DIs.
There are some product data that are on the label that also needs to be incorporated into the UDI-PI. Among them are serial number, batch number, expiry date, and software identifier. The date of manufacture only needs to be included as a UDI-PI if the date is mandatory for product control or if no other UDI-PIs are available. Reusable medical devices must also have a Direct Marking UDI (DM UDI) on the device itself. Furthermore, this also applies if they are reprocessed between uses. Excluded from the DM UDI marking on the device are products where it is not possible due to technical or safety reasons or where the product and its function would be impaired as a result.
The UDI has to apply in two different ways. In HRI form, i.e., human-readable, and in AIDC form, Automatic Identification and Data Capture, i.e., via barcodes or RFID. However, if manufacturers use RFID technology, they must also incorporate a 2D barcode into the label. Lastly, the UDIs must be provided on all packaging levels, except on the shipping cartons.
Some additional requirements apply to software as medical devices or implants, for example.
When must a new UDI be assigned?
Within the SFDA, several defined events lead to the assignment of a new UDI. These include the change of the following attributes, among others:
- Traceability or Identifiability are affected.
- Change of UDI issuing authority.
- In the case of a new, related packaging unit.
- New product version or model.
- Changes in the safety information
Since the Saudi authorities have followed the framework guidelines of the International Medical Device Regulators Forum (IMDRF) and existing regulations such as those in the USA or the EU, the requirements are similar. Of course, there are also deviations, such as in the classification or special requirements.
The long-term compliance of our customers is important to us. That is why we always keep an eye on international regulations. Additionally, to the EU-MDR requirements, we have structured mytracekey MedTech in a way to easily map other international regulations.[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: July 2022)