Welcome to the first entry in our blog series on pharmaceutical serialization across the Gulf Cooperation Council (GCC). In this series, we’ll explore each GCC country’s current serialization landscape, starting with a deep dive into Saudi Arabia—the region’s frontrunner in pharmaceutical traceability. As of April 2025, the GCC nations have made substantial strides in implementing serialization frameworks, with Saudi Arabia leading the charge. Here's an in-depth look at the Kingdom’s current status and future direction.
Saudi Arabia: Leading the Way Toward Full Serialization by 2030
Saudi Arabia, through the Saudi Food and Drug Authority (SFDA), has built a robust serialization and traceability framework for both pharmaceuticals and medical devices. The goal: a fully serialized and traceable pharmaceutical supply chain by 2030.
Serialization Specifications (Pharmaceutical Prescription Products)
Serialization is currently mandatory at the secondary packaging level, incorporating the following data elements in GS1 format:
- Global Trade Item Number (GTIN)
- Randomized Serial Number
- Expiry Date
- Batch or Lot Number
Aggregation is also a requirement for manufacturers, who must label all packaging levels using Serialized Shipping Container Codes (SSCCs).
Centralized Reporting via RSD
The SFDA operates a central Reporting and Stakeholder Data (RSD) system. All stakeholders in the pharmaceutical supply chain must report product movement events to this centralized platform.
Saudi Arabia has developed two distinct portals for managing stakeholders and reporting:
- Stakeholders Management Portal
Used by establishments for initial RSD registration, stakeholder management, and adding new stakeholders.
- Stakeholder Operation Portal
Used for reporting drug movements within the supply chain. Once a stakeholder’s system is integrated with RSD, these transactions are logged automatically without manual input.
Serialization Specifications (Pharmaceutical Medical Devices)
Medical Devices: UDI Regulation in Focus
Saudi Arabia has also implemented a Unique Device Identification (UDI) system under the “Executive Regulation of Medical Devices Law” (SFDA Board of Directors decree No. 3-29-1443). This regulation aims to ensure:
- Standardized device identification
- Improved traceability
- Rapid recall of unsafe devices
- Enhanced incident and adverse event reporting
Scope and Participants
Applies to all medical devices and accessories on the Saudi market (unless exempt from marketing authorization). Key players include:
- Manufacturers
- Authorized Representatives (ARs)
UDI Implementation Timelines
Although the revised implementation deadlines for UDI compliance were set as September 1, 2023 for Class B, C, and D devices and September 1, 2024 for Class A devices, there has been no formal enforcement from the regulatory authorities to date.
UDI Structure & Saudi-DI Registration
Manufacturers must assign UDI using accepted standards (GS1, HIBCC, ICCBBA) and register in the Saudi-DI database. The UDI consists of:
- UDI-DI (Device Identifier): Product-level unique ID tied to product info in Saudi-DI.
- UDI-PI (Production Identifiers): Includes optional elements like lot number, serial number, manufacturing date, etc.
Both elements must appear in:
- Human-readable format (HRI)
- AIDC format (e.g., barcode or RFID)
Stakeholders—including manufacturers, ARs, importers, and distributors—must maintain a searchable database of all received and distributed UDIs.
Importers must submit for each UDI-DI:
- Relevant UDI-PI(s)
- Quantity of lot-controlled devices
- Shipment date
- Destination (e.g., distributor or hospital)
SFDA Track & Trace System
All serialized medical devices are entered into the SFDA Track & Trace System, which monitors:
- Supply chain movements
- Product information confirmation by importers/distributors
- Usage in medical facilities
This ensures visibility, accountability, and swift response across the device lifecycle.
Conclusion
Saudi Arabia is laying the groundwork for a fully traceable healthcare supply chain by 2030. Its advanced serialization and medical device identification programs not only enhance regulatory oversight but also prioritize public health and safety.
Stay tuned for the next blog in our series as we explore serialization developments in the United Arab Emirates (UAE)—home of the innovative Tatmeen traceability platform.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the GCC pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.