Navigating Saudi Arabia’s New UDI System: A Key to Enhanced Medical Device Safety and Global Market Access
Introduction
The Kingdom of Saudi Arabia has taken a significant step forward in medical device regulation with the implementation of a comprehensive Unique Device Identification (UDI) framework overseen by the Saudi Food and Drug Authority (SFDA). This milestone aligns with global best practices, aiming to improve device traceability, safety, and post-market surveillance, ultimately ensuring better patient outcomes and a more transparent healthcare supply chain.
In this blog, we explore the core elements of the Saudi UDI system, its strategic phased implementation, and how medical device companies—especially international manufacturers—can navigate this complex yet rewarding regulatory environment effectively.
The Foundations of Saudi’s UDI Framework
What is UDI and Why Is It Important?
Unique Device Identification (UDI) is a standardized system designed to assign a unique code to each medical device throughout its lifecycle. This code facilitates rapid identification, enhances safety monitoring, and simplifies recall processes. For Saudi Arabia, implementing UDI is a critical regulatory milestone that aligns with global standards, notably those from the International Medical Device Regulators Forum (IMDRF).
The Regulatory Foundation: MDS-G34
The UDI system in Saudi Arabia is outlined in the guidance document MDS-G34. It mandates a standardized method for identifying and tracking medical devices from manufacturing to patient use, thereby creating a transparent, efficient, and secure supply chain.
Key Components of the Saudi UDI System
UDI-DI (Device Identifier)
- Static and mandatory
- Unique alphanumeric or numeric code for each device model or version
- Acts as the primary key into the Saudi UDI Database (Saudi-DI)
- Contains core information such as manufacturer details and device specifications
UDI-PI (Production Identifier)
- Dynamic component
- Contains production-specific data, including batch/lot number, serial number, manufacturing date, and expiry date
- Provides real-time information about each device instance
UDI Carrier and Presentation
- Dual format requirement: Human-readable (plain text) and machine-readable (linear barcode or 2D DataMatrix)
- Ensures accessibility for healthcare professionals and automated systems alike
Standardization and Interoperability
Manufacturers are mandated to obtain UDIs from SFDA-accredited issuing agencies such as GS1, HIBCC, or ICCBBA, ensuring compatibility with international standards.
Phased Implementation and Compliance Timeline
The SFDA has adopted a risk-based phased approach, allowing manufacturers sufficient time to adapt:
- High-risk Class D devices: First compliance deadline
- Medium-risk Class C and B devices: Second phase
- Low-risk Class A devices: Final phase
Manufacturers must place UDI labels on device labels and packaging (excluding shipping containers) and upload detailed device information into the Saudi-DI database prior to market entry.
Special Considerations for Reusable Devices
Reusable devices requiring sterilization or reprocessing must feature a permanent UDI via Direct Part Marking (DPM), ensuring continuous traceability throughout their operational life.
Data Submission and Ongoing Compliance
Data Requirements
For each UDI-DI, manufacturers—through their Authorized Representative (AR) in Saudi Arabia—must upload comprehensive data, including:
- Device identification details
- Medical Device Marketing Authorization (MDMA) number
- Risk classification
- Post-market surveillance obligations
- Clinical data: sterility, storage, packaging
Centralized Database and Oversight
This data repository provides SFDA with critical oversight capabilities, enabling swift responses to adverse events and facilitating effective recalls.
Challenges for International Manufacturers
Navigating Saudi’s UDI landscape requires a nuanced understanding of local regulations, robust data management systems, and strategic planning. Smaller startups or even large multinationals may find the process complex and resource-intensive, highlighting the need for expert local support.
How Pure Global Facilitates Market Entry and Compliance
Your Regulatory Partner in Saudi Arabia
Pure Global specializes in helping MedTech and HealthTech companies access the Saudi market efficiently. Acting as the official local Authorized Representative, Pure Global manages all communications, submissions, and compliance requirements with the SFDA.
Streamlined, Global-Ready Processes
Using advanced AI tools and expert knowledge, Pure Global ensures meticulous preparation of technical dossiers and accurate data entry into the Saudi-DI database, reducing errors and delays.
Single Process, Multiple Markets
Their integrated approach leverages the work done for Saudi UDI compliance to facilitate market access in over 30 jurisdictions worldwide, simplifying international expansion.
End-to-End Support
From regulatory strategy and market selection to post-market surveillance and ongoing compliance monitoring, Pure Global provides continuous support to ensure your business remains compliant and agile in a rapidly evolving global environment.
Conclusion
Saudi Arabia’s UDI system represents a significant leap forward in medical device regulation, emphasizing safety, transparency, and global harmonization. While compliance may seem daunting initially, partnering with experienced regulatory experts like Pure Global can turn this challenge into an opportunity for market expansion and enhanced patient safety.
To learn more about how you can successfully navigate the Saudi UDI landscape and unlock access to the Kingdom’s lucrative healthcare market, contact Pure Global at info@pureglobal.com or visit pureglobal.com.
Together, we can ensure your medical devices meet all regulatory requirements and are prepared for global success.
