The Saudi Food and Drug Authority (SFDA) has established a Unique Device Identification (UDI) system for medical devices. Through unified device coding and database management, the system strengthens the identification and traceability of medical devices in the Saudi market and supports regulatory activities such as adverse event reporting, product safety vigilance and field safety corrective actions.
UDI for medical devices in Saudi Arabia has been mandatory for all risk classes since September 1, 2024. Applicable medical devices must complete UDI labeling as well as registration and maintenance of information in the Saudi-DI database in accordance with SFDA requirements.
1. Regulations and Official Systems
| Regulation or System | Date | Main Content |
|---|---|---|
| Requirements for Unique Device Identification (UDI) for Medical Devices (MDS-REQ-007-V4) | Issued on May 24, 2022 | Sets out requirements for UDI coding, labeling, direct marking, the Saudi-DI database and special types of devices |
| Saudi-DI database | Launched on October 1, 2020 | Used for the registration, maintenance and query of UDI-DI and related product information for medical devices |
2. Components of the UDI System
| Item | Main Requirements |
|---|---|
| UDI-DI (Device Identifier) | Identifies the specific device and its model, and is the key identifier for querying related information in the Saudi-DI database |
| UDI-PI (Production Identifier) | Identifies production information, including lot number, serial number, expiration date, manufacturing date and software version, where applicable |
| UDI carrier | UDI is presented through automatic identification and data capture (AIDC) technologies such as barcodes and QR codes, together with human-readable information (HRI) |
| UDI issuing agency | Standards of issuing agencies accepted by SFDA must be used, including GS1, HIBCC and ICCBBA |
| Saudi-DI database | Used for the registration, maintenance and query of UDI-DI and related product information for medical devices |
The UDI consists of two parts: UDI-DI and UDI-PI. UDI-DI is mainly used for device identification, while UDI-PI is mainly used for production traceability. Companies should complete code assignment and labeling according to the product and its packaging.
3. UDI Implementation Timeline
| Product Risk Class | Mandatory Compliance Date |
|---|---|
| Class D (high risk) | September 1, 2023 |
| Class C (medium-high risk) | September 1, 2023 |
| Class B (medium-low risk) | September 1, 2023 |
| Class A (low risk) | September 1, 2024 |
4. Parties Responsible for UDI Data Submission and Their Duties
| Responsible Party | Main Duties |
|---|---|
| Manufacturer | Assign UDI to products; ensure that labeling of the product and applicable packaging levels meets requirements; ensure the accuracy of submitted data; maintain records related to product changes |
| Authorized Representative | Assist with the submission and maintenance of Saudi-DI data as required, and cooperate with SFDA regulatory requirements |
| Own-brand or private-label responsible party | For devices labeled under its own name or brand, bear the corresponding UDI manufacturer responsibilities as specified in the document |
5. Scope of UDI Application and Exemptions
UDI requirements apply to medical devices, medical supplies and accessories intended for the Saudi market that are not exempt from marketing authorization requirements. The following situations may qualify for partial exemptions from UDI requirements:
| Situation | Applicable Rules |
|---|---|
| Qualifying single-use devices | Certain individually packaged single-use devices may be exempt from carrying UDI on the label or packaging of each individual device, provided that all conditions specified in the document are met, UDI is marked on the outer packaging as required, and the Unit of Use DI is handled in the database |
| Reusable devices | Exemption from direct marking (DM) requirements on the device body may be granted when the conditions specified in the document are met and sufficient justification and documentation are provided |
| Devices sold at retail | For devices sold only through retail channels, the AIDC on the retail package may omit UDI-PI; higher non-retail packaging levels must still carry the complete UDI |
| Repeated marking on outer packaging | UDI does not need to be repeated on the outer packaging when the UDI within the package can be clearly read and the AIDC can be scanned through the packaging |
| Special exemptions or alternative approaches | Manufacturers or authorized representatives may submit a written application to SFDA describing the specific device, the requirement to be exempted or replaced, and the justification |
6. UDI Labeling and Direct Marking Requirements
1. Product Labels and Packaging
The applicable UDI should be marked on the primary product label and the corresponding higher levels of packaging, providing both human-readable information (HRI) and an automatic identification and data capture (AIDC) carrier.
HRI on the label should comply with the format requirements of the issuing agency. If a linear barcode is used to present the UDI on the primary packaging, the complete UDI should be combined into a single barcode; the use of stacked barcodes alone does not meet the relevant requirements for primary packaging specified in the document.
If RFID technology is used, the label should also provide a linear barcode, a two-dimensional barcode or another applicable barcode. Barcodes should be verified in accordance with the applicable ISO/IEC standards and meet the grade requirements of the issuing agency. The UDI should remain readable under normal conditions of use and throughout the intended lifetime of the device, without affecting the safety or performance of the product.
2. Direct Marking of Reusable Devices
Applicable reusable devices that are intended for use on more than one patient and require reprocessing between uses on different patients should bear a permanent direct marking (DM) on the device body. The direct marking should remain readable under normal conditions of use and throughout the intended lifetime of the device, and should remain readable after the specified reprocessing cycles.
If the primary label on the device body is itself permanently marked with the UDI, an additional direct marking is not required, but the applicable labeling requirements must still be met.
7. UDI-DI Change Requirements
When specific product changes occur, a new unique UDI-DI must be assigned. These mainly include:
- Changes to the product model, version, etc.;
- Changes that could cause ambiguity in device identification or affect traceability;
- Addition of new packaging configurations or changes to packaging quantity;
- Changes to brand name or clinically relevant dimensions;
- Changes to single-use designation, natural rubber latex designation, MRI safety information or sterile packaging status;
- Other changes specified in the document that require a new UDI-DI.
Not all changes require a new UDI-DI. For changes that do not require a new UDI-DI, relevant records should still be updated in a timely manner in accordance with the database maintenance requirements.
8. Saudi-DI Data Items
| Data Category | Main Content |
|---|---|
| Product identification information | Primary UDI-DI, issuing agency, model, version, catalog number |
| Product and registration information | Product name, brand, description, risk class, SFDA product registration number, etc. |
| Manufacturer and authorized representative information | Manufacturer name and address, and authorized representative details |
| Production identification information | Applicable lot number, serial number, expiration date, manufacturing date, software version |
| Packaging information | Package UDI-DI, quantity per package, package type and other packaging level information |
| Product attributes | Clinically relevant dimensions, natural rubber latex designation, MRI safety status |
| Use and risk information | Single-use attribute, maximum number of reuses, critical warnings and contraindication information |
| Storage information | Special storage conditions specified on the label |
| Component and kit information | Component names, component DIs and issuing agencies, where applicable |
| Direct marking information | Direct marking DI and corresponding identification information, where applicable |
9. UDI Requirements for Special Types of Medical Devices
| Product Type | Main Requirements |
|---|---|
| Software as a medical device (SaMD/SiMD) | The UDI should be displayed on a user-accessible interface; software without a user interface should be able to provide the human-readable information through an API |
| Implantable devices | The implant card should contain device identification information; the complete UDI should be obtainable at the time of implantation; active implantable devices must be controlled by serial number |
| Configurable devices | The complete configurable system should be assigned its own UDI, and components should be marked as required |
| Components and subsystems sold separately | Detachable, separable or separately marketed components and subsystems should have their own UDI |
| Accessories | Accessories that can be installed or removed by the end user, or that are marketed separately, should have their own UDI |
| Combination products | Applicable devices and accessories should meet UDI requirements according to SFDA classification and authorization requirements |
| Procedure packs and system kits | The pack or kit itself should have its own UDI; devices within the pack should in principle also meet UDI requirements, except as otherwise provided in the document |
| Devices sold at retail | Devices sold only through retail channels may be subject to specific UDI-PI carrier requirements; products also used in clinical settings must still provide the complete UDI |
| Own-brand and private-label devices | The relevant responsible party should fulfill the UDI manufacturer responsibilities as specified in the document |
| Relabeled, repackaged and remanufactured devices | A new UDI should be created as required by the document, and records of the original device UDI should be retained where available |
Official Sources
- SFDA MDS-REQ-007-V4: Requirements for Unique Device Identification (UDI) for Medical Devices
- SFDA Saudi-DI Database
This article is compiled from publicly available SFDA regulations and Saudi-DI materials for compliance planning reference. For the applicable requirements for specific products and packaging, exemption conditions and database fields, the current SFDA documents and system requirements prevail.