Saudi Food and Drug Authority (SFDA) issued final “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices” (MDS-G34) (MDS-G34 at HIBCC) in April 2019. The guidance published an update in December 2019 and a third update released in September 2020.
‘Guidance on Classification of Medical Devices and Supplies‘ was published December 2022.
The goals for SFDA UDI are to increase patient safety by improving device traceability, documentation and associated data for the reporting of adverse event reports, recalls and post-market surveillance. UDI is expected to be utilized for better control at ports-of-entry, for patient EHR and in purchasing and inventory management systems.
Learning from the initiatives for US and EU, SFDA has adopted many of the basic definitions around data attributes with some exceptions.
Many of the data attributes carry the same definition from US FDA with some noted differences. For instance, a medical device labeled for use in any environment outside of a healthcare facility is known as a ‘home use device’. If the medical device is intended to be used in healthcare facilities and outside those facilities, it meets this definition.
Another example is reusable devices, defined as those devices that require cleaning, disinfection, sterilization or refurbishing between uses on different patients. This concept is different from the US and EU, specifying between patient uses.
Under the Medical Devices Interim Regulation (MDIR), Decree No. 1-8-1429/2008, a medical device must have prior market authorization from one of these global health authorities (US, Japan, Australia, Canada or European Union), before being sold in the Kingdom of Saudi Arabia (KSA).
Compliance Requirements Scope
Current Indications are that UDI submission will be manual entry and SFDA will eventually offer an Excel capability to submit larger quantities to the database. From a more traditional machine-to-machine perspective, there is no indication of that type of submission offering yet. Six months after the official release of the database launch (currently 01 October 2020), the first wave of IVD UDI requirements will go into effect.
- All Devices (A, B, C, D) including IVDs, Kits, Accessories
- Unique DI with PI (Lot #, Serial #, Exp Data, Manufacturing Date conditional)
- Use GS1, HIBCC, or ICCBBA Standards
- UDI on Base Product and all Packaging Level
- UDI Presented in Human Readable Text and Bar Code (AIDC)
- Direct Marking for reusable devices
UDI Data Reporting to Saudi Arabia UDI Database (SAUDI-DI)
- Approximately 50 data elements (~14 derived from Registration)
- Manual or Electronic (XML) Submission Methods
- Non-private data to be made public
- MD listing number
- Arabic language for brand name and description
Timing for UDI Compliance
The SFDA Database has an effective date of 01 October 2020 for manual UDI submissions. For each device category, manufacturers are required to submit in Saudi-DI database prior to the compliance deadline.
For existing inventory, any devices labeled prior to the applicable compliance date have one year after before compliance is enforced. If a device is required to be direct-marked, it must comply with the dates below without exception.
UDI Label and UDI Submission phased by class (Direct Mark 1 year later)
- Class D (high-risk) SAUDI-DI open + 6 m / 01 August 2021
- Class B & C (medium-risk) SAUDI-DI open + 1 year / 01 February 2022
- Class A (low-risk) SAUDI-DI open + 2 years / 01 February 2023
Navigating the complexities of regulatory requirements for UDI for the US FDA or other global health authorities can quickly become a burden. Get in touch with the expertise at Reed Tech for help. email us: [email protected]