Jay Crowley, Vice President of Unique Device Identification Solutions at USDM, answers questions from medical device manufacturers selling products in Saudi Arabia
The goal of the webinar was to provide an overview of the Saudi Arabia UDI Database (SAUDI-D) and help medical device manufacturers understand the details of the compliance requirements. Watch How to Comply with Saudi Arabia UDI Requirements on-demand.
Key Takeaways
- SAUDI-D compliance dates are class-based: Class D devices by August 1, 2021; Class B and C by February 1, 2022; Class A by February 1, 2023 — and the same dates apply to both label/package and database submission.
- GS1 US codes are accepted for the Saudi Arabia UDI Database, and a device already carrying a U.S. UDI can generally be registered in SAUDI-D as an equivalent device using the same DI.
- Data entry is web interface only — there is no machine-to-machine (M2M) capability, spreadsheet upload, or test environment at this point.
- Data must be reconfirmed annually, and access is currently limited to the authorized representative (intended to change in the future).
- Manufacturers already compliant with FDA and EU requirements will likely not need different label content for SFDA, but additional requirements must be assessed on a device-by-device basis.
Database, Submission, and Data Entry
Are GS1 US codes applicable for the Saudi Arabia UDI Database (Saudi-D)?
Yes, they are.
How will the data be entered in the SAUDI-DI database? Will it be via a web interface? Or would a specific data format be required?
At this point, it is web interface only.
Will Saudi Arabia have machine-to-machine (M2M) capabilities for data entry, or a spreadsheet upload, or both?
No.
Other than a web-based UI, what other mechanisms are being made available for data input (template upload, machine-to-machine API)?
That is not known at this point.
Is there a test environment to view the entry fields or published look of the records prior to releasing the information to the SAUDI-DI production database?
No, there is no test environment.
Since the SAUDI-D would only be available to the authorized representative, that would indicate no one from the United States, for example, can access the system for data entry, correct?
That is true for now; it is intended to change in the future.
Is it necessary to confirm your data annually?
Yes, you must reconfirm your data annually. Building the kind of repeatable, audited submission process that survives an annual reconfirmation is closely related to the data integrity disciplines USDM applies across regulated systems.
Can we make changes in the database? I heard that once we submit data, we must send an email to get things changed.
It is unclear at this point how corrections will be made.
Is it required to do the DI hierarchy in reverse order from the United States?
No, only the data is entered in reverse order (highest to lowest).
Do we have metadata requirements available?
Yes, see the user guide for information. Please be aware that the user guide is in the process of being updated.
Compliance Timelines
What are the database timelines?
The compliance due dates are the same for label/package and database submission. Everything is due on the dates indicated below.
- Class D devices: August 1, 2021
- Class B and C devices: February 1, 2022
- Class A devices: February 1, 2023
USDM's point of view: SAUDI-D is one more node in an expanding global UDI landscape that already includes the FDA's GUDID, the EU's Eudamed, and China's NMPA. The manufacturers who manage this well treat UDI as a single, governed master-data program rather than a series of one-off country filings. USDM's UDI Solutions team helps device makers map their existing FDA and EU data to SFDA requirements, validate the submission workflow, and keep the records defensible through the annual reconfirmation — applying the same continuous compliance discipline we bring to the rest of the regulated technology stack.
Labeling, Barcodes, and Direct Marking
If you are compliant with the FDA and EU, must you have something different identified on the label to support SFDA requirements under UDI?
Likely not, though there are a handful of differences among the three.
Is it acceptable to use a 2D barcode or can this be used only if a linear barcode is also displayed?
Yes, a 2D barcode is acceptable.
If a 2D barcode is present on the label with non-concatenated linear barcodes, must the human readable interpretation (HRI) also accompany the 2D barcode even if it is already present on the linear?
Yes, the HRI must accompany the 2D barcode.
Does the SFDA listing number need to be present on the UDI label? I understand that this is a required data element, but I'm not sure if it needs to go on the label.
No, the SFDA listing number does not need to be on the UDI label.
Brand names are not translated, but for a home use/lay person device, is this still a required field?
Yes, it is still a required field.
General direct marking understanding from the database screenshots is that a device is either exempt from direct marking requirements or it requires direct marking. If I have a single use, disposable device, it appears as though I would still have to answer the direct marking questions; is this correct?
Yes, that seems to be true.
What's a direct marking requirement for capital equipment where it's used for multiple patients but doesn't go for reprocessing?
None if not reprocessed between patient uses.
Kits, Procedure Packs, and Configurable Devices
If a non-medical device is in the procedure pack or kit, does it also need a UDI?
No, it does not.
What if a kit only has a top-level Global Trade Item Number (GTIN)? Is it exempt from stating the GTINs of the devices within? They are all the same in this case?
No, the devices within need GTINs.
The guidance lists requirements for kits and procedure packs separately from configurable devices, but in the screenshots of the database, the requirement shows kits, procedure packs, and configurable devices all together. This is impactful because if configurable devices are included, then we would have to include all of the parts that make up the device even though the guidance states the configurable device should have a UDI allocated to it in its entirety. Perhaps this will be updated within the database, but if not, which is correct, the guidance or screenshots?
From a data submission perspective, the user guide will dictate what needs to be done.
What's the definition of a removable accessory or component?
An accessory or component that can be removed from the medical device.
Can UDI-DIs of non-configurable devices be only in the system software?
No.
Implant Cards
In the EU, the implant card is required when applying for certification under the Medical Device Reporting (MDR) regulation, which will take place over several years, depending on the Medical Device Directive (MDD) certification status. In this regulation, is the implant card required by the August 1, 2021, compliance date and existing inventory is then subject to 1-year limitations? If so, this would make the SFDA requirement much earlier in many cases.
Yes, the implant card is due earlier than MDR.
Will the implant cards use the same symbology as the EU requirements to avoid the Arabic translation requirements (outside of device description)?
Yes, implant cards will use the same symbology as the EU requirements.
Cross-Jurisdiction and Equivalent Devices
How do I obtain the previous UDI of a device?
The previous UDI of a device is that same as the product you made and are commercializing; check your records from the original device.
When a device gets upgraded with a new component or accessory that changes the performance or features of the device, do we need to relabel the device?
Yes, you would need to relabel the device.
If we are (will be) compliant with the MDR/MDD, is there a list of specific additional requirements for SFDA compliance?
It will need to be assessed on a device-by-device basis.
Did the FDA postpone implementation or just the enforcement of UDI for Class I devices?
Just enforcement.
We use a third party to submit to GUDID, Eudamed, and NMPA. Will they be able to send data to SAUDI-DI?
Not at this point. Coordinating multiple submission vendors across jurisdictions is itself a third-party risk management question worth governing deliberately.
If we had already implemented UDI for a device in United States, can we use the same DI to register the product in the SAUDI-DI as an equivalent device?
Yes, generally speaking.
FAQ: Saudi Arabia UDI Compliance
What are the SAUDI-D compliance deadlines for medical devices?
The Saudi Arabia UDI Database compliance dates are class-based: Class D devices by August 1, 2021; Class B and C devices by February 1, 2022; and Class A devices by February 1, 2023. The same due dates apply to both label/package marking and database submission.
How is data submitted to the Saudi Arabia UDI Database?
At this point, data entry to SAUDI-D is web interface only. There is no machine-to-machine (M2M) capability, spreadsheet upload, or test environment, and access is currently limited to the authorized representative (intended to change in the future). Data must be reconfirmed annually.
Can I reuse my FDA or EU UDI data for Saudi Arabia?
Generally, yes. GS1 US codes are accepted for SAUDI-D, and a device already carrying a U.S. UDI can typically be registered as an equivalent device using the same DI. If you are compliant with FDA and EU requirements, you will likely not need different content on the label for SFDA, though there are a handful of differences and any additional requirements should be assessed on a device-by-device basis.
Does the SFDA listing number have to appear on the UDI label?
No. While the SFDA listing number is a required data element, it does not need to be printed on the UDI label.
Are 2D barcodes acceptable for Saudi Arabia UDI labeling?
Yes, a 2D barcode is acceptable. If a 2D barcode is present alongside non-concatenated linear barcodes, the human readable interpretation (HRI) must still accompany the 2D barcode even if it already appears on the linear barcode.
Plan your SAUDI-D submission with confidence. USDM's Unique Device Identification Solutions team helps medical device manufacturers interpret SFDA requirements, reconcile them against existing FDA and EU UDI data, and stand up a defensible, repeatable submission process. Contact USDM to talk through your Saudi Arabia UDI compliance plan.