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.
If a non-medical device is in the procedure pack or kit, does it also need a UDI?
No, it does not.
Are GS1 US codes applicable for the Saudi Arabia UDI Database (Saudi-D)?
Yes, they are.
Is it necessary to confirm your data annually?
Yes, you must reconfirm your data annually.
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.
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.
Will Saudi Arabia have machine-to-machine (M2M) capabilities for data entry, or a spreadsheet upload, or both?
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.
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.
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.
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).
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
What’s the definition of a removable accessory or component?
An accessory or component that can be removed from the medical device.
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.
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.
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.
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.
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.
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.
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.
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.
What is the link to the guidance document?
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?
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.
Can UDI-DIs of non-configurable devices be only in the system software?
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.
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.
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.
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.