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More and more countries are adopting laws that require companies that manufacture, label or distribute medical devices to identify these with a “Unique Device Identifier” (UDI). As you may know, in addition to its many other uses, a GS1 barcode number issued by GS1 Singapore can be used as an UDI in several jurisdictions (e.g. U.S., EU).
Specifically, GS1 is accredited as an issuing agency for UDI by the U.S. FDA. In that capacity, GS1 is required by law to declare to the U.S. FDA on an annual basis which companies use GS1 barcode numbers to identify medical devices that they (or their affiliates) are putting on the U.S. market under their label.
Therefore, if your company uses GS1 barcode numbers to identify medical devices that are currently on the U.S. market for UDI purposes, we kindly ask you to fill in the “UDI DECLARATION” by 30 June 2021.
You are still required to declare if you are not using GS1 barcode numbers to identify medical devices.
If you do not report the use of GS1 barcode numbers to identify medical devices marketed in the U.S. under your label by 30 June 2021, your company will not be identified in our annual report to the U.S. FDA. GS1 disclaims any liability for any consequences (e.g. costs, administrative processes, requests from regulators) that may result thereof.
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