One UDI per country?

Watchcat

Watchcat

Trusted Information Resource
Can someone confirm whether a different UDI is needed for each country that requires a UDI?
 
B

Billy Milly

Involved In Discussions
In general, this depends on the labelling standards. If you are using GS1, see their standards for UDI labelling GS1 Healthcare GTIN Allocation Rules Standard | GS1 . I am not familiar with HIBBC standards.
Need for new UDIs is determined by those - for example, if you, per GS1, label the same product with two languages (different labels for same device), you need two UDIs, if you combine them you need one. If you add an additional trade name, you need new UDI, etc.
There may be specific national requirements for the product driving a need for new UDI, as described above (different language, different user profile, different materials, diferent indications...).
This info is based on my current knowledge.
 
Watchcat

Watchcat

Trusted Information Resource
My question is whether all jurisdictions that recognize HIBCC will accept the same product code.
 
L

LUFAN

Quite Involved in Discussions
On the device or secondary/shipping packaging level, they can be shared between FDA/EU. Just make sure you create your Basic UDI-DI for Europe in a way that make sense for the product family. I can't speak to specific countries outside of US/EU.
 
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