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Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for global health authorities and RIMS compliance platform, supports global medical device companies. LexisNexis Legal & Professional today announced,...
The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing UDI compliance News of note: • TGA has announced that they will have a similar model to the FDA, adopting some elements of the EUDAMED model• A...
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements of multiple regulatory agencies.An important component of achieving regulatory approval is a classification of the medical device, according to the...
As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device Identification (UDI), one of the first major decisions they needed to make: choose a device identifier (DI)...