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Home » Efforts to Map Global UDI System Benefit From FDA First Steps

Efforts to Map Global UDI System Benefit From FDA First Steps

December 28, 2012

Efforts to develop a roadmap for an international unique device identifier system will draw heavily on the FDA’s emerging UDI system, members of a group working on the blueprint say.

“The whole point of this work item is to design a global unique UDI system that could be the basis for full international harmonization,” Laurent Selles, deputy head of the medical devices unit of the European Commission’s Directorate-General Health and Consumers, said.

He is part of an 18-member International Medical Device Regulators Forum working group that met in Washington, D.C., in early December to discuss the roadmap.

International compliance is no longer simply a matter of following the same old rules.  Enforcement activities and practices are changing. Countries are beginning to share data about manufacturing companies, increase the number of inspections, and crack down on issues such as counterfeiting and improper marketing. You learn the new rules of the game, or cede the playing field to competitors.

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  • Essential international regulatory changes from all of 2012; and
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