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Regulatory Focus™ > News Articles > Regulatory Process Enhancements Can Reduce Risk for Device Manufacturers Using Local Agents

Regulatory Process Enhancements Can Reduce Risk for Device Manufacturers Using Local Agents

Posted 01 April 2011

US-based manufacturers working with local agents to register medical devices outside the US (OUS) are at risk of legal action if they do not have a method to verify that the documentation submitted by the agent accurately represents the product that the manufacturer intends to sell in the given market.

 

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