FDA Reminds Manufacturers and Importers of Medical Device Import Requirements

Posted by Kelsay Calvaruso on 5/25/23 5:00 PM

On May 22, 2023, in Cargo Systems Messaging Service (CSMS) #56355955, U.S. Food and Drug Administration (FDA) issued a reminder to manufacturers and importers of medical devices that Unique Device Identification (UDI) requirements apply to “most medical devices offered for import into the United States.” The UDI Rule was established in 2013 and requires device labelers to include a UDI on labels and packages and to submit device information to the Global Unique Device Identification Database (GUDID). FDA has a variety of resources to support compliance including documentation on obtaining a UDI, FAQs, and compliance policies.

Details can be found in the CSMS here:


Topics: Import, FDA

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