Customer Advisory: U.S. Compliance Update

• Important Reminder about FDA Registration and Device Listing - All device establishments are required to complete their annual registration for each device Fiscal Year between October 1 and December 31. As the U.S. Food and Drug Administration (FDA) communicates with registered medical device establishments by email, please be sure to set your spam filters to accept email from any @fda.gov, @cdrh.fda.gov, or @fda.hhs.gov email address. Bear in mind when completing product listings for facilities, that you are required to identify any that are combination products. If you are uncertain whether a product is a device or a combination product, information is available at combination product definition, or you may contact the FDA’s Office of Combination Products at combination@fda.gov for assistance.
• Agreement on Reciprocal Trade Between the U.S. and Malaysia
• Agreement on Reciprocal Trade Between the U.S. and Cambodia
• Agreement on Reciprocal Trade Between the U.S. and Thailand
• Agreement on Reciprocal Trade Between the U.S. and Vietnam
• United States Trade Representative (USTR) Announces Notice of Initiation of Sec. 301 Investigation, Hearing, and Request for Comments – China’s Implementation of Phase One
• White House Proclamation on Copper, granting two-year exemption from emissions control compliance, to help promote American mineral security by reducing regulatory burdens on domestic copper producers.
• Cargo Systems Messaging Service (CSMS) 66577014 - Enhanced ACE Portal Account Application Coming October 30 –Ensure CBP Form 5106 Information Is Up-to-Date.

STAY AHEAD — ONE FORWARDER, ONE BROKER, OVERALL COMPLIANCE 

Informational document brought to you by KWE-USA Corporate Compliance.

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