White Paper: Importing Medical Devices - 5 Key Factors to Ensure Regulatory Compliance

• By: ComplianceOnline
• Date: July 08, 2014

The FDA strictly regulates the import of medical devices into the United States. It has detailed regulatory requirements for foreign medical device manufacturers that should be followed if imported devices are to be sold in the US market. Non-compliance with these rules can result in detention of products at ports of entry, unnecessary expenses involved in paperwork, queries and hearing and a loss of revenue for the importer. This white paper provides five best practices that both foreign medical device manufacturers and importers in the US can follow in order to ensure that the device import process is quick and efficient.

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