US FDA Agent Representation for the Food & Drug Administration

The Food and Drug Administration (FDA) require all medical device and IVD companies without an office in the United States to appoint a registered US FDA Initial Importer. The US Importer must be a resident of the United States or maintain a legal office for business in the United States. Techlink International Consulting, LLC can serve as an official US Initial Importer for medical device and IVD companies. We do not offer US Initial Importer services to food or pharmaceutical companies.

Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

Why appoint Techlink International Consulting, LLC as your US FDA Initial Importer?

• We act as a liaison between your company and the FDA.
• We respond to questions regarding your products and can assist you and the FDA to ensure import compliance.
• Minimum yearly fee for US Initial Importer representation.