Knowledge Center

Resource Library

Working guides on entering the U.S. market and running operations once you are there. Each one stands alone, so you can start wherever your situation sits today.

3 of 13 guides

FDA & Compliance

First-Time FDA Import of Medical Devices, Step by Step

Registration, product codes, U.S. Agent designation, labeling and entry review all have to line up before the shipment lands. This is the order they happen in.

11 min readRead guide

FDA & Compliance

When FDA Holds Your Entry: Common Causes and How to Respond

Most holds trace to registration, product code or labeling mismatches. The response window is short, and what you file next decides the outcome.

7 min readRead guide

FDA & Compliance

UDI and 21 CFR Part 801 Labeling for Imported Devices

Part 801 content, a compliant UDI, a GUDID record and a controlled relabeling process all have to align before a device can be distributed.

9 min readRead guide

Need a short answer instead?

The FAQ covers entity, agent, import, warehousing and support questions in a few lines each.