Classification, Compliance Key to Avoiding Import Delays for Medical Devices

Properly classifying imports helps ensure a smooth transaction for any product but is especially important for items that are or might be considered medical devices regulated by the Food and Drug Administration, according to Shelly Garg, an attorney with Sandler, Travis & Rosenberg’s FDA practice. Garg told an audience at the FIME medical device fair recently that investing time and resources into compliance with FDA rules is also key to getting medical devices into the U.S. market in a timely manner.

Garg pointed out that an incorrect tariff classification – e.g., using a tariff number that applies to medical devices for a product that is not a medical device – can trigger FDA review and delay importation. In addition, she said, it is particularly difficult to prove a non-medical intended use after entry if the product is declared as a medical device.

Importers should also carefully review other compliance-related issues, Garg said, including annual device manufacturing establishment registration, labeling, FDA classification (Class I, II, or III), pre-market clearance or approval (510(k) or PMA), device reporting, affirmations of compliance and/or FDA product codes, and good manufacturing practices.

FDA compliance officer Carlos Hernandez echoed this guidance. “A lot of mistakes happen with the broker and the filer,” he said. “Be certain you are giving the right information to these parties to get the product in.”

For more information on medical device imports, FDA compliance, and other requirements, please contact Shelly Garg at (305) 894-1043.

This article was originally published in the Sandler, Travis & Rosenberg Trade Report on July 30, 2018

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