FDA Medical Device Import Customs Clearance Services

Medical imports are highly regulated and often confusing — especially when it comes to FDA codes, documentation, and agency filings. Whether you’re importing OTC products, diagnostic devices, machines, surgical tools, or wellness products, we help classify your items correctly, coordinate with manufacturers for the needed compliance, and handle all FDA and APHIS filings to ensure a smooth clearance. We make sure your product meets both customs and FDA standards before it arrives — saving you from costly delays, holds, or rejections.

FDA & APHIS Filing

We handle all required electronic filings with FDA and APHIS (if your product contains animal-based ingredients like collagen or gelatin), ensuring proper clearance without delays.

FDA Compliance Code Advisement

We determine what documentation your manufacturer needs to provide based on your product type — including 510(k) approvals, device listings, and facility registrations — and guide you through what’s required to clear FDA review.

Duty & Fee Advisement

We review the expected duties, taxes, and fees based on your product type, classification, and country of origin — helping you avoid surprise costs.

FDA Product Code & Tariff Classification

We identify both your FDA product code and your customs tariff (HTS) classification, ensuring your product is correctly declared and filed with the proper regulatory agencies.

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