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Yes. Most medical devices can be imported into the U.S. as long as the shipment complies with FDA and CBP regulations. Your medical device shipment can typically be imported if the device classification is determined, the establishment is registered with the FDA, and the devices are properly listed. Furthermore, the shipment must include proper customs documentation, such as 510(k) or PMA numbers where applicable, and all duties and taxes must be paid. Medical devices commonly imported into the U.S. include ventilators, bandages, face masks, wheelchairs, stethoscopes, and hospital beds. These items may be imported for personal use, retail resale, or commercial distribution. Before importing, it is highly recommended to confirm tariff classification and marketing authorization requirements. BorderBuddy can review your documentation and classification before your shipment arrives to help prevent border delays or refusals. Need help confirming import requirements? Request a customs compliance review before shipping your medical devices.
Importing medical devices into the U.S. is a seamless process when you partner with the experts at BorderBuddy. Our comprehensive guide walks you through every essential step, from determining the correct FDA classification (Class I, II, or III) to ensuring full compliance with CBP regulations. We handle the complexities of customs documentation, including establishment registration, device listing (LST), and premarket requirements like 510(k) or PMA numbers. Whether you are transporting individual diagnostic tools or bulk surgical supplies, our professional customs brokers provide the reliable oversight needed to manage Affirmations of Compliance and prevent costly delays. Trust BorderBuddy to ensure your medical devices arrive at their U.S. destination safely, on time, and in full accordance with all federal safety standards.
Prepare import documentation
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Navigating the U.S. customs clearance process for medical devices typically takes anywhere from a few hours to several days, though complex entries can take longer. Because medical devices are regulated by the FDA, timelines depend heavily on the accuracy of your Premarket Notification 510(k) or Premarket Approval (PMA) data, establishment registration, and medical device listings. While air freight often clears faster than ocean freight, delays frequently stem from intensive examinations or requests for information regarding labeling and country-of-origin marking. At BorderBuddy, we help streamline this process by ensuring your HTS codes and Affirmations of Compliance are correctly filed in the ACE system, reducing the risk of FDA holds and helping your life-saving technology reach the market without unnecessary wait times.
Navigating the complex regulations of the FDA and CBP is essential for a smooth supply chain, but many businesses stumble on common mistakes when importing medical devices. The most frequent errors include mislabeling product codes, failing to provide accurate device listing numbers (LST), and using incorrect Affirmation of Compliance (AofC) codes. Additionally, many importers face delays because they haven't verified that their foreign manufacturer’s registration is current or have failed to designate a proper U.S. Initial Importer. At BorderBuddy, we help you avoid these costly pitfalls—such as incorrect Harmonized Tariff Schedule (HTS) classifications and incomplete country of origin markings—ensuring your life-saving equipment clears customs without unnecessary detentions or fines.
Ready to import medical devices to the USA? Let BorderBuddy handle the complex FDA registrations and customs entries for you. Request a quote today at service@borderbuddy.com or call us at +1 (877) 409-8163.
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What are the FDA requirements for importing medical devices to the USA?To import medical devices, you must ensure the foreign manufacturer is registered with the FDA, the specific device is listed, and you have obtained the necessary premarket clearance, such as a 510(k) or Premarket Approval (PMA), unless the device is exempt.Do I need a U.S. Agent to import medical devices from abroad?Yes, all foreign medical device establishments must designate a U.S. Agent who resides or maintains a place of business in the United States to serve as a primary point of contact for the FDA.What is an Affirmation of Compliance (AofC) code?AofC codes are mandatory qualifiers used during the customs entry process to provide the FDA with specific information, such as the manufacturer's registration number (DEV), the device listing number (LST), or the premarket submission number (PM\#).Do I need a customs broker to import medical devices?While not legally required, working with a licensed customs broker is highly recommended due to the complexity of FDA regulations; we ensure your documentation is accurate, help navigate electronic filing through the ACE system, and minimize the risk of costly shipment detentions.How long does the FDA import review process take?The timeline varies, but providing complete and accurate data at the time of entry can expedite the process; however, if the FDA decides to physically examine a shipment or collect samples, it can lead to delays of several days or longer.What labeling is required for imported medical devices?Devices must be labeled in English and include the manufacturer's name and address, intended use, adequate directions for use, necessary warnings, and a Unique Device Identifier (UDI) where applicable.Are there registration fees for medical device importers?Yes, the FDA requires most establishments involved in the production and distribution of medical devices, including initial importers and foreign manufacturers, to pay an annual establishment registration fee.
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