Billions of dollars worth of medical equipment cross international borders every year to support hospitals, clinics, and labs. In 2025, the United States medical device market reached nearly $191 billion, and continues to grow.
Surprisingly, though, a number of medical device shipments are stalled at U.S. ports -- and they aren't for reasons that you would think, like product quality or safety. Most cases are because of paperwork.
Shipping medical equipment is more than just managing freight schedules. You deal with Food & Drug Administration (FDA) regulations, customs enforcement, and often temperature controls all at the same time. If there is even one incorrect product code or labeling error, clearance slows down and usually comes to a halt.
Before a medical device shipment gets the "all clear," it's run through the FDA's PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) screening system. Each entry receives a risk score based on product type, manufacturer history, country of origin, and whether the data filed at entry matches agency records. Less than 2% of shipments face a physical inspection. But when delays happen, they're usually tied to compliance paperwork rather than the product itself.
That's where many importers miscalculate. The FDA's requirements are very specific for medical devices, and they aren't processed like general commercial freight. Save yourself from experiencing any mishaps by avoiding some of the most common documentation inconsistencies that tend to surface quickly.
No Class, No Pass
Everything begins with product classification.
Importers are responsible for confirming a medical device's FDA Product Classification and making sure it's accurately shared with their customs broker. Classification determines a device's regulatory pathway. It affects premarket requirements, documentation filing, and how closely the shipment may be reviewed at the port.
The FDA organizes medical devices into three risk-based categories:
- Class I (Lowest Risk): Items such as bandages, tongue depressors, and examination gloves. Most Class I devices are 510(k)-exempt, but manufacturers must still register and list the device.
- Class II (Moderate Risk): Items such as blood pressure monitors, infusion pumps, and surgical drapes. Most Class II devices require 510(k) clearance, proving the device is substantially equivalent to an existing, legally marketed device.
- Class III (Highest Risk): Items such as heart valves, cochlear implants, and defibrillators. Most Class III devices require full Premarket Approval (PMA) supported by clinical data, although some novel medical devices may qualify for the De Novo review pathway.
Mislabeling a product code is one of the most common reasons delays occur at ports. Prevent this from happening to you -- check and then double-check your product code before shipping.
Confirming Registration and Premarket Approval
Facilities that are involved in producing or distributing medical devices for use in the U.S. must register annually with the FDA. If you are an importer, you need to make sure your foreign supplier's registration is current -- and that your own registration is up to date.
Foreign manufacturers must register their facilities with the FDA, and each device must be formally listed. If the FDA can't verify a manufacturer's registration when a shipment arrives, it may very well be refused. At that point, the burden quickly shifts to you, the importer.
Initial Importers -- the first U.S. entity to commercially market a device -- have additional responsibilities. These include registering through FURLS (FDA Unified Registration and Listing System), and managing Medical Device Reporting requirements, which includes adverse event reporting and complaint file maintenance. For certain tracked products, distribution monitoring requirements under 21 CFR Part 821 also apply.
When your customs broker files an entry, the FDA cross-references the declared manufacturer and importer against its database. Something as simple as a listing error or inactive registration can delay release.
Your customs broker also needs the device's premarket authorization number at entry. Refer to the section above as a guide. For Class II devices, that means a 510(k) clearance number. Class III devices require a PMA approval number, and De Novo devices require a DEN number. These are submitted as AofC codes through CBP's Automated Commercial Environment (ACE) system: DEV for establishment registration, LST for device listing, and PM# for premarket authorization. You can verify submissions through the 510(k) database or PMA database.
When these details are accurate, entries tend to move as expected. But when they are not, a manual review or even a detention is likely.
Import-ant Info the FDA Reviews
Most inspections start long before your shipment even hits the port. The FDA's electronic screening verifies registration, device listing, premarket authorization status, and labeling compliance under 21 CFR Part 801, and quality system compliance, particularly the new Quality Management System Regulation (QMSR) rules effective February 2, 2026 (Note: This aligns U.S. requirements with the international ISO 13485 standard).
If a manufacturer, shipper, or product has past violations, the FDA can automatically detain future shipments under Detention Without Physical Examination (DWPE). A recent example is Import Alert 89-04 from June 2025, which blocks imports of specific medical devices from Japan manufactured by Olympus Medical Systems Corporation (Olympus) and its subsidiaries, for failure to meet quality system regulation requirements.
Scanning the Import Alert database before shipping can prevent avoidable surprises.
Once a shipment is detained, you generally have ten business days to sort things out. Otherwise, the FDA can formally refuse the shipment, and you'll have 90 days to export or destroy it. CBP may also impose penalties that can reach up to three times the declared value. If one of your containers is worth $10,000, that's not only a financial loss in sales but a $40,000 loss on top of it.
Exporting to Europe
If you're exporting medical equipment to Europe, the EU Medical Device Regulation (MDR 2017/745) applies as well as securing CE marking. This usually includes a conformity assessment, and achieving it typically involves a Notified Body audit of both your quality systems and technical documentation.
Europe sorts devices into four classes -- Class I, IIa, IIb, III. It's conceptually similar to the FDA's, but the criteria is different. FDA clearance doesn't satisfy EU requirements, and vice versa.
Three things to keep in mind:
- EUDAMED (European Database on Medical Devices) device registration and unique device identification (UDI) compliance will become mandatory on May 28, 2026.
- Legacy MDD-certified devices face staggered MDR deadlines through 2027-2028.
- Notified Bodies are currently reporting review timelines of 13 to 18 months, so delays are real.
On a positive note, the United Kingdom's MHRA (Medicines and Healthcare products Regulatory Agency) plans to indefinitely recognize CE-marked devices in Great Britain, which could help simplify access for U.S. exporters with CE marking.
Cold Chain Considerations
Are you shipping temperature controlled devices like diagnostic reagents, biologics-adjacent devices, or calibration-sensitive electronics? Some devices, like these, require temperature-controlled shipping. The manufacturer's labeling dictates acceptable conditions.
Refrigerated products typically move between 35.6 °F to 46.4 °F (2 °C to 8 °C), while others require frozen conditions at minus 4 °F (minus 20°C) or colder. Even a brief degree of deviation during a port transfer or warehouse hold can compromise a product's integrity and create regulatory liability.
Another thing to keep in mind for refrigerated products is packaging. Packaging must be validated for the specific route and transit duration. A solution that works for a three-day air transit from Germany will not hold up for a 30-day ocean sailing from Southeast Asia. Careful consideration needs to be given.
Temperature data loggers should accompany every cold chain shipment to document compliance. The most vulnerable moments are always the handoff points: truck to warehouse, warehouse to vessel, vessel to port. Each transfer is a potential temperature excursion.
Make sure the logistics provider you hire has protocols in place to minimize exposure time at each handoff, so that you have added peace of mind.
Importing from China
If you're importing medical devices from China, Section 301 tariffs are likely part of the equation. Depending on the product, that can mean up to 25 percent on top of standard import duties.
Some importers have secured exclusions through the Office of the U.S. Trade Representative, but decisions are evaluated case by case based on whether comparable sourcing options exist and what economic consequences the tariff may create domestically.
Additionally, there is the Harmonized Tariff Schedule (HTS) code to consider. An incorrect HTS code doesn't just create duty exposure, it can greatly increase your chances of an inspection from CBP.
For medical devices, there is a fine line between classifications -- for example, a specialized diagnostic instrument versus a general electronic component. The duty rates can differ significantly. Prepare yourself ahead of time by verifying the USITC Harmonized Tariff Schedule.
Your Guided Tour Through Customs
Codes, regulations, classifications -- it all matters. You want a customs broker who handles these types of products regularly because they'll be familiar with all the fine print:
- Reviews publicly available registration and device listing records prior to shipment.
- Reviews premarket authorization numbers as filed.
- Files accurate AofC codes and HTS classifications in ACE.
- Responds promptly if the FDA's Office of Import Operations issues a request or detention.
Ready to Move? We're Ready to Help.
Importers whose medical devices generally move smoothly at the port treat compliance paperwork as an important step and build documentation practices that can withstand inspection. The cost of getting it right is always less than a detained shipment, a missed delivery window and an unhappy customer.
When importing or exporting medical equipment, you want to know your compliance paperwork is in order. You can trust Zarach Logistics to handle the regulatory details so your devices clear customs and get where they need to go.
Key Resources
- FDA: Importing Medical Devices: Classification, registration, and import requirements
- FDA Product Classification Database: Device class and product code lookup
- FDA PREDICT / Entry Screening: How automated import screening works
- FDA Registration and Listing (FURLS): Registration system for manufacturers and importers
- FDA 510(k) Database: Search cleared 510(k) submissions
- FDA PMA Database: Search approved PMA devices
- FDA Import Alert Database: Check manufacturer/product import alert status
- FDA QMSR Regulation: New QMS requirements effective February 2, 2026
- 21 CFR Part 801: Labeling: FDA labeling standards for medical devices
- CBP ACE Portal: Electronic system for filing import entries
- USITC Harmonized Tariff Schedule: HTS code lookup for tariff classification
- EU MDR 2017/745: Full text of the EU Medical Device Regulation
- EUDAMED: EU device database, mandatory May 28, 2026
- UK MHRA Device Regulation: UK regulation and CE recognition guidance