Customs Broker for Medical Devices

A general broker files the CBP entry and pays the duty. A device entry adds a second filing that decides whether the goods can be sold at all: the FDA PGA message set in ACE, with an FDA product code and affirmation of compliance codes on every line. The broker has to know which codes apply to which device, which suppliers sit on an FDA import alert, and which premarket number appears on the listing record, because FDA screening compares them. Duty is the other difference. Most chapter 90 lines are free at MFN, so the real cost comes from chapter 99 measures such as Section 301 on China and the forced-labor tariffs, which change by origin and HTS line. Add lithium battery rules and labeled storage conditions, and a device entry needs a broker who treats FDA data, tariff exposure, and freight handling as one job.

FDA's current ACE guide, effective March 10, 2026, lists the device codes. DEV carries the foreign manufacturer's registration number, DFE the foreign exporter's, and DDM a US manufacturer's. LST is the device listing number, PM# the premarket number (510(k), PMA, De Novo, HDE and similar), and FDA says it should match the number on the listing record. IDE covers investigational devices, DI carries the UDI device identifier, KIT flags imported kits of finished devices, and LWC covers electrode lead wires and patient cables. Radiation-emitting products add the Form FDA 2877 declarations as RA, RB, RC and RD codes. There is no code for the initial importer's own registration, and REG is a drug establishment registration code, not a device code. FDA states that declaring a code it does not list results in an entry rejection, so the mapping is done per SKU before the first shipment.

The unique device identifier now matters at the border, not only on the label. FDA's ACE guide includes a DI affirmation of compliance code that carries the device identifier portion of the UDI, and Import Alert 99-49, published June 22, 2026, allows detention without physical examination of devices that lack a UDI or a matching GUDID record. UDI labeling and GUDID submission are the labeler's duties under 21 CFR 801 and 830, not a customs task, but a gap there detains the importer's shipment all the same. FDA's quick reference guide lists DI as optional on a standard device entry (DEV, DFE and LST are mandatory), but transmitting it lets FDA match the shipment to GUDID, which is what Import Alert 99-49 screens. The same identifier appears downstream: MDR reports and corrections and removals reports both carry the UDI. We collect device identifiers with the catalog, check them against GUDID before the first entry, and flag any SKU whose label and database record disagree.

Import alerts let FDA detain goods without physical examination, and several target devices directly. Import Alert 99-34 covers drugs and devices from firms without a valid registration or listing. 89-08 covers devices without an approved PMA or IDE, or without 510(k) clearance. 89-04 targets firms that have not met device quality system requirements, and 89-16 firms that refused an FDA foreign inspection. 99-49, published June 22, 2026, covers devices without a unique device identifier or a matching GUDID record. Product-specific alerts include 80-04 for surgeon's and patient examination gloves, 89-18 for filtering facepiece respirators, 79-01 for bandages and gauze with microbiological contamination, and 76-01 for medical instruments from Pakistan. A supplier or product code on one of these lists turns every entry into a detention, so we check the lists before the purchase order ships, not after the goods land.

Every registered device establishment pays an annual fee, with no small-business discount on registration. For FY2026 (October 1, 2025 to September 30, 2026) it was $11,423. For FY2027, which starts October 1, 2026, FDA set it at $13,785 in a Federal Register notice published July 30, 2026. Registration is renewed each year between October 1 and December 31. Foreign manufacturers, foreign exporters, specification developers, and initial importers all register and pay. Foreign manufacturers and specification developers also list their devices; an initial importer meets its listing obligation by identifying the manufacturer. Registration and listing matter at the border because 21 CFR 807.40(c) bars importing a device unless it is listed and made at a registered foreign establishment, which is also what Import Alert 99-34 enforces. We confirm the status of every manufacturer in your supply base before the first entry.

USTR's four-year review, finalized September 18, 2024, raised several medical lines. Syringes under HTS 9018.31.00 and tubular metal and suture needles under 9018.32.00 went to 100% in 2024. Medical and surgical rubber gloves under 4015.12.10 went to 50% in 2025 and 100% from January 1, 2026. Surgical and non-surgical N95 respirators, other textile respirators, and textile face masks under the 6307.90.98 subheadings reached 50% in 2026. Those rates stack on top of MFN duty and on top of the separate forced-labor tariff that took effect July 24, 2026. A set of 178 legacy exclusions runs to November 10, 2026, and USTR opened a second four-year review of the China actions on May 6, 2026, so the rates can move again. We price each line by HTS and origin, and whether an exclusion covers a given device is checked against the annex, never assumed.

No. USTR's forced-labor action covers 60 economies from 12:01 a.m. ET on July 24, 2026, at 10% or 12.5% depending on the trading partner. For major device sources: the EU is 10% net of MFN, Mexico, Canada, the UK and Malaysia 10%, and China, Singapore, Israel, Costa Rica and the Dominican Republic 12.5%, while Japan, Switzerland and South Korea are 12.5% net of MFN. Commenters asked for a medical device exemption and USTR did not add one, and it declined to create an exclusion process. Three carve-outs matter: USMCA duty-free goods of Canada and Mexico are exempt, articles subject to Section 232 tariffs are exempt, and goods properly entered under chapter 98 are exempt, except 9802.00.40, .50, .60 and 9802.00.80, where the tariff applies only to the value added abroad. For a device OEM, that makes USMCA qualification and chapter 98 eligibility worth checking line by line, since the chapter 90 MFN rate is often zero.

Not yet. Commerce opened a Section 232 investigation into personal protective equipment, medical consumables, and medical equipment, including devices, on September 2, 2025. The notice named masks, N95s, gloves, gowns, syringes, needles, infusion pumps, IV bags, catheters, bandages, diagnostic reagents, wheelchairs, crutches and hospital beds. Comments closed October 17, 2025. The statute gives Commerce 270 days to report, which put the report on or about May 30, 2026, and the President 90 days after that to act. As of September 2026 no proclamation has been issued on medical products, while 232 actions have been taken on semiconductors, pharmaceuticals, critical minerals and other sectors. Whether Commerce has delivered its report is not public. If a proclamation issues, goods it covers would drop out of the forced-labor 301 tariff, so we track the docket and our Section 232 tariff consulting team models both scenarios.

HTS 9817.00.96 implements the Nairobi Protocol and is free of duty. It covers articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons, and their parts, where the person has a permanent or chronic impairment that substantially limits a major life activity. The exclusions are what trip importers up: articles for acute or transient disability, spectacles, dentures and cosmetic articles for people who are not substantially disabled, therapeutic and diagnostic articles, and medicine are all outside it. Parts of braces and artificial limb prosthetics are excluded from the parts clause. The claim matters more than it used to, because goods properly entered under chapter 98 are exempt from the forced-labor 301 tariff. We review design documents and intended use before claiming it, because a claim that CBP later rejects reopens the full chapter 99 duty.

A device with its battery installed ships as lithium ion batteries contained in equipment, UN3481, or lithium metal batteries contained in equipment, UN3091, under 49 CFR 173.185. Small consignments of batteries in equipment can qualify for relief from the lithium battery mark, and the rule has specific provisions for medical devices: up to two replacement cells or batteries for a medical device may go as cargo on a passenger aircraft with PHMSA approval when the destination has no daily cargo service, and medical-device lithium ion cells can be excepted from the state-of-charge limit under stated conditions. Airline acceptance adds its own layer, so we confirm each carrier's rules before booking. Urgent device replenishment usually moves on air freight, which is exactly where battery documentation errors cause refused tenders, so classification is fixed at booking rather than at the terminal.

FDA does not publish a transport temperature rule for devices. The requirement comes from the manufacturer's labeling and from its quality system. The Quality Management System Regulation, in effect since February 2, 2026 and incorporating ISO 13485:2016, requires manufacturers to control labeling and packaging integrity during storage, handling and distribution, and ISO 13485 clause 7.5.11 covers product preservation. OEMs pass those duties to their logistics providers through quality agreements and supplier audits, and a sterile barrier is part of that packaging integrity. We book carriers to the labeled range, protect sterile packaging from crush and moisture, and arrange warehouse and distribution storage matched to the manufacturer's labeled conditions, per shipment. If your quality agreement sets temperature logging, excursion reporting, or audit rights, those terms are built into the lane before the first shipment moves.

FDA issues a Notice of FDA Action marked Detained, which works as the notice of detention and hearing. The response is due within 10 business days, and the notice usually shows a date 20 calendar days out; FDA can extend it on a justified request. The response is evidence: a registration or listing record, a 510(k) or PMA number, corrected affirmation codes, or labeling. If the problem can be fixed, a reconditioning proposal goes in on Form FDA 766. With no response, FDA can refuse admission, and refused goods must be exported or destroyed under CBP supervision within 90 days. Because we file the FDA data and hold the supplier records, we see the notice when it posts, tell you the cause, and prepare the response from documents already in the file, which is what keeps a detention from becoming a refusal and a re-export bill.

Under 21 CFR 807.3(g), the initial importer furthers the marketing of a foreign manufacturer's device to the party who makes final delivery or sale, without repackaging or changing its labeling. Relabel or repack, and the rules treat you as a manufacturer. A US brand owner that sets specifications for a device a contract manufacturer builds abroad is a specification developer: it registers, lists, pays the fee, and falls under the QMSR. The US Agent, required under 807.40(b) for each foreign establishment, is the foreign firm's FDA contact and does not take on importer duties. Foreign manufacturers must also identify each importer and each person who offers the device for import, brokers included, in their registration. For device tracking under 21 CFR 821, brokers and warehousers are expressly not the importer. We map which role each entity in your chain holds before the first entry.

Start with the device catalog: FDA product codes, device class, the 510(k), PMA or De Novo number on each listing, the registration numbers of each foreign manufacturer and exporter, and UDI device identifiers where you have them. Then the trade data: HTS classification, country of origin, and any USMCA or chapter 98 claims you make today. For freight, we need lanes, monthly volumes, which devices contain lithium batteries and in what configuration, labeled storage temperatures, sterile items, and any OEM quality agreement terms. With that we map affirmation codes per SKU, screen suppliers against the device import alerts, model Section 301 and forced-labor exposure per line, and quote brokerage, freight and storage separately so the fixed and per-entry costs are visible. Gaps in the catalog are normal; finding them before the first entry is part of the review.