Medical devices · FDA CDRH
Importing medical devices into the United States
FDA checks every device entry against its registration, listing and premarket records. Allied CHB, a licensed customs broker, files the entry with the right FDA codes and applies the 2026 duties for devices.
Agencies
Which agencies regulate medical devices?
- FDA CDRH
Registration and listing
Each foreign site that makes a device for the U.S. market must register, list its devices and name a U.S. agent (21 CFR 807.40). Registration is renewed each year from October 1 to December 31 (21 CFR 807.22). The initial importer must also register, but it does not list devices. - FDA CDRH
Device class and premarket status
FDA places each device in Class I, II or III (21 CFR Part 860). Most Class I devices are exempt from premarket review. Most Class II devices need 510(k) clearance. Class III devices need premarket approval (PMA). Some new devices use the De Novo route. - FDA CDRH
Labels, UDI and quality system
The label and each device package must carry a unique device identifier (21 CFR 801.20). Since February 2, 2026, the device quality rule in 21 CFR Part 820 incorporates ISO 13485. - FDA CDRH
Radiation-emitting products
X-ray, laser and other radiation-emitting products must meet FDA performance standards (21 CFR Parts 1020 to 1050). The entry must carry the Form FDA 2877 declarations (21 CFR 1.77). The foreign maker must name a U.S. agent for service (21 CFR 1005.25). - FCC
Devices with a radio
A device with Bluetooth, Wi-Fi or cellular radio also needs FCC equipment authorization. Our electronics page explains the FCC import conditions. - CBP
Duty, origin and marking
CBP collects the duty, checks the country of origin and its marking, and holds goods that FDA has not released. Since July 24, 2026, most devices also pay the Section 301 forced labor duty.
HTS and duties
Which HTS chapters and duties apply in 2026?
| HTS | Goods | Base duty | Chapter 99 duties in effect (September 26, 2026) |
|---|---|---|---|
| 9018 | Medical, surgical and dental instruments: imaging, patient monitors, catheters, surgical tools | Free | Forced labor duty applies, except most U.K. goods. China: electro-diagnostic and some other lines 25 percent (List 1). Many lines have no China list duty. |
| 9018.31, 9018.32 | Syringes; tubular metal needles and suture needles | Free | China: 100 percent (9903.91.03). Forced labor duty applies. |
| 4015.12.10 | Medical and surgical gloves of rubber | Free | China: 100 percent since January 1, 2026 (9903.91.08). Forced labor duty applies. |
| 6307.90.98 | Textile face masks and respirators, including N95 | 7% | China: 50 percent since January 1, 2026 (9903.91.07). Forced labor duty applies. |
| 9019, 9021 | Therapy and breathing apparatus; orthopedic devices, implants, hearing aids, pacemakers | Free | Forced labor duty applies, except most U.K. goods. China: pacemakers (9021.50) 25 percent. Most other lines have no China list duty. |
| 9022 | X-ray, CT and other radiation apparatus and parts | Free to 1.4% | China: most lines 25 percent (List 1). Forced labor duty applies, except U.K. goods. |
| 3005, 3822 | Bandages and dressings; diagnostic test reagents | Free | Forced labor duty applies. No Section 301 China list duty on the main lines. |
Base duty is the column 1 general rate in the Harmonized Tariff Schedule. A trade agreement can lower it. The rate for your goods depends on the full 10-digit number and the country of origin.
- U.K. goods in most subheadings of 9018 to 9022 are exempt from the forced labor duty (9903.05.96). Goods of the EU and Taiwan pay a combined rate of 10 percent, and goods of Japan, South Korea and Switzerland 12.5 percent. For a device with a free base rate, that is the full extra duty.
- The 100 percent rate on syringes and needles of China has applied since September 27, 2024. The 100 percent rate on medical gloves and the 50 percent rate on masks and respirators apply since January 1, 2026. Both are in U.S. note 31 to Chapter 99.
- Articles for the handicapped entered under 9817.00.96 (Nairobi Protocol) are free of duty. When the claim is proper, Section 301 duties do not apply, because they exclude goods properly entered under Chapter 98.
Section 301 forced labor duty: 10 or 12.5 percent since July 24, 2026
USTR set an extra duty on goods of 60 economies (HTS 9903.05.20 to 9903.05.84). For example, goods of China, Hong Kong, Vietnam and Thailand pay 12.5 percent. Goods of India, Bangladesh, Indonesia and the United Kingdom pay 10 percent. Canada and Mexico pay 10 percent, except on goods that enter free under USMCA.
For the EU and Taiwan, the duty tops up the base rate to 10 percent. For Japan, South Korea and Switzerland, it tops up to 12.5 percent. Products listed in U.S. note 52 and goods properly entered under Chapter 98 do not pay it. CBP guidance, CSMS 69326983.
What else changed in 2026
IEEPA duties ended in February 2026. CBP refunds them with interest through CAPE declarations in the ACE Portal. IEEPA refunds.
The 10 percent Section 122 surcharge applied from February 24 to July 24, 2026. Section 301 duties on goods of China and Section 232 duties still apply where the actions say so. Section 301 China duties add to the forced labor duty. Goods under the Section 232 duties on metals, vehicles and parts, wood products and semiconductors do not pay the forced labor duty (9903.05.90).
Checklist
What documents do I need?
Commercial invoice and packing list
Model and catalog numbers, a plain description of what the device does, quantity, unit value, and the manufacturer's name and address.
Registration and listing numbers
The foreign manufacturer's registration number (DEV), the foreign exporter's number if different (DFE) and the device listing number (LST).
Premarket number
The 510(k), PMA, De Novo or HDE number (PM#), or the reason the device is exempt. For an investigational device, the IDE number.
FDA product code
The product code and device class from FDA's classification database. The code must match the invoice description (21 CFR 1.72).
Radiation declarations
For X-ray, laser and similar products: the Form FDA 2877 declaration and the accession number of the product report.
Power of attorney and bond
A signed customs power of attorney and a customs bond. You can sign our power of attorney online.
Holds
What causes holds?
Site not registered or device not listed
A device from an unregistered site, or one that is not listed, may not be imported (21 CFR 807.40). A site that does not renew from October 1 to December 31 is no longer active (21 CFR 807.22).No 510(k) or PMA
A device that needs premarket clearance or approval and has none is adulterated or misbranded. FDA can refuse it.Wrong product code or missing codes
A product code that does not match the description, or a missing DEV, LST or PM# code, delays the FDA review of the line.FDA import alert
Devices of a firm on an import alert are detained without physical examination until the importer shows compliance.Radiation data missing
A product under an FDA performance standard needs the Form FDA 2877 data in the entry (21 CFR 1.77). Without a compliance label, it is refused (21 CFR 1005.3).Refused goods
Refused devices must be exported or destroyed under CBP supervision. FDA can destroy a refused device valued at $2,500 or less (21 CFR 1.94).
Process
How do we clear it?
- YouBefore shipping
Send the device list
Send the invoice, the model list, and the registration, listing and premarket numbers for each device.
- Allied
Check FDA records and classify
We check the registration, listing and 510(k) or PMA in FDA's databases. We assign the HTS number and the Chapter 99 numbers for the origin.
- AlliedBefore arrival
File the entry with FDA data
We file the entry in ACE with the FDA product code and the DEV, DFE, LST and PM# codes. For radiation products we add the Form FDA 2877 data.
- AlliedOn arrival
Follow the FDA review
Most lines get a May Proceed. If FDA holds a line or asks for an exam, we tell you what FDA needs.
- You
Send records on request
If FDA asks for labels, test data or a 510(k) letter, send it to us. We submit it and follow the line until release.
- AlliedAfter release
Entry summary and duty
We file the entry summary, pay the duty by ACH and file corrections or protests when needed.
Request: Medical device import clearance
Quote on request
Questions
Importing medical devices: common questions
Does the importer need to register with FDA?
Yes, if you are the initial importer of a device. The initial importer registers but does not list devices. The foreign manufacturer registers, lists each device and names a U.S. agent (21 CFR 807.40).
Which FDA codes go in a device entry?
The main affirmation of compliance codes are DEV (foreign manufacturer registration), DFE (foreign exporter), DDM (domestic manufacturer), LST (device listing) and PM# (premarket number). The entry also carries the FDA product code and the intended use code.
Can I import a device before the 510(k) is cleared?
Not for sale. A device that needs a 510(k) cannot be marketed before clearance. Devices for a clinical study can enter under an investigational device exemption, with the IDE number in the entry.
Can a person import a device for personal use?
FDA's personal importation policy can allow up to a 90-day supply of a device for personal use, not for sale. It is enforcement discretion, and FDA decides case by case.
Do medical devices pay the Section 301 forced labor duty?
Most do. The Section 301 forced labor duty applies to goods of 60 listed economies. Goods of China, Vietnam and Thailand pay 12.5 percent, and goods of India and Mexico 10 percent (USMCA goods are exempt). U.K. devices in most subheadings of 9018 to 9022 are exempt.
What is a UDI and does it matter at the border?
A unique device identifier is a code on the device label and package (21 CFR 801.20). FDA can treat a device without a required UDI as misbranded, which can lead to a hold or refusal.
Importing medical devices? Send us the device list.
Call (908) 291-8001 or email info@alliedchb.com
Last reviewed September 26, 2026. This page explains customs rules in general terms. It is not legal advice. Duty rates and CBP procedures change often, and we confirm the figures for your shipment in writing before you commit.