HS Code for Disposable Syringes
The HS Code for disposable syringes is 901831. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 901831 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9018 |
| Last Updated | 2026-05 |
Description
Syringes, with or without needles
HS Code 901831 covers disposable syringes, with or without needles, which are imported duty-free into the United States.
Frequently Asked Questions
What additional duties or fees should I expect when importing disposable syringes under HTS 901831?
Beyond the general 0% Most Favored Nation (MFN) duty rate, you must pay the Medical Device Excise Tax of 2.3% on the manufacturer's sales price in the United States. You may also be liable for Merchandise Processing Fees (MPF) and Harbor Maintenance Fees (HMF) upon entry, which add a fixed cost per shipment.
What specific FDA pre-market approval is required for importing disposable syringes under HTS 901831 into the United States?
For commercial import, disposable syringes generally require a 510(k) pre-market notification cleared by the FDA, as they are Class II medical devices. You must provide the FDA's 510(k) clearance number to U.S. Customs and Border Protection (CBP) at entry. Note that syringes intended for specific uses, like those with safety-engineered sharps injury protection features, have unique classification and regulatory controls.
What are the critical packaging requirements for shipping disposable syringes (HTS 901831) internationally?
Disposable syringes must be packed in sterile, sealed inner packaging (e.g., blister packs or tamper-evident bags) to maintain sterility, and outer cartons must be clearly marked 'Medical Devices' and 'Fragile'. For air transport, packaging must comply with IATA Packing Instruction 650 to prevent damage and leakage, and shipments containing needles often require specific 'Sharps' labeling.
Seasonal Import Trends for Disposable Syringes
Import volumes for disposable syringes (HTS 901831) typically show a moderate seasonal pattern, with a consistent baseline demand due to ongoing medical needs. The most pronounced peak occurs in Q4, often a 15-20% increase over average quarterly volumes, driven by healthcare system budget cycles, flu season preparedness, and year-end inventory stocking. A secondary, smaller uptick is sometimes observed in late Q2/Q3 as manufacturers build inventory ahead of the peak season. Analysis of U.S. import data from 2020-2023 shows this Q4 peak is a reliable annual trend.
Compliance Notes for Disposable Syringes
Disposable syringes (9018.31) are strictly regulated medical devices. In the United States, they must comply with FDA pre-market notification (510(k)) or pre-market approval (PMA) requirements, and be listed with the FDA. For the EU market, they require CE marking under the Medical Device Regulation (MDR) 2017/745, typically as a Class I, IIa, or IIb device. Importers must maintain clear documentation, including the Unique Device Identification (UDI), to prove regulatory clearance for customs entry. Syringes intended for use with controlled substances may face additional DEA and state-level regulations.
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