HS code by category
HS code for medical devices: HTS 9018, 9021 and 9022 codes and duty
Most medical devices classify in Chapter 90 and enter the US duty-free, but the code depends entirely on what the device does, and some items you would call medical are not in Chapter 90 at all. Describe your device on the right and the AI returns the HS/HTS code with its reasoning.
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FORM TW-01
The short answer
There is no single HS code for medical devices, because the term covers dozens of tariff lines. Diagnostic and surgical instruments sit in heading 9018, mechano-therapy and massage apparatus in 9019, orthopedic and prosthetic appliances, hearing aids and pacemakers in 9021, and X-ray and radiation apparatus in 9022. Clinical thermometers land in 9025. Nearly every one of these lines carries a US Column 1 base rate of Free, which is why medical imports are usually duty-free at the base. The traps are the items that are not in Chapter 90 at all: surgical gloves are rubber articles in heading 4015, medicaments are Chapter 30, hospital furniture is 9402, and a consumer smartwatch is a data device in 8517. Classification is done device by device, not by a blanket medical-device label.
Anatomy of a code: a disposable syringe
9018.31
- 90
- Chapter: optical, measuring, checking, precision, medical and surgical instruments and apparatus.
- 9018
- Heading: instruments and appliances used in medical, surgical, dental or veterinary sciences, and parts thereof.
- 9018.31
- Subheading: syringes, with or without needles. This international six-digit level is the same worldwide.
- .00.40
- US digits: the Harmonized Tariff Schedule sets the rate at the eight-digit line (9018.31.00, Free); the last two digits (.40 hypodermic) are for statistics only.
Where common medical devices classify
A starting map, not a ruling. Base rates below are US Column 1 (MFN) rates and are Free unless noted. A Free base rate does not mean zero total duty: a country-specific trade action can still stack on top by origin, so confirm the code with the classifier above and check the origin layer before you file.
9018.31 / .32
Syringes and needles
Disposable syringes 9018.31, tubular needles 9018.32. Free base rate.
9018.39
Catheters and cannulae
Catheters, cannulae and the like. Free base rate.
9018.11
ECG and electro-diagnostic
Electrocardiographs and other electro-diagnostic apparatus. Free base rate.
9018.12 / .13
Ultrasound and MRI
Ultrasonic scanning 9018.12, magnetic resonance imaging 9018.13. Free base rate.
9018.41 / .49
Dental instruments
Dental drill engines, burs and hand instruments. Free base rate.
9021
Orthopedic and prosthetic
Splints, artificial joints and body parts, and appliances worn to compensate for a disability. Free base rate.
9021.40 / .50
Hearing aids and pacemakers
Complete hearing aids 9021.40, cardiac pacemakers 9021.50. Free base rate.
9022
X-ray and radiation apparatus
Radiography and radiotherapy apparatus. Apparatus Free; a few 9022.90 parts lines carry under 2%.
4015.11
Surgical gloves (NOT Ch. 90)
Vulcanized-rubber surgical and exam gloves are Chapter 40 rubber articles, not medical instruments.
How to find the HS code for a medical device
Start with what the device does, not what it treats. A diagnostic or surgical instrument is heading 9018. If it is an orthopedic or prosthetic appliance, a hearing aid or an implanted device that compensates for a disability, it is 9021. If it uses X-rays or ionizing radiation, it is 9022. Mechano-therapy and massage apparatus are 9019, and a clinical thermometer is 9025. Inside each heading the subheading names the specific instrument, and the US then adds digits to reach the ten-digit code. Because the base rate is almost always Free, the classification effort is mostly about landing in the right heading and documenting it defensibly, not chasing a rate. For the general method that works on any product, see the Harmonized System code guide.
Why most medical devices are duty-free, and when they are not
The US has long kept diagnostic and therapeutic medical instruments at a Free Column 1 rate, so the base duty on most 9018, 9021 and 9022 apparatus is zero. Two things break that. First, a handful of parts and accessory lines carry a small positive rate even when the finished apparatus is Free, for example certain X-ray parts under 9022.90 at under two percent, so classifying a component is not the same as classifying the machine. Second, a Free base rate is only the base. A trade action tied to country of origin, such as a Section 301 tariff on Chinese-origin goods or a current reciprocal duty, can stack on top through a Chapter 99 special line and has its own effective and expiry dates. Check the origin layer for the week you actually file, then run the numbers in the import duty calculator.
The FDA layer, and the classification traps that catch importers
Tariff classification and FDA regulation are two separate systems that both apply at entry. The HS code sets the duty; FDA clearance sets whether the device may legally enter at all. Most devices need premarket clearance (a 510(k), De Novo or PMA) and the manufacturer and device must be FDA registered and listed, with the listing and submission numbers declared on the entry. A device can sit on a duty-free HTS line and still be held for missing FDA data, so the two must line up. The recurring classification traps are worth memorizing: surgical and exam gloves are Chapter 40 rubber articles in 4015, not 9018; a drug-device combination product can pull toward Chapter 30 depending on which function dominates; hospital beds and exam tables are furniture in 9402; and a consumer smartwatch or fitness tracker is generally a data-transmission device in 8517, because CBP has found the communication function to carry the essential character. When two headings genuinely compete, that is binding-ruling territory, covered in how to request a CBP binding ruling.
Medical device HS code questions, answered
What is the HS code for medical devices?
There is no single code. Medical device spans dozens of HTS lines. Most diagnostic and surgical instruments fall under heading 9018, orthopedic and prosthetic items under 9021, and X-ray equipment under 9022. The correct code depends on the specific device and its function, so classification is done item by item rather than by a generic medical-device label.
Are medical devices duty-free when imported into the US?
Most are. The US Column 1 base rate for the large majority of 9018, 9021 and 9022 apparatus lines is Free. But a few parts and accessory sub-lines carry small positive rates, and a country-specific action such as a Section 301 or reciprocal tariff can add duty on top by origin. So Free refers to the base HTS rate, not always the total you pay.
What HS code do surgical gloves use?
Surgical and medical gloves classify in Chapter 40, the rubber-articles chapter, under heading 4015, not in Chapter 90 with medical instruments. Vulcanized-rubber surgical gloves fall at 4015.11, with exam and nitrile gloves nearby in 4015.12 and 4015.19. This trips up importers who search for a medical-device code and expect to land in 9018.
Do medical devices need FDA approval to be imported into the US?
Generally yes. Most devices need FDA premarket clearance, a 510(k), De Novo or PMA, unless exempt, and the manufacturer and device must be FDA registered and listed. This is separate from tariff classification. A device can have a duty-free HTS code and still be refused entry without the proper FDA clearance and listing numbers on the filing.
What is the Nairobi Protocol duty exemption?
Subheading 9817.00.96 gives duty-free treatment to articles specially designed or adapted for blind or physically or mentally handicapped persons, implementing the 1976 Nairobi Protocol. It requires a significant, purpose-built adaptation, not incidental usability by a disabled person, and is layered on top of, not a replacement for, the item regular HTS classification.
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Related: HS code lookup by product, HS code for machinery.