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%.
4015.12.10
Surgical gloves (NOT Ch. 90)
Medical and surgical rubber gloves are Chapter 40 rubber articles, not medical instruments. Free base rate.
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.
Where medical device classifications go wrong in 2026
Beyond the chapter boundaries above, coatings and the relationship between a part and its machine need a closer look. A drug-coated dressing cannot simply inherit the code for a plain dressing; the coating can move it to 3005.10 or 3005.90.10. For parts and accessories, check Note 2 to Chapter 90 before choosing a generic parts line, including whether the item is suitable for use solely or principally with a particular machine. Under 19 USC 1484, the importer of record owes reasonable care whoever supplied the code, so retain the reasoning for each SKU.
Is a Free general rate the same as duty-free?
No. The practical risk in 2026 is reusing a catalog rate after a Chapter 99 change. For Chinese-origin syringes on 9018.31.00 and medical gloves on 4015.12.10, the 100 percent Section 301 rate plus the 12.5 percent layer under 9903.05.31 produces 112.5 percent where that layer applies. Textile face masks on 6307.90.98 reach 69.5 percent from a 7 percent base, 50 percent Section 301 and the same 12.5 percent layer. That layer has applied since July 24, 2026, subject to its exemption annex. The enteral syringe carve-out for 9018.31.0080 expired at the end of 2025. Check the exact line, origin, exemption and entry date before carrying an old rate forward.
Do medical devices need FDA clearance as well as an HTS code?
Yes, unless the device is exempt from premarket requirements. Keep the HTS classification, FDA product code, establishment registration, device listing and applicable submission data together in the SKU record. The receiving team also needs to know which documents to supply if FDA holds a shipment. Classification software does not run FDA submissions, so confirm that responsibility when choosing a tool.
Medical device classification software compared
Compare the code, reasoning and origin-based duty each tool returns for your own medical catalog. Vendor prices below follow the published pricing in the comparison; the broker range is a typical per-product review cost.
| Tool | Published pricing | Best for | Watch out for |
|---|---|---|---|
| TariffWise | $59, $199 or $499 a month for 100, 1,000 or 10,000 classifications | US importers who want the 10-digit code, written reasoning and 2026 duty by origin together, in bulk | US import focus; it does not file the entry or run FDA prior submissions |
| Descartes CustomsInfo | Quote only | Enterprises that need tariff content for many countries and ERP feeds | Sales-led contract for a team that may only need US codes |
| ONESOURCE Global Trade | Quote only | Large trade departments buying screening, export and FTA modules together | Suite pricing for what is often a lookup job |
| Avalara Tariff Code Classification | No published pricing | Teams already buying Avalara tax and cross-border products | Automated, self-serve and managed tiers are all quoted, not priced |
| Gaia Dynamics | From $99 a month, billed yearly in credits | Teams that want CROSS ruling citations alongside codes | Yearly prepayment; credits per classification are not published |
| SimplyDuty | GBP 0.10 per classification call, prepaid packs | Occasional single lookups | Prepaid packs priced in pounds, with duty calls billed separately |
| Licensed customs broker | Commonly $50 to $200 per new product review | The entry itself and genuinely contested lines | Cost scales with every SKU and every re-check |
A four-step test before you pick a tool
Use ten of your own SKUs across gloves, a syringe, a mask, a monitor, an orthopedic brace, a hospital bed, a dressing, a spare part and an accessory. Run the same sample through each tool, including the classifier above, then check each result against these four requirements.
1. Confirm that the result includes the full 10-digit HTSUS code.
2. Check that it catches chapter changes, including gloves in Chapter 40, beds in Chapter 94 and masks in Chapter 63.
3. Check that it shows the applicable Chapter 99 lines for Chinese-origin goods.
4. Make sure it records why the code fits, so you can keep the reasoning with the SKU.
For a broader shortlist, see the best HS code classification software comparison. If you mainly use an enterprise suite for US code lookups, the Descartes CustomsInfo alternative guide explains which modules a smaller tool can replace.
What classifying a medical device catalog costs a distributor
Medical distributors carry thousands of consumable and instrument lines, and most sit at a Free base rate, so the work is proving the code rather than paying the duty. The origin layer on Chinese-made goods, the parts lines with small positive rates and the FDA product code that has to match the entry all depend on getting the HTS right per SKU. Broker bands below are documented per-product review rates; TariffWise figures are the published plans.
| Catalog | Broker review per product | TariffWise |
|---|---|---|
| 80 instrument lines for one 510(k) family | $4,000 to $16,000 at $50 to $200 each | $59 for one month of Starter, 100 classifications |
| 900 consumables, gloves, drapes and parts | $45,000 to $180,000 | $199 for one month of Growth, 1,000 classifications with bulk CSV |
| A 7,000-line distributor catalog | Not realistic per product | $499 for one month of Business, 10,000 classifications |
What a regulatory team actually needs from the file is the rationale per line: why a glove is 4015 and not 6116, why an accessory follows the apparatus under Note 2 to Chapter 90, why a diagnostic kit is 3822 rather than 9027. Saved reasoning is what turns a catalog classification into evidence of reasonable care during a CBP focused assessment, and the tools that produce it are compared in the medical device classification software comparison above. Distributors already licensing an enterprise trade content suite for this one job can compare the module-by-module case on the Descartes CustomsInfo alternative page; teams that want codes flowing into the item master automatically should start with the HS code API. Per-classification cost on each route is on the classification cost for importers page.
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 rubber gloves classify under US line 4015.12.10 in Chapter 40, not in Chapter 90 with medical instruments. The general rate is Free, but origin-based duties can still apply. This trips up importers who search for a medical-device code and expect to land in 9018.
What is the HS code for nitrile gloves?
Nitrile exam and surgical gloves fall under heading 4015, with US medical and surgical gloves on 4015.12.10 at a Free general rate. For Chinese-origin gloves, Section 301 has been 100 percent since January 1, 2026. Adding the 12.5 percent 2026 layer produces 112.5 percent where that layer applies, so verify the exemption annex and entry date.
Are medical devices exempt from tariffs?
No blanket tariff exemption applies to medical devices. A Free general rate does not remove Chapter 99 duties. Chinese-origin syringes and medical gloves can carry 100 percent Section 301 duty, while textile face masks can carry 50 percent, before the 2026 layer. Check the exact tariff line against the exemption annex rather than treating a medical label as an exemption.
Can classification software replace a customs broker for medical imports?
Classification software can replace per-product classification work, but it does not replace the customs broker. It gives your team a first pass with written reasoning for each SKU, while the broker files the entry and reviews contested lines. Using both lets the broker's time focus on difficult classifications instead of routine catalog lookups.
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.
Classify your device now, keep the rationale for your entry file.
Related: HS code lookup by product, HS code for machinery.