Most medical devices enter the US at a Free general rate, which is exactly why distributors stop paying attention to the code. Then a container of nitrile exam gloves from China lands at 112.5 percent, a pallet of syringes at the same rate, and surgical masks at 69.5 percent. This is a buyer's comparison of the software that classifies a medical device and supplies catalog, with the 2026 duty on the lines that actually cost money and what each route costs per SKU.
What is the best HS code classification software for medical device importers?
For a US medical distributor, a private-label supplies brand or a device company importing finished goods and spare parts, the best fit is a classifier that returns the full 10-digit HTSUS code from a plain description, separates Chapter 90 instruments from the consumables that live in other chapters, and shows the 2026 duty by origin on the same screen. TariffWise does that from $59 a month, with bulk CSV classification of a whole catalog on the $199 Growth plan. A licensed customs broker stays the right call for the entry itself and for lines where two headings genuinely compete.
Medical catalogs look uniform and are not. Instruments and monitors sit in heading 9018, orthopedic appliances in 9021, massage and therapy apparatus in 9019, clinical thermometers in 9025, hospital furniture in 9402, gloves in Chapter 40, dressings in Chapter 30 and masks in Chapter 63. Almost all of the instruments are Free. Almost all of the expensive surprises are in the consumables.
Where medical products sit in the US tariff schedule in 2026
General rates below are read from the current HTSUS. The China figure adds the Section 301 rate where the line is covered by the 2024 four-year review, plus the 12.5 percent layer under heading 9903.05.31 in force since July 24, 2026, assuming the line is not in that layer's exemption annex. For lines where the Section 301 status depends on the exact 10-digit suffix, the table says so instead of guessing.
| Product | HTSUS line | General rate | From China in 2026 |
|---|---|---|---|
| Syringes, with or without needles | 9018.31.00 | Free | 112.5% (Section 301 at 100% under 9903.91.03 plus 12.5%) |
| Medical and surgical gloves, including nitrile exam gloves | 4015.12.10 | Free | 112.5% (Section 301 at 100% from January 1, 2026 plus 12.5%) |
| Non-medical rubber gloves | 4015.12.90 | 14% | 26.5% plus any 301 list rate |
| Face masks of textile | 6307.90.98 | 7% | 69.5% (Section 301 at 50% from January 1, 2026 plus 12.5%) |
| Patient monitoring systems | 9018.19.55.00 | Free | 12.5% plus the 301 list rate for that line |
| Orthopedic and fracture appliances | 9021.10.00 | Free | 12.5% plus the 301 list rate for that line |
| Massage and mechano-therapy apparatus | 9019.10.20 | Free | 12.5% plus the 301 list rate for that line |
| Clinical thermometers | 9025.11.20.00 | Free | 12.5% plus the 301 list rate for that line |
| Hospital and medical furniture | 9402.90.00 | Free | 12.5% plus the 301 list rate for that line |
| Wound dressings, not coated with a drug | 3005.90.50 | Free | 12.5% plus the 301 list rate for that line |
The top three rows are the reason this category needs software rather than a spreadsheet. The 2024 review set syringes and needles at 100 percent from September 27, 2024, raised medical gloves to 50 percent in 2025 and to 100 percent on January 1, 2026, and moved face masks to 25 percent in 2024 and 50 percent on January 1, 2026. Those are consumables a distributor reorders every month, so a code that was right in 2023 and never re-checked is now off by a multiple of the invoice. One detail worth knowing: enteral syringes under 9018.31.0080 had a carve-out through the end of 2025 under heading 9903.91.10, which has now expired.
Is a Free general rate the same as duty-free?
No. Free in the general column only means the base rate is zero. Section 301 and the 2026 layer are charged through Chapter 99 headings that sit on top of the base rate, by country of origin, so a Free line from China still pays at least 12.5 percent in October 2026 unless it is in the annex. That is why a catalog costed off the general column alone can look fully duty-free and still carry real duty on every entry. Origin changes the answer too: Vietnam and Thailand pay 12.5 percent on top, Malaysia and Indonesia 10 percent, and Taiwan, Korea, Japan and the EU pay a top-up to a fixed total.
Where medical device classifications go wrong
The errors repeat across distributors. Exam gloves filed under 9018 as medical instruments, when gloves are rubber articles in heading 4015 whatever they are used for. A hospital bed filed as a medical apparatus instead of furniture under 9402. A drug-coated dressing filed with plain dressings, when the coating moves it to 3005.10 or 3005.90.10. Accessories filed as parts when Note 2 to Chapter 90 sends parts and accessories suitable for use solely or principally with one machine to that machine's heading. A consumer fitness tracker filed as a medical monitor, when CBP has generally treated it as a data device in 8517.
Each one is a correction CBP can make after liquidation, with interest. Under 19 USC 1484 the importer of record owes reasonable care on the classification whoever filled in the code, and saved reasoning per line is what shows that care when a focused assessment asks for it.
How do the classification tools compare for a medical catalog?
The comparison below uses vendor-published pricing only. Where a vendor publishes no price, the table says so rather than estimating one.
| 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 |
If you are holding a renewal for an enterprise suite and mostly use it to look up HTS codes, the Descartes CustomsInfo alternative page walks through which modules a smaller tool can replace and which it cannot. Every route's cost per product is on the HS code classification cost for importers page.
What does it cost to classify a medical supplies catalog?
| Catalog | Broker review at $50 to $200 per product | TariffWise |
|---|---|---|
| A device startup importing 40 finished units, spares and accessories | $2,000 to $8,000 | $59 for one month of Starter |
| A regional distributor with 900 consumables, gloves, drapes and parts | $45,000 to $180,000 | $199 for one month of Growth, 1,000 classifications with bulk CSV |
| A national distributor re-checking 6,000 lines after the January step-up | Not realistic per product | $499 for one month of Business, 10,000 classifications |
The arithmetic is lopsided because medical catalogs are wide. A distributor with a few hundred glove, syringe and mask SKUs from China has more duty riding on those lines than on the entire instrument range, and the instruments are where most catalogs spend their classification budget.
Do medical devices need FDA clearance as well as an HTS code?
Yes. The HTS code sets the duty, and FDA decides whether the device may enter at all. Most devices need a 510(k), De Novo or PMA unless exempt, the establishment and device must be registered and listed, and the FDA product code and listing data go on the entry. A duty-free code with missing FDA data still gets held. Keep the two in one record per SKU, and make sure the people on the receiving dock know which documents a held shipment needs: a short compliance training course for the import team saves more demurrage than any tool.
A four-step test before you pick a tool
Take ten of your own SKUs: two gloves, a syringe, a mask, a monitor, an orthopedic brace, a hospital bed, a dressing, a spare part and an accessory. Run them through each tool you are considering. Check four things on every result: the full 10-digit code, whether the tool caught the chapter jumps (gloves to 40, beds to 94, masks to 63), whether it shows the Chapter 99 lines for China, and whether it writes down why. A tool that gets the instruments right and the consumables wrong is the expensive kind of wrong.
You can run that test on TariffWise now with the classifier at the top of this page, and the HS code for medical devices guide maps every Chapter 90 heading in more depth. Battery-powered devices shipped with spare packs raise one more question, covered on the lithium battery HS code page.
Frequently asked questions
What is the HS code for medical devices?
There is no single code. Diagnostic and surgical instruments sit in heading 9018, orthopedic appliances, hearing aids and pacemakers in 9021, therapy and massage apparatus in 9019 and X-ray apparatus in 9022. Gloves, masks, dressings and hospital furniture sit in other chapters entirely, so a medical catalog is classified item by item.
What is the HS code for nitrile gloves?
Nitrile exam and surgical gloves classify in heading 4015 as rubber articles, with medical and surgical gloves on US line 4015.12.10 at a Free general rate. From China they carry Section 301 at 100 percent since January 1, 2026, plus the 12.5 percent 2026 layer, so the total is 112.5 percent.
Are medical devices exempt from tariffs?
Most have a Free general rate, but that is not an exemption from the Chapter 99 layers. From China they pay at least the 12.5 percent 2026 layer, and some lines pay Section 301 on top, from 50 percent on face masks to 100 percent on syringes and medical gloves. Check the exemption annex to the 2026 layer for your exact line.
Can classification software replace a customs broker for medical imports?
It replaces the per-product classification fee, not the broker. Software gives your team a defensible first pass on every SKU at a flat monthly cost, and the broker files the entry and reviews the contested lines. Most distributors end up using both, with the broker's time spent on the few hard calls.