Medical device importers: cut duty through classification and recover overpaid tariffs

Bauerhin Technologies Ltd. v. United States, 110 F.3d 774 (Fed. Cir. 1997)

The Federal Circuit set the controlling framework for what counts as a 'part' in the tariff, reconciling two lines of authority: under Willoughby Camera, a part is an integral component without which the article cannot function as such; under Pompeo, an item dedicated solely for use with an article is a part of it. This is the foundational parts test applied throughout Chapter 90, and it is why a component's dedication and function — not its appearance — decide whether it stays in a Free medical heading or falls to a dutiable material line.

CBP Ruling H304940 (stethoscope covers, 2019) — CBP ruling, not a court case

CBP held that Stethocap plastic covers snapped onto a stethoscope diaphragm are NOT accessories of heading 9018, because they do not directly add to or enhance the stethoscope's function of detecting sound; Note 2(b) to Chapter 90 was therefore inapplicable and the covers classified as other articles of plastic under 3926.90 (roughly 5.3%) instead of Free. This is the clearest illustration of the parts-and-accessories fork moving a 'medical' item from duty-free into a dutiable material heading. Labeled as an administrative ruling, not litigated case law.

CBP Ruling N289084 (syringe accessories, China) — CBP ruling, not a court case

CBP classified syringe accessories under heading 9018 (9018.31, syringes and parts/accessories thereof), the opposite outcome from the stethoscope covers, because the items were dedicated to and directly served a medical instrument's function. Read together with H304940, it marks both sides of the Note 2 line: dedicated, function-serving items stay in Chapter 90; barrier or material items that merely cover an instrument do not. Labeled as an administrative ruling, not litigated case law.

Are pharmaceuticals duty-free to import into the U.S.?

Many are, but not all. Under the WTO Pharmaceutical Agreement, thousands of active ingredients and finished drugs enter duty-free through the HTS Pharmaceutical Appendix, claimed with the 'K' special-rate indicator under General Note 13, and most finished medicaments in heading 3004 read Free at MFN. A drug or ingredient that is not listed in the appendix pays its Chapter 29 or 30 rate, so eligibility has to be screened line by line (as of July 2026).

How much duty do I pay on a medical device imported from China in 2026?

As of July 2026, a China-origin device is often near 35%: its base MFN rate plus Section 301 (List 3 at 25%, or List 4A at 7.5%) plus the 10% Section 122 surcharge, plus MPF and HMF. Certain medical-product exclusions run through November 10, 2026 and can remove the Section 301 layer, so confirm whether your exact HTS line has an active exclusion at ustr.gov before you assume the full rate.

What is the Pharmaceutical Appendix and how do I use it?

The Pharmaceutical Appendix is a list in the HTS of thousands of pharmaceutical active ingredients and intermediates that enter the U.S. duty-free under General Note 13. It has three tables — International Non-proprietary Names, combinable chemical prefixes and suffixes for derivatives, and specified intermediates — and a listed derivative must fall in the same 6-digit provision as its parent to qualify. When an 8-digit line shows 'K' in the special-rate column and the product is listed, the rate is Free. We screen your molecules against it.

Is there a Section 232 tariff on pharmaceuticals?

Yes — a Section 232 tariff on patented pharmaceuticals and their active ingredients takes effect July 31, 2026 for large manufacturers and September 29, 2026 for others. The standard rate is 100% ad valorem, reduced to 20% under an onshoring plan, 15% for the EU, Japan, Korea, and Switzerland-Liechtenstein, 10% for the UK, and 0% under an MFN pricing agreement. It covers only patented drugs and APIs listed in FDA's Orange or Purple Book; generic drugs and biosimilars are exempt. Verify current status before you rely on this.

Does the pharmaceutical Section 232 tariff apply to medical devices?

No. The July 2026 Section 232 tariff covers patented pharmaceuticals and active pharmaceutical ingredients only, not medical devices. There is a separate open Commerce investigation into medical equipment and devices, consumables, PPE, and robotics, but as of July 2026 no device tariff has been proclaimed and none is in force. Do not price a device 232 tariff into a current landed cost.

What is the difference between heading 9018 and a 'part' of a device?

Heading 9018 covers medical and surgical instruments themselves, and many of its lines read Free, while a part or accessory is governed by Note 2 to Chapter 90. A part that is solely or principally for a Chapter 90 instrument stays in Chapter 90, but an item that does not directly contribute to the instrument's function is thrown out to its material heading — which is how a plastic cover can land in dutiable Chapter 39 instead of Free 9018. We document the call with GRI reasoning and the Chapter 90 Notes.

Can I claim duty drawback on re-exported medical devices?

Yes. Drawback refunds up to 99% of duties, taxes, and fees on imported devices that are later exported or destroyed, including Section 301 duties, MPF, and HMF, which fits devices that are kitted or rebalanced in the U.S. and then distributed globally. Substitution drawback only requires the export to share the same 8-digit HTS subheading as the import. Note the boundary: Section 232 duties, including the new pharmaceutical 232, are not drawback-eligible. We estimate the claim and a partner executes the filing.

Are lab equipment, reagents, and disposables also duty-free?

Often no — this is where a 'medical' shipment quietly carries duty. Plastic disposables such as syringes, tubing, and labware sit in Chapter 39 at roughly 3 to 6.5%, diagnostic reagents and kits in headings 3002 and 3006, and bioprocessing and lab equipment such as chromatography, filtration, and bioreactors in Chapters 84 and 85, which are often low but not uniformly Free. Each line needs its own rate check rather than an assumption that anything medical is duty-free (as of July 2026).

Do medical devices still have Section 301 exclusions?

Yes, for now. A set of Section 301 exclusions covering certain medical products — including some devices, face masks, and gloves — was extended and currently runs through November 10, 2026. USTR has consistently treated these as temporary, short-window extensions rather than a path to permanence, so treat that date as a hard sourcing deadline and confirm whether your specific HTS line is on the active exclusion list at ustr.gov.

Does the 10% Section 122 surcharge apply to my pharmaceuticals?

Sometimes not — Annex II to Proclamation 11012 enumerates roughly 120 specific Chapter 29 and 30 pharmaceutical codes that are excluded from the 10% surcharge, so some drugs and ingredients escape it while devices generally do not. Section 122 is capped at 150 days and set to expire around July 24, 2026, and a Federal Circuit stay currently keeps it in force after the Court of International Trade struck it down, so verify both your exact line and the current status before relying on any figure.

Are the IEEPA tariffs I paid in 2025 on medical imports refundable?

Yes. The Supreme Court struck down the IEEPA reciprocal and fentanyl tariffs in Learning Resources v. Trump (decided February 20, 2026), and CBP stopped collecting them on February 24, 2026, so duties paid from early 2025 through that date are refundable. Unliquidated entries flow through CBP's process automatically, but liquidated entries require a protest within 180 days of liquidation. We estimate the refund and file the full package.

How do I lower duty on devices I buy through a trading company?

First Sale valuation lets you declare the earlier bona-fide factory sale rather than the marked-up price you pay a middleman, which lowers the customs value that Section 301, Section 122, and any applicable 232 all calculate on at once. It requires an arm's-length first sale with the goods clearly destined for the U.S., and the importer bears the burden of proof. We assess eligibility and structure the documentation through Trade Advisory, which is strategic trade guidance, not legal counsel.