Medical devices carry some of the lowest customs duty of any product category worldwide — but regulatory documentation (CE, FDA, ANVISA) matters far more than the tariff itself.
Medical, surgical, dental and veterinary instruments are classified under heading 9018; mechano-therapy and orthopaedic appliances under 9019 and 9021; and diagnostic imaging equipment under 9022. Under long-standing WTO practice most countries apply zero or very low most-favoured-nation duty to genuine medical devices, reflecting their essential, non-discretionary nature — this is one of the few product categories where the customs duty itself is rarely the main cost or complexity. The real barrier to international medical device trade is regulatory: CE marking under the EU's Medical Device Regulation, FDA clearance for the US market, and equivalent registration schemes elsewhere, none of which is checked at the customs border but all of which govern whether you can legally sell the device commercially.
Import duty rates shown for the EU (from non-EU), UK (from non-UK), and USA (from non-USA). Intra-EU shipments have 0% duty.
| HS Code | Product description | EU duty | UK duty | USA duty | Notes |
|---|---|---|---|---|---|
| 9018.11 | Electro-diagnostic apparatus — ECG machines | 0% | 0% | 0% | Duty-free in nearly all markets under WTO medical goods practice |
| 9018.12 | Ultrasonic scanning apparatus | 0% | 0% | 0% | Diagnostic imaging equipment |
| 9018.31 | Syringes, with or without needles | 0% | 0% | 0% | Includes insulin pen needles |
| 9018.39 | Needles, catheters, cannulae and similar | 0% | 0% | 0% | General catch-all for tubular medical instruments |
| 9018.90 | Other medical, surgical, dental instruments n.e.s. (CPAP machines, monitors) | 0% | 0% | 0% | Broad residual heading — covers most consumer-facing devices like CPAP and glucose monitors |
| 9019.10 | Mechano-therapy and massage appliances | 1.7%–2.2% | 0% | 0% | Some EU sub-headings carry a small duty unlike core diagnostic/surgical equipment |
| 9021.10 | Orthopaedic appliances (braces, splints) | 0% | 0% | 0% | Includes fracture appliances |
| 9021.31 / 9021.39 | Artificial joints and implants | 0% | 0% | 0% | Hip/knee replacements and other implantable devices |
| 9021.40 / 9021.90 | Hearing aids, pacemakers, other implantable/wearable devices | 0% | 0% | 0% | Cochlear implants and pacemakers also fall here |
Duty rates are indicative based on standard MFN (Most Favoured Nation) tariffs. Actual rates may vary by country of origin and applicable trade agreements. Always verify with the official tariff database of the destination country.
The vast majority of genuine medical devices under Chapter 90 headings 9018, 9019 and 9021 enter the EU, UK and USA at 0% duty, reflecting a long-standing international convention treating essential medical goods as duty-exempt. A small number of borderline sub-headings (some mechano-therapy and wellness devices under 9019.10) carry low single-digit EU duty — verify the exact 8-digit code if your product sits close to the wellness/medical boundary.
Import duty being 0% does not mean import is unrestricted — EU VAT still applies on the customs value, and commercial placement on the EU market requires CE marking under Medical Device Regulation (MDR) 2017/745 or, for diagnostics, the In Vitro Diagnostic Regulation (IVDR) 2017/746. Non-CE-marked devices can be physically imported but cannot legally be sold commercially in the EU.
Duty-free entry under HTS Chapter 90 doesn't bypass FDA requirements. Commercial import of medical devices for US sale generally requires FDA clearance (510(k)), Premarket Approval (PMA), or qualifying as an exempt Class I device, plus FDA establishment registration and device listing. Personal-use imports of a patient's own prescribed device (CPAP, insulin pump) are generally treated more leniently at the border.
Brazil (ANVISA) and India (CDSCO) require commercial import registration for most medical devices regardless of the 0% or low customs duty — the registration and Importer of Record requirements, not the tariff, are the real barrier to entry in these markets.
Label commercial shipments clearly as 'Medical Device — [Class] — For Clinical/Personal Use' and include the CE Declaration of Conformity reference — even at 0% duty, unclear declarations can trigger customs holds for regulatory verification, especially into the USA and Brazil.
For a patient's personal prescribed device (CPAP, insulin pump, glucose monitor) travelling with or being shipped to them abroad: include a copy of the prescription or clinical letter. This significantly reduces the chance of a customs query even though duty is typically 0% either way.
Sterile devices must maintain sealed, tamper-evident packaging through customs inspection — if a customs officer opens and doesn't correctly reseal a sterile pack, it may no longer be usable clinically. Include documentation inside the box so inspection doesn't require full unpacking.
For commercial exports of CE-marked devices outside the EU, include the CE Declaration of Conformity, the notified body number (required for Class IIa/IIb/III devices), and your Authorised Representative details — these are what US, UK and other importers typically request even though customs itself doesn't check them.
High-value equipment for temporary export (trade show demonstration, clinical trial, repair and return) can use an ATA Carnet to avoid paying full import duty at destination, since the device is only temporarily entering the country and will be re-exported.
Devices with lithium batteries (portable ECG monitors, infusion pumps) follow the same IATA lithium battery rules as any electronic device — battery installed in the device (UN3481) is far less restricted than a loose spare battery (UN3480).
Do I pay customs duty shipping a CPAP machine internationally?
In most cases, no — CPAP machines fall under HS 9018.90 (other medical instruments), which carries 0% duty in the EU, UK and USA. VAT may still apply on the import value in VAT-charging jurisdictions, and a copy of the prescription helps avoid customs queries, but duty itself is typically not the cost concern.
Is CE marking checked when a medical device passes through EU customs?
No — CE marking is not verified at the point of physical customs clearance; a non-CE-marked device can still physically enter the EU. However, selling a non-CE-marked device commercially within the EU is illegal regardless of how it entered, and EU market surveillance authorities enforce this separately from customs, including product recalls and fines for non-compliant sellers.
What HS code covers hearing aids and pacemakers?
Hearing aids and pacemakers are classified under 9021.40 and 9021.90 respectively, within the broader 9021 heading for orthopaedic and prosthetic appliances. Both carry 0% duty in the EU, UK and USA under the standard treatment of implantable and wearable medical devices.
Do I need FDA approval to send a medical device sample to the USA?
For commercial sale in the USA, yes — most medical devices need FDA clearance (510(k)), Premarket Approval, or must qualify as an exempt Class I device, plus FDA facility registration. A single unit shipped for personal use by a patient, or a sample sent for evaluation/testing rather than sale, is typically treated differently — mark such shipments clearly as 'sample for evaluation, not for resale' and check current FDA import guidance for your specific device type.
Are surgical instruments duty-free to ship internationally?
Yes, in most markets — surgical instruments (scalpels, forceps, retractors) fall under HS 9018 at 0% duty in the EU, UK and USA. Sterile instruments must maintain sealed sterile packaging throughout transit; non-sterile instruments ship as standard precision goods with normal fragile-item packing.
What's the difference in duty between a wellness massage device and a genuine medical device?
This is one of the few genuinely ambiguous areas in medical device classification. Core diagnostic and therapeutic equipment (9018) is reliably 0% duty, but some mechano-therapy and massage appliances under 9019.10 can carry a small EU duty (roughly 1.7–2.2%) if classified as general wellness rather than clinical equipment. If your product sits near this boundary, get a specific classification ruling rather than assuming 0% applies.
Do I need an Importer of Record to ship medical devices to Brazil?
For commercial imports, yes — Brazil's ANVISA requires product registration and typically an in-country Importer of Record for medical device imports, regardless of the customs duty rate itself. This registration process, not the tariff, is the main barrier to entering the Brazilian medical device market and should be arranged well before attempting a commercial shipment.
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