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Medical Devices HS Code — Equipment, Instruments & Supplies

Quick Answer

Surgical instruments: HS 9018. X-ray equipment: 9022. Prosthetics: 9021. Most are 0% US duty.

US0% (most)EU0-2.5%BR14% + taxes

Medical devices are one of the few product categories where the compliance burden far exceeds the duty cost. Most medical devices enter the US at 0% duty under Chapter 90, but FDA registration, 510(k) clearance, and MDR reporting requirements make the regulatory side the real bottleneck.

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Key medical device HS codes

Chapter 90 covers most medical devices. The rate is typically 0% in the US and EU, making classification more about compliance than cost.

  • 9018.11 — Electrocardiographs. US: 0%.
  • 9018.12 — Ultrasonic scanning apparatus. US: 0%.
  • 9018.19 — Other electro-diagnostic apparatus. US: 0%.
  • 9018.31 — Syringes, with or without needles. US: 0%.
  • 9018.39 — Catheters, cannulae, and similar. US: 0%.
  • 9018.41 — Dental drill engines. US: 0%.
  • 9018.90 — Other medical instruments and appliances. US: 0%.
  • 9021.10 — Orthopedic appliances (braces, splints). US: 0%.
  • 9021.29 — Artificial teeth. US: 0%.
  • 9021.39 — Other artificial body parts. US: 0%.
  • 9022.14 — X-ray apparatus for medical use. US: 0%.

FDA requirements

Every medical device entering the US needs: FDA Establishment Registration (foreign manufacturer + US importer), FDA Device Listing, and the correct FDA product code. Class II devices need 510(k) clearance before marketing. Class III need PMA approval.

The import alert system means FDA can detain devices at the border without examination if the manufacturer has compliance history issues. Check the FDA import alert database for your supplier before ordering.

Brazil and Mexico

Brazil: ANVISA registration required. II 14% + IPI 0% (medical devices often exempt) + PIS/COFINS + ICMS. Effective total ~30% even though IPI is waived.

Mexico: COFEPRIS registration required. IGI 5% on most medical devices + IVA 0% (medical devices are IVA-exempt in Mexico, a rare exception to the 16% standard rate).

Frequently asked questions

Are face masks medical devices?
Surgical masks (intended for medical use): yes, 9018.90 or 6307.90 depending on classification. N95 respirators: 6307.90 (textile articles). Regular cloth masks: 6307.90. The HS code depends on construction, not marketing claims.
Do home health devices (blood pressure monitors) need FDA clearance?
Yes. Blood pressure monitors are Class II medical devices and need 510(k) clearance. OTC availability doesn't exempt them from FDA requirements. Import without clearance = seizure at customs.

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