Medical devices export rules: United States

Rules to check before you export medical devices to the United States (3), each with its official source. Must clear before you sell: Main rule for medical devices.

Official sources checked between 2026-10-09 and 2026-11-04

Duty and FTAs: Even at the KORUS FTA 0% rate (with proof of origin), a Section 301 duty since 24 Jul 2026 makes most Korean goods 12.5% in total (higher rates stay; some exemptions). hts.usitc.gov, checked 2026-10-14

This is not legal or tax advice. Rules and rates change, so confirm with the official source and a local authority, your importer or an expert before you sell.

• Main rule for medical devices: In this order. (1) Most Class II devices need 510(k) clearance first (it takes months, and a device can only be listed after clearance, with that number). (2) FDA establishment registration and device listing, with a US Agent named by foreign makers (renewed every year between 1 October and 31 December). (3) Follow the Quality Management System Regulation (QMSR). fda.gov, checked 2026-10-09, fda.gov, checked 2026-10-09, fda.gov, checked 2026-10-09, fda.gov, checked 2026-10-09
• US FDA clearance for LED and microcurrent skin devices: In the US, LED devices sold to reduce wrinkles or treat acne (FDA product codes OHS and OLP) and microcurrent devices for aesthetic use (code NFO) are Class II medical devices that need 510(k) clearance before sale; LED masks are cleared under OHS. As the maker you also register your factory with FDA, list the device and name a US agent. Check your device's FDA product code before you market it. Your company does it · accessdata.fda.gov, checked 2026-10-15
• US: ‘FDA registered’ is not ‘FDA approved’: FDA registration and listing are not FDA approval. FDA says cosmetic facility registration and product listing are neither an approval program nor a promotional tool, that a registration or listing number does not indicate approval, and that it issues no certificates; for medical devices it warns that ‘FDA registered’ or ‘FDA certified’ wording and look-alike certificates mislead. The FDA name and logo are not for private-sector materials without written permission. Keep these badges and the FDA logo out of ads, creator briefs, listings, packs and sales decks, and give a buyer who asks the registration number in plain text. Done with your importer · fda.gov, checked 2026-11-04
• Open the checklist
• Work out the export price
• Same product, other countries: EU
• Same country, other products: Cosmetics
• Same country, other products: Instant noodles & pasta
• Same country, other products: Sauces & seasonings
• Same country, other products: Food supplements & preparations
• Same country, other products: Spirits (incl. soju)
• Same country, other products: Toys
• Same country, other products: Furniture
• Same country, other products: Pet food & feed
• Sources: fda.gov, checked 2026-10-09
• Sources: fda.gov, checked 2026-10-09
• Sources: fda.gov, checked 2026-10-09
• Sources: fda.gov, checked 2026-10-09
• Sources: accessdata.fda.gov, checked 2026-10-15
• Sources: fda.gov, checked 2026-11-04
• Sources: hts.usitc.gov, checked 2026-10-14
• Sources: federalregister.gov, checked 2026-10-14

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