FDA · Establishment Registration · Device Listing · 510(k)
The United States is the world's largest medical-device market and one of the most tightly regulated. Devices are governed by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
Foreign manufacturers and the initial importer must complete FDA Establishment Registration and Device Listing, and pay the annual establishment fee. A foreign manufacturer must also designate a U.S. Agent. SWIFTSKY supplies the manufacturer documentation needed for these steps.
Most disposables are Class I or Class II. Many Class I devices are exempt from premarket notification, while Class II devices typically require 510(k) clearance demonstrating substantial equivalence.
Honest note: 510(k) clearance, FDA registration, listing and the U.S. Agent must be in place before commercial import. SWIFTSKY is a merchant exporter — we supply manufacturer documentation and can source factories that already hold the relevant FDA clearances. The registrations themselves are held by the manufacturer/importer.
| Item | Rate | Notes |
|---|---|---|
| Import duty — medical devices (general) | 0% | Many medical items are duty-free under HTSUS |
| Merchandise Processing Fee | Ad valorem | Per CBP schedule |
| Customs / broker charges | Variable | Confirm with your customs broker |
Rates are indicative and subject to change. Verify current HTSUS classification and any applicable measures with a licensed U.S. customs broker before importing.
We can source FDA-registered factories and supply the documentation your importer and U.S. Agent need. You handle the registrations; we handle the supply chain.