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Medical Device Import Compliance & Customs Support – XPRO AMERICA

Ensuring FDA import compliance is essential for foreign medical device manufacturers and U.S. importers to avoid detention, refusal, or penalties at U.S. ports. The FDA enforces strict regulations on medical devices entering the U.S., including establishment registration, device listing, labeling, and prior notice requirements. At XPRO AMERICA, we provide comprehensive [...]

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Medical Device Registration & Listing Compliance – XPRO AMERICA

All medical device manufacturers, repackers, relabelers, specification developers, and initial importers must comply with FDA regulations for establishment registration and device listing under 21 CFR Part 807. Annual registration ensures FDA oversight of facilities marketing devices in the United States, while device listing identifies each medical device available in the [...]

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