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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 [...]

USFDA Establishment Registration – XPRO America – Food, Drugs, Cosmetic, Medical Devices – Alternative to Registrar Corp

USFDA Registration Services @XPRO AMERICA – Simplifying Your Path to the U.S. Market If your business aims to export food, cosmetics, dietary supplements, or medical devices to the United States, obtaining a USFDA Establishment Registration is a mandatory step. This process ensures your facility is recognized by the U.S. Food and Drug Administration (FDA) and is compliant [...]