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 support to guarantee seamless FDA import compliance and customs clearance for medical devices, reducing regulatory risks and enabling timely market access.

Key Services:

• Import Entry Compliance: We review documentation, labeling, and device registration to ensure that foreign-made medical devices comply with FDA entry requirements.
• Customs Clearance Support: XPRO AMERICA assists in preparing import documentation, coordinating with U.S. Customs and FDA, and resolving issues that could lead to detention or refusal.
• Regulatory Consultation: We provide guidance on FDA registration, device listing, UDI compliance, and prior notice requirements to ensure all imports meet federal regulations.
• Inspection Preparedness: Our team helps foreign manufacturers prepare for potential FDA inspections at U.S. ports, ensuring that quality system and documentation standards are met.
• Ongoing Compliance Monitoring: We advise on maintaining up-to-date registrations, listings, and regulatory updates to prevent future import issues.

Why Choose XPRO AMERICA?

• Expertise in FDA import regulations for medical devices.
• Ensures seamless customs clearance and minimizes risk of detention.
• End-to-end support from documentation review to FDA coordination.
• Keeps manufacturers and importers compliant with evolving regulatory requirements.

Partnering with XPRO AMERICA guarantees that foreign-made medical devices comply with all FDA import regulations, avoid delays at U.S. ports, and maintain smooth market entry. Our services streamline regulatory compliance, facilitate customs clearance, and provide confidence in import operations.

XPRO AMERICA ensures FDA import compliance for foreign devices, preventing detention and facilitating smooth customs clearance.