Representative Services

US AGENT

Your Trusted US Agent for FDA Compliance

Under FDA regulations (21 CFR Part 807), foreign manufacturers looking to market medical devices in the United States must appoint a US Agent. As your official US Agent, we provide expert regulatory support, ensuring seamless compliance with FDA registration and listing requirements.

Our US Agent Services

US Agent Representation for FDA Compliance

  • As per 21 CFR Part 807, foreign manufacturers must appoint a US Agent to facilitate communication with the FDA. We serve as your official US Agent, ensuring full compliance.

FDA Establishment Registration & Device Listing

  • We assist in establishment registration and medical device listing with the FDA, ensuring accurate and up-to-date compliance.

510(k), PMA, and De Novo Submission Support

  • We provide guidance on preparing and submitting regulatory applications, including 510(k) premarket notifications, Premarket Approval (PMA), and De Novo requests.

FDA Communication & Inspection Support

  • We handle all FDA correspondence, assist during FDA audits and inspections, and address compliance issues efficiently.

Import & Regulatory Compliance Assistance

  • We help navigate US import regulations, respond to detention notices, and ensure compliance with FDA import requirements.

Who Needs a US Agent?

Contract Manufacturers & Suppliers

Foreign Medical Device Manufacturers without a US presence.

Medical Device & IVD Manufacturers

Companies Exporting Medical Devices to the US market.

Distributors & Importers

Regulatory Consultants assisting manufacturers with US compliance.

How to Appoint Us as Your US Agent?

  • Contact Us – Discuss your US regulatory requirements with our experts.
  • Agreement & Documentation – Sign a formal US Agent service agreement.
  • FDA Registration & Listing – We assist in device listing and establishment registration.
  • Ongoing Compliance Support – We provide continuous FDA regulatory assistance.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

Links

Services

Contact

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

© Alpine Quality Consultants 2025 | All Rights Reserved

TOP