INITIAL IMPORTER

MEDICAL DEVICE

Medical Device Initial Importer Support Services

North Haven Imports & Compliance Group LLC provides regulatory support services for companies acting as Initial Importers of medical devices into the United States. We assist U.S. importers, distributors, and foreign manufacturers in understanding and addressing FDA regulatory requirements applicable to the importation of medical devices and device components.

Our services are designed to support import readiness, documentation alignment, and regulatory compliance maintenance throughout the import process. We work with clients to help ensure regulatory responsibilities are clearly understood and that required records and procedures are organized and inspection-ready.

What We Support

Our medical device initial importer services support businesses across all stages of importation and compliance, including:

  • Guidance on FDA Initial Importer roles and regulatory obligations

  • Review of manufacturer FDA registration and device listing status

  • Support with import documentation and recordkeeping requirements

  • Compliance readiness support for FDA and U.S. Customs inspections

  • Identification of compliance gaps and corrective guidance

  • Ongoing regulatory support to help maintain compliance posture

Our Role

North Haven serves as a regulatory support partner, helping clients interpret FDA requirements and apply them in a practical, structured manner. Our goal is to support compliant importation while helping minimize delays, refusals, and enforcement actions at the port of entry.

Industries Served

  • Medical device manufacturers

  • U.S. importers and distributors

  • Device component and accessory suppliers

  • Regulated healthcare product companies

Commitment to Compliance

Our medical device importer services are advisory in nature and intended to support compliance with applicable FDA regulations, including requirements under 21 CFR. We prioritize accuracy, documentation integrity, and clear communication to help clients confidently navigate the U.S. medical device import environment.

Let’s Work Together

If you're interested in working with us, complete the form with a few details about your project. We'll review your message and get back to you within 48 hours.