Medical Device Importer Solutions for the USA Compliance

Embark on Specialized Medical Device Importer Services with Freyr's Expertise!

Medical Device Importers in the USA

Medical device importer in the USA is a company or entity that brings medical devices from foreign countries into the United States for distribution, sale, or use. These importers are responsible for ensuring that the medical devices they import comply with all applicable regulations set by the US Food and Drug Administration (FDA). This includes verifying that the devices meet Medical Device Tracking, Medical Device Reporting, Reports of Corrections and Removals, and any other Regulatory obligations. Importers must register their establishment with the FDA.

Who can act as medical device importers in the USA?

Initial Importers: Establishments who facilitate the distribution of a device from a foreign manufacturer to the final consumer or user without repackaging or modifying the device's container, wrapper, or labeling.

Regulatory requirements that govern the import of medical devices in the USA

Medical device Importers should ensure that they comply with the following:

  • Registering establishment with the FDA.
  • Listing the devices with the agency.
  • To import any medical device into the United States, the manufacturers must provide market approval reference number or the product code and the tradename for the 510(k) exempt devices.
  • The devices that are subject to import must comply with the general controls of the medical device and the special controls, if applicable.
  • Foreign manufacturers must appoint a designated US agent.

Streamline your Medical Device Importation process with our expert support. Contact Freyr's specialists today to ensure your medical device meets all the Regulatory requirements and achieves timely market access in the USA.

Freyr Medical Device Importer Competencies in the USA

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    Distributor Identification/Qualification of distributor for compliance with the US FDA requirements.
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    Support for the custom clearances.
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    Labeling services as per the US FDA labeling requirements for medical devices.
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    Reviewing of the labeling documents.
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    US agent.

Frequently Asked Questions (FAQs)

Compliance with QSR ensures that medical devices are manufactured consistently and meet quality standards. It involves establishing robust processes for design, production, and distribution, which are critical for Regulatory approval and market success.

Freyr offers end-to-end Regulatory support, including registration, compliance, and agent representation. This comprehensive approach ensures that all aspects of the import process are handled efficiently and in compliance with the Regulatory standards.

Book a meeting with our Regulatory experts

Medical Device Regulatory Consulting – Proven Expertise

120

+

Countries
1900

+

Global Customers
2200

+

In-house Regulatory Experts
850

+

In-country Regulatory Affiliates
8
Global Delivery Hubs

Why Freyr?

  • Our Regulatory experts guide you through the registration, listing, and compliance processes.
  • Freyr act as your designated US agent, handling the FDA communications and inspections.
  • Freyr offers tailored training programs to help your team understand and adhere to the Regulatory requirements.
  • From initial importation to responding to the FDA notices, we provide end-to-end support to ensure your products meet the US standards.