US Importer Service

Ensure full compliance with FDA regulations for medical device and IVD companies with Razalution's US Importer service

Introduction

The US FDA defines US Initial Importer as, "any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package." 21 CFR § 807.3(g).

Why do you need a US Initial Importer?

As governed by the Code of Federal Regulation, US Initial Importers are required to hold FDA registration and pay associated annual registration fees. Initial Importers must have a physical address in the United States and are responsible for ensuring the compliance of imported devices with all applicable FDA regulations and requirements. Without a US Importer, you cannot establish compliance with the FDA for your medical device(s) in the US market.

Razalution Global's executive management has been an FDA registered medical device US Importer for 500+ overseas medical device companies.

Our central office in Texas, meets the FDA's physical address requirement for Importers as mandated by the FDA and ensures seamless communication with both your company and the FDA.

US Initial Importer services provided by Razalution

As your US Initial Importer, Razalution commits to providing you with the following services:

• Maintain registration/listing with the FDA as the Initial Importer for foreign manufactured medical devices
• Act on your behalf as the FDA's primary contact for all regulatory communications as it relates to your device
• Assist in the facilitation of FDA inspections, notifications and resolution of any FDA product detentions
• Assume reporting responsibilities as required by the FDA including:
  • Corrections and Removals
  • Death, serious injury and malfunctions
  • Non-conformities, customer complaints, recalls and post-market activities
• Review and ensure you, as the Manufacturer, comply with all FDA regulations and quality system requirements including:
  • Registration requirements
  • Labeling standards
  • Product safety
  • Adverse event reporting
  • Recall coordination and execution
  • Inspection requirements
  • Storage, handling and distribution
  • Importation laws and customs clearance
• Conduct Medical Device Tracking, if applicable
• Maintain all necessary records of the importation, sales, and distribution of Medical Devices in accordance with FDA traceability requirements

US FDA Agent Service (Optional)

In addition to our Importer services, we also offer US FDA Agent services for manufacturers who require this specific designation:

• Facilitating FDA communication with non-US-based manufacturers
• Providing swift responses to queries about your foreign establishment's devices intended for import into the US
• Assisting the FDA in scheduling inspections of your foreign establishment

Please note that the US Agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation, or submitting 510(k) Premarket Notifications.

Your FDA Official Correspondent

Our FDA Official Correspondent service is focused on engaging with the FDA concerning your establishment registration and device listing information.

Unlike the US FDA Importer, the Official Correspondent is not constrained to the US and can be a representative of your company, regardless of your company's location. However, some foreign establishments opt to appoint their selected US Importer as their Official Correspondent, ensuring they are the primary point of contact for FDA interactions.

FDA Establishment and Medical Device Registration Support

If you are involved in the creation, importation, reprocessing/rebranding, or specification development for medical devices or IVDs intended for commercial sale in the US, annual registration with the FDA is mandatory. This process, known as "Establishment Registration," is distinct from device clearances or approvals.

As your partner for US Importer services, Medical Device Registrations, and FDA Establishment Registration, we uphold the highest service standards to ensure your regulatory compliance.