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3335 Tuscarawas Rd
Beaver, PA 15009

+1 412 418 8066

info@qaraconsultinggroup.com

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U.S. AGENT AND CORRESPONDENT

U.S. AGENT/
CORRESPONDENT

 

The FDA requires that foreign manufacturers that wish to sell their products in the United States have a US Agent that maintains a physical address within the United States.  We can act as this agent. 

 

In addition, devices must be registered with the FDA.  This is most easily accomplished with an official correspondent.  We can serve as a correspondent and, backed by decades of FDA communication, can quickly get your product to market.

REQUIREMENTS

 

This registration requirement applies to the following categories of foreign establishments:

  • Primary Manufacturers

  • Contract Manufacturers and Remanufacturers

  • Contract Sterilizers

  • Foreign Exporter of devices located in a foreign country

  • Specification Developers/Reprocessors of single use devices

OUR SERVICES

 

  • Assist FDA in communication with the foreign manufacturer/ establishment.

  • Respond to questions from the FDA regarding the foreign establishment’s devices that are offered for import into the US.

  • Assist FDA in scheduling inspections of the foreign manufacturer.

  • Reporting adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations) 

  • Initial Registration of a new Establishment via the on-line FDA Unified Registration and Listing System (FURLS).

  • Facilitate processing of Client’s payment of the FDA Establishment Registration Fee (annual requirement)

  • Initial Listing of medical devices that will be imported into and marketed in the US.

  • Update the on-line Registration and Listing records annually as required by FDA and as needed.

  • Provide an importation letter template, as requested, to facilitate importation.

  • Provide notifications and updates from the FDA regarding changes to the Registration and Listing requirements.