Interpreting FDA’s requirements for US Agent representation can be a daunting task… but Qserve Group US, Inc. can assist manufacturers with navigating this process.
What are the FDA requirements for bringing your medical device to the US market?
Establishments located outside of the United States, which are involved in the production and distribution of medical devices for commercial purposes, are required to:
(1) identify a United States (US) Agent for that establishment/facility;
(2) register their facility with the FDA prior to exporting devices for import into the US.
To whom will these requirements apply to?
Such establishments include: contract manufacturers and sterilizers, custom device manufacturers, foreign exporters, foreign manufacturers (including kit assemblers), manufacturers of components, re-labelers/re-packagers, remanufacturers, re-processors, establishments that maintain complaint files and specification developers.
What you need to do prior to, or during the registration process?
The establishment must designate a US Agent to act as a liaison between FDA and the registered party. The Agent must reside at a US address (not a PO box) and be available to assist FDA during regular business hours. Communication between FDA and US Agents may include responding to questions concerning devices registered for import, assistance with scheduling FDA inspections of foreign establishments, and general questions about an establishment’s activities.
Included in Qserve’s US Agent service contract, is initial FDA establishment
Registration and Listing of devices to be imported, and annual renewals and updating to the registration and listing information. The initial registration and listing must be made in FDA’s online database before importing devices, but after obtaining 510(k) clearances and PMA approvals
. All imported devices,
regardless of Class (I, II and III) must be Listed before import.
What are the advantages of Qserve’s US Agent service?
Qserve includes 4 hours of service with its annual US Agent contract, allowing clients to request changes to their account such as updating a facility address, deleting or activating device listings, adding initial importers, and managing the account through FURLS (FDA’s Unified Registration and Listing System) at little or no additional charge. Manufacturers (and other registered establishments) are notified by the agent when FDA’s annual registration and renewal period is approaching, and the US agent can assist with facilitating payments on the establishment’s behalf. FDA’s fiscal year begins October 1st and ends September 30th of the following year. For FDA’s fiscal year 2018, the annual registration fee for establishments is $4,624. This fee can fluctuate year-to-year and is published by FDA before the annual renewal period begins.
Do not be intimidated by the various acronyms associated with FDA, such as; FURLS, DFUF, CDRH, DRLM, OC, and OO, to name a few. With Qserve, designated as your organization’s US Agent
, the process from initial registration through annual renewal can be simplified, and painless.
If questions remain about the role of a US Agent, please contact us for more information.
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Jennifer Hadfield, US Agent Representative