FDA US Agent Representation

The Food and Drug Administration (FDA) requires all medical device and IVD companies without an office in the United States to appoint a registered US Agent. The US Agent must be a resident of the United States or maintain a legal office for business in the United States. Techlink International Consulting, LLC can serve as an official US Agent medical device and IVD companies. We do not offer US Agent services to food or pharmaceutical companies.

Do contract manufacturers and sterilizers need to appoint a US Agent?

Yes, all foreign manufacturers and foreign sterilization companies of finished medical devices must appoint a US Agent regardless of whether the manufacturer/sterilizer puts the device into commercial distribution or returns the device to the customer.

Why appoint Techlink International Consulting, LLC as your US FDA Agent?

• We act as a liaison between your company and the FDA.
• We respond to questions regarding your products and can assist you and the FDA to schedule inspections.
• Manufacturers who appoint distributors as their FDA US Agent can experience challenges.
• Minimum yearly fee for US Agent representation.

US FDA Agent / Establishment Registration

FDA Designated Agent | U.S. Designated Agent

Monday, 10 May 2010 08:49

All Foreign products to be imported into the US must receive FDA approval. You will need to register with the FDA as well as appoint a US Agent. Such regulations apply to products such as Human Drugs, Animal Drugs, Biological Products, Devices and Foreign Food.

Why is a US Agent Required?

The US FDA holds the US Agent responsible for the following steps: Having an actual physical office within the USA

U.S. Agent Program for Pharmaceutical / Medical Device Manufacturers

Reporting all updates related to the registration and product listing processes Acting as a mediator between the FDA and the Company regarding various issues such as the inspections of the foreign site.

Foreign Facility’s Responsibilities towards the US Agent

The US Agent must be aware of any changes related to the Establishment Registration such as a change of address, phone or fax number, or ownership The Foreign Facility is responsible for notifying the US Agent regarding any changes made to existing products already listed as well as any new products

To learn more from a US FDA Designated Agent, please go to FDA GMP Overview Training.

Establishment Registration

All domestic and foreign manufacturers as well as importers of medical devices must register with the FDA.

All registered firms receive form FDA-2891(a) from the FDA every year. It is your responsibility to check and amend what need be and to return the form back to the FDA. Please note that foreign manufacturers are also required to designate a US Agent.

What Is Medical Device Listing

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Who Must List

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment including devices imported to the US.

The following establishment types are required to list their devices:

Contract Manufacturer

Manufactures a finished device to another establishment’s specifications and places the device into commercial distribution.

Contract Sterilizer

Provides a sterilization service for another establishment’s devices and places the device into commercial distribution.

Manufacturer

Makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Remanufacturer

Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or in any way changes the intended use.

Repackager and/or Relabeler Repackager

Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers). Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment’s own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Specification Developer

Develops specifications for a device that is distributed under the establishment’s own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

Foreign Exporter

Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign

Initial Distributor

Importer

Medical Devices Registration & Listing Exemptions

(a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part.

(b) A manufacturer of devices to be used solely for veterinary purposes.

(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.

(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.

(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy.

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.

(g) [Reserved]

(h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers.

(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic x-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic