mdi ConsultantsUS Agent Services
U.S. market presents an attractive business opportunity for many foreign companies in the medical device, pharmaceutical, cosmetic and dietary supplement fields.
Do you know that to be able to enjoy the privileges of marketing and distributing regulated products in U.S., every foreign establishment must designate a U.S. Agent? U.S. Agent is required by FDA for all companies that do not have a place of business within the U.S. If you are a foreign based manufacturer, you will not be able to register your facility, list your products and even submit your FDA marketing authorization applications unless you designate a U.S. Agent.
Identification of and contact information for a U.S. agent is required for all foreign manufacturers when they register and list with FDA.
In addition, for all Pre-market Applications (PMA) for class III devices submitted by an applicant that does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative residing or maintaining a place of business in the U.S. and must identify the representative’s name and address.
Furthermore, to facilitate timely communication, US FDA recommends that a U.S. representative is included for all submission types (e.g. 510(k), pre-Submission, 513(g)), in addition to PMAs where U.S. representative is legally required.
The responsibilities of U.S. Agent include:
- assisting FDA in communications with the foreign establishment
- responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States
- assisting FDA in scheduling inspections of the foreign establishment
- if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment
Over the years, mdi Consultants successfully represented many foreign based companies as their U.S. Agent. Besides fulfilling all the responsibilities required for a U.S. Agent under the law, we also pride ourselves on being an effective liaison between the client company and the FDA. We assist with all communications between the Agency and the company, scheduling and negotiation of FDA inspections, import detention issues and any other compliance questions that may come your way.