European Authorized Representative Center

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USagent

EAAR MEMBER

ISO 9001:2001

NON-U.S. MEDICAL DEVICE MANUFACTURERS

In November 2001, the U.S. Food & Drug Administration (FDA) published the final regulation, All foreign manufacturers, who wish to market medical devices in the U.S., must retain the services of a U.S. Agent and identify that agent for the U.S. Food and Drug Administration (FDA). The Obelis U.S. Agent office collaboration with Qserve America, Inc. (QSA) As a U.S. Agent, implementing the new requirement for every non-U.S. manufacturer of drugs and medical devices to appoint a U.S. Agent

FDA requirement.

The primary function of a U.S. Agent as defined in the federal regulations is to serve as a point of contact for the FDA in communicating with a foreign device manufacturer. The U.S. Agent must have a domestic U.S. street address (no post office box number). The U.S. Agent will be contacted, whenever the FDA cannot contact the manufacturer directly. The U.S. Agent will also assist in scheduling FDA inspections of the manufacturer’s facilities.

With over 24 years of US FDA and international regulatory and quality experience, Qserve America, Inc. working with the Qserve Group, B.V. and as a member of the One Link One Solution network, provides coordinated American and European regulatory and quality strategic planning, guidance and implementation from design and development through market launch, including all regulatory documentation and filings. These services are provided to medical device companies worldwide. Additional services include training in FDA regulations and project management, US Medicare reimbursement assistance, and identification of US distribution partners.