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Importing into the United States and into its highly regulated markets can be confusing, complex, and costly -- particularly if you lack the information you need to comply with the myriad of federal & state regulatory requirements. Once you make that first attempt, you may find a US agency refuses to allow your product across the border, out of Customs custody, or into the U.S. market. This can be very costly to you and your importing clients. Don't let it happen to you. Be prepared: Be compliant. |
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As part of a Food, Drugs, Cosmetics or Device facility registration, each company outside the USA must appoint and notify FDA of their United States agent. The role of the U.S. agent is to act as a communications link between the facility and FDA, FDA will communicate with the U.S. agent in both routine and emergency situations. This means that we, as your U.S. agent, are accessible to FDA 24 hours a day, 7 days a week. |
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U.S. Agent An U.S. agent means a person residing or maintaining a place of business in the U.S. whom a foreign facility designates as its U.S. agent for purposes of the registration regulation. The U.S. agent acts as a communications link between FDA and the foreign facility. FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent equivalent to providing the information or documents to the foreign facility. Having a single U.S. agent for the purposes of registration does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes. |
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One of the most important choices you, as a manufacturer of medical devices and/ or laboratory equipment, will need to make is appointing a proper authorized Regulatory Designated Agent before the FDA. |
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From the very moment you appoint us as your Regulatory Designated Agent before FDA we shall handle all your regulatory affairs: registration and listing of devices and manufacturers, as well as corresponding, complaint handling and reporting regulatory issues to FDA in the USA. |
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What are the Responsibilities of the US Regulatory Designated Agent? |
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The responsibilities of the Regulatory Designated Agent are: |
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Assisting FDA in communications with foreign establishments, |
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Responding to questions concerning the products of foreign establishment that are imported or offered for import into the United States. |
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Assisting FDA in scheduling inspections of the foreign establishment |
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Contact us:. for complete & reliable answers to questions about FDA Compliance or Enforcement problems, Customs matters involving FDA regulated products, or import and export requirements. |
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