In order to market your product in the United States, it will need to clear the import requirements set forth by the US Food and Drug Administration (FDA). In addition to product approval or clearance, the FDA has strict requirements for labeling, reporting, traceability, and more. Failure to comply with these regulations can have serious consequences for commercial success. Kapstone has extensive experience in this area and can help you position your product and company for compliance while focusing on the needs of the business.
Companies that sell products within the U.S. are required to register their company with the FDA and to list the products they are selling. If you do not have an in-country presence already, Kapstone can import your products for sale and distribution. Call us to learn more.
In addition to import requirements, if your company is based outside the United States but you wish to commercialize in the U.S. market, you will need to appoint an authorized representative. Kapstone can assist here along with being an official correspondent for FDA submissions.