Are you planning to import medical devices into the U.S., but do not want to establish an FDA registered US entity? Therefore, you will need an FDA registered initial importer &/or US Agent. Perhaps you have designated a distributor as your Initial Importer and/or US Agent and need to make a change, or you might want to use a distributor that is not registered with FDA. As your FDA registered Initial Importer and/or U.S. Agent, PaxMed will assist your company’s medical device importations into the U.S. by providing the services that FDA requires of an initial importer. We provide a simple approach for these services and would appreciate the opportunity to speak with you about realizing your U.S. marketing strategies for your medical devices. Please call PaxMed International at +1 (858) 792-1235 or +1 (877) 792-1235 or email us at info@paxmed.com. We will be in touch with you soon thereafter!
