SERVICES | US Agent

January 10, 2024

Are you a medical device manufacturer looking to sell your products in the United States?

The FDA requires that all foreign manufacturers have a US Agent to act as their official representative in the United States. At Asphalion MedTech, we offer comprehensive US Agent services for medical device manufacturers looking to expand their business in the US market.

How can we help you?

  • Assistance with FDA registration and listing requirements
  • Expert guidance on US regulations and compliance requirements
  • Support for post-market reporting obligations, including adverse events, corrections, and removals
  • Coordination with FDA on behalf of the foreign manufacturer
  • Assistance with communications with FDA, including responses to inquiries and requests for information

 

Check out all the services we can offer you and how we can adapt them to your project: US AGENT SERVICES

For further information you can contact us at: medtech@asphalion.com

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