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:

Search News & Events

  • Filter by category


Related news and events

NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

The European Union’s AI Act & its Impact on Medical Devices

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting