REPRESENTAtion | Usa

We are your FDA agent in the United States

We offer FDA Agent services in the United States to ensure that your products comply with FDA requirements and can successfully enter the US market.

FDA Agent in the United States

As a foreign manufacturer of medical devices and/or IVD products destined for the United States, you can ensure your path to success in the market by partnering with our exclusive FDA agent services in the USA.

With CMC as your trusted agent in the USA, you can focus on your core business while we handle regulatory complexities for you.

Secure your position in the US market by ensuring that your devices are imported smoothly and compliantly.

CMC MEDICAL DEVICES LLC, with our team of professionals who have extensive knowledge and experience in FDA regulations and requirements, will navigate the complexities on your behalf.

Our functions as your FDA Agent in the USA:

  • Verify your labels and technical documentation to ensure compliance.
  • Provide guidance on establishing product safety justification.
  • Have documentation to substantiate safety.
  • Register your facilities and products.
  • Maintain updated records.
  • Advise you on regulatory requirements.
  • Receive, evaluate, and record adverse events.
  • Report and register serious adverse events.
  • Represent you before the FDA.
  • Support you in case of market withdrawals, registration suspensions, inspections.
  • Inform about regulatory updates.