FDA US Agent

CMC Medical Devices offers US FDA Agent Representation for Medical Device

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.

Select CMC as Your FDA agent in the United States

Complete the contact form and one of our consultants will get in touch as soon as possible.

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Frequently asked questions about FDA Registration Agent

Yes, any foreign company that wants to sell FDA-regulated products in the U.S. market must appoint a U.S.-based FDA agent.

The agent is responsible for receiving and forwarding communications from the FDA, coordinating inspections, and responding to inquiries on behalf of the foreign company. They do not make operational decisions but are essential for ensuring compliance with FDA regulations.

No, the agent only acts as a communication link between the company and the FDA. The company remains fully responsible for the quality, safety, and compliance of its products.

Yes, your distributor or any individual/entity based in the U.S. can be designated as your agent, provided they are willing to assume the responsibilities that come with the role.

Costs vary depending on the service provider and the level of support offered, but it’s important to hire a reliable agent since they play a crucial role in communication with the FDA.

Why appoint CMC Medical Devices as your FDA Agent?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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