US FDA Agent For Medical Device

For foreign manufacturers looking to market their medical devices, pharmaceuticals, or food products in the United States, appointing a US FDA Agent is a critical regulatory requirement. We offer specialized US FDA Agent services to ensure seamless communication with the FDA and compliance with all regulatory obligations.

A US FDA Agent acts as a liaison between foreign manufacturers and the FDA. This agent is responsible for facilitating communication, responding to FDA inquiries, assisting with product registrations, and ensuring timely submission of regulatory documents. Having a reliable FDA Agent is essential for maintaining compliance and addressing any regulatory issues that may arise.

Cert3global is a reputed and experienced FDA Agent for assisting medical device manufacturers (also food, drugs, nutraceuticals, toys, and cosmetic exporters). Each Foreign manufacturer must appoint only one US Agent & can also (not required) appoint them as its official correspondent.

Responsibilities of US FDA Agent!

  • Serve as a liaison (bridge) between the FDA and foreign manufacturers.
  • Be aware of the latest happenings from the FDA.
  • Facilitate facility registration and account maintenance
  • Communicate with the FDA as needed
  • Provide label review services and GMP[Good Manufacturing Practice]  guidance (additional fees may apply)
  • Assist the FDA with scheduling foreign facility inspections
  • Conduct annual registration updates
  • Update importer information for drugs and medical devices
  • Allow additional listings throughout the service year
  • Perform initial Registration and listing
  • Verify DUNS [Data Universal Numbering System] numbers and addresses
  • safeguard login information, and Issue Registration Certificates.

Additional Information

Key Considerations When Choosing a US FDA Registration Agent:

Foreign Medical Device manufacturers and exporters must be careful about selecting competent FDA Agents who are established & have relevant regulatory experience.
Following are the key considerations you should keep in mind :

  •  Ensure the firm is officially registered in the USA
  •  Look for expertise across Drugs, Food, Medical Devices, and Cosmetics regulations
  •  Avoid solo practitioners working from home or small setups
  •  Seek out a team dedicated to regulatory compliance on a full-time basis
  •  Opt for a partner who stays up-to-date with FDA regulatory changes and shares them openly
  •  Choose a neutral partner with no ties to US importers or dealers

Should you hire a distributor instead of a professional Regulatory Firm as an FDA Agent?
We understand that at prima facia, it seems logical and cost-effective to appoint a distributor as your Agent, but do consider the following aspects also:

  • A distributor is appointed to sell your device, they may not be a regulatory expert.
  • They may not have the right competence to detail uncertain situations(like technical faults, urgent FDA communications, or requirements)
  • If you change distributor, then transferring your sensitive details in between and updating the FDA may not be a smooth process.

A distributor‘s interests may not be in sync with your interests all the time. That’s where we do our part, as an experienced regulatory expert, we don’t have any conflict of interest in serving you in the best way, and also assisting you (acting on your behalf) in any uncertainty. hat’s why hiring a regulatory expert like cert3global will be a better idea than a distributor respectively for you in the long term.

Who is an Official Correspondent? How are they different from US FDA Agents?
During the time of establishment registration, a person identified as the first person to contact (during the time of any issue) is called an Official Correspondent.
However, unlike FDA Agent:

    • It is not necessary to appoint an Official correspondent
    • Correspondent need not stay (or be established) in the US

Many times, clients prefer to appoint Cert3global as their Official Correspondent to ensure seamless communications and dealing with the FDA on their behalf.

Appoint Cert3global as your US FDA Agent

  • Cert3global brings over two decades of expertise as an official US Agent for numerous medical device and IVD [In Vitro Diagnostics] companies worldwide.
  • As a leading regulatory consulting firm specialising in medical devices and IVDs, we offer unparalleled compliance solutions tailored to your needs.
  • Our dedicated team is committed to handling your regulatory obligations promptly, professionally, and with utmost confidentiality.
  • Serving as an independent representative, we prioritise your company’s interests, ensuring unbiased support and advocacy.
  • With representation available in multiple global markets, we provide comprehensive coverage to support your international expansion.
  • We maintain direct communication and support through our staffed offices in key locations, including Germany, France, the UK, and more.
  • Choosing us as your US Agent guarantees professional representation and regulatory compliance at a competitive value.

Connect with our consultant for free by sending us a query, we will help you in the best way possible.

Our Comprehensive FDA Agent Services

At CERT3Global, our experienced team provides end-to-end FDA Agent services tailored to your specific needs. Our services include:

  • Regulatory Support: We assist with product registration, facility registration, and other regulatory submissions.
  • Communication Facilitation: We manage all correspondence with the FDA, ensuring prompt and accurate responses to inquiries.
  • Compliance Monitoring: Our experts keep you informed about changes in FDA regulations and ensure ongoing compliance.
  • Emergency Assistance: In case of any regulatory emergencies, we provide immediate support to address and resolve issues.