US FDA Agent
for Medical Devices

Appoint Cert3global as your registered US FDA Agent representation and learn about our responsibilities as the Intermediary between your medical device organisation and the FDA. Read below to understand the responsibilities, considerations .

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Who is a US FDA Agent?

  • US FDA [Food and Drug Administration] Agent acts as a primary point of contact between the facility (of foreign manufacturers) and the FDA for routine registration matters or in case of any emergency.
  • If you are a medical device manufacturer looking to export in the United States, then you must appoint an FDA Agent.
  • 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.

What are The Responsibilities of FDA Agents?

An FDA Agent must:
  • 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.

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.