AF Pharma: US FDA Agent Representation for Medical Device and IVD Companies
In the United States, it is a requirement for medical device and IVD companies without a presence in the country to appoint a registered US FDA Agent. This agent acts as a liaison between your company and the FDA. At AF Pharma, we offer expert US FDA Agent representation services, ensuring that your regulatory obligations are met.
What is the representation requirement in the United States?
The representation requirement in the United States mandates that medical device and IVD companies without a physical presence in the country must appoint a registered US FDA Agent. This agent must be a resident of the United States or maintain a physical place of business in the US. The US FDA Agent acts as the bridge between your company and the FDA, facilitating communication and ensuring compliance.
What are the responsibilities of a US Agent?
Appointing a US Agent goes beyond fulfilling a regulatory obligation. The responsibilities of a US FDA Agent include:
Assisting the FDA in communications with your company:
The US Agent serves as a primary contact for the FDA, facilitating effective communication between your company and the regulatory authorities.
Responding to questions concerning your imported products sold in the US: The US Agent is responsible for addressing any inquiries or concerns from the FDA regarding your imported medical devices or IVDs sold in the US market.
Assisting the FDA in scheduling inspections of your facilities: The US Agent collaborates with the FDA to schedule inspections of your company's facilities when necessary.
Furthermore, the FDA may provide information or documents to your US Agent, which is equivalent to providing them to your company directly. Therefore, it is crucial to appoint a reliable and professional regulatory firm to represent your company's interests effectively.
Appoint AF Pharma as your registered US FDA Agent representation
At AF Pharma, we specialize in providing comprehensive regulatory consulting services for medical device and IVD companies worldwide. With over 12 years of experience, we have established ourselves as the largest regulatory consulting firm dedicated to medical devices and IVDs globally. Here's why you should choose us as your US FDA Agent:
Compliance expertise: We have a dedicated team of compliance specialists who ensure that your regulatory obligations are met efficiently, confidentially, and promptly.
Independent representation: As an independent "third party" representative, we prioritize your interests. We ensure that your company's needs are met and that you receive unbiased guidance throughout the regulatory process.
Global representation: In addition to being your US FDA Agent, we can also act as your in-country representative in 20+ other markets worldwide. Our extensive global presence sets us apart from other consulting firms, providing you with a single source for representation in multiple markets.
International offices: Unlike many other consulting firms offering representation services, AF Pharma maintains employee-staffed offices in Spain, Germany, UK, US, Japan, Australia, Canada, and various other countries. Our local presence ensures effective communication and support for your regulatory needs.
Hiring AF Pharma as your US Agent is a small investment that establishes professional representation for your company, ensuring compliance with FDA regulations and facilitating successful market entry into the US.