Establishment Registration

In accordance with the medical device regulations set by the U.S. FDA, all medical device companies involved in the development, manufacturing, packaging, assembly, labeling, export, or import of medical devices are obligated to register with the FDA (FDA Device Establishment Registration) and pay an annual FDA user fee. The fee for the year 2023 amounts to $6,493. Additionally, these registered medical device establishments must individually list all their medical devices (FDA Device Listing) before they can be commercially distributed in the U.S. market. Furthermore, any medical device companies located outside the United States are required to appoint an official correspondent, also known as a U.S. agent, who serves as the primary point of contact with the FDA prior to importing into the United States.

Importance of Having a U.S. FDA Agent

The role of the U.S. agent is crucial as they may be called upon to communicate with the FDA on behalf of the foreign registered facility. This can be a time-sensitive matter. Therefore, it is imperative that the U.S. agent possesses a comprehensive understanding of FDA regulations and is capable of advising the foreign establishment on the specific FDA medical device requirements that must be adhered to. Moreover, having an independent U.S. agent helps avoid potential conflicts of interest that could arise when assigning a business partner as the U.S. agent.

AF Pharma: Your U FDA Agent

AF Pharma is a leading provider of FDA medical devices establishment registration and medical device listing services. We offer our expertise to non-U.S. companies that are already operating in the market or planning to enter the U.S. market. By choosing AF Pharma as your U.S. FDA agent, you can ensure compliance with FDA regulations and receive reliable guidance throughout the registration and listing process. To initiate your medical device establishment registration and device listing, simply click the start button provided on our website.

FDA Registration Certificate

Upon the completion of your registration, your medical device establishment will be assigned a unique FDA registration number. This number serves as your company's identification with the FDA and aids in the customs clearance process. It is important to note that the FDA does not issue registration certificates. However, as a third-party firm, AF Pharma will furnish you with a certificate of FDA registration, which can be used as confirmation of your registration with the FDA. The FDA registration certificate is valid for one year, and you can present a copy of it as proof of registration to U.S. customs, importers, distributors, and other commercial outlets.

Ensuring Compliance and Market Access

Complying with the FDA's medical device regulations is vital for companies wishing to operate within the U.S. market. By partnering with AF Pharma as your U.S. FDA agent, you gain access to our extensive knowledge and experience in navigating the FDA registration and listing requirements. We strive to facilitate your entry into the U.S. market while ensuring regulatory compliance, allowing you to focus on delivering innovative medical devices to improve patient care.

Don't hesitate to contact AF Pharma today to begin the process of U.S. FDA medical device establishment registration and device listing. We are here to support you every step of the way, providing the expertise and guidance you need to successfully navigate the complex regulatory landscape.