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Medical Devices Establishment FDA Registration & Device Listing

Who must register with the FDA?

According to the U.S. FDA, all medical device establishments that develop, manufacture, pack, assemble, label, export, or import medical devices into the US must register with the agency and pay an annual user fee of 9,280 USD (2025). Registered medical device establishments must also list all their medical devices individually through the Device Listing process before starting commercial distribution in the U.S. market. Medical devices cannot be cleared to enter the US market without a valid device listing number.
In addition to device establishment registration and listing, all medical device firms outside the U.S. must appoint a U.S. agent as the FDA’s primary point of contact. The owner or operator of a medical device establishment, whether domestic or foreign, must also appoint an official correspondent for the company. Device establishment registration must be renewed every year.
Third-party trading companies that purchase medical devices from foreign suppliers, referred to as foreign exporters, must register with the FDA and pay an annual fee. The foreign exporter registration will not exempt the original manufacturer of the medical device from registering and listing their products with the FDA. Additionally, companies that import medical devices into the U.S., known as initial importers, must register and pay the annual FDA fee.

What is FDA device classification?

Companies must classify medical devices for proper listing as part of device establishment registration. The FDA categorizes medical devices into three classes: Class I, Class II, and Class III, based on the associated risks, with Class III representing the highest risk. The FDA Device Classification Database contains device names, technical descriptions, and related product codes that identify a device’s generic category for the FDA.
Upon registration, medical device establishment registration information becomes available on the FDA Device Establishment Database, yet a specific part of information known as the device listing number will remain private. This is because the FDA aims to honor medical device establishments’ sovereignty and exclusivity rights over the import and marketing of their products.

Required information & registration steps

When applying for a medical device registration number, the following information is required:
● DUNS number and Tax ID/EIN (only for US firms)● Establishment name, address, and official correspondent● Information on the owner, operator, or agent in charge● Device classification and types of activities conducted● List of trade names (brand names)●U.S. Agent who has accepted the designation

Medical Device FDA Registration Process Cost: $494

  • Step 1
    Complete the initial form below, and tell us about your company
  • Step 2
    We will issue you a short and simple questionnaire to collect additional company and medical device details
  • Step 3
    We prepare a draft for your review and approval, then submit it to the FDA
  • Step 4
    We will work with the FDA to get your medical device establishment registered (1 week)
  • Step 5
    Your medical device establishment and device listing will be FDA registered, and we will issue your FDA Agent Pro certificate
A Few Important Things To Note: - Our fee includes U.S. Agent services for foreign companies. We provide professional U.S. Agent representation to facilitate compliance and communication with the U.S. FDA. No additional fees required for U.S. Agent services. - FDA registration is not the same thing as FDA clearance or approval. Registration simply informs the FDA company’s activities and device portfolio. 510(k) clearance or Premarket Approval (PMA), by contrast, is the FDA’s formal evaluation and acceptance of a product’s safety and effectiveness. In short: registration is about presence. Approval is about performance. Failure to register and list a device as required may result in regulatory enforcement actions by the FDA, including product seizures, injunctions, fines, or import bans. - Medical device facilities are also required to pay FDA registration fees (for 2025 $9,280). We can help you set up your account and create your PIN to pay your fees directly to the FDA. - Includes Device Listing (5 classes) and free assistance to update the registration/listing information

Medical Device Establishment Registration And Device Listing Form

Include suffix e.g, LLC, Limited, Inc, Pte Ltd, Pvt Ltd, etc.
This should be the facility address where the products are manufactured, packed, processed, or stored.
You will receive a receipt code to this email to confirm the medical device registration. Please provide the correct email address.
Include Country Code
Quantity of medical device(s) intended for US distribution
Importer of Record
I Agree With The Terms and Conditions and Scope of Services Below
Medical Device Establishment FDA Registration Terms and Conditions / Scope of Services

U.S. FDA Agent

Foreign companies must appoint a U.S. agent to be able to register with the FDA. The agent can serve as the primary contact with the FDA on behalf of a registered company. Simple mistakes during online registration can create critical adverse situations when the devices are at the U.S. port of entry. Therefore, it is crucial that the U.S. agent understands FDA regulations and can advise the company on FDA compliance requirements. Additionally, an independent FDA agent can prevent potential conflicts of interest when using a trade partner as an agent. Our fee includes U.S. Agent services for foreign companies. We provide professional U.S. Agent representation to facilitate compliance and communication with the U.S. FDA.
To clarify, the FDA neither approves nor disapproves US agent firms. During initial registrations, renewals, and updates to information about U.S. agents, the FDA will verify that the person or company identified as the U.S. agent for the foreign establishment has agreed to serve as the agent.

FDA Registration Certificate

Although the FDA does not issue certificates, upon completion of registration, FDA Agent Pro will provide a valid registration certificate for the current year that can be used as proof of registration. A copy of the certificate can also be used to confirm registration with U.S. customs, importers, distributors, and other commercial outlets. Please call or email us if you need medical device establishment registration assistance.