Follow Us:

FDA Medical Device Registration Consultants and US Agents

More than 15 years of experience as global regulatory compliance consultants and US agents for FDA medical device registration. Start selling medical devices in the USA in just 3 to 4 working days.

US FDA Registration
Contact Us

FDA Medical Device Registration

Foreign and domestic establishments such as manufacturers, initial exporters, initial importers, and specification developers of medical devices intended to be sold in the USA must register and list with the US Food and Drug Administration. It is mandatory to designate FDA US agents by establishments located outside the USA for better communication with the FDA authorities.

FDA Medical Device registration and listing process

Step 1: Identify the Device Code and Regulation Number

The first step is to determine the device class, device code and regulation number. The device excluded from 510(k) can be directly listed with the FDA. 

Step 2: Appoint US Agent

Once you identified the device class and know the 510(k) status, appoint an FDA US Agent by filling out the below form online and making an annual payment.

US Agent Appointment form >>>


Verify device codes are correct, and that 510(k) exemption status is known before proceeding. If you need assistance, please contact us via link on the left


FDA US Agent will create a payment identification number (PIN) for submitting the annual registration fee for the current fiscal year

Step 3: FDA Annual Fee payment

Organisations must submit payments to the FDA via transfer or credit card using a PIN provided by the US Agent. Once payment is processed, the FDA will send a Payment Confirmation Number (PCN) to the registered email of the owner/operator. 

Step 4: Establishment Registration

Upon receipt of the PCN, the US Agent will complete FDA establishment registration. 

Step 5: FDA Medical Device Listing

Medical Device listing with codes will be completed in two business days. 

Step 6: Start Importing / Selling in USA.

Verify your establishment and device information before exporting to and/or marketing in the USA. 


Verify registration and listing status from the FDA Website >>>

Do you need an email containing full details within 2 minutes?

Medical Device Registration Cost

The US Federal government’s fiscal year begins on October 1 and ends on September 30.  Thus, the annual FDA registration fee is to be paid between October and December 31st.


  • FDA Establishment Registration Fee for FY 24 is $7653
  • Annual US FDA Agent Fee is $649
  • Device listing up to 5 devices $100/device


FDA Registration Fee payment is to be paid directly to FDA via wire transfer or credit card using the PIN provided by the US FDA Agent.


The medical device listing fee is for a maximum of three models/brands per device listing. There will be an additional fee of $50 per device if FDA device codes are not provided.


Additional Consultation of $50/device applicable for FDA device code verification/identification

Why I3CGlobal for Device Registration and Listing

We are an internationally renowned and highly regarded consultancy firm specialising in FDA regulatory compliance, and we proudly serve as US FDA Agents. Our comprehensive FDA regulatory services encompass, but are not limited to, the following:


  • US Agent service for foreign establishments
  • FDA Medical Device Registration and Listing
  • UDI and GUDID Service
  • Electronic Medical Device Reporting (eMDR)
  • Medical Device Master Files (MAFs)
  • Label Review
  • FDA Pre and post Inspection and 483 closing service
  • 21 CFR 820 Implementation and EN ISO 13485 Integration


With a proud history spanning 25 years, we’ve established ourselves as a formidable presence in the medical device industry. Our journey has taken us across the globe, with offices strategically located in Australia, Germany, India, Malaysia, Vietnam, Thailand, South Korea, the UK, and the United States (USA). This global footprint is a testament to our commitment to excellence and the relationships we’ve built over the years.

Establishment Registrations
Medical Device Listings
Serving Customers from

Why Foreign exporters Hiring FDA Agent?

The Federal Drug Administration (FDA) mandates that a foreign establishment engaged in the manufacturing, preparation, or processing of a device destined for import into the United States must appoint a US Agent. This designated US Agent must be a resident of the United States and be accessible to respond to FDA inquiries during standard business hours.


Additionally, as part of the registration process, the establishment is required to designate an Official Correspondent who will be responsible for the ongoing maintenance of the registration and device listing account. It’s worth noting that Qserve is well-equipped to fulfill both roles as both the US Agent and the Official Correspondent for establishments registered with the FDA.

Frequently Asked Questions (FAQ's)

How do I search for FDA Medical Device Establishment Registration?

Establishment Registration and Listing Search

FDA Website Link >>

How to check DUNS?

Use the below presentation

Read More>>

Best service offer for US FDA Medical Device Establishment Registration and Listing