FDA Medical Device Registration & Listing
With over 24 years of experience as US FDA Consultants and Agents for Medical Device Registration and listing, we can help you start selling your medical devices in the USA in as little as 5-8 working days.
Contact Us
FDA Medical Device Registration
FDA Medical Device Registration cover 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 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.
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
Step 5: FDA Medical Device Listing
Step 6: Start Importing / Selling in USA.
Verify registration and listing status from the FDA Website >>>
US FDA Establishment Registration Fee
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 25 is $9280
- The annual US FDA Agent Fee is $649
- Device listing up to 5 devices $100/device
US FDA Medical Device 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 FDA Medical Device Registration
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
- 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.
Would you like an email with all the details sent within 2 minutes? Privacy Policy>
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 FDA Medical Device 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 I3CGlobal is well-equipped to fulfil both roles as both the US Agent and the Official Correspondent for establishments registered with the FDA.