US Agent for FDA Medical Device Establishment Registration

Who Needs Medical Device Establishment Registration?

• Manufacturers, including contract manufacturers
• Specification developers
• Contract sterilizers
• Repackagers and relabelers
• Reprocessors of single-use devices
• Foreign exporters of devices to the US
• Initial importers based in the US

Registration does not replace premarket requirements. Many devices also need FDA 510(k) clearance before they can be listed and sold.

Registration and Device Listing Requirements

• Payment of the annual establishment registration user fee before registering
• Establishment name, address and owner or operator details
• Official correspondent contact
• US Agent details (foreign establishments)
• Device listing for each device, with its FDA product code and 510(k), De Novo or PMA number where applicable
• Activities performed at the establishment for each device

Annual Renewal Between October 1 and December 31

Medical device establishment registration must be renewed every year between October 1 and December 31, with the annual user fee paid first. Device listings must be reviewed at the same time. If a registration is not renewed, the establishment is no longer considered registered and devices may be refused entry at the US border.

US Agent for Medical Device Establishment Registration

Every foreign device establishment must name one US Agent. FDA emails the US Agent to confirm the appointment before the registration is accepted. The US Agent must be physically present in the US and available during business hours. FDA – U.S. Agents. MedDeviceCorp acts as your US FDA Agent for device registration.

Our Medical Device Establishment Registration Process

1. Classification check – we confirm device class, product code and any premarket requirement.
2. User fee – we guide you through paying the annual establishment registration fee.
3. Registration – we submit your establishment registration in FURLS.
4. Device listing – we list each device with the correct product code.
5. US Agent confirmation – we accept our appointment as your US Agent.
6. Annual renewal – reminders and renewal every October to December.

Device Listing and FDA Product Codes

Every device sold in the US must be listed under the correct FDA product code, which links the device to its classification regulation and premarket pathway. For Class II and most Class III devices, the listing must show the 510(k), De Novo or PMA number. Exempt Class I and some Class II devices are listed without a premarket number. Choosing the wrong product code is one of the most common listing errors, and it can cause problems at import.

Common Reasons Device Registrations Are Delayed

• User fee not paid first – FDA will not accept the registration until the annual fee payment is confirmed.
• US Agent does not confirm – FDA emails the US Agent, and the registration stays pending until the agent replies.
• Wrong establishment type – for example registering as a manufacturer when the site is a specification developer or contract sterilizer.
• Missing premarket number – a device needing 510(k) clearance is listed before clearance is obtained.
• Late renewal – registration not renewed between October 1 and December 31.

After Registration: Quality System and Post-Market Duties

Registered device establishments must follow the Quality Management System Regulation (QMSR) in 21 CFR Part 820, which now aligns with ISO 13485. They must also report adverse events under the Medical Device Reporting rules (21 CFR Part 803) and, for most devices, meet Unique Device Identification (UDI) requirements. FDA can inspect foreign device establishments at any time. FDA – U.S. Agents

How Long Does Medical Device Establishment Registration Take?

The registration itself is an online submission, but a few steps must happen in order:

• Classification check – confirming the product code and whether 510(k), De Novo or PMA is needed first.
• User fee payment – the annual establishment registration fee must be paid and confirmed before registration.
• Registration and listing in FURLS – establishment details and each device are entered.
• US Agent confirmation – FDA emails your US Agent, and the registration is completed once the agent confirms.

For devices that are exempt or already cleared, registration usually moves quickly once the fee is paid. We give you a clear timeline after reviewing your devices and documents, so you can plan your first US shipment.

Why Choose MedDeviceCorp for Medical Device Establishment Registration?

At MedDeviceCorp, one team of regulatory specialists prepares your medical device establishment registration and device listing, acts as your US FDA Agent and tracks every renewal date, so you are not juggling separate providers.

• Registration prepared and checked by regulatory specialists, not a form-filling service
• US Agent confirmation handled promptly when FDA sends the request
• Renewal reminders well before each FDA window opens
• Support with related FDA, EU Representative and UK Responsible Person requirements

Medical Device Establishment Registration FAQs

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