ESTABLISHMENT REGISTRATION (FDA MEDICAL DEVICE REGISTRATION)

The manufacturers, initial exporters, initial importers, labeller, reprocessor, specification developer, US manufacturer for the export only medical device and contract sterilizers of facilities intended for use in the United States are required to register with the FDA on an annual basis. Establishment registration is the term for this procedure (Title 21 CFR Part 807).

All establishments that are required to register with the FDA must also specify the devices they manufacture and the operations they do on those devices. majority of the device needs 510k, De Novo, PMA, PDP, HDE number prior to listing.

MEDICAL DEVICE LISTING

The process of Listing is explained below.

  • Check facility DUNS number

  • FURLS account creation and FDA fee payemnt

  • Identify the device code and regulation number

  • Confirm the device name and trade name along with models

  • Receipt of FDA fee payment confirmation

  • Verify Registration and Listing details in FDA Website

FDA US AGENT

The US Agent Service is vital for FDA medical device registration of foreign medical and in-vitro diagnostic devices manufacturers and initial exporters.

Check the responsibilities of the US agents.

BEST PRICE OFFER

Appointing the US Agent, Making a payment to FDA, Complete the registration and Listing all can be completed in just 2-3 days.

  • 24X6 Chat support

  • 6 days working and processing files

  • Economic pricing and polite staff

Annual US Agent Fees: $449

Device Listing one-time fee: $100

Annual US Agent Fees: $549

Device Listing one-time fee: $100

Annual US Agent Fees: $649

Device Listing one-time fee: $150

Review and Guide device Label $950

Timeline: 7 Working days

FDA REGISTRATION FORM

Medical Devices

Registration and Listing can be completed in 3-4 working days. This is not an FDA form.

TRANSFER OF US AGENT

MEDICAL DEVICES

We are happy to act as US Agent for any non-US manufacturers.  Please bring us the FDA FURLS account details to update the Agent Infomation.

CONTACT US

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