Medical Device FDA Registration
Global Regulatory Compliance Consultants and US Agents for Medical Device FDA Registration and Listing
We have more than 15 years of experience in Medical Device FDA Registration & Listing.
Foreign and domestic establishments such as (a) Manufactures (b) Initial Exporters (c) Initial Importers of Medical Devices intended to be sold in the USA must register and list with the FDA. It is mandatory to designate FDA US Agent by establishments located outside USA for better communication with the FDA Authorities.
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EXPORT / MARKET MEDICAL DEVICE IN USA
in Just 3 to 4 working days by completing FDA Registration & Medical Device Listing
Assistance with FDA Classification, Device Code Identification, DUNS Validation & Device Listing
Up to 03 Devices only $ 750 (each additional devices $ 100 each)
US Agent appointment and FURLS system setup
US Agent Annual Fees is 649 USD
(Application form refer bottom of this page)
Facilitate with US Government (FDA) fee payment
Financial Year 2020-2021 Fees is $ 5546
* FDA Registration & Listing possible only for 510k exempt or 510k / PMA cleared devices