FDA Medical Device Registration
Global Regulatory Compliance Consultants and US Agents for FDA Medical Device Registration and Listing
We have more than 15 years of experience in FDA Medical Device Registration & Listing.
FDA Medical Device Registration 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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MEDICAL DEVICE
FDA Registrations
MEDICAL DEVICE
Listings
from
25 COUNTRIES
EXPORT / MARKET MEDICAL DEVICE IN USA
in Just 3 to 4 working days by completing FDA Medical Device Registration & 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 2021-2022 Fees is $ 5672
* FDA Registration & Listing possible only for 510k exempt or 510k / PMA cleared devices
Device Classification
Device Classification
US FDA Classified Medical Devices into Class I, Class II & Class III
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FDA 510k
FDA 510k
Medium to High-Risk device must apply 510k before FDA Registration & Device Listing.
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Application Form
21 CFR 820
21 CFR 820
We support organization implement quality system requirement as per 21 CFR 820.
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