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Medical Device FDA Registration

Global Regulatory Compliance Consultants and US Agents for Medical Device FDA Registration and Listing

US FDA Approval

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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Medical Device FDA Registration
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850

MEDICAL DEVICE
FDA Registrations

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6000

MEDICAL DEVICE
Listings

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25

from
25 COUNTRIES

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

Medical Device FDA Registration 1

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

Application Form

Customers can fill the online application form and make payment.

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21 CFR 820

21 CFR 820

We support organization implement quality system requirement as per 21 CFR 820.

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