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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 involved in the production or distribution of Medical Devices intended to be sold in the USA must register and list with the FDA. It is mandatory to designate FDA US agents of establishments located outside the 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

Establishment Registration & Listing

Medical Device FDA Registration in 3-8 working days!
Assistance with FDA Classification, FDA Code and DUNS Number

Fees start as low as 300 USD

US Agent appointment and FURLS system setup

US Agent Annual Fees is 649 USD
(Application form refer bottom of this page)

Facilitate with fee payment and Device Listing

FY 19-20, FDA Fees is 5236 USD
Device Listing is 200 USD / device

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Application Form

Application Form

Customers can fill the online application form and make payment.

Fill it Online!
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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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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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21 CFR 820

21 CFR 820

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

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