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 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.
Our core values shape the culture of our organization and define the character of our company!
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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