Medical Device Facility Registration with US FDA


We are consultants and US Agents helping manufactures, Exporters and Importers of Medical Device to sell there Medical Device In U.S.A. from across the globe.

The main services we provide include proper guidance, Registration, Listing and US Agent service. Readers are requested to read more about USFDA Medical Device Regulation before starting the activities.

Important

  • Make sure either the device is 510k exempted or you hold a valid 510k Number to proceed with Registration activities.
  • If you are an Initial Distributor or Reseller, make sure manufacturer has already Listed the devices.

Below table explains the FDA Medical Device Registration Process and Fees.

Steps

Activity

Fees

01

Appoint US FDA Agent

449 USD

02

Submit the Application Form online
  Need Expert Assistance? We charge 100 USD additional

Free!!

03

FDA Annual Fee for the Year 2019-2020 [ to be paid directly to FDA]

5236 USD

04

We will Complete the registration, Listings and Issue Agent Certificate.

05

Verify the Registration and Listing Details in FDA website
[ Type your company name in the establishment name column provided]

For payment and Invoice please write to enquiry@meddevicecorp.com

 


Our company experts will study, understand your Medical Device planning to launch in USA Market. Guide you correctly considering all the possible errors which can happen during filling. Our support ends with successful submission of Application Form till Facility Registration and Listing is over.

Yes, 500 USD includes 2 medical devices listing absolutely free. Additional medical devices will be charged 50 USD each.

It is not possible to to complete Establishment Registration. You must have atleast one 510k cleread or exempted device for FDA registration.

Once you submit the form, Our experts will cross verify and if found more number of devices for Listing we will send intimation/invoice or chek for various payment options.

2-3 weeks. Once FDA assigns the owner-operator number and Listing is completed, you can start marketing the medical devices in USA.


More information http://www.fda.gov/

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mail enquiry@meddevicecorp.com