MEDICAL DEVICE FACILITY REGISTRATION


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 step by step simple process in detail.

Steps

Activity

Fees

01

Appoint US FDA Agent

500 USD

02

Submit the Application Form online
  Need Expert assistance?   Fees is

150 USD

03

FDA Registration Fee for the Year 2016 [ to be paid directly]

3845 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]

Payments made from USA

USFDA Medical Device Registration

Payments made from INDIA

USFDA Medical Device Registration

Payments made from Other Countries

USFDA Medical Device Registration

BILLING / PAYMENT assistance write to accounts@i3cglobal.com

 

Frequently asked Questions


1. What you mean by expert guidance? For how long?
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.

2. U S Agent Fees of 500 USD includes Listing also?
Yes, 500 USD includes 2 medical devices listing absolutely free. Additional medical devices will be charged 50 USD each.

3. How can I register and List, if my device is not cleared 510k?
It is not possible to to complete Establishment Registration. You must have atleast one 510k cleread or exempted device for FDA registration.

4. How can I make payment for listing more than 2 Nos.?
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.

5. How long it will take to complete the Medical Device registration and Listing process? When I can sell the product in USA?
2-3 weeks. Once FDA assigns the owner-operator number and Listing is completed, you can start marketting the medical devices in USA.


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


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