Free Sale Certificate from CDSCO for regulated In- Vitro Diagnostics in India in India


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    A Free Sale Certificate for IVD's is mandatory to import or export of In-Vitro diagnostic kits to and from India. CliniExperts helps companies secure A Free Sale Certificate or Certificate for Export of In-Vitro diagnostic kits

    Free Sale Certificate from CDSCO for regulated In- Vitro Diagnostics– Overview


    A free sale certificate, also known as a "Certificate for Export" is a document issued by the national regulatory authority. The Central Drugs Standards Control Organization (CDSCO) streamlines the application process for free sale certificate for notified In-vitro diagnostic kits in India.

    Any manufacturer needs to follow the procedure laid down by CDSCO which involves filling an application with requisite documents on the Online system of medical devices to obtain the certificate. It takes about 30 days to receive the certificate.

    Who Can Apply?


    A manufacturer who has a valid manufacturing license can apply for the Free sale certificate for regulated IVDs.


    How To Apply?

    The application can be made on the online portal:

    Applicants must register themselves at the Sugam Registration portal
    Draft of FSC Application must be prepared in appropriate format
    Upload the documents as per the checklist of FSC
    Payment of the Requisite Government Fee
    Submission of Application on Online medical device portal

    Fee Involved

    Government charge 1000 INR for each distinct medical device.

    Validity

    The Free sale certificate will remain valid along with the validity of the manufacturing license.

    Important Documents

    Few major documents required are as follows: A cover letter on the letterhead of the manufacturer with the name and address of the applicant, duly signed and stamped by the head of the organization. An undertaking on a Rs.100 notarized stamp paper. (Against No market complaint and adverse event) List of products in word file for which the free sale certificate is required. Manufacturing license along with approved product list.

    Timeline to get Form from Central Drugs Standard Control Organisation

    Government Timeline for obtaining Free Sale Certificate for Medical Device is 30 working Days

    Essential Tips

    The main things to keep in mind during the process of license application preparation and submission are-

     

    A valid copy of the manufacturing license must be attached


    Legal Undertaking on 100Rs stamp paper


    Applicable Government Fee

    Few potential problems can be faced during the application, filling, or submission process,

     

    Only notified category products are eligible to obtain a FSC


    Manufacturers with no market complaints can easily avail the FSC

    Expert Advise

    CliniExperts advice their clients to prepare documents as per the checklist of FSC and must carry a valid manufacturing license.

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    Frequently Asked Questions

    Is the FSC Application process currently online or offline?

    Yes. The application process for FSC is online at CDSCO online system of medical devices.

    What is the requisite fee for the FSC?

    As per the Government, the requisite fee for each medical device is INR 1000.

    Can FSC be obtained from the CDSCO for non-notified products?

    No. The FSC cannot be obtained from the CDSCO for non-notified products.

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