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.
A manufacturer who has a valid manufacturing license can apply for the Free sale certificate for regulated IVDs.
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|
The Free sale certificate will remain valid along with the validity of the manufacturing license.
Government Timeline for obtaining Free Sale Certificate for Medical Device is 30 working Days
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
CliniExperts advice their clients to prepare documents as per the checklist of FSC and must carry a valid manufacturing license.
Yes. The application process for FSC is online at CDSCO online system of medical devices.
As per the Government, the requisite fee for each medical device is INR 1000.
No. The FSC cannot be obtained from the CDSCO for non-notified products.