Free Sale Certificate from CDSCO for regulated Medical Devices in India - FSC
A Free Sale Certificate for Medical Devices is mandatory to import or export of medical devices to and from India. CliniExperts helps medical device companies secure A Free Sale Certificate or Certificate for Export of Medical Devices.
Free Sale Certificate from CDSCO for regulated Medical Devices – 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 medical devices in India.
The manufacturer can obtain a Free Sale Certificate of regulated /notified medical device through online medical device portal and the certificate shall be issued by CDSCO within 30 working days. Application for the free sale certificate must be filled out online via the Sugam portal with a list of the necessary documents.
Who Can Apply?
Any manufacturer holding a valid manufacturing license can apply for the Free sale certificate from CDSCO.
How To Apply?
The Applicant must follow the following process:
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Step 1: Register on Sugam portal
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Step 2: Draft an FSC Application
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Step 3: Upload document according to FSC checklist
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Step 4: Pay and process the Requisite government fee
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Step 5: Submit Application on Online medical device portal
Validity
A Free Sale Certificate is valid for as long as the Manufacturing license is valid.
Fee Involved
INR 1000 for each separate medical device.Important Documents
- Cover letter on letterhead with the applicant's name and address, duly signed and stamped by the organization's head.
- A Rs.100 notarized stamp paper undertaking (Against No market complaint and adverse event)
- A word file containing a list of products for which a free sale is required.
- A manufacturing license as well as a list of approved products.
Timeline to get
FSC
from Central Drugs Standard Control Organisation
30
WORKING DAYSEssential Tips
- A valid manufacturing license is the most important requirement for obtaining FSC from CDSCO
- A Legal Undertaking on 100Rs stamp paper (Against No Market Complaint and Adverse Event) is a must.
- The applicable government fee must be paid.
- To qualify for FSC certification through CDSCO, products must fall under the notified categories
- A manufacturer with no complaints against their products can easily obtain the FSC from CDSCO.
Expert Advise
All the documents must comply with the FSC checklist.
Manufacturer must have a valid license.
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Frequently Asked Questions
Is the FSC application process currently conducted online or in person?
The FSC application process has been made available online by CDSCO.
What is the FSC application fee?
Each medical equipment requires a fee of INR 1000.
Can the CDSCO provide FSC for non-notified products?
No