Free Sale Certificate
(FSC)
Unlock global markets and expedite your international export processes with a CDSCO-issued Certificate for Export.
Consult Our CDSCO Experts
What is a Free Sale Certificate?
A Free Sale Certificate (FSC), also widely known as a Certificate for Export, is a critical regulatory document for Indian medical device companies looking to expand internationally. It serves as official verification from the Central Drugs Standard Control Organization (CDSCO) that your medical device can be freely sold and distributed without restriction within India, and is therefore safe for export.
Who Needs an FSC?
Any manufacturer based in India holding a valid, current manufacturing license can apply to the CDSCO for an FSC for their approved devices. This certificate is often a mandatory prerequisite demanded by regulatory authorities in the importing countries.
Why Obtain a Free Sale Certificate?
Simplified Export Logistics
An FSC actively removes regulatory hurdles at customs, ensuring smooth and compliant exportation of your medical devices to international partners.
Enhanced Global Credibility
Possessing an FSC immediately demonstrates your strict compliance with Indian quality regulations, boosting your brand’s reputation in the eyes of foreign buyers and regulators.
Faster Time to Market
By fulfilling a primary requirement of foreign regulatory bodies upfront, you can seize global commercial opportunities much faster.
The CDSCO Online Process
The CDSCO has streamlined the FSC application process via their MD Online Registration portal. However, meticulous document preparation remains critical.
Required Documents:
- Copy of your valid manufacturing license.
- Comprehensive list of specific products for export.
- Formal Cover Letter on company letterhead.
- Notarized Undertaking (on Rs. 100 stamp paper) guaranteeing no market complaints.
Fast-Track Your Global Exports
While the process is online, navigating CDSCO requirements and correctly formatting the legal undertakings can be challenging. We ensure zero delays.
- Expert drafting of required undertakings
- Seamless CDSCO MD Online submission
- Expedited follow-up for faster turnaround