Free Sale Certificate(FSC)

What is a Free Sale Certificate (FSC)?

A Free Sale Certificate (FSC), also known as a Certificate for Export, is a critical document for Indian medical device companies. It verifies that a medical device can be freely sold and exported from the country. This certificate is mandatory for both importing and exporting regulated medical devices. A valid manufacturing licence is the most important requirement for obtaining FSC from CDSCO.

Who Needs a Free Sale Certificate?

Any manufacturer in India with a valid manufacturing license can apply for a Free Sale Certificate from the Central Drugs Standard Control Organization (CDSCO).

Benefits of Obtaining a Free Sale Certificate

• Simplified Import/Export: An FSC removes any regulatory hurdles associated with importing or exporting your medical devices.
• Enhanced Credibility: Possessing an FSC demonstrates compliance with Indian regulations, boosting your brand reputation in the international market.
• Faster Time to Market: An expedited FSC application process allows you to seize global opportunities quicker.

A Streamlined Online Process

MDR consultants can guide you through the streamlined online application process via the CDSCO MD online Registration. Here’s a breakdown of the steps involved:

1. Registration: Begin by registering on the CDSCO MD online Registration.
2. Drafting the Application: Prepare a Free Sale Certificate application outlining the specific devices requiring certification.
3. Document Upload: Upload all necessary documents as per the CDSCO’s FSC checklist.
4. Fee Payment: Pay the requisite government fee associated with the application.
5. Online Submission: Submit your completed application electronically through the online medical device portal.

Required Documents for FSC Application

• Cover Letter: A signed and stamped letter on your company’s letterhead, outlining your request for the FSC.
• Undertaking: A notarized undertaking on Rs. 100 stamp paper, guaranteeing no market complaints or adverse events related to the exported devices.
• Product List: A document listing all the medical devices for which you require the FSC.
• Manufacturing License: A copy of your valid manufacturing license along with a list of approved products under the license.

Partner with an MDR Consultant for a Smooth Process

While the CDSCO has streamlined the FSC application process, navigating medical device regulations can still be complex. MDR consultants can ensure a smooth and efficient application process, saving you time and minimizing the risk of errors. They can assist with:

• Understanding FSC requirements specific to your devices.
• Compiling the necessary documentation.
• Completing and submitting the online application accurately.

Expediting the application process for faster turnaround.