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Free Sale Certificate for Medical Devices in India: A Streamlined Process with MDR Consultant Support

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.

Ready to Streamline Your Free Sale Certificate Process?

Don’t wait! Contact MDR consultant today to discuss your specific needs and get a free quote. With their expertise, you can obtain your Free Sale Certificate efficiently and confidently, paving the way for successful medical device export.

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