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First Auditors platform is a technology-driven platform that offers specialized legal and financial advisory services in India.

Free Sale Certificate for Medical Devices

We specialize in Free Sale Certificate services to help your business meet compliance requirements and contribute to sustainable growth. Our services include the following:

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01 Overview 02 Who Needs 03 Eligibility 04 Documents 05 Procedure 06 Authority & Fees 07 Guidelines 08 Rejection 09 How We Help 10 FAQ
Overview

Free Sale Certificate from CDSCO for Regulated Medical Devices

A certificate for export, commonly referred to as a Free Sale Certificate (FSC), is an official document provided by the national regulatory authority. In India, the Central Drugs Standards Control Organization (CDSCO) simplifies the application procedure for obtaining a Free Sale Certificate for medical devices that have been notified.

Manufacturers can apply for a Free Sale Certificate for their regulated or notified medical devices through the online medical device portal, and CDSCO will issue the certificate within 30 working days. The Free Sale Certificate serves as proof that the medical device is freely sold in the country of origin and is compliant with all regulatory requirements.

Free Sale Certificate Services
Who Needs This Service

Is Free Sale Certificate the right fit for your business?

A Free Sale Certificate is essential for manufacturers looking to export medical devices to international markets.

  • Medical device manufacturers
  • IVD manufacturers
  • Exporters of medical devices
  • Manufacturers with valid CDSCO license
  • Businesses expanding to international markets
  • Any manufacturer exporting regulated medical devices
Eligibility Requirements

Who can apply for Free Sale Certificate?

Manufacturers with a valid manufacturing license are eligible to request a Free Sale Certificate from CDSCO. The following requirements must be met:

  • Valid CDSCO manufacturing license
  • Products must belong to notified categories
  • No market complaints or adverse events reported
  • Compliance with Medical Device Rules, 2017
  • Legal Undertaking on Rs. 100 stamp paper
  • Payment of applicable government fees
Documents Required

Vital Documentation for Free Sale Certificate

The following documents are required for Free Sale Certificate application:

Application Documents
  • Cover letter on official letterhead
  • Signed and stamped by organization head
  • Applicant's name and address
Legal Documents
  • Notarized stamp paper undertaking (Rs. 100)
  • No market complaint declaration
  • No adverse event declaration
Product Documents
  • Product list in Word format
  • Valid manufacturing license copy
  • Comprehensive inventory of endorsed products
Step-by-Step Procedure

Procedure for Free Sale Certificate

Each stage is a real, sequential step through the Free Sale Certificate application process.

01
1–2 working days

Connect with First Auditor Team

Get in touch with our experts to discuss your Free Sale Certificate requirements and product list.

02
2–3 working days

Document Collection & Verification

Submit all necessary documents including cover letter, stamp paper undertaking, and product list.

03
3–5 working days

Application Preparation

Prepare the Free Sale Certificate application with all required documents and information.

04
1–2 working days

Application Submission on SUGAM Portal

Submit the application through the CDSCO SUGAM portal with all required documents and fees.

05
15–30 working days

Application Processing & Review

CDSCO reviews the application, verifies documents, and processes the Free Sale Certificate.

06
1–3 working days

Certificate Issuance

Upon approval, CDSCO issues the Free Sale Certificate and we send a copy to you via email or courier.

Authority, Timeline & Fees

Where the application goes, and what it costs

Government Authority

Central Drugs Standards Control Organization (CDSCO), Drug Controller General of India (DCGI), Ministry of Health and Family Welfare, Government of India.

Estimated Processing Period

Typically 30 working days from complete document submission, depending on application completeness and workload.

Certificate Issued

Free Sale Certificate (FSC) with unique reference number, product list, and validity period.

Fee Structure

Government fee as prescribed by CDSCO. Professional fee quoted upfront by First Auditor.

ComponentPaid ToNature of charge
CDSCO Application Fee CDSCO / DCGI As prescribed by Medical Device Rules, 2017
Stamp Paper Fee Government Rs. 100 (notarized)
Professional fee First Auditor Quoted upfront, one-time

Government fees are prescribed by CDSCO. Our team quotes both components separately before you proceed, with nothing added later.

Important Guidelines

Key Guidelines for Free Sale Certificate

  • Obtaining FSC from CDSCO necessitates a valid manufacturing license, which is the foremost essential requirement.
  • It is necessary to have a Legal Undertaking on a Rs. 100 stamp paper in order to protect against any market complaints and adverse events.
  • The government fee that is relevant must be paid.
  • In order to be eligible for FSC certification from CDSCO, products must belong to the specified categories.
  • A manufacturer whose products have not received any complaints can readily acquire the FSC from CDSCO.
  • The application must be submitted through the online medical device portal.
  • All documents must be properly signed and stamped by the authorized signatory.
Common Reasons for Rejection

What causes CDSCO to reject a Free Sale Certificate application

  • Incomplete or incorrect application form submission
  • Missing or invalid manufacturing license
  • Products not belonging to notified categories
  • Incomplete product list or specifications
  • Missing notarized stamp paper undertaking
  • Market complaints or adverse events reported against products
  • Non-compliance with Medical Device Rules, 2017
  • Documents not properly signed or stamped
  • Outstanding government fees not paid
How First Auditor Assists

One team, from document collection to certificate issuance

We manage every step, document, and follow-up with CDSCO so you can focus on your export business.

Eligibility & Document Check

We verify your eligibility and ensure all required documents are complete and valid.

Application Preparation

Complete Free Sale Certificate application drafting and verification to ensure error-free submission.

Product List Compilation

Assistance in compiling and formatting the comprehensive product list for FSC application.

Application Filing

Complete CDSCO application filing through the SUGAM portal.

Query Handling

We respond to all queries from CDSCO on your behalf.

Dedicated Support

A single point of contact for questions throughout the entire process.

Stamp Paper Assistance

Help with preparing and notarizing the Rs. 100 stamp paper undertaking.

Timely Follow-up

Regular follow-up with CDSCO to ensure timely processing of your application.

Export Guidance

Assistance with understanding international market requirements for medical device exports.

Frequently Asked Questions

FAQ

A Free Sale Certificate is an official document issued by CDSCO that certifies that medical devices are freely sold in India and compliant with all regulatory requirements. It is essential for exporting medical devices to international markets.

Manufacturers of medical devices who wish to export their products to international markets need a Free Sale Certificate. It serves as proof that the product is compliant with Indian regulations and is freely sold in the domestic market.

The Free Sale Certificate typically has a validity period of 1 to 2 years, depending on the requirements of the importing country and the issuance by CDSCO.

Key documents include cover letter, notarized stamp paper undertaking (Rs. 100), product list in Word format, and a valid manufacturing license with comprehensive product inventory.

CDSCO typically issues the Free Sale Certificate within 30 working days from the date of complete application submission, provided all documents are in order.

Yes, a valid CDSCO manufacturing license is the foremost requirement for obtaining a Free Sale Certificate. Without a valid manufacturing license, the FSC application will be rejected.

Products that belong to the notified categories under the Medical Device Rules, 2017 are eligible for FSC. Products must be compliant with all regulatory requirements.

First Auditor provides end-to-end assistance for Free Sale Certificate applications including document verification, application preparation, SUGAM portal filing, and follow-up with CDSCO. We ensure error-free submission and timely issuance of your certificate.
FSC
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Disclaimer: This page is provided for general informational purposes only and does not constitute legal, tax, or professional advice. Government fees, processing timelines, and documentation requirements are prescribed by the Central Drugs Standards Control Organization (CDSCO) under the Medical Device Rules, 2017 and are subject to change without notice. First Auditor is an independent professional services firm and is not affiliated with, or an agent of, any government department. Please consult our team or a qualified professional for advice specific to your situation before making any registration decision.
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