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Free Sales Certificate

Certificate of free sale also known as export certificate, free trade certificate, free sales certificate. Theirs is no general agreement regarding the name among the authorities. However, the “certificates of free sale” is essential for exporting manufacturers.

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In India, the central licensing authority is responsible for issuing free sales certificate (FSC) for medical device for export purpose. Application for FSC shall be made by the manufacturer, having a valid license to manufacture for sale and distribution of Medical Device.

The below-mentioned documents are required for issuing a Free Sales Certificate:

  • Cover Letter: The covering letter should clearly indicate the reason of the application. The list of documents that are being submitted as well as other important and relevant information. The covering letter should be duly signed and stamped by the authorized signatory, with the name & designation of the authorized signatory and the name and address of the firm.
  • A valid copy of license to manufacture for sales and distribution of medical devices.
  • Product list for which free sales certificate is required.
  • Prerequisite fees- prescribed in second schedule of Medical Devices Rules 2017 for Certificate to export medical device.
  • Fees: The Applicant shall pay fees of 1000 INR for obtaining Free Sale Certificate for each medical device through challan or by electronic mode.
  • Undertaking by the manufacturer – stating that no action has been initiated against them due to adverse events, market complaint and Not of Standard Quality (NSQ) report of any product in India.
  • Establish user interface evaluation plan
  • Perform user interface design, implementation and formative evaluation
  • Perform summative evaluation of the usability of the user interface

A Free Sales Certificate is valid for 2 years from date of issue.

For other than notified medical devices Free Sale Certificate is issued by Directorate General of Foreign Trade, Ministry of Commerce and Industry Udyog Bhawan, H-Wing, Gate No. 2, Maulana Azad Road, New Delhi – 110011.
Kindly go through the guidance document issued by CDSCO- https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA3OQ
We, at Maven Profcon Services LLP, can help you obtain free sales certificate. Our experience in applying for certificate of free sale has been consistently positive.

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