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Karan Singh
| Updated: 05 Aug, 2022 | Category: Medical device

What is a Free Sale Certificate?

Free Sale Certificate

The Free Sale Certificates (FSC) in India are issued for the export of Medical Devices or Equipment not covered under the Drugs & Cosmetics Act. As per the FTP (Foreign Trade Policy)[1] in India, the Regional Authority (RA) of DGFT issues FSC to the exporter. An FSC is issued by the National Regulatory Authority of the exporting country as per the legislative requirements of the country. This Certification is also known as Export Certificate or International Government Certificate. Scroll down to check more information regarding the Free Sale Certificate.

What is a Free Sale Certificate (FSC)?

It’s an export document required by certain nations for certain commodities such as medical devices of the exporting nation and, as such, can be freely sold in the markets of the exporting country & as such can be freely sold in the market of importing nation. Manufacturers who wish to export their product to other country require a Free Sale Certificate in order to give proof that the specific product is not restricted or prohibited for export & is freely sold in the nation, but without any indication that the product or item is evaluated for safety & efficacy is registered for use in the country.

Responsibility of Regional Authority of DGFT in India

The Regional Authorities need to take knowledge of the applications for FSCs received in the official email id & issued the certificate via the mail and a deficiency letter also needs to be sent via email.

Prerequisites of Free Sale Certificate (FSC)

Some of the prerequisites of FSC are mentioned below:

  1. The most important thing is your profile must be linked with an Import Export Code;
  2. Valid DSC (Digital Signature Certificate) must be registered in your system;
  3. RCMC (Registration Cum Membership Certificate) has to be issued to the IEC.

Note: In case your IEC is cancelled, then you will not be allowed to proceed further with your request for the issuance of a Free Sale Certificate (FSC).

Vital Documents Required for Free Sale Certificate

The following documents must be arranged before proceeding with the application procedure:

  • A valid copy of the IEC and RCMC;
  • A valid manufacturing license;
  • List of export products for which FSC are required;
  • Letter of the concerned authority demanding certificate;
  • Copy of the Authorisation Letter or Power of Attorney;
  • The product permission letters of the requested products.

Procedure for the FSC

Following is the step-by-step procedure for the Free Sale Certificate:

  1. First, the applicant needs to visit the official website of DGFT and then select the ECOM application form for the Free Sale Certificate from the service tab.
  2. Once you get access to the ECOM application page, then you need to click on the e-MPS option in order to make payment for the same certificate.
  3. After providing the PAN details of the individual or firm, enter the PAN and Name of the individual or firm and submit it;
  4. After validating the details of the e-MP system will be shown then the main screen; click on the make a payment option from the tab to proceed further.
  5. After that, you have to fill in the below-mentioned details:
  6. Firm Name;
  7. PAN or IEC;
  8. Subject;
  9. DGFT (Regional Authority Office);
  10. Scheme;
  11. ECOM Reference Number;
  12. The payment amount in INR;
  13. Transaction Reference Number;
  14. Remarks (if any).
  15. After providing the information, click on the pay now button, a new window will open and you can make a payment.
  16. On successful payment of the fee, the transaction status at the DGFT portal will be shown and taken a printout of the payment receipt.
  17. Now, the applicant can take the printout of it easily and submit it to the concerned DGFT with the application.

Note: A Free Sale Certificate is valid for two years unless specified further.

Making an Application Through Email

The applicant can also file the application through email; here, the applicant needs to send the application form, i.e., the ANF-2H Form, along with the receipt of the payment to the respective Regional Authority’s official mail ID and you can access the official website of the DGFT in order to get the mail-id of the Regional Authority.

Conclusion

Various countries in the world are now demanding a Free Sale Certificate, also known as an Export Certificate, which is a promise from a foreign agency that the products available on the FSC Certificate are freely sold & manufactured in the desired countries, which enhances the ease of doing business.

Read our Article:Difference Between Notified and Non-Notified Medical Device

Karan Singh

A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

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