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.
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.
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.
Some of the prerequisites of FSC are mentioned below:
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).
The following documents must be arranged before proceeding with the application procedure:
Following is the step-by-step procedure for the Free Sale Certificate:
Note: A Free Sale Certificate is valid for two years unless specified further.
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.
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.