What is a Free Sale Certificate?
A Free Sale Certificate (“FSC”) is a certificate issued by the national regulatory authority of the exporting country on the basis of national legislation stating that the product is freely available in the country but without any confirmation that the product is tested for safety and effectiveness and is licensed for use in the country.
The Free Selling Certificate is also known as the "Export Certificate" or the "International Government Certificate." It offers confirmation from a foreign entity that the goods included in the certificate are freely distributed and produced in a country that intends to export a specific drug. https://www.corpzo.com/free-sale-certificate--fsc
In India, the State licensing authority is responsible for issuing the free selling certificate for export purposes.
The exports of medical devices are dealt with by Rule 91 of the Medical Devices Regulations 2017 ("Laws". When a person wishes to export any medical device manufactured in India, he must apply for a certificate of quality, health and performance with regard to the medical device in the form of a free sale certificate or a credential, which is provided by the importing country authority. The Central Licensing Authority shall grant a certificate to the applicant if the required conditions are met. The guide has been issued under Rule 91 by the CDSCO


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