A Free Sale Certificate is also known as Certificate of Export or Certificate to Foreign Governments, it is a document required in a certain country for certain commodities such as Medical Devices, food items, cosmetics, and biological, which is issued by the national regularity authority of the country from which the product is being exported.

Free sale certificate certifying that the products stated in the certificates are regularly and freely sold, consumed in their country of origin and are authorized for export.

It is granted for the export of items that are not subject to the Drugs & Cosmetics Act 1940, and are used in nursing homes, clinics, and hospitals for medical and surgical procedures, and are not otherwise forbidden from export.

The certificate is issued by the Ministry of Commerce and Industry in India as confirmation that the products specified on it are manufactured and sold freely in the open market places of the exporting nation.

Certificates are issued in one of two categories:

1) Certificate for products relating related to medical instruments and devices

2) Certificate for products not related to medical instruments or devices for use in medicine

Purpose to obtain a Free Sale Certificate

Free Sale Certificate is crucial for following reasons for the manufacturers going International with their products-

For verification of Manufacturer

A Free Sale and Commerce Certificate is a proof that the manufacturer holds a valid manufacturing license.

For the verification of products

Countries that import want to have a high standard of safety and security in place. As a result, they won’t let the use of products from a manufacturer who is unable to demonstrate that certain exporting products are permitted to be used in their country of origin.

To Verify Good Manufacturing Practice (GMP) Compliance

A free Sale Certificate serves as further verification that the export goods in issue adhere to GMP standards for international trade.

A manufacturer may apply for the Free sale certificate if they have a current manufacturing licence.


A Free Sale Certificate is valid for two years from the date of issue.

A free Sale certificate for the pharmaceuticals products certify that TAJ PHARMACEUTICALS LTD; having manufacturing premises situated at Gujarat, India is holding valid Drug Manufacturing License In Form No: 25 bearing No: xxxxx is issued on xxxxx and valid up to xxxxxx  by the administration under the provisions of Drugs & Cosmetics Act, 1940 and Rules there under.

Under the above License the firm is permitted to manufacture and market the products listed below to be exported freely. Such types of similar products are available in country of origin subject to laws of land in question.

The Certificate is also to certify that manufacturing plant which the product is manufactured is subjected to regular inspection at suitable intervals.