Free Sale Certificate | FSC

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.

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

Why is FSC needed?

Free Sale Certificate is compulsory for import or export of medical devices to and from India. Free Sale Certificate has certain benefits as well:

1. Verification of the Manufacturer

Although verification that the manufacturer is an authorized business entity can be carried out in a number of ways, CFS is a definitive proof that the manufacturer contains a valid license. An authentication of the producer's license immediately validates that the company complies with the CE labeling guideline.

2. Facilitates Verification of the Product

Importing countries want to maintain a strict level of health and safety in their healthcare sector. They will therefore not permit the use by a manufacturer of medical devices, pharmaceutical products and other critical products which can not provide proof that a certain exporting medical product is authorized to be used in the country where it is based.

For this purpose, CFS is an important piece of information where an associated regulatory body vouches to the importing manufacturer that a specific certified medical device is an authorized health product in the county where it is manufactured.

3. Verification of GMP Certification

CFS also confirms that the device in question complies with the Good Manufacturing Practice (GMP) guidelines of the International Society for Pharmaceutical Engineering. Apart from the CE marking, there is another important certification which further confirms the veracity of any medical product.

As you can see how important the CFS information for a medical device can be. The fact that it makes CFS more important is that it is essentially a guarantee issued by the importing country to the exporting country as to the authenticity of the manufacturer and its product.

For manufacturers interested in moving globally with their medical devices, we can provide them with the services to apply and secure CFS from the Ministry of Exports. We also provide the necessary tests required for CE marking and other relevant certifications.

4. Mandatory for permission to import medical devices

FSC is a mandatory attachment for application to import medical devices (MD-15) in India. 

Documents & Timeline

1. The following documents are required for the issuance of a Free Sale Certificate – Request in the Descriptive cover letter form.

2. Copy of valid manufacturing licenses

3. List of products for which a Free Sale Certificate is needed

4. Copies of the Product

5. Permission Letters of the requested products for the issuance of Free Sale Certificate

6. Fees of Rs. 250/-+ service Tax per Free Sale Certificate containing a maximum of 10 products in one certificate and Rs. 50 + service Tax for each additional copy in the form Demand draft or pay order. The list can vary depending on the requirement of the regulatory authority from time to time.

The validity of a Free SaleCertificate is of 2 years from the date of issue.

Procedure

➲ Prepare and file the application along with a cover letter and respective attachments.

➲ Submit a list of products for which the Free Sale Certificate is required

➲ Make a payment of INR 1000 (prescribed fees) in accordance with the second schedule of Rules for Certificate to export medical device. The fee is to be paid for each distinct medical device through electronic means of a challan vide the banks authorised by the Ministry of Health and Family Welfare.

➲ Once the licence is issued, share a valid copy of same with the manufacturer for Sale or for Distribution of Medical Devices along with the list of approved products issued by the competent authority (State Licensing Authority or Central licensing).

➲ The application is to be accompanied by an undertaking stating that no action has been initiated against the applicant pertaining to adverse events or market complaints and Not of Standard Quality (NSQ) report of any product in India.