Free Sale Certificate

A Free Sale and Commerce Certificate is a certificate provided for the export of any other item which is not prescribed or prohibited for export to authenticate that the product is freely traded in the country but without any indication that the product is evaluated for safety and benefit and is registered for use in the country.

A free sale certificate is a document required in a certain country for certain materials such as Medical Devices, food items, cosmetics, and biological products. This certificate is also known as a Certificate of Export or Certificate to Foreign Governments, and it is issued by the national regulatory authority of the country from which the product is being exported. Free sale certificate certifying that the products listed in the certificates are typically and freely sold and put to use in their country of origin and are accepted for export. The Ministry of Commerce and Industry of India issues the certificate as a guarantee that the products specified on the certificate are freely made and marketed in the exporting country's open marketplaces.

Application for Free Sale and Commerce Certificate

The Free Sale and business Certificates are provided for the export of Medical Devices/machines not covered under the Drugs & Cosmetics Act. According to the Foreign Trade Policy of India, the Regional Authority (RA) of DGFT provided a Free Sale and business certificate to the exporter. There has been a delay in the declaration of free sale and business certificates. As a trade simplification measure, the Director General of Foreign Trade (DGFT) has notified the clarification regarding the processing of an application for free sale and business certificates. According to this trade notice, exporters should send their applications for the Free Sale and Business Certificate to the concerned Regional Authority (RA) of the DGFT's official email address.

Key Highlights Point of Notifications:

• The Trade and Industry need to send the request to get the free sale and business Certificates to the official email ID of the concerned Regional Authority (RA).
• The application to be made as per the prescribed format of ANF 2H and the fee payment needs to be done through the DGFT Miscellaneous Payment System (e-MPS system).

Responsibility Of The Regional Authority of DGFT

The regional power needs to take aware of the applications for free sale and business certificates received in the official email id and provide the certificate through the mail, and insufficiency letters also need to be sent through email.

The Regional Authorities seek to process a soft copy of the application without asking for the hard copy of the application.

Business Certificate

The business certificate is a document that recognizes the origin of products being exported and is provided by a DGFT, Government of India. This document is required for procedure authorization in the buyer’s country to regulate duty rates and find out the origin of the goods.

Certificate of Free Sale (CFS) for Medical Device Exports

Many Ministries of Health and other controllers around the world require foreign manufacturers to provide a Certificate of Free Sale (CFS) showing that their products are approved for sale in Europe. In these markets, your CFS must be handed over to power as part of your filing process. Emergo has obtained CFS documents for many clients seeking medical device filling in Asian, Middle Eastern, and Latin American markets, and can procure a CFS on your behalf for your medical device.

A Certificate of Free Sale is a document that suggests a particular product is marketed in the United States or is permitted for export, and that the particular manufacturer has no pending implementation actions pending before or taken by the U.S. Food and Drug Administration (FDA).

Getting a Certificate of Free Sale

A Certificate of Free Sale, sometimes called a “Certificate for Export” or “Certificate to Foreign Governments,” is evidence that goods, such as food items, cosmetics, biologics, or medical devices, are legally sold or administered in the open market, freely without limitation, and accepted by the officially command in the country of origin (United States).

Free Sale and business Certificate are certificates provided for export of any other item which is not cramped or banned for export substantiating that the product is freely sold in the country but without any evidence that the product is estimated for safety and effectiveness and is recorded for use in the country. It is an assurance from a foreign agency that the products stated on the certificate are freely sold and manufactured in the country requesting to export a specific item.

Why is FSC Needed?

A free Sale Certificate is mandatory for the 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 approved business organization can be conveyed out in a number of ways, CFS is conclusive proof that the manufacturer holds a valid license. Documentations of the producer's license are instantly authentic that the company complies with the CE labeling guideline.

2. Facilitates Verification of the Product

Importing countries want to maintain a careful level of health and safety in their healthcare sector. They will therefore not allow the use by a manufacturer of medical devices, pharmaceutical products and other disapproving products which cannot provide proof that a certain exporting medical outcome is allow to be used in the country where it is based.

For this purpose, CFS is an important piece of information where an officially connected body confirms to the importing manufacturer that a specific certified medical device is a recognized health product in the county where it is a Producer.

3. Verification of GMP Certification

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

As you can see, the CFS specifics for medical equipment are extremely important. The fact that it makes CFS more maintainable is due to the fact that it is a warranty offered by the importing country to the exporting country as to the manufacturer's and product's originality.

For producers attentive in operating extensively 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 compulsory tests required for CE marking and other applicable certifications.

4. Mandatory for permission to import medical devices

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

According to the Notification of DGFT, the trade needs to forward the following documents along with the order application to the RA:Fee payment receipt

• Valid manufacturing license
• List of products for which Free Sale and Commerce Certificates are required
• Product permission letters of the requested products
• A letter from the concerned authority-demanding certificate
• Copy of the power of attorney or clearance letter.

If my IEC is in DEL/cancelled/suspended, am I eligible to apply for Free Sale and Commerce Certificate?

If your IEC is suspended/cancelled/in DEL, you shall not be allowed to proceed with submission of your request for the issuance of a Free Sale and Commerce Certificate.

DOMAIN: https://www.dgft.gov.in/CP/

• Introduce a list of products for which the Free Sale Certificate is required.
• Make a payment of INR 1000 (prescribed fees) in line with the second schedule of Rules for Certificate to export medical device. The fee is to be paid for each clear medical device through computerized means of a challan vide the banks sanctioned by the Ministry of Health and Family Welfare.
• Once the license is issued, share a valid copy of same with the producer for Sale or for Distribution of Medical Devices along with the list of accept products provided by the capable authority (State Licensing Authority or Central licensing).
• The application is to be go along with by an agreement express that no action has been begin against the applicant concern to unfavorable events or market grievance and Not of excellence grade (NSQ) report of any product in India.
• The validity of Free Sale and Commerce Certificates
• Validity of the Free Sale and business certificate will be two years from the date of issue unless otherwise differently.

Fees Structure 

The applicant needs to pay a Fees of Rs. 250/-+ service Tax per Free Sale Certificate. It is to be noted that the maximum number of products for a single certificate cannot exceed ten.

GUIDELINES: PLEASE OPEN THIS MENTIONED BELOW LINK

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/GuidanceFreeSalecertificate.pdf