Free Sale Certificate

FSC - Free Sale Certificate for Import of Medical Equipment

A free sales certificate is also known as a "certificate for export" or "certificate to foreign governments". It provides assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country that wishes to export a particular drug.

Free Sale Certificate Definition?

A free sale certificate is an evidence that goods, such as foods, cosmetics, biologics, or medical devices, are legally sold or distributed on the open market, without restriction, and approved by regulatory authorities in the country of origin Huh.

What is needed for a Free Sale Certificate?

A certificate of free sale is used when you are registering a new product in a country. You are sending the certificate of sale free of charge to the customs authority in that country, in fact, "This is a new thing that I am going to start importing, and here are my supporting documents confirming that it is legal to sell the product in the country of manufacture."

The Purpose of Free Sale Certificate:

The FSC is an important certification for manufacturers of medical devices to conduct business in the open market.

FSC is a verification that the device is safe to use in the country where it is being exported.

FSC is important for several reasons for manufacturers to go international with their medical products.

Do I need a Free Sales Certificate for each shipment to a particular country?

Only one Free Sales Certificate is required for each product that goes into each country.


Who applied to get the Free Sales Certificate?

An application shall be made to the Central Licensing Authority by the manufacturer holding a valid license for the sale or distribution of the notified medical device.


What are the documents required to issue of Free Sales Certificate?

Application in the form of a descriptive covering letter.

Copy of valid manufacturing license.

List of products that require a free sale certificate

Copies of Product Permission Letters of the requested products for the issue of Free Sales Certificate.

The fee is prescribed in the Second Schedule to the Medical Devices Rules 2017.

Copy of Power of Attorney/authorization letter.

A valid copy of the license for sale or for distribution of medical devices, along with an approved product list issued by the State Licensing Authority, as the case may be.

What are the benefits of a Free Sale Certificate?

It provides assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country to be exported for a particular item.

ELT Corporate and Medical Device Registration:

ELT is renowned for its services in all areas of scientific licensing from Corporate Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, and Environmental Protection to New Technology Patents. ELT Corporate has a team of Advocates, M.Pharma, Engineers, Chartered Accountants, and Company Secretaries. With such a unique combination of talent under one roof, it has always been a hassle-free wonderful experience for large corporates.

ELT Corporate is one of the best Medical Device Consultants in India and has always endeavored to provide the best experience to its clients.

Free Sale Certificate.

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