Services

FSC - Free Sale Certificate for Import of Medical Device

eed3013c-5fa5-47b3-8a7b-2626842148a3

A Free Sale Certificate is also known as a “Certificate for Export” or “Certificate to Foreign Governments”. It gives an assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country seeking to export a particular drug.

Free Sale Certificate Definition ?

Free Sale Certificate is evidence that goods, such as food items, cosmetics, biologics, or medical devices, are legally sold or distributed in the open market, freely without restriction, and approved by the regulatory authorities in the country of origin.

What is need of Free Sale Certificate ?

A Certificate of Free Sale is used when you are registering a new product in a country. you are sending a certificate of Free Sale to the customs authority in that country saying, in effect, “This is a new thing I am going to start importing, and here are my support documents that confirm this product(s) is legal to sell in the country of manufacture.”


The Purpose of Free Sale Certificate:

  • FSC is a vital certification for the manufacturers of medical instruments to do business in open market.

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

  • FSC is crucial for multiple reasons for manufacturers going international with their medical products.


Do I need a Certificate of Free Sale for every shipment to a particular country?

Only one Certificate of Free Sale is required for each product going to each country.


To whom the application made for getting Free Sale Certificate ?

An application shall be made to the Central Licensing Authority by the manufacture, having a valid license to manufacture for sale or for distribution of notified Medical Device .


What are the documents required for issuing of Free Sale Certificate ?

  1. Application in the form of descriptive covering letter.

  2. Copy of the valid manufacturing licenses.

  3. List of products for which Free Sale Certificate are required

  4. Copies of the product permission letters of the requested products for the issue of Free Sale Certificate.

  5. Fees as per prescribed in second schedule of Medical Device Rules 2017.

  6. Copy of the power of attorney/ authorization letter.

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


What are the benefits of Free Sale Certificate ?
It gives an assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country seeking to export a particular item.

ELT Corporate and Medical Device Registration:

ELT Corporate is renowned for its services in all the fields of scientific licenses staring from Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, Environment safety to New Technology Patent. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, Company Secretary. With such a unique combination of talent under a single roof, it has always been a hassle-free wonderful experience to the big corporates.

ELT Corporate is one of the best medical device consultant in India and always try to provide the best experience to the clients.

Request A Consultation

Fill Out The From Below, We Will Get Back You Soon. You Can Also Call Us Now On (+91) 9899997002