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Free Sale Certificate

The CE marked product shows conformity to all obligations for medical devices as required by the European community as per Medical Devices Directives. This means you have fulfilled all laws as per EU, EEA and the few other countries having mutual recognition agreements in place.

However, a Free Sale Certificate is required to lounge your products in the Non EU Countries. This certificate should be submitted by the manufacturer itself to the non European country intended to market your products.

The Free Sales Certificate demonstrates from the government that you place products, legally with the CE mark on the European market.  It’s Just a guarantee!!!

  1. The European Free Sale Certificate (FSC) / Certificate of Marketability, can be is issued by the Competent Authority of the EU member state where the “manufacturer” in Europe or his authorized representative has his registered place of business.  
  2. If the manufacturer is not situated in Europe only the Authorized Representative is able to obtain the Free Sales Certificate on behalf of the manufacturer.

The cost of Free Sale Certificate depends on

# Device Class

# Number of GMDN / UMDNS Codes

# Number of Countries documet to be attested.

Some of the countries require European Free sale certificate are the following……..
Argentina, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.

Looking for European Medical Device Free Sale Certificate; please write to us or call the nearest location.

INDIA – Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY – Bremen
+49 2161 990 8831
Phone / WhatsApp


mail enquiry@i3cglobal.com
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