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THE CERTIFICATE OF FREE SALE FOR CE-MARKED MEDICAL DEVICES

QA/RA Directors of US manufacturers of Medical Devices may receive a request from their International sales department for Certificates of Free Sale (CFS). They are effectively mandatory for the registration of CE marked devices which are not yet FDA approved in the main countries of Latin America, Asia and non-EU Eastern Europe.In addition the CFS may need to be apostilled or legalized depending upon the concerned area. Where and how to obtain these CFS? MediMark® Europe, European authorized representative, answers to these questions for helping US QA/RA Directors to understand the process.

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