Latest / Medical Device Global Market Access
Certificate of Free Sale: Who Is Eligible to Apply?
This episode clarifies the complex eligibility requirements for obtaining a Certificate of Free Sale (FSC) for medical device exports. We dissect the critical differences between the regulatory frameworks in the United States and the European Union, explaining precisely who—from manufacturer to exporter to authorized representative—can legally apply for this essential market access document in each region. Key Questions: • What is a Certificate of Free Sale (FSC) and why do exporters need it? • In the United States, can a distributor or exporter apply directly for an FDA Certificate to…
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