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A Free Sales Certificate (FSC) is a document issued by the regulatory authorities of a country or economic bloc, such as the European Union (EU), to certify that a particular product, often a medical device or in vitro diagnostic device, is freely sold in the country or region of origin. This certificate serves as evidence that the product complies with the regulatory requirements of the issuing authority and is approved for sale within that jurisdiction.

For medical devices, a Free Sales Certificate(FSC) is often required when a manufacturer intends to export their products to another country or market. It assures the regulatory authorities of the importing country that the product is legally marketed in the country of origin and meets the necessary safety and quality standards.

In the context of the EU, the Free Sales Certificate(FSC) may be needed when a manufacturer wants to export medical devices to countries outside the EU. It confirms that the devices are legally sold and conform to the applicable EU regulations. The certificate is typically issued by the competent authority responsible for medical device regulation in the country of origin.

It’s important for manufacturers to check the specific requirements of the destination country or region, as the documentation and certification needed for export may vary. The Free Sales Certificate(FSC) is part of the regulatory documentation that facilitates international trade of medical devices by providing evidence of compliance with the regulatory framework of the exporting country.

The terms “FSC with legalization” and “FSC without legalization” typically refer to whether the Free Sales Certificate (FSC) has undergone an additional process of legalization, often involving authentication by relevant authorities. Let’s explore the distinctions:

Free Sales Certificate with and without legalization

FSC Without Legalization:

  • Definition:
    • An FSC without legalization means that the certificate has been issued by the competent authority of the exporting country and is presented in its original form without additional authentication or legalization steps.
  • Use Case:
    • This type of FSC may be sufficient for some countries or regions that accept the FSC without requiring further verification or authentication beyond the original issuing authority’s certification.

FSC With Legalization:

    • Definition:
      • An FSC with legalization involves an additional step of authentication or legalization by relevant authorities, often including embassy or consular services. This process aims to provide an extra layer of verification to the FSC.
    • Authentication Steps:
      • After the FSC is issued, it may be submitted to the relevant government authorities, usually the Ministry of Foreign Affairs or similar, for authentication. Following that, the document may be further legalized by the embassy or consulate of the destination country.
    • Use Case:
      • Some countries or regions may require an FSC with legalization as a means of ensuring the authenticity of the document. It is particularly common in international trade when exporting medical devices or other regulated products.


Country-Specific Requirements:

      • The decision to obtain an FSC with or without legalization depends on the specific requirements of the destination country. Some countries may explicitly require legalization for regulatory or trade purposes.

Additional Time and Costs:

      • Legalization involves additional administrative steps and may incur extra costs. Manufacturers should factor in the time and expenses associated with the legalization process.

Consular or Embassy Services:

      • Legalization typically involves the services of consulates or embassies. Manufacturers may need to coordinate with diplomatic missions to complete the legalization process.

Trade Facilitation:

      • While not all countries may require legalization, having an FSC with legalization may facilitate smoother international trade by meeting the authentication requirements of certain jurisdictions.

Manufacturers should consult with regulatory experts, trade associations, or diplomatic missions to understand the specific requirements of the destination country and determine whether obtaining an FSC with or without legalization is necessary for compliance with the applicable regulations.