What is a Free Sale Certificate for medical devices?

A Free Sale Certificate (FSC) is an official document confirming that a medical device or in vitro diagnostic device complies with European regulations MDR (2017/745) or IVDR (2017/746), has been CE marked, and can be legally placed on the market within the European Union.

The FSC serves as proof of regulatory compliance for third-country authorities that require official evidence of EU market approval prior to product import or registration.

The issuance of FSCs in the European Union is governed by the MDR and IVDR regulations. In Poland, the competent authority for issuing this certificate is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), operating under the Medical Devices Act.

When is the FSC required?

An FSC is required when exporting medical devices to countries outside the European Economic Area. The most common cases of use include:

  • Registering the product in local regulatory systems (e.g., in South America, Asia, the Middle East).
  • Submitting the document to customs authorities as proof of compliance with country-of-origin regulations.
  • Meeting foreign distributor requirements as a condition for cooperation.

The process of obtaining a Free Sale Certificate

The FSC issuance procedure in Poland includes the following steps:

  1. Application preparation – including attachments confirming the device registration and compliance with MDR/IVDR.
  2. Submitting the application to URPL via the ePUAP system or e-URPL platform.
  3. Data verification – the authority checks consistency with the previously submitted device registration.
  4. Issuing the certificate – the document is issued in electronic or paper form.

Benefits of having a Free Sale Certificate

The benefits of holding an FSC include:

  • Facilitating medical device exports – the FSC is widely accepted as proof of lawful sale in the EU by many third countries.
  • Increased trust from business partners – the certificate confirms compliance with European legal requirements and quality standards.
  • Reduced administrative barriers – the document standardizes and simplifies registration processes in importing countries.
  • Improved competitiveness – the certificate enhances the company’s credibility with foreign distributors and institutional clients.
  • Proof of MDR/IVDR compliance – the FSC confirms the product’s alignment with current EU legislation.

Common mistakes when applying for an FSC

The most common errors during the FSC application process include:

  • Lack of prior device registration – an FSC can only be issued for devices officially registered with URPL.
  • Data discrepancies – inconsistencies between the application and the previously submitted information.
  • Unpaid fee – failure to provide proof of payment results in application suspension.
  • Outdated registration documentation – missing or outdated documents may delay FSC issuance.

Verification and validity of the Free Sale Certificate

The authenticity of an FSC can be verified by the regulatory authority of the importing country. The document must include device identification details, manufacturer information, address, CE marking, and reference to MDR or IVDR compliance.

Does the FSC have a validity period?

Yes, the FSC is typically valid for 12 months, although this period may vary depending on the requirements of the third country. After expiration, a new application must be submitted.

How can Pure Clinical help with obtaining a Free Sale Certificate?

Pure Clinical provides expert and procedural support throughout the entire process of obtaining an FSC for medical devices and IVDs in compliance with MDR and IVDR regulations. Our services include:

  • documentation gap analysis and verification of formal compliance,
  • device registration with URPL, if not already submitted,
  • preparation of a complete FSC application with required attachments,
  • coordination of communication with URPL and monitoring of application status,
  • adaptation of documentation to the requirements of third countries (e.g., Saudi Arabia, Brazil, Turkey).

With Pure Clinical’s support, the process of obtaining a Free Sale Certificate is compliant with both EU and international requirements and optimized for export efficiency and reduced procedural risks.

FAQ

Can a Free Sale Certificate cover multiple medical devices?

Yes, an FSC may include multiple products if they belong to the same product family and are manufactured by the same company. Data consistency and product group conformity are essential for approval.

Can an FSC be revoked or canceled?

Yes, if the device no longer complies with MDR/IVDR or the registration is withdrawn, the Polish authority (URPL) can revoke the certificate. Regular documentation updates help prevent revocation.

What additional documents may be required by third countries apart from the FSC?

Countries like China, Brazil, or Saudi Arabia may require FSC legalization via consulates, sworn translations into the local language, or notarization with an apostille depending on local laws.

Can a distributor apply for an FSC on behalf of the manufacturer?

No, only the manufacturer or their EU Authorized Representative (EC REP) may submit the FSC application. Distributors do not hold legal authority for regulatory representation.