What is a Free Sales Certificate?
Many manufacturers hold CE marking to sell products across the EU, yet face requests from numerous non-EU countries to provide a Free Sales Certificate issued by EU authorities. This article explains the purpose of this document and where to obtain it.
An EU Free Sales Certificate, also known as an Export Sales Certificate, is officially named Free Sales Certificate (FSC), Certificate of Free Sale or Certificate For Exportation of Medical Products, abbreviated as FSC or CFS.
The Free Sales Certificate system originated in Europe. Initially, individual European Economic Area (EEA) member states and local industry associations issued such certificates to help domestic manufacturers promote goods to third countries outside the EEA. The document certifies that products comply with national standards and relevant EU directives, are safe, meet quality specifications, may be freely circulated within the issuing country, and are eligible for export.
Early FSCs were issued by European industry associations and chambers of commerce, before many European governments refined their own national issuance frameworks. This European-originated trade certification requirement has been widely adopted globally; numerous nations mandate importers to submit valid Free Sales Certificates for customs clearance.
It is critical to note: under EU directives, only the Competent Authorities (CAs) (official medical device regulatory bodies) of EEA member states are legally authorized to issue EU Free Sales Certificates, not private manufacturing associations.
Chinese manufacturers exporting to the EU do not require an FSC if they hold valid CE marking and complete EU registration as required by relevant directives.
Scope of Application for Free Sales Certificates
Countries outside the EU may request FSCs for imported goods. Based on industry experience, high-demand regions include South America, the Middle East and Southeast Asia, such as Egypt, Uruguay, Venezuela, Saudi Arabia, Turkey, Brazil, Argentina, Kazakhstan, Thailand, India, Indonesia, etc.
EU authorities only issue FSCs to entities registered within the EEA, including manufacturers and EU Authorized Representatives.
Classification of Free Sales Certificates
FSCs are divided into three main categories based on issuing bodies:
- National & Industry Associations Applicable to products without dedicated government regulatory authorities.
- National Competent Authorities (Ministry of Health, Medical Products Administration, Inspection & Quarantine Bureaus, etc.) Applicable to regulated products fully compliant with domestic national laws.
- Overseas Competent Authorities (UK, EU, US regulatory bodies, etc.) Applicable to regulated products that only satisfy export regulatory criteria.
Manufacturers and export traders shall select the appropriate FSC type based on product category and business scenario.
For Medical Device Manufacturers with Domestic Registration & Production Licenses：
Enterprises holding valid domestic medical device registration certificates and manufacturing licenses may apply for a Chinese FSC from the National Medical Products Administration (NMPA). Issuance is administered by national, provincial or municipal authorities based on device risk class. This certificate is exclusively issued to licensed manufacturers with complete registration filings.
For Trading/E-commerce Companies or Manufacturers Without Domestic Registration：
If you are a trader, or your medical devices lack domestic Chinese registration/manufacturing permits but you need an FSC for overseas customs clearance, you may apply for the third category: FSCs issued by overseas competent authorities.
In addition to EU authority-issued FSCs, overseas buyers often require consular authentication or Apostille certification. Supported by our extensive industry resources, Wiselink can arrange FSCs issued by the health ministries of Spain, the Netherlands, Germany and the United Kingdom.
Due to the unique regulatory landscape of the medical device sector, many countries lack independent domestic medical device oversight systems and rely on foreign registration documentation to manage imported goods — this created global demand for Free Sales Certificates.
Processing EU Free Sales Certificates (FSC)
EU FSC applications are initiated by manufacturers and handled by their EU Authorized Representative (EU REP).
Eligibility:Products must hold valid CE marking. Multiple product models can be listed on a single certificate.
Fees:Pricing differs from standard EU REP annual fees; a single FSC typically costs around RMB 15,000.
Apostille Note:Unless otherwise specified, all EU FSCs will undergo Apostille certification, which is recognized across all Hague Convention member countries.
Remark: Most American and Oceanian jurisdictions accept EU-issued FSCs as supporting documentation for local product registration.
Processing Chinese Domestic Free Sales Certificates
Chinese FSC issuance is free of charge. Previously administered by the national NMPA, authority was delegated to provincial drug administrations in 2015.
Processing Timeline:Certificates are normally available within 7 working days after online submission and can be instantly downloaded from the official portal upon approval.
Eligibility:Applicants must hold valid domestic medical device registration certificates or filing records; the full application process is completed online.
Remark: Most East Asian countries require FSCs issued by China (the country of origin) and do not accept EU FSCs. The core supporting document required is the domestic product registration certificate.
(Attached image: Sample of China’s Certificate for Exportation of Medical Products issued by a provincial medical products administration)
FSC Issued by China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE)
Required materials & procedures:
- Fully complete the official CCCMHPIE FSC form (no revisions permitted after submission)
- Copies of business licenses for both the manufacturer and overseas buyer
- Supporting documentation: manufacturing license, CE certificate or ISO 13485 certificate
Processing Lead Time：3–5 working days. Contact Wiselink for one-stop hassle-free FSC services.
(Attached image: Sample CCCMHPIE Certificate of Free Sale)
Document Authentication Reminder：Virtually all overseas buyers require FSCs to be authenticated via CCPIT certification, embassy legalization or Apostille. For detailed guidance on document authentication, refer to our dedicated article: [Global Registration] Full Guide to Apostille Certification.
