Free Sale Certificate (FSC)

Obtain Free Sale Certificate to facilitate global market access

We offer Free Sale Certificate (FSC) services to support the export of your products and comply with international regulatory requirements.

What is the Free Sale Certificate – FSC?

The Free Sale Certificate (FSC) is an international document used to export medical devices and IVD products. It indicates that your products are legally marketed and can be freely sold without export limitations.

The FSC is required for exporting medical devices and IVD products to certain countries. It serves as proof that your products comply with regulations and are eligible for export. The certificate is used for registering or renewing registration in non-European countries.

Not all Free Sale Certificates (FSCs) have the same acceptance rate with competent authorities in some importing countries. It’s crucial that your FSC is issued by a country accepted by the relevant authorities.

EU FSC

CMC can issue EU FSCs either as your EU Authorized Representative (EU REP) or without being your EU REP, offering flexibility depending on your case and need. Spain is considered a reference country, and our FSCs are widely accepted, providing clients reliable access to new markets.

UK FSC

The United Kingdom is also a reference country. CMC can issue UK FSCs certifying that your products are legally marketed in the UK and accepted for export to countries that require proof of sale in the UK.

CH FSC

Switzerland is widely accepted as a reference country. CMC can issue Swiss FSCs confirming that your products are legally marketed in Switzerland and accepted for export to countries requesting a Swiss FSC.

AU FSC

For countries with special requirements, FSCs issued from Australia are sometimes requested. CMC can assist in obtaining Australian FSCs, confirming that your products are legally marketed there and accepted for export.

USA FSC

CMC can issue FSCs from the USA, certifying that your products are legally marketed in the United States and accepted for export to countries requiring a US FSC.

Expert FSC services for medical device manufacturers

Complete the contact form and one of our consultants will get in touch as soon as possible.

    Frequently asked questions about Free Sale Certificate (FSC)

    Generally, products that require stringent regulation such as food, cosmetics, pharmaceuticals, medical devices and food supplements.

    Because many countries require proof that the product is already approved for sale in the country of origin, ensuring that it complies with safety norms and standards.

    The issuance time may vary depending on the country and the regulatory body, but it can take from a few days to several weeks.

    The cost varies by country and issuing authority, but can also depend on the type of product or the number of products you need to certify.

    The FSC doesn’t have a specific expiration date. Its validity depends on the regulations of each country. For instance, in some countries, it must be renewed from time to time.

    Not necessarily. FSC is an important step, but each country may have its own additional requirements, such as laboratory analysis or sanitary registrations.

    Why choose CMC Medical Devices as your expert for FSC services for medical device manufacturers?

    Fast response

    We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

    Efficient communication

    Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

    Immediate support

    We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

    Quick resolution

    Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.