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 or FSC is an international document used to export medical devices and IVD products. It indicates that your products are marketed in Europe and can be freely sold without export limitations.

The FSC is required for exporting medical devices and IVD products to certain countries. This document serves as proof that your products comply with European 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 recognized country.

Spain is one of the so-called “reference countries,” and all our certificates have always been accepted, providing our clients access to new markets.

We can also issue FSCs from the United Kingdom, Switzerland, Australia, and the USA.

Expert FSC services for medical device manufacturers

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Find Us Around the World

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.

FGenerally, the FSC has a limited validity, which can be from 6 months to 1 year, after which you will need to renew it if you continue to export the product.

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.

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