Certificates of Free Sale to Danish Manufacturers of Medical Devices

On 12 September 2022 the Danish Medicines Agency updated the medical devices guidance on certificates of free sale.

The Danish Medicines Agency issues Free Sales Certificates (FSC) to manufacturers and authorized representatives of medical devices, who are headquartered in Denmark and registered with the Danish Medicines Agency. Free Sale Certificates are issued for products which are exported outside of the European Economic Cooperation and to countries without a mutual recognition agreement with the EU.

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