The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on "Export Certificates" effective 19 March 2025. this guidance provides detailed instructions on obtaining Export Certificates for medical devices.
An Export Certificate (Free Sales Certificate - FSC) is an official document issued by Swissmedic to certify that a medical device meets all Swiss regulatory requirements and is legally marketed within Switzerland.
Applicable Legislation
Swissmedic issues export certificates under the authority of the Therapeutic Products Act (TPA), the Medical Devices Ordinance (MedDO), and the In Vitro Diagnostic Medical Devices Ordinance (IvDO). These regulations are aligned with European Union (EU) directives to maintain high safety and quality standards for medical devices.
Eligibility for Export Certificates
Export certificates are available for medical devices that comply with Swiss laws and are marketed in Switzerland. They are particularly useful for devices being exported to countries requiring official certification for product registration. However, Swissmedic does not issue export certificates for veterinary devices, food products, cosmetics, or medical device components.
Application Process
Manufacturers or their authorised representatives in Switzerland must submit an application for an export certificate through the Swissmedic eGov Portal (eMessage). The application process involves completing a detailed form that includes information about the certificate type, company details, billing address, and product specifications. Supporting documents, such as CE conformity certificates and declarations of conformity, must be included. Additionally, applicants should specify the intended importing countries. After submission, the applicable fees will be invoiced.
Types of Certificates
Swissmedic provides different types of export certificates depending on the device and its regulatory status. A Free Sales Certificate (FSC) certifies that a device is legally marketed in Switzerland. A Certificate for Old Legislation Devices is issued for devices compliant with previous EU directives, valid until their transition to the current Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). For systems and procedure packs containing multiple components, a specific Certificate for Systems and Procedure Packs is available.
Processing Time and Validity
Swissmedic typically processes export certificate applications within 30 days of receiving a complete application. Once issued, the certificates are generally valid for three years, except for those intended for export to Thailand, where they are valid for five years.
Fees
Applicants are required to pay a fee of CHF 200 for each export certificate. Additional fees may apply for incomplete or withdrawn applications, so it is recommended that applicants ensure all required documents are submitted accurately.
Manufacturers aiming to expand into foreign markets should ensure their products meet all applicable regulatory standards and provide complete and accurate documentation to avoid any processing delays. By following the outlined procedures, companies can efficiently obtain the necessary certification for their medical devices.
🔗 For full details, visit: Swissmedic Export Certificates Guidance
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