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January 10, 2026
Approximately 5 minutes
Swiss Export Certificates and Free Sale Certificates for Medical Devices
Swiss Export Certificates and Free Sale Certificates for Medical Devices
Purpose and Types of Certificates
Swissmedic provides two main types of certificates for medical devices intended for export:
- Free Sale Certificate (FSC) – Confirms that the device is authorised for placing on the Swiss market (or would be if placed), including conformity assessment details and any restrictions.
- Export Certificate – Attests to the regulatory status in Switzerland, often required by importing countries when no equivalent FSC exists or for specific export purposes.
These certificates support manufacturers and authorised representatives in meeting foreign regulatory requirements for market access. They do not replace destination country approvals. Exportzertifikate FSC - Swissmedic
Eligibility and Application Requirements
Certificates are issued to:
- Manufacturers with registered place of business in Switzerland.
- Swiss Authorised Representatives (CH-REP) for foreign manufacturers.
- Importers under certain conditions.
Key prerequisites include:
- Device must comply with Swiss MedDO requirements (or be in conformity assessment process).
- Valid declaration of conformity and, where applicable, notified body certificate.
- UDI assignment and registration in the Swiss database (where required).
- No ongoing serious safety concerns or restrictions affecting export.
Applications must specify certificate type, destination country, device details (including UDI-DI), and intended use.
Application Process
- Submit via the Swissmedic e-Business portal using the dedicated online form.
- Upload supporting documents: declaration of conformity, certificates, technical documentation summary, labelling/IFU samples.
- Pay applicable fees (per certificate type and urgency).
- Swissmedic reviews completeness and compliance, typically issuing within 10–20 working days (expedited options available).
- Certificates are issued electronically with digital signature and QR code for verification.
Multiple devices can be covered in one certificate if they share the same regulatory status.
Validity and Use
- Certificates are valid for 12 months from issuance.
- Must be renewed for continued export.
- Original or certified copy presented to foreign authorities.
- Any changes in device status (e.g., recall, suspension) require immediate notification to Swissmedic and may invalidate the certificate.
Practical Considerations
Swissmedic provides guidance on certificate formats accepted by major markets, fee schedules, processing times, and FAQs. Applicants should verify importing country requirements in advance, as some accept only specific wording or additional attestations. For legacy devices under transitional provisions, certificates reflect current MedDO status.
This certification service supports Swiss medical device industry's global competitiveness by providing official confirmation of regulatory compliance, facilitating smoother customs clearance and market entry abroad. Detailed application instructions, forms, fees, and contact information are available on the Swissmedic export certificates page. Exportzertifikate FSC - Swissmedic
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