Swissmedic Updates Guidance on Export Certificates for Medical Devices
Swissmedic has updated its guidance document “Export Certificates”, identification number BW690_00_002, version 4.1, valid from 3 August 2026.
The document explains the requirements and process for obtaining export certificates, also known as Free Sales Certificates, for medical devices exported from Switzerland to third countries.
Purpose of Export Certificates
Swissmedic issues export certificates for medical devices based on the Therapeutic Products Act, the Medical Devices Ordinance and the Ordinance on In Vitro Diagnostic Medical Devices.
The certificates confirm the formal conformity of the medical devices with Swiss legal requirements and their basic eligibility for being marketed at the time the certificate is issued.
Swissmedic can issue export certificates to manufacturers and authorised representatives located in Switzerland, provided the required documentation is submitted.
The guidance also clarifies that Swissmedic does not issue export certificates to companies located outside Switzerland.
Products Covered
Swissmedic issues export certificates for medical devices and in vitro diagnostic medical devices that are formally compliant with Swiss law and may, in principle, be placed on the Swiss market without restriction.
The guidance states that Swissmedic does not issue export certificates for components of medical devices, only for finished goods.
It also clarifies that export certificates are not issued for products outside the medical device definition, such as veterinary devices, commodities, foods and certain DEVIT products.
Ordering an Export Certificate
Requests must be submitted using the electronic order form available on the Swissmedic website.
Swissmedic highlights that the content entered in the form is automatically transferred to the export certificate without changes. Therefore, the requesting company is responsible for the accuracy of the information provided.
All required documentation and the product list must be submitted electronically via the Swissmedic Portal eGov “eMessage” service. Paper-based orders will be rejected.
Product Lists and Supporting Documents
The guidance sets detailed requirements for product lists, including information such as:
CHRN;
Basic UDI-DI;
UDI-DI;
certificate number, where available;
declaration of conformity number, where available;
reference or article number;
device name;
class;
recognised nomenclature code.
The visual examples on pages 8 and 9 show how product lists should be formatted, including company letterhead, margins, page numbering and specific product information fields.
Swissmedic also explains that supporting documents must be valid and complete. Otherwise, the order may be rejected.
Current Legislation, Old Legislation and Transitional Provisions
The guidance distinguishes between medical devices and IVDs under current legislation and those under old legislation.
For medical devices under old legislation, certificates expired on 26 May 2024 at the latest, and the applicable transitional provisions must be met for those devices to remain marketable.
For IVDs under old legislation, certificates expired on 26 May 2025 at the latest, and the guidance sets out specific evidence and deadlines linked to transitional provisions.
The document also provides detailed tables on the required declarations of conformity and certificates of conformity for medical devices and IVDs under both current and old legislation.
swissdamed Registration Requirement
A key update in version 4.1 concerns device registration.
The guidance states that, since 1 July 2026, both devices and systems/procedure packs in Switzerland must be registered in swissdamed.
During the initial phase, economic operators have until 31 December 2026 to register their devices. After that date, devices must be registered before being placed on the market.
For FSC orders processed on or after 1 January 2027, all medical devices included in the product list must be registered in swissdamed. If the devices are not registered, the application will not be considered.
Validity, Deadlines and Fees
Export certificates are issued in English only.
They are generally valid for three years, or five years if the country of importation is Thailand.
Swissmedic issues export certificates within 30 days of receiving a complete order and appropriate electronic documentation.
For incomplete applications, the requesting company has 30 days to submit a complete version. If the application remains incomplete or incorrect, Swissmedic will not accept it and will close the order.
The fee for issuing an export certificate is CHF 200 per certificate. A reduced fee of CHF 100 may apply if an order is cancelled, withdrawn or not accepted due to incomplete documentation.
Impact on Medical Device and IVD Manufacturers
For Swiss medical device and IVD manufacturers, and Swiss authorised representatives, the updated guidance reinforces the importance of accurate, complete and well-prepared FSC applications.
Manufacturers and authorised representatives should pay particular attention to:
Swiss location eligibility for requesting export certificates;
correct use of the electronic order form;
complete product lists;
CHRN, Basic UDI-DI and UDI-DI information;
valid CE conformity supporting documentation;
distinction between current and old legislation;
transitional provisions for legacy devices and IVDs;
swissdamed registration deadlines;
documentation for systems and procedure packs;
30-day processing and correction timelines;
applicable Swissmedic fees.
For companies exporting medical devices from Switzerland, the updated guidance highlights the need to align FSC preparation with Swiss conformity, device registration and documentation requirements.
