Swissmedic Export Certificates: A Practical Guide for Medical Device Manufacturers

Sharan Murugan
3 days ago
3 min read

The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify safety, quality, and legal conformity. Swissmedic, Switzerland’s regulatory authority for therapeutic products, plays a central role by issuing export certificates—commonly known as Free Sales Certificates (FSCs)—which facilitate the export and global acceptance of Swiss medical devices.

What are Swissmedic export certificates?

Export certificates (FSCs) formally certify that:

The listed medical devices comply with Swiss legislation.
They are legally marketable in Switzerland at the time the certificate is issued.

These certificates are especially required by countries that do not accept CE marking alone, such as China, India, Brazil, Japan, Egypt, Peru, and Saudi Arabia.

Swissmedic issues these certificates:

Only to manufacturers or authorized representatives based in Switzerland.
Only for finished medical devices (not components).
Not for veterinary devices, foods, or cosmetics.

Products concerned

Products must meet the Swiss definition of medical devices:

Instruments, apparatus, implants, software, in vitro diagnostics (IVDs), or other products with a medical use, where the primary effect is not pharmacological.
Products with a non-medical intended use under Annex I MedDO can also be included.

Swissmedic does not issue export certificates for:

Devices used exclusively in veterinary medicine.
Foods and commodities (handled by the Federal Food Safety and Veterinary Office).

Types of certificates & content

Swissmedic issues:

Free Sales Certificate (FSC): For a group of devices under one legal manufacturer, covered by the same certificate of conformity.

Each certificate lists:

Device name, class, reference/article number.
Basic UDI-DI and UDI-DI (for products under current legislation).
Certificates of conformity details.
Manufacturer’s CHRN (Swiss Single Registration Number).

All product details must be supplied in English.

How to apply

Applications are submitted electronically only:

Complete the official form (available in English, German, French, or Italian).
Submit via Swissmedic’s eGov “eMessage” portal: www.swissmedic.ch/emessage-en.
Paper applications are not accepted.

Key rules:

Separate forms must be used for products under current legislation (MedDO, IvDO) and old legislation (Directives 93/42/EEC, 90/385/EEC, 98/79/EC).
Mixed orders are not allowed.
No duplicates or copies of FSCs are issued.

Supporting documents required

Depending on the product and legislation, documents include:

CE certificates of conformity.
Declarations of conformity.
For legacy products under old legislation: confirmation letters from notified bodies that a conformity assessment has been requested.

For systems and procedure packs:

List of included products.
Declarations by the assembler.
Certificates covering each included device.

Countries of importation & validity

One FSC is usually issued per country.
For Algeria, Saudi Arabia, Libya, or Turkey: one FSC is issued per distributor.
Certificates are valid for:
- 3 years generally.
- 5 years for Thailand.

If the destination country isn’t known at the time of application, it can be marked as “unspecified.”

Processing times & deadlines

Swissmedic usually processes complete applications within 30 days.
If an application is incomplete, applicants have 30 days to correct it.
Failure to complete results in rejection and a flat fee of CHF 100.

Fees

Standard fee: CHF 200 per FSC.
Fees may be reduced if Swissmedic cannot process the application (as per Swissmedic Fee Ordinance).

Expert tips & obligations

Keep product lists clear, structured, and on official letterhead.
Use consistent CHRN, UDI-DI, and Basic UDI-DI numbers.
Notify Swissmedic of any changes in company name or address before applying.
Manufacturers must also maintain an EU authorized representative/importer to place products on the EU market.

By following the guidelines carefully—using the correct forms, providing valid supporting documents, and submitting electronically—companies can ensure a smooth certification process, helping patients worldwide access Swiss-made medical innovations.

For complete official guidance, visit:📄 Swissmedic Export Certificates (FSC) page