Switzerland
Switzerland boasts a highly developed medical device sector, with a revenue of 17.9 billion CHF in 2019, equivalent to 2.6% of the national GDP. The sector continues to grow thanks to strong technological innovation and the presence of globally leading companies.
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Regulatory Framework
Swiss legislation is aligned with the European MDR and IVDR regulations, but the lack of an updated MRA agreement with the EU has classified Switzerland as a third country.
- Competent authority: Swissmedic.
- Compliance requirements: Switzerland recognizes CE marking but imposes additional requirements for device registration.
Economic operators must register with Swissmedic within 3 months of the first placing of a medical device on the market.
Specific Local Requirements
| Language | Documentation accepted in German, French, and Italian.
|
| Swiss Authorized Representative (CH-REP) | Mandatory for foreign manufacturers. |
| Registration of Economic Operators | Mandatory, with the assignment of a CHRN number. |
| Quality System | ISO 13485 is highly recommended. |
Challenges and Operational Advice
Switzerland considered a third country by the EU: This implies additional obligations for non-EU manufacturers.
Why Choose ISEMED
- International expertise and deep knowledge
We support companies in complying with Swiss regulations. - Tailored support
Dedicated assistance for registration and regulatory adaptation. - Local network in Switzerland
Collaborations with regulatory experts and CH-REP representatives to streamline the registration process.
FAQ
- Is a local representative required? Yes, a CH-REP.
- Which languages are accepted? German, French, Italian.
- Is device registration mandatory? Yes, starting from July 1, 2026.