Medical Devices → Switzerland

Compliance Services for Medical Devices and IVDs in Switzerland

The Swiss market maintains a robust and innovation-driven medical devices sector, closely aligned with European standards but governed by its own national legislation. Since the end of the Mutual Recognition Agreement in 2021, Switzerland now requires third country manufacturers, non-Swiss manufacturers, to fulfill Swiss-specific obligations to maintain market access within its high-quality healthcare system., including appointment of a Swiss Authorised Representative (CH-REP) and device registration with Swissmedic.

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Authorised Representative (CH-REP)

Technical Documentation Review

Swissdamed Device Registration

Regulatory Consultation for Swiss Medical Devices

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Other Regions

Our international standing means we offer compliance services around the globe. This makes us an ideal choice for manufacturers who market their products in several global markets.

United Kingdom

The United Kingdom’s medical device market remains a key opportunity post-Brexit, but requires navigating its own regulatory framework, including UK-specific compliance for market access.

European Union

The European Union medical device market, serving over 500 million patients, offers vast opportunities but requires strict compliance with Regulation (EU) 2017/745 (MDR).

United States

The United States is the world’s largest and most lucrative medical device market, offering vast opportunities but demanding rigorous FDA compliance for market entry.

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