CH REP Mandate and Swissmedic Device Registration for Medical Devices
Legal background
Swissdamed is being introduced in phases. While the “Devices” module is not yet active as of August 2025 , authorized representatives registered in the “Actor” module with a CHRN (Swiss registration number) can already register their mandates with non-Swiss manufacturers on the platform.
Under MedDO and IVDO, manufacturers not domiciled in Switzerland must have a written mandate with a Swiss authorized representative before placing devices on the Swiss market.
Without this mandate:
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- Your product cannot be legally marketed in Switzerland
- Swissmedic may impose enforcement actions or market restrictions
- You will be non-compliant with Swiss legal obligations
- Distributors and end-users may lose confidence in your brand
Our services
How Obelis Handles Your Swissmedic Registration
Obelis acts as your professional regulatory partner, already registered as an Actor on Swissdamed. We handle your CH-REP Mandate notification, keep you informed about the upcoming Swissdamed deadlines for device registration, and ensure proper filing of your custom-made devices to Swissmedic. We review your documentation for full compliance with Swiss laws and provide assistance with incident reporting. We provide a smooth Swiss market experience by avoiding administrative errors and offering regular updates, leveraging tools like the MDlaw Library – Switzerland to keep your compliance accurate and up to date.
