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Swissdamed Device Registration

Swissdamed is the database for registering economic operators, medical devices, and in-vitro diagnostic devices placed on the Swiss market. Starting 1 July 2026, all devices, systems, and procedure packs placed on the Swiss market must be registered in Swissdamed, including legacy devices. Manufacturers or their authorised representatives, if located outside Switzerland, must complete registration prior to placing the product on the market, or by 31 December 2026 for products that were already on the market before 1 July 2026. Immediate device registration is required from 1 July 2026 when reporting a serious incident, field safety corrective action, or trend.

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CH REP Mandate and Swissmedic Device Registration for Medical Devices

Legal background

Under the Swiss Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Medical Devices Ordinance (IVDO), manufacturers not domiciled in Switzerland are required to appoint a Swiss Authorised Representative (CH-REP) by written mandate before placing devices on the Swiss market. And as of 1 July 2026, manufacturers placing medical devices on the Swiss market must ensure they comply with Swiss device registration requirements.

Without CH-REP mandate:

- 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 and Device registrations, and ensure proper notification of custom-made devices to Swissmedic. We review your documentation for full compliance with MedDO and IvDO 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.

Begin Your Swissdamed Registration