Siotec AG
Swiss Authorized Representative (CH-REP) for Medical Devices
Siotec AG acts as a Swiss Authorized Representative (CH-REP) for manufacturers of medical devices established outside Switzerland and Liechtenstein. We offer structured regulatory support covering the entire device lifecycle – from initial market access to post-market activities – ensuring compliance, transparency, and operational continuity with the Swiss Medical Devices Ordinance (MedDO).
Your partner in Switzerland
Regulatory clarity for market access and compliance
Swiss Authorized Representative
(CH-REP)
The designation of a Swiss Authorized Representative (CH-REP) is a mandatory requirement under the Medical Devices Ordinance (MedDO) for manufacturers outside Switzerland and Liechtenstein placing medical devices on the Swiss market.
Acting on the basis of a written mandate, the CH-REP assumes defined regulatory responsibilities, verifies compliance, and serves as the official interface to Swissmedic, ensuring structured and compliant market access in Switzerland.
Market Access
Following the discontinuation of the Mutual Recognition Agreement (MRA) between the European Union and Switzerland for medical devices, Switzerland applies an autonomous regulatory framework under the Medical Devices Ordinance (MedDO).
Market access is subject to national requirements, including the designation of a Swiss Authorized Representative (CH-REP), registration in Swissdamed, and direct interaction with Swissmedic. Compliance with the Swiss regulatory framework is mandatory throughout the entire product lifecycle.
About Siotec AG
Siotec AG acts as a Swiss Authorized Representative (CH-REP) for manufacturers of medical devices established outside Switzerland and Liechtenstein.
Our services include formal regulatory representation, verification of conformity requirements, and structured support across the entire lifecycle of medical devices placed on the Swiss market.