ABOUT THE SERVICE
Acts as the regulatory link between non-Swiss manufacturers of medical devices or in vitro diagnostics and Swiss authorities. The CH-REP is established in Switzerland and represents the manufacturer under a written mandate, verifying regulatory obligations, supporting complaint handling, recalls, and reporting serious incidents to Swissmedic.
WHAT'S INCLUDED
Swissmedic registration | Registered CH-REP & Importer |
Coverage | Medical devices and IVDs (MedDO/IvDO) |
Languages | English and German |
FREQUENTLY ASKED QUESTIONS
Yes. Non-Swiss manufacturers of medical devices and IVDs must appoint a Swiss Authorised Representative (CH-REP) before placing devices on the Swiss market. The CH-REP is the manufacturer's regulatory contact for Swissmedic and must be named on the labelling. CHREP.me provides this service from CHF 99 per month with clear responsibilities and transparent pricing.
These answers were provided directly by CHREP.me GmbH. Last updated 6 hours ago
Information is owner-confirmed
Last updated 6 hours ago
Remote/WorldWide
Switzerland
Swissmedic registration
Registered CH-REP & Importer
Coverage
Medical devices and IVDs (MedDO/IvDO)
Languages
English and German
