Swiss CH-REP & Importer Services for Medical Devices and IVDs
CHREP.me specialises in Swiss market access for medical devices and IVDs. Our team combines experience in medical device regulation, quality assurance and regulatory representation for non-Swiss companies. We are registered with Swissmedic for our activities as a Swiss Authorised Representative (CH-REP) and Swiss Importer (CH-Importer).
Dedicated to your Swiss market success
Pursuing goal-oriented approach for all of our mandates
Personal support for small and medium-sized companies
Always focused on full Swiss regulatory compliance
Experienced in CH-REP & Swiss Importer services since 2021
Simple, transparent and cost-efficient processes
As your Swiss regulatory partner, we provide CH-REP and Swiss Importer services for non-Swiss medical device manufacturers and distributors. We focus on simple processes, clear responsibilities and practical regulatory support, allowing our customers to access the Swiss market efficiently and remain compliant with applicable Swiss requirements.
Since 2021, we have supported non-Swiss medical device companies with CH-REP and Swiss Importer services for Switzerland. Our approach is practical and straightforward: clear requirements, transparent pricing and efficient communication throughout the entire process.
Swiss Medical Device Market Access
Switzerland has specific regulatory requirements for medical devices and in vitro diagnostic medical devices (IVDs). Non-Swiss manufacturers generally require a Swiss Authorised Representative (CH-REP) to place their devices on the Swiss market, while non-Swiss distributors and dealers may require a Swiss Importer (CH-Importer) depending on their supply chain and market access model.
The CH-REP represents the foreign manufacturer for defined regulatory obligations in Switzerland and acts as an important contact point for Swissmedic. The Swiss Importer is a separate economic operator responsible for specific verification, traceability and post-market obligations for devices it places on the Swiss market.
Since 1 July 2026, device registration in swissdamed is mandatory, subject to the applicable transition period. Authorised representatives of foreign manufacturers can register mandated devices in swissdamed, while Swiss Importers (CH-Importer) link their importer actor to devices that have already been registered.
Why Choose CHREP.me?
CHREP.me provides CH-REP and Swiss Importer services with a focus on simple processes, transparent pricing and cost-efficient Swiss market access. Since 2021, we have supported non-Swiss medical device manufacturers and distributors with practical regulatory solutions for Switzerland.
Stay Informed
The CHREP.me Blog provides updates and practical information on Swiss medical device regulations, CH-REP requirements, Swiss Importer (CH-Importer) obligations, swissdamed and Swiss market access.