CH-REP Swiss Authorized Representative for Medical Devices
Swissmedic compliance
Accessing the Swiss Market
According to the Swiss Medical Devices Ordinance (MedDO, SR 812.213), non-Swiss manufacturers placing medical devices or in vitro diagnostics on the Swiss market must appoint a Swiss Authorized Representative (CH-REP).
The CH-REP acts as the official legal representative of the foreign manufacturer in Switzerland, ensuring compliance with Swissmedic requirements, serving as the primary point of contact with authorities, and managing product registration in Swissdamed, the national database for medical devices.
ALTRION, based in Ticino, operates as your local CH-REP, ensuring regulatory alignment, correct labeling in the required Swiss languages (German, French, Italian), and continuous support throughout the entire product life cycle.
Our Services
CH-REP Appointment & Registration
- Formal CH-REP appointment
- Registration in Swissdamed for all device classes (Class I, IIa, IIb, III, and IVD)
Labeling & Language Compliance
- Verification of labeling and Instructions for Use (IFU)
- Compliance with MedDO and MedDO-IVD multilingual requirements
Documentation Review
- Review of Declaration of Conformity
- Verification of technical documentation consistency with MDR/IVDR evidence
Regulatory Communication
- Communication with Swissmedic on behalf of the manufacturer
- Notifications, vigilance reporting, and market surveillance follow-up
Post-Market Activities
- Management of Post-Market Surveillance (PMS)
- Coordination of Field Safety Corrective Actions (FSCA)
Documentation Management
- Archiving and maintenance of regulatory documentation in Switzerland
- Ensuring traceability and availability for Swissmedic inspections
Lifecycle Support
- Support for renewals, modifications, and Swissdamed updates
- Management of Basic UDI-DI and manufacturer data changes
Regulatory Intelligence (Optional)
- Updates on Swissmedic guidance
- Monitoring of EU–Swiss regulatory alignment
Our Approach
We act as a reliable local partner in Switzerland, ensuring that manufacturers meet all regulatory obligations while maintaining full control over their products and compliance strategy.
Why Choose Altrion
- Registered Swiss legal entity located in Ticino, ensuring official local presence and legal standing under MedDO
- Multilingual regulatory team fluent in Italian, English, German, and French, ensuring proper communication and document review in all Swiss official languages
- Extensive experience in EU–Swiss regulatory alignment, MDR-to-MedDO transition, and adaptation to Swissdamed data requirements
- Efficient and transparent communication with Swissmedic and with your EU-REP for streamlined submissions
- Secure document management system, compliant with ISO 13485 and GDPR requirements
- Part of a global representation network covering EU (EU-REP), UK (UKRP), and US FDA Agent services for complete international regulatory support
Deliverables
- CH-REP Designation Letter and Service Agreement compliant with Article 51 MedDO requirements
- Confirmation of Swissdamed registration, including manufacturer and device listing
- Contact details for labeling and documentation, as required by Annex IX MedDO
- Annual PMS and vigilance summary report, including Swissmedic communications log
- Ongoing regulatory support for product renewals and data updates in Swissdamed
Contact Us
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