CH REP
Swiss Authorized Representative
for medical devices
Swissmedic compliance
CH REP
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 serves as the official legal representative of the foreign manufacturer in Switzerland, ensuring full compliance with Swissmedic regulations, acting 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, guaranteeing regulatory alignment, proper labeling in the required Swiss languages (German, French, Italian), and continuous support throughout the product life cycle.
Our Services
- Formal CH-REP appointment and registration in Swissdamed for all device classes (Class I, IIa, IIb, III, and IVD)
- Verification of labeling, Instructions for Use, and multilingual compliance with MedDO and MedDO-IVD language requirements
- Review of Declaration of Conformity and supporting technical documentation to ensure consistency with MDR/IVDR evidence
- Communication with Swissmedic on behalf of the manufacturer, including notifications, vigilance reporting, and market surveillance follow-up
- Management of Post-Market Surveillance (PMS) and Field Safety Corrective Actions (FSCA) coordination
- Archiving and maintenance of all regulatory documentation in Switzerland, ensuring traceability and immediate availability for Swissmedic review
- Support for renewals, modifications, and Swissdamed updates, including Basic UDI-DI and manufacturer data changes
- Optional regulatory intelligence service providing updates on Swissmedic guidance and EU–Swiss bilateral alignment
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
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