Why You Need a Swiss Authorised Representative
Legal background
Switzerland is no longer aligned with the EU regulatory framework for Medical and IVD devices. Given the complexity and importance of these regulations, appointing a qualified and experienced CH-REP is essential for accessing and maintaining presence in the Swiss market.
Without a Swiss Authorised Representative:
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- You cannot legally sell or distribute your products in Switzerland.
- You cannot register your devices in the Swiss Database of Medical Devices (Swissdamed).
- You will fail to meet requirements under the Swiss MedDO and IvDO.
- You may face delays, product recalls, or legal consequences.
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Our services
How to Appoint a CH‑REP & Enter the Swiss Market
As your designated Swiss Authorised Representative, Obelis ensures your seamless compliance with Swiss regulations. Swiss law has clearly defined the role and tasks of a Swiss Authorised Representative, where professionalism and qualifications need to be at the same level as those under the EU MDR and IVDR. When Obelis is appointed as your CH-REP, our team verifies and maintains your technical documentation for inspection, assists with actor and device registration on Swissdamed, liaises with Swissmedic (Switzerland’s national authority for medical devices and in-vitro diagnostics) on your behalf, manages and reports incidents and complaints, and provides ongoing regulatory updates to keep you informed. Obelis ensures that your entry into the Swiss market is fully compliant, risk-free, and supported by a professional, experienced regulatory partner.
