What is a Swiss Authorized Representative (CH-REP), and when do you need one?

## What is a Swiss Authorized Representative (CH-REP)? A **Swiss Authorized Representative (CH-REP)** is a Switzerland-established legal entity that acts as the regulatory interface for manufacturers not established in Switzerland. According to Swissmedic, the CH-REP represents the manufacturer for "formal and safety-related issues" connected with placing medical devices and IVDs on the Swiss market. ### When Do You Need a CH-REP? You typically need a CH-REP if: 1. **Your legal manufacturer address is outside Switzerland** - This includes manufacturers based in the EU/EEA, United States, Asia, or any other country outside Switzerland. Swissmedic treats all non-Swiss manufacturers as "foreign" for regulatory purposes. 2. **You want to place medical devices or IVDs on the Swiss/Liechtenstein market** - The CH-REP requirement applies to: - Medical devices regulated under the Medical Devices Ordinance (MedDO) - In vitro diagnostic medical devices (IVDs) regulated under the IVD Ordinance (IvDO) - Both Switzerland and Liechtenstein (due to customs union rules) ### Practical Takeaway If you ship medical devices into Switzerland under your non-Swiss manufacturer name, you should assume you need a CH-REP. The requirement is independent of whether you have CE marking or other certifications—Switzerland has its own market access requirements that must be met. **Important Note**: Even if you have an EU Authorized Representative (EU-REP), you still need a separate CH-REP for the Swiss market. The roles are distinct and cannot be combined. ### Next Steps 1. Verify your manufacturer location and distribution model 2. Confirm your device classification (medical device vs. IVD) 3. Engage a qualified CH-REP provider before placing devices on the market 4. **[Compare Swiss CH-REP providers & request quotes](https://cruxi.ai/regulatory-directories/ch_rep)** - Use our directory to find and compare qualified CH-REP providers --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Swissmedic - Economic Operators](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)