How should you label devices for Switzerland (CH-REP symbol vs text)?

## How Should You Label Devices for Switzerland? Swissmedic provides clear rules for CH-REP indication on device labels, packaging, and accompanying documents. Understanding these requirements is critical to avoid compliance issues and market access delays. ### CH-REP Symbol vs. Text Swissmedic offers **two options** for indicating the CH-REP: #### Option 1: CH-REP Symbol You can use the official CH-REP symbol (if available) on your labeling. #### Option 2: Text Indication You can write **"CH authorised representative"** or **"CH-REP"** in text instead of using the symbol. **Both options are acceptable**—choose based on your labeling design and space constraints. ### Required Information Adjacent to Symbol/Text Regardless of which option you choose, Swissmedic requires that **the name and address of the authorized representative must appear adjacent to the symbol or text**. ### Address Requirements The address must allow direct contact. According to Swissmedic: - ❌ **PO box alone is NOT sufficient** - You cannot use only a PO box - ❌ **Email/phone alone is NOT sufficient** - You cannot use only contact information without a physical address - ✅ **Physical address is required** - The CH-REP's complete physical address must be included The address should be complete enough for Swissmedic or other authorities to contact the CH-REP directly. ### Manufacturer Indication Swissmedic's obligations sheet states that **the manufacturer must always be indicated on the label**. The CH-REP indication is in addition to (not instead of) the manufacturer information. **Label Hierarchy:** 1. Manufacturer name and address (required) 2. CH-REP name and address (required for non-Swiss manufacturers) 3. Importer indication (if applicable, under Swiss rules) ### Where to Place CH-REP Information Swissmedic allows flexibility in where CH-REP information appears: - **Device label** - Directly on the device (if space permits) - **Packaging** - On the outer packaging - **IFU (Instructions for Use)** - In the accompanying documentation - **Accompanying documents** - Other documentation that accompanies the device ### Practical Best Practice To reduce regulatory risk and ensure compliance: **Put CH-REP details on:** 1. **Packaging** - At minimum, include on outer packaging 2. **IFU/accompanying document** - Include in Instructions for Use or other accompanying documents 3. **Device label** - If space permits and your device type allows **Why this approach?** - Ensures information is always accessible - Meets Swissmedic requirements regardless of which document is reviewed - Provides redundancy in case one label/document is missing - Aligns with best practices for international regulatory compliance ### Labeling Checklist Before printing labels for the Swiss market, verify: - ✅ Manufacturer name and address is present - ✅ CH-REP name and address is present (adjacent to symbol or "CH-REP" text) - ✅ CH-REP address is a complete physical address (not just PO box) - ✅ Information appears on packaging and/or IFU - ✅ Text is legible and in appropriate language(s) - ✅ Labeling complies with other Swiss requirements (language, UDI, etc.) ### Common Mistakes to Avoid - ❌ Using only a PO box for CH-REP address - ❌ Omitting manufacturer information - ❌ Placing CH-REP info only on device label (may not have space) - ❌ Using incomplete or incorrect CH-REP address - ❌ Forgetting to update labeling when switching CH-REPs ### Coordination with CH-REP Before finalizing your labeling: 1. **Confirm CH-REP details** - Get the exact name and complete address from your CH-REP 2. **Review with CH-REP** - Some CH-REPs have specific preferences for how their information is displayed 3. **Plan for updates** - If you switch CH-REPs, you'll need to update all labeling—plan your label print runs accordingly ### Next Steps 1. **[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 - Labeling Requirements](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)