What does a CH-REP actually do (and what they don't do)?

## What Does a CH-REP Actually Do? Think of the CH-REP as your **Swiss compliance interface**, not your commercial distributor. Understanding the distinction between their regulatory responsibilities and what they don't do is critical for setting proper expectations. ### Common CH-REP Responsibilities According to Swissmedic, the CH-REP has several key responsibilities: #### 1. **Documentation Management** - **Holding or ensuring access to key compliance artifacts** - The CH-REP must either: - Physically hold the technical documentation, OR - Contractually ensure the manufacturer can provide it to Swissmedic within 7 days upon request - Ensuring technical documentation can be provided to Swissmedic quickly when requested #### 2. **Mandate Governance** - Ensuring the relationship is governed by a **written mandate** with the manufacturer - The mandate must clearly define scope, responsibilities, and operational procedures #### 3. **Vigilance and Safety Reporting** - Supporting and ensuring required reporting flows to Swissmedic for: - **Serious incidents** occurring in Switzerland - **Field Safety Corrective Actions (FSCAs)** in Switzerland - **Trend reporting** as required - The CH-REP is responsible for ensuring reports are sent to Swissmedic (not just facilitating) #### 4. **Regulatory Cooperation** - Cooperating with Swissmedic on preventive and corrective actions when needed - Responding to Swissmedic inquiries and requests for information - Maintaining communication channels with the regulatory authority #### 5. **Registration and Compliance** - Registering for CHRN (Swiss Single Registration Number) if required - Maintaining compliance with Swissmedic's economic operator obligations ### What a CH-REP Usually Is NOT #### ❌ Not Automatically Your Importer of Record The CH-REP and importer are **separate legal roles** with distinct obligations. A company can serve as both, but they must: - Register separately for each role (may receive two CHRNs) - Meet both sets of obligations - Clearly distinguish the roles in their operations #### ❌ Not Your Commercial Seller Unless you specifically contract them to do so, the CH-REP is not your distributor or sales agent. Their role is regulatory, not commercial. #### ❌ Not Your Quality System Auditor The CH-REP doesn't audit your quality system or manufacturing processes. They rely on your existing certifications and documentation. #### ❌ Not Your Legal Representative for Commercial Disputes The CH-REP represents you for regulatory matters with Swissmedic, not for commercial or legal disputes with customers or partners. ### Practical Implications When selecting a CH-REP, ask: - Do they hold technical files or rely on 7-day manufacturer submission? - What is their vigilance reporting process and response time? - How do they handle Swissmedic inquiries and requests? - What documentation and support do they provide? ### 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 - CH-REP Obligations](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)